EDITING FOR BIOMEDICAL PUBLICATION


  UNIFORM REQUIREMENTS FOR MANUSCRIPTS SUBMITTED TO BIOMEDICAL JOURNALS: WRITING AND EDITING FOR BIOMEDICAL PUBLICATION (UPDATED IN NOVEMBER 2003)

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I.      STATEMENT OF PURPOSE

I. A. About the Uniform Requirements

A small group of editors of general medical journals met informally in Vancouver, British Columbia, in 1978 to establish guidelines for the format of manuscripts submitted to their journals. The group became known as the Vancouver Group. Its requirements for manuscripts, including formats for bibliographic references developed by the National Library of Medicine, were first published in 1979. The Vancouver Group expanded and evolved into the International Committee of Medical Journal Editors (ICMJE), which meets annually. The ICMJE gradually has broadened its concerns to include ethical principles related to publication in biomedical journals.

        The ICJME has produced multiple editions of the Uniform Requirements for Manuscripts Submitted to Biomedical Journals. Over the years, issues have arisen that go beyond manuscript preparation, resulting in the development of a number of Separate Statements on editorial policy. The entire Uniform Requirements document was revised in 1997; sections were updated in May 1999 and May 2000. In May 2001, the ICMJE revised the sections related to potential conflict of interest. For the present revision (2003), the committee revised and reorganized the entire document and incorporated the Separate Statements into the text.

        The total content of the Uniform Requirements for Manuscripts Submitted to Biomedical Journals may be reproduced for educational, not-for-profit purposes without regard for copyright; the committee encourages distribution of the material.

        Journals that agree to use the Uniform Requirements are encouraged to state in their instructions to authors that their requirements are in accordance with the Uniform Requirements and to cite this version.

I.B. Potential Users of the Uniform Requirements

The ICMJE created the Uniform Requirements primarily to help authors and editors in their mutual task of creating and distributing accurate, clear, easily accessible reports of biomedical studies. The initial sections address the ethical principles related to the process of evaluating, improving, and publishing manuscripts in biomedical journals and the relationships between editors and authors, peer reviewers, and the media. The latter sections address the more technical aspects of preparing and submitting manuscripts. The ICMJE believes the entire document is relevant to the concerns of both authors and editors.

        The Uniform Requirements can provide many other stakeholders - peer reviewers, publishers, the media, patients and their families, and general readers - with useful insights into the biomedical authoring and editing process.

I. C. How to Use the Uniform Requirements

The Uniform Requirements state the ethical principles in the conduct and reporting of research and provide recommendations relating to specific elements of editing and writing. These recommendations are based largely on the shared experience of a moderate number of editors and authors, collected over many years, rather than on the results of methodical, planned investigation that aspires to be "evidence-based." Wherever possible, recommendations are accompanied by a rationale that justifies them; as such, the document serves an educational purpose.

Authors will find it helpful to follow the recommendations in this document whenever possible because, as described in the explanations, doing so improves the quality and clarity of reporting in manuscripts submitted to any journal, as well as the ease of editing. At the same time, every journal has editorial requirements uniquely suited to its purposes. Authors therefore need to become familiar with the specific instructions to authors published by the journal they have chosen for their manuscript - for example, the topics suitable for that journal, and the types of papers that may be submitted (for example, original articles, reviews, or case reports) - and should follow those instructions. The Mulford Library at the Medical College of Ohio maintains a useful compendium of instructions to authors at www.mco.edu/lib/instr/libinsta.html.

II. ETHICAL CONSIDERATIONS IN THE CONDUCT AND REPORTING OF RESEARCH

II.A Authorship and Contributorship

II.A.1. Byline Authors

An "author" is generally considered to be someone who has made substantive intellectual contributions to a published study, and biomedical authorship continues to have important academic, social, and financial implications. (1) In the past, readers were rarely provided with information about contributions to studies from those listed as authors and in acknowledgments. (2) Some journals now request and publish information about the contributions of each person named as having participated in a submitted study, at least for original research. Editors are strongly encouraged to develop and implement a contributorship policy, as well as a policy on identifying who is responsible for the integrity of the work as a whole.

        While contributorship and guarantorship policies obviously remove much of the ambiguity surrounding contributions, it leaves unresolved the question of the quantity and quality of contribution that qualify for authorship. The International Committee of Medical Journal Editors has recommended the following criteria for authorship; these criteria are still appropriate for those journals that distinguish authors from other contributors.

·         Authorship credit should be based on 1) substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content; and 3) final approval of the version to be published. Authors should meet conditions 1, 2, and 3.

·         When a large, multi-center group has conducted the work, the group should identify the individuals who accept direct responsibility for the manuscript (3). These individuals should fully meet the criteria for authorship defined above and editors will ask these individuals to complete journal-specific author and conflict of interest disclosure forms. When submitting a group author manuscript, the corresponding author should clearly indicate the preferred citation and should clearly identify all individual authors as well as the group name. Journals will generally list other members of the group in the acknowledgements. The National Library of Medicine indexes the group name and the names of individuals the group has identified as being directly responsible for the manuscript.

·         Acquisition of funding, collection of data, or general supervision of the research group, alone, does not justify authorship.

·         All persons designated as authors should qualify for authorship, and all those who qualify should be listed.

·         Each author should have participated sufficiently in the work to take public responsibility for appropriate portions of the content.

        Some journals now also request that one or more authors, referred to as "guarantors," be identified as the persons who take responsibility for the integrity of the work as a whole, from inception to published article, and publish that information.

        Increasingly, authorship of multi-center trials is attributed to a group. All members of the group who are named as authors should fully meet the above criteria for authorship.

        The order of authorship on the byline should be a joint decision of the co-authors. Authors should be prepared to explain the order in which authors are listed.

II.A.2. Contributors Listed in Acknowledgments

All contributors who do not meet the criteria for authorship should be listed in an acknowledgments section. Examples of those who might be acknowledged include a person who provided purely technical help, writing assistance, or a department chair who provided only general support. Financial and material support should also be acknowledged.

        Groups of persons who have contributed materially to the paper but whose contributions do not justify authorship may be listed under a heading such as "clinical investigators" or "participating investigators," and their function or contribution should be described - for example, "served as scientific advisors," "critically reviewed the study proposal," "collected data," or "provided and cared for study patients."

        Because readers may infer their endorsement of the data and conclusions, all persons must give written permission to be acknowledged.

II.B. Editorship

II.B.1. The Role of the Editor

The editor of a journal is the person responsible for its entire content. Owners and editors of medical journals have a common endeavor - the publication of a reliable and readable journal, produced with due respect for the stated aims of the journal and for costs. The functions of owners and editors, however, are different. Owners have the right to appoint and dismiss editors and to make important business decisions in which editors should be involved to the fullest extent possible. Editors must have full authority for determining the editorial content of the journal. This concept of editorial freedom should be resolutely defended by editors even to the extent of their placing their positions at stake. To secure this freedom in practice, the editor should have direct access to the highest level of ownership, not only to a delegated manager.

        Editors of medical journals should have a contract that clearly states the editor's rights and duties in addition to the general terms of the appointment and that defines mechanisms for resolving conflict.

        An independent editorial advisory board may be useful in helping the editor establish and maintain editorial policy.

II.B.2. Editorial Freedom

The ICMJE adopts the World Association of Medical Editors' definition of editorial freedom (http://www.wame.org/wamestmt. htm). This definition states that editorial freedom or independence is the concept that editors-in chief should have full authority over the editorial content of their journal. Journal owners should not interfere in the evaluation; selection or editing of individual articles either directly or by creating an environment that strongly influences decisions. Editors should base decisions on the validity of the work and its importance to the journal's readers not on the commercial success of the journal. Editors should be free to express critical but responsible views about all aspects of medicine without fear of retribution, even if these views might conflict with the commercial goals of the publisher. Editors and editors' organizations have the obligation to support the concept of editorial freedom and to draw major transgressions of such freedom to the attention of the international medical, academic, and lay communities.

II.C. Peer Review

Unbiased, independent, critical assessment is an intrinsic part of all scholarly work, including the scientific process. Peer review is the critical assessment of manuscripts submitted to journals by experts who are not part of the editorial staff. Peer review can therefore be viewed as an important extension of the scientific process. Although its actual value has been little studied, and is widely debated (4), peer review helps editors decide which manuscripts are suitable for their journals, and helps authors and editors in their efforts to improve the quality of reporting. A peer-reviewed journal is one that submits most of its published research articles for outside review. The number and kind of manuscripts sent for review, the number of reviewers, the reviewing procedures, and the use made of the reviewers' opinions may vary. In the interests of transparency, each journal should publicly disclose its policies in its instructions to authors.

II.D. Conflicts of Interest

Public trust in the peer review process and the credibility of published articles depend in part on how well conflict of interest is handled during writing, peer review, and editorial decision making. Conflict of interest exists when an author (or the author's institution), reviewer, or editor has financial or personal relationships that inappropriately influence (bias) his or her actions (such relationships are also known as dual commitments, competing interests, or competing loyalties). These relationships vary from those with negligible potential to those with great potential to influence judgment, and not all relationships represent true conflict of interest. The potential for conflict of interest can exist whether or not an individual believes that the relationship affects his or her scientific judgment. Financial relationships (such as employment, consultancies, stock ownership, honoraria, paid expert testimony) are the most easily identifiable conflicts of interest and the most likely to undermine the credibility of the journal, the authors, and of science itself. However, conflicts can occur for other reasons, such as personal relationships, academic competition, and intellectual passion.

        All participants in the peer review and publication process must disclose all relationships that could be viewed as presenting a potential conflict of interest. Disclosure of these relationships is also important in connection with editorials and review articles, because it is can be more difficult to detect bias in these types of publications than in reports of original research. Editors may use information disclosed in conflict of interest and financial interest statements as a basis for editorial decisions. Editors should publish this information if they believe it is important in judging the manuscript.

II.D.1. Potential Conflicts of Interest Related to Individual Authors' Commitments

When authors submit a manuscript, whether an article or a letter, they are responsible for disclosing all financial and personal relationships that might bias their work. To prevent ambiguity, authors must state explicitly whether potential conflicts do or do not exist. Authors should do so in the manuscript on a conflict of interest notification page that follows the title page, providing additional detail, if necessary, in a cover letter that accompanies the manuscript (See Section IV.A.3. Conflict of Interest Notification Page).

        Investigators must disclose potential conflicts to study participants and should state in the manuscript whether they have done so.

Editors also need to decide when to publish information disclosed by authors about potential conflicts. If doubt exists, it is best to err on the side of publication.

II.D.2. Potential Conflicts of Interest Related to Project Support

Increasingly, individual studies receive funding from commercial firms, private foundations, and government. The conditions of this funding have the potential to bias and otherwise discredit the research.

        Scientists have an ethical obligation to submit creditable research results for publication. Moreover, as the persons directly responsible for their work, researchers should not enter into agreements that interfere with their access to the data and their ability to analyze it independently, to prepare manuscripts, and to publish them. Authors should describe the role of the study sponsor(s), if any, in study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the report for publication. If the supporting source had no such involvement, the authors should so state. Biases potentially introduced when sponsors are directly involved in research are analogous to methodological biases of other sorts. Some journals, therefore, choose to include information about the sponsor's involvement in the methods section.

        Editors may request that authors of a study funded by an agency with a proprietary or financial interest in the outcome sign a statement such as, "I had full access to all of the data in this study and I take complete responsibility for the integrity of the data and the accuracy of the data analysis." Editors should be encouraged to review copies of the protocol and/or contracts associated with project-specific studies before accepting such studies for publication. Editors may choose not to consider an article if a sponsor has asserted control over the authors' right to publish.

II.D.3.    Potential Conflicts of Interest Related to Commitments of Editors, Journal Staff, or Reviewers

Editors should avoid selecting external peer reviewers with obvious potential conflicts of interest, for example, those who work in the same department or institution as any of the authors. Authors often provide editors with the names of persons they feel should not be asked to review a manuscript because of potential conflicts of interest, usually professional. When possible, authors should be asked to explain or justify their concerns; that information is important to editors in deciding whether to honor such requests.

        Reviewers must disclose to editors any conflicts of interest that could bias their opinions of the manuscript, and they should disqualify themselves from reviewing specific manuscripts if they believe it to be appropriate. As in the case of authors, silence on the part of reviewers concerning potential conflicts may mean either that such conflicts exist that they have failed to disclose, or that conflicts do not exist. Reviewers must therefore also be asked to state explicitly whether conflicts do or do not exist. Reviewers must not use knowledge of the work, before its publication, to further their own interests.

Editors who make final decisions about manuscripts must have no personal, professional, or financial involvement in any of the issues they might judge. Other members of the editorial staff, if they participate in editorial decisions, must provide editors with a current description of their financial interests (as they might relate to editorial judgments) and disqualify themselves from any decisions where they have a conflict of interest. Editorial staff must not use the information gained through working with manuscripts for private gain. Editors should publish regular disclosure statements about potential conflicts of interests related to the commitments of journal staff.

II.E. Privacy and Confidentiality

II. E.1. Patients and Study Participants

Patients have a right to privacy that should not be infringed without informed consent. Identifying information, including patients' names, initials, or hospital numbers, should not be published in written descriptions, photographs, and pedigrees unless the information is essential for scientific purposes and the patient (or parent or guardian) gives written informed consent for publication. Informed consent for this purpose requires that a patient who is identifiable be shown the manuscript to be published.

        Identifying details should be omitted if they are not essential. Complete anonymity is difficult to achieve, however, and informed consent should be obtained if there is any doubt. For example, masking the eye region in photographs of patients is inadequate protection of anonymity. If data are changed to protect anonymity, authors should provide assurance that alterations of the data do not distort scientific meaning.

        The requirement for informed consent should be included in the journal's instructions for authors. When informed consent has been obtained it should be indicated in the published article.

II.E.2. Authors and Reviewers

Manuscripts must be reviewed with due respect for authors' confidentiality. In submitting their manuscripts for review, authors entrust editors with the results of their scientific work and creative effort, on which their reputation and career may depend. Authors' rights may be violated by disclosure of the confidential details of the review of their manuscript. Reviewers also have rights to confidentiality, which must be respected by the editor. Confidentiality may have to be breached if dishonesty or fraud is alleged but otherwise must be honored.

        Editors must not disclose information about manuscripts (including their receipt, content, status in the reviewing process, criticism by reviewers, or ultimate fate) to anyone other than the authors and reviewers. This includes requests to use the materials for legal proceedings.

        Editors must make clear to their reviewers that manuscripts sent for review are privileged communications and are the private property of the authors. Therefore, reviewers and members of the editorial staff must respect the authors' rights by not publicly discussing the authors' work or appropriating their ideas before the manuscript is published. Reviewers must not be allowed to make copies of the manuscript for their files and must be prohibited from sharing it with others, except with the permission of the editor. Reviewers should return or destroy copies of manuscripts after submitting reviews. Editors should not keep copies of rejected manuscripts.

        Reviewer comments should not be published or otherwise made public without permission of the reviewer, author, and editor.

        Opinions differ on whether reviewers should remain anonymous. Authors should consult the information for authors of the journal they have chosen to learn whether the reviews are anonymous. When comments are not signed the reviewers' identity must not be revealed to the author or anyone else without the reviewer's permission.

        Some journals publish reviewers' comments with the manuscript. No such procedure should be adopted without the consent of the authors and reviewers. However, reviewers' comments should be sent to other reviewers of the same manuscript, which helps reviewers learn from the review process, and reviewers may be notified of the editor's decision.

II.F. Protection of Human Subjects and Animals in Research

When reporting experiments on human subjects, authors should indicate whether the procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000 (5). If doubt exists whether the research was conducted in accordance with the Helsinki Declaration, the authors must explain the rationale for their approach, and demonstrate that the institutional review body explicitly approved the doubtful aspects of the study. When reporting experiments on animals, authors should be asked to indicate whether the institutional and national guide for the care and use of laboratory animals was followed.

III. PUBLISHING AND EDITORIAL ISSUES RELATED TO PUBLICATION IN BIOMEDICAL JOURNALS

III.A. Obligation to Publish Negative Studies

Editors should consider seriously for publication any carefully done study of an important question, relevant to their readers, whether the results are negative (that is, convincingly allow the null hypothesis to be accepted) or positive (that is, allow the null hypothesis to be rejected). Failure to submit or publish negative studies, in particular, contributes to publication bias. Many studies that purport to be negative are, in fact, inconclusive; publication of inconclusive studies is problematic, since they add little to biomedical knowledge and consume journal resources. The Cochrane Library may be interested in publishing inconclusive trials (www.cochrane.org).

III.B. Corrections, Retractions and "Expressions of Concern"

Editors must assume initially that authors are reporting work based on honest observations. Nevertheless, two types of difficulty may arise.

First, errors may be noted in published articles that require the publication of a correction or erratum of part of the work. The corrections should appear on a numbered page, be listed in the contents page, include the complete original citation, and link to the original article and vice versa if online. It is conceivable that an error could be so serious as to vitiate the entire body of the work, but this is unlikely and should be handled by editors and authors on an individual basis. Such an error should not be confused with inadequacies exposed by the emergence of new scientific information in the normal course of research. The latter require no corrections or withdrawals.

        The second type of difficulty is scientific fraud. If substantial doubts arise about the honesty or integrity of work, either submitted or published, it is the editor's responsibility to ensure that the question is appropriately pursued, usually by the authors' sponsoring institution. However, it is not ordinarily the task of editors to conduct a full investigation or to make a determination; that responsibility lies with the institution where the work was done or with the funding agency. The editor should be promptly informed of the final decision, and if a fraudulent paper has been published, the journal must print a retraction. If this method of investigation does not result in a satisfactory conclusion, the editor may choose to conduct his or her own investigation. As an alternative to retraction, the editor may choose to publish an expression of concern about aspects of the conduct or integrity of the work.

        The retraction or expression of concern, so labeled, should appear on a numbered page in a prominent section of the print journal as well as in the online version, be listed in the contents page, and include in its heading the title of the original article. It should not simply be a letter to the editor. Ideally, the first author should be the same in the retraction as in the article, although under certain circumstances the editor may accept retractions by other responsible persons. The text of the retraction should explain why the article is being retracted and include a full original citation reference to it.

The validity of previous work by the author of a fraudulent paper cannot be assumed. Editors may ask the author's institution to assure them of the validity of earlier work published in their journals or to retract it. If this is not done editors may choose to publish an announcement expressing concern that the validity of previously published work is uncertain.

III.C. Copyright

Many biomedical journals ask authors to transfer copyright to the journal. However, an increasing number of "open access" journals do not require authors to transfer copyright to the journal. Editors should make their position on copyright transfer clear to authors and to others who might be interested in using editorial content from their journals. The copyright status of articles in a given journal can vary: some content cannot be copyrighted (articles written by employees of the U.S. and some other governments in the course of their work, for example); editors may agree to waive copyright on others; still others may be protected under serial rights (that is, use in publications other than journals, including electronic publications, is permitted).

III.D. Overlapping Publications

III.D.1. Duplicate Submission

Most biomedical journals will not consider manuscripts that are simultaneously being considered by other journals. Among the principal considerations that have led to this policy are: 1) the potential for disagreement when two (or more) journals claim the right to publish a manuscript that has been submitted simultaneously to more than one; and 2) the possibility that two or more journals will unknowingly and unnecessarily undertake the work of peer review and editing of the same manuscript, and publish same article.

        However, editors of different journals may decide to simultaneously or jointly publish an article if they believe that doing so would be in the best interest of the public's health.

III.D.2. Redundant Publication

Redundant (or duplicate) publication is publication of a paper that overlaps substantially with one already published in print or electronic media.

Readers of primary source periodicals, whether print or electronic, deserve to be able to trust that what they are reading is original unless there is a clear statement that the article is being republished by the choice of the author and editor. The bases of this position are international copyright laws, ethical conduct, and cost-effective use of resources. Duplicate publication of original research is particularly problematic, since it can result in inadvertent double counting or inappropriate weighting of the results of a single study, which distorts the available evidence.

        Most journals do not wish to receive papers on work that has already been reported in large part in a published article or is contained in another paper that has been submitted or accepted for publication elsewhere, in print or in electronic media. This policy does not preclude the journal considering a paper that has been rejected by another journal, or a complete report that follows publication of a preliminary report, such as an abstract or poster displayed at a professional meeting. Nor does it prevent journals considering a paper that has been presented at a scientific meeting but not published in full or that is being considered for publication in a proceedings or similar format. Press reports of scheduled meetings will not usually be regarded as breaches of this rule, but additional data or copies of tables and illustrations should not amplify such reports.

        When submitting a paper, the author must always make a full statement to the editor about all submissions and previous reports that might be regarded as redundant or duplicate publication of the same or very similar work. The author must alert the editor if the manuscript includes subjects about which the authors have published a previous report or have submitted a related report to another publication. Any such report must be referred to and referenced in the new paper. Copies of such material should be included with the submitted paper to help the editor decide how to handle the matter.

If redundant or duplicate publication is attempted or occurs without such notification, authors should expect editorial action to be taken. At the least, prompt rejection of the submitted manuscript should be expected. If the editor was not aware of the violations and the article has already been published, then a notice of redundant or duplicate publication will probably be published with or without the author's explanation or approval.

        Preliminary reporting to public media, governmental agencies, or manufacturers, of scientific information described in a paper or a letter to the editor that has been accepted but not yet published violates the policies of many journals. Such reporting may be warranted when the paper or letter describes major therapeutic advances or public health hazards such as serious adverse effects of drugs, vaccines, other biological products, or medicinal devices, or reportable diseases. This reporting should not jeopardize publication, but should be discussed with and agreed upon by the editor in advance.

III.D.3. Acceptable Secondary Publication

Certain types of articles, such as guidelines produced by governmental agencies and professional organizations, may need to reach the widest possible audience. In such instances, editors sometimes choose deliberately to publish material that is also being published in other journals, with the agreement of the authors and the editors of those other journals. Secondary publication for various other reasons, in the same or another language, especially in other countries, is justifiable, and can be beneficial, provided all of the following conditions are met.

1.     The authors have received approval from the editors of both journals; the editor concerned with secondary publication must have a photocopy, reprint, or manuscript of the primary version.

2.     The priority of the primary publication is respected by a publication interval of at least one week (unless specifically negotiated otherwise by both editors).

3.     The paper for secondary publication is intended for a different group of readers; an abbreviated version could be sufficient.

4.     The secondary version faithfully reflects the data and interpretations of the primary version.

5.     The footnote on the title page of the secondary version informs readers, peers, and documenting agencies that the paper has been published in whole or in part and states the primary reference. A suitable footnote might read: "This article is based on a study first reported in the [title of journal, with full reference]." Permission for such secondary publication should be free of charge.

III.D.4. Competing Manuscripts Based on the Same Study

Publication of manuscripts to air co-investigators disputes may waste journal space and confuse readers. On the other hand, if editors knowingly publish a manuscript written by only some of a collaborating team, they could be denying the rest of the team their legitimate co authorship rights; they could also be denying the journal's readers access to legitimate differences of opinion about the interpretation of a study.

        Two kinds of competing submissions are considered: submissions by coworkers who disagree on the analysis and interpretation of their study, and submissions by coworkers who disagree on what the facts are and which data should be reported.

        Setting aside the unresolved question of ownership of the data, the following general observations may help editors and others dealing with these problems.

III. D.4.a. Differences in Analysis or Interpretation

If the dispute centers on the analysis or interpretation of data, the authors should submit a manuscript that clearly presents both versions. The difference of opinion should be explained in a cover letter. The normal process of peer and editorial review of the manuscript may help the authors to resolve their disagreement regarding analysis or interpretation.

        If the dispute cannot be resolved and the study merits publication, both versions should be published. Options include publishing two papers on the same study, or a single paper with two analyses or interpretations. In such cases it would be appropriate for the editor to publish a statement outlining the disagreement and the journal's involvement in attempts to resolve it.

III.D.4. b. Differences in Reported Methods or Results

If the dispute centers on differing opinions of what was actually done or observed during the study, the journal editor should refuse publication until the disagreement is resolved. Peer review cannot be expected to resolve such problems. If there are allegations of dishonesty or fraud, editors should inform the appropriate authorities; authors should be notified of an editor's intention to report a suspicion of research misconduct.

III.D.5. Competing Manuscripts Based on the Same Database

Editors sometimes receive manuscripts from separate research groups that have analyzed the same data set, e.g., from a public database. The manuscripts may differ in their analytic methods, conclusions, or both. Each manuscript should be considered separately. Where interpretations of the same data are very similar, it is reasonable but not necessary for editors to give preference to the manuscript that was received earlier. However, editorial consideration of multiple submissions may be justified in this circumstance, and there may even be a good reason for publishing more than one manuscript because different analytical approaches may be complementary and equally valid.

III.E. Correspondence

Biomedical journals should provide its readership with a mechanism for submitting comments, questions, or criticisms about published articles, as well as brief reports and commentary unrelated to previously published articles. This will likely, but not necessarily, take the form of a correspondence section or column. The authors of articles discussed in correspondence should be given an opportunity to respond, preferably in the same issue in which the original correspondence appears. Authors of correspondence should be asked to declare any competing or conflicting interests.

        Published correspondence may be edited for length, grammatical correctness, and journal style. Alternatively, editors may choose to publish correspondence unedited for length or style, as for example in rapid response sections on the Internet; the journal should declare its editorial practice in this regard. Authors should approve editorial changes that alter the substance or tone of a letter or response.

        Although editors have the prerogative to sift out correspondence material that is irrelevant, uninteresting, or lacking in cogency, they have a responsibility to allow a range of opinion to be expressed. The correspondence column should not be used merely to promote the journal's, or the editors', point of view. In all instances, editors must make an effort to screen out discourteous, inaccurate, or libelous statements, and should not allow ad hominem arguments intended to discredit opinions or findings.

In the interests of fairness and to keep correspondence within manageable proportions, journals may want to set time limits for responding to articles and correspondence, and for debate on a given topic. Journals should also decide whether they would notify authors when correspondence bearing on their published work is going to appear in standard or rapid response sections. Journals should also set policy with regard to the archiving of unedited correspondence that appears on line. These policies should be published both in print and electronic versions of the journal.

III.F. Supplements, Theme Issues, and Special Series

Supplements are collections of papers that deal with related issues or topics, are published as a separate issue of the journal or as part of a regular issue, and are usually funded by sources other than the journal's publisher. Supplements can serve useful purposes: education, exchange of research information, ease of access to focused content, and improved cooperation between academic and corporate entities. Because funding sources can bias the content of supplements through the choice of topics and viewpoints, journals should consider adopting the following principles. These same principles apply to theme issues or special series that have external funding and/or guest editors.

1.        The journal editor must take full responsibility for the policies, practices, and content of supplements, including complete control of the decision to publish all portions of the supplement. Editing by the funding organization should not be permitted.

2.        The journal editor must retain the authority to send supplement manuscripts for external peer review and to reject manuscripts submitted for the supplement. These conditions should be made known to authors and external supplement editors before beginning editorial work on the supplement.

3.        The journal editor must approve the appointment of any external editor of the supplement and take responsibility for the work of the external editor.

4.        The sources of funding for the research, publication, and the products the funding source make that are considered in the supplement should be clearly stated and prominently located in the supplement, preferably on each page. Whenever possible, funding should come from more than one sponsor.

5.        Advertising in supplements should follow the same policies as those of the rest of the journal.

6.        Journal editors must enable readers to distinguish readily between ordinary editorial pages and supplement pages.

7.        Journal editors and supplement editors must not accept personal favors or personal remuneration from sponsors of supplements.

8.        Secondary publication in supplements (republication of papers previously published elsewhere) should be clearly identified by the citation of the original paper. Supplements should avoid redundant or duplicate publication. Supplements should not republish research results, but the republication of guidelines or other material in the public interest might be appropriate.

9.        The principles of authorship and potential conflict of interest disclosure articulated elsewhere in this document should apply to supplements.

III.G. Electronic Publishing

Most biomedical journals are now published in electronic as well as print versions, and some are published in electronic form only. Electronic publishing (which includes the Internet) is publishing. In the interests of clarity and consistency, the medical and health information published on the Internet should follow the recommendations in this document whenever possible.

The nature of electronic publication requires some special considerations, both within and beyond this document. At a minimum, websites should indicate the following: names, appropriate credentials, affiliations, and relevant conflicts of interest of editors, authors, and contributors; documentation and attribution of references and sources for all content; information about copyright; disclosure of site ownership; and disclosure of sponsorship, advertising, and commercial funding.

        Linking from one health or medical Internet site to another may be perceived as an implicit recommendation of the quality of the second site. Journals thus should exercise caution in linking to other sites; when users are linking to another site, it may be helpful to provide an explicit message to that they are leaving the journal's site. If links to other sites are posted as a result of financial considerations, such should be clearly indicated. All dates of content posting and updating should be indicated. In electronic layout as in print, advertising and promotional messages should not be juxtaposed with editorial content, and commercial content should be clearly identifiable as such.

Electronic publication is an area that is in flux. Editors should develop, make available to authors, and implement policies on issues unique to electronic publishing. These issues include archiving, error correction, version control, and choice of the electronic or print version of the journal as the journal of record, publication of ancillary material, and electronic publication

III.H. Advertising

Most medical journals carry advertising, which generates income for their publishers, but advertising must not be allowed to influence editorial decisions. Journals should have formal, explicit, written policies for advertising in both print and electronic versions; website advertising policy should parallel policy for the print version as much as possible. Editors must have full and final authority for approving advertisements and enforcing advertising policy. Where independent bodies for reviewing advertising exist editors should make use of their judgments.

        Readers should be able to distinguish readily between advertising and editorial material. The juxtaposition of editorial and advertising material on the same products or subjects should be avoided. Interleafing advertising pages within articles discourages readers by interrupting the flow of editorial content, and should be discouraged. Advertising should not be sold on the condition that it will appear in the same issue as a particular article.

        Journals should not be dominated by advertising, but editors should be careful about publishing advertisements from only one or two advertisers, as readers may perceive that these advertisers have influenced the editor.

Journals should not carry advertisements for products that have proved to be seriously harmful to health-for example, tobacco. Editors should ensure that existing regulatory or industry standards for advertisements specific to their country are enforced, or develop their own standards. The interests of organizations or agencies should not control classified and other non-display advertising, except where required by law. Finally, editors should consider all criticisms of advertisements for publication.

III. I. Medical Journals and the General Media

The public's interest in news of medical research has led the popular media to compete vigorously to get information about research as soon as possible. Researchers and institutions sometimes encourage the reporting of research in the non-medical media before full publication in a scientific journal by holding a press conference or giving interviews.

        The public is entitled to important medical information without unreasonable delay, and editors have a responsibility to play their part in this process. Biomedical journals are published primarily for their readers, but the general public has a legitimate interest in their content; an appropriate balance should therefore guide journals' interaction with the media between these complementary interests. Doctors in practice need to have reports available in full detail before they can advise their patients about the reports' conclusions. Moreover, media reports of scientific research before the work has been peer reviewed and fully published may lead to the dissemination of inaccurate or premature conclusions.

        An embargo system has been established in some countries to prevent publication of stories in the general media before the original paper on which they are based appears in the journal. The embargo creates a "level playing field," which most reporters appreciate since it minimizes the pressure on them to publish stories which they have not had time to prepare carefully. Consistency in the timing of public release of biomedical information is also important in minimizing economic chaos, since some articles contain information that has great potential to influence financial markets. On the other hand, the embargo system has been challenged as being self-serving of journals' interests, and impeding the rapid dissemination of scientific information.

        Editors may find the following recommendations useful as they seek to establish policies on these issues.

·         Editors can foster the orderly transmission of medical information from researchers, through peer-reviewed journals, to the public. This can be accomplished by an agreement with authors that they will not publicize their work while their manuscript is under consideration or awaiting publication and an agreement with the media that they will not release stories before publication in the journal, in return for which the journal will cooperate with them in preparing accurate stories.

·         Editors need to keep in mind that an embargo system works on the honor system; no formal enforcement or policing mechanism exists. The decision of any significant number of media outlets, or of biomedical journals, not to respect the embargo system would therefore lead to its rapid dissolution.

·         Very little medical research has such clear and urgently important clinical implications for the public's health that the news must be released before full publication in a journal. In such exceptional circumstances, however, appropriate authorities responsible for public health should make the decision and should be responsible for the advance dissemination of information to physicians and the media. If the author and the appropriate authorities wish to have a manuscript considered by a particular journal, the editor should be consulted before any public release. If editors accept the need for immediate release, they should waive their policies limiting prepublication publicity.

·         Policies designed to limit prepublication publicity should not apply to accounts in the media of presentations at scientific meetings or to the abstracts from these meetings (see Redundant Publication). Researchers who present their work at a scientific meeting should feel free to discuss their presentations with reporters, but they should be discouraged from offering more detail about their study than was presented in their talk.

·         When an article is soon to be published, editors should help the media prepare accurate reports by providing news releases, answering questions, supplying advance copies of the journal, or referring reporters to the appropriate experts. Most responsible reporters find this assistance should be contingent on the media's cooperation in timing their release of stories to coincide with the publication of the article.

·         Editors, authors, and the media should apply the above stated principles to material released early in electronic versions of journals.

IV. MANUSCRIPT PREPARATION AND SUBMISSION

IV.A. Preparing a Manuscript for Submission to a Biomedical Journal

Editors and reviewers spend many hours reading manuscripts, and therefore appreciate receiving with manuscripts that are easy to read and edit. Much of the information in journals' instructions to authors is designed to accomplish that goal in ways that meet each journal's particular editorial needs. The guidance that follows provides a general background and rationale for preparing manuscripts for any journal.

IV.A.1.a. General Principles

The text of observational and experimental articles is usually (but not necessarily) divided into sections with the headings Introduction, Methods, Results, and Discussion. This so-called "IMRAD" structure is not simply an arbitrary publication format, but rather a direct reflection of the process of scientific discovery. Long articles may need subheadings within some sections (especially the Results and Discussion sections) to clarify their content. Other types of articles, such as case reports, reviews, and editorials, are likely to need other formats.

        Publication in electronic formats has created opportunities for adding details or whole sections in the electronic version only, layering information, cross-linking or extracting portions of articles, and the like. Authors need to work closely with editors in developing or using such new publication formats and should submit material for potential supplementary electronic formats for peer review.

        Double spacing of all portions of the manuscript - including the title page, abstract, text, acknowledgments, references, individual tables, and legends - and generous margins make it possible for editors and reviewers to edit the text line by line, and add comments and queries, directly on the paper copy. If manuscripts are submitted electronically, the files should be double spaced, because the manuscript may need to be printed out for reviewing and editing.

During the editorial process reviewers and editors frequently need to refer to specific portions of the manuscript, which is difficult unless the pages are numbered. Authors should therefore number all of the pages of the manuscript consecutively, beginning with the title page.

IV.A.1.b. Reporting Guidelines for Specific Study Designs

Research reports frequently omit important information. The general requirements listed in the next section relate to reporting essential elements for all study designs. Authors are encouraged in addition to consult reporting guidelines relevant to their specific research design. For reports of randomized controlled trials authors should refer to the CONSORT statement (www.consort-statement.org).This guideline provides a set of recommendations comprising a list of items to report and a patient flow diagram. Reporting guidelines have also been developed for a number of other study designs that some journals may ask authors to follow. Authors should consult the information for authors of the journal they have chosen.

IV.A.2. Title Page

The title page should carry the following information:

1.        The title of the article. Concise titles are easier to read than long, convoluted ones. Titles that are too short may, however, lack important information, such as study design (which is particularly important in identifying randomized controlled trials). Authors should include all information in the title that will make electronic retrieval of the article both sensitive and specific.

2.        Authors' names and institutional affiliations. Some journals publish each author's highest academic degree(s), while others do not.

3.        The name of the department(s) and institution(s) to which the work should be attributed.

4.        Disclaimers, if any.

5.        Corresponding authors. The name, mailing address, telephone and fax numbers, and e-mail address of the author responsible for correspondence about the manuscript (the "corresponding author;" this author may or may not be the "guarantor" for the integrity of the study as a whole, if someone is identified in that role. The corresponding author should indicate clearly whether his or her e-mail address is to be published.

6.        The name and address of the author to whom requests for reprints should be addressed or a statement that reprints will not be available from the authors.

7.        Source(s) of support in the form of grants, equipment, drugs, or all of these.

8.        A running head. Some journals request a short running head or foot line, usually of no more than 40 characters (count letters and spaces) at the foot of the title page. Running heads are published in most journals, but are also sometimes used within the editorial office for filing and locating manuscripts.

9.        Word counts. A word count for the text only (excluding abstract, acknowledgments, figure legends, and references) allows editors and reviewers to assess whether the information contained in the paper warrants the amount of space devoted to it, and whether the submitted manuscript fits within the journal's word limits. A separate word count for the Abstract is also useful for the same reason.

10.     The number of figures and tables. It is difficult for editorial staff and reviewers to tell if the figures and tables that should have accompanied a manuscript were actually included unless the numbers of figures and tables that belong to the manuscript are noted on the title page.

IV.A.3. Conflict of Interest Notification Page

To prevent the information on potential conflict of interest for authors from being overlooked or misplaced, it is necessary for that information to be part of the manuscript. It should therefore also be included on a separate page or pages immediately following the title page. However, individual journals may differ in where they ask authors to provide this information and some journals do not send information on conflicts of interest to reviewers. (See Section II.D. Conflicts of Interest)

IV.A.4. Abstract and Key Words

An abstract (requirements for length and structured format vary by journal) should follow the title page. The abstract should provide the context or background for the study and should state the study's purposes, basic procedures (selection of study subjects or laboratory animals, observational and analytical methods), main findings (giving specific effect sizes and their statistical significance, if possible), and principal conclusions. It should emphasize new and important aspects of the study or observations.

Because abstracts are the only substantive portion of the article indexed in many electronic databases, and the only portion many readers read, authors need to be careful that abstracts reflect the content of the article accurately. Unfortunately, many abstracts disagree with the text of the article (6). The format required for structured abstracts differs from journal to journal, and some journals use more than one structure; authors should make it a point prepare their abstracts in the format specified by the journal they have chosen.

        Some journals request that, following the abstract, authors provide, and identify as such, 3 to 10 key words or short phrases that capture the main topics of the article. These will assist indexers in cross-indexing the article and may be published with the abstract. Terms from the Medical Subject Headings (MeSH) list of Index Medicus should be used; if suitable MeSH terms are not yet available for recently introduced terms, present terms may be used.

IV.A.5. Introduction

Provide a context or background for the study (i.e., the nature of the problem and its significance). State the specific purpose or research objective of, or hypothesis tested by, the study or observation; the research objective is often more sharply focused when stated as a question. Both the main and secondary objectives should be made clear, and any pre-specified subgroup analyses should be described. Give only strictly pertinent references and do not include data or conclusions from the work being reported.

IV.A.6. Methods

The Methods section should include only information that was available at the time the plan or protocol for the study was written; all information obtained during the conduct of the study belongs in the Results section.

IV.A.6.a. Selection and Description of Participants

Describe your selection of the observational or experimental participants (patients or laboratory animals, including controls) clearly, including eligibility and exclusion criteria and a description of the source population. Because the relevance of such variables as age and sex to the object of research is not always clear, authors should explain their use when they are included in a study report; for example, authors should explain why only subjects of certain ages were included or why women were excluded. The guiding principle should be clarity about how and why a study was done in a particular way. When authors use variables such as race or ethnicity, they should define how they measured the variables and justify their relevance.

IV.A.6.b. Technical information

Identify the methods, apparatus (give the manufacturer's name and address in parentheses), and procedures in sufficient detail to allow other workers to reproduce the results. Give references to established methods, including statistical methods (see below); provide references and brief descriptions for methods that have been published but are not well known; describe new or substantially modified methods, give reasons for using them, and evaluate their limitations. Identify precisely all drugs and chemicals used, including generic name(s), dose(s), and route(s) of administration.

        Authors submitting review manuscripts should include a section describing the methods used for locating, selecting, extracting, and synthesizing data. These methods should also be summarized in the abstract.

IV.A.6.c. Statistics

Describe statistical methods with enough detail to enable a knowledgeable reader with access to the original data to verify the reported results. When possible, quantify findings and present them with appropriate indicators of measurement error or uncertainty (such as confidence intervals). Avoid relying solely on statistical hypothesis testing, such as the use of P values, which fails to convey important information about effect size. References for the design of the study and statistical methods should be to standard works when possible (with pages stated). Define statistical terms, abbreviations, and most symbols. Specify the computer software used.

IV.A.7. Results

Present your results in logical sequence in the text, tables, and illustrations, giving the main or most important findings first. Do not repeat in the text all the data in the tables or illustrations; emphasize or summarize only important observations. Extra or supplementary materials and technical detail can be placed in an appendix where it will be accessible but will not interrupt the flow of the text; alternatively, it can be published only in the electronic version of the journal.

        When data are summarized in the Results section, give numeric results not only as derivatives (for example, percentages) but also as the absolute numbers from which the derivatives were calculated, and specify the statistical methods used to analyze them. Restrict tables and figures to those needed to explain the argument of the paper and to assess its support. Use graphs as an alternative to tables with many entries; do not duplicate data in graphs and tables. Avoid non-technical uses of technical terms in statistics, such as "random" (which implies a randomizing device), "normal," "significant," "correlations," and "sample."

        Where scientifically appropriate, analyses of the data by variables such as age and sex should be included.

IV.A.8. Discussion

Emphasize the new and important aspects of the study and the conclusions that follow from them. Do not repeat in detail data or other material given in the Introduction or the Results section. For experimental studies it is useful to begin the discussion by summarizing briefly the main findings, then explore possible mechanisms or explanations for these findings, compare and contrast the results with other relevant studies, state the limitations of the study, and explore the implications of the findings for future research and for clinical practice.

        Link the conclusions with the goals of the study but avoid unqualified statements and conclusions not adequately supported by the data. In particular, authors should avoid making statements on economic benefits and costs unless their manuscript includes the appropriate economic data and analyses. Avoid claiming priority and alluding to work that has not been completed. State new hypotheses when warranted, but clearly label them as such.

IV.A.9. References

IV.A.9.a. General Considerations Related to References

Although references to review articles can be an efficient way of guiding readers to a body of literature, review articles do not always reflect original work accurately. Readers should therefore be provided with direct references to original research sources whenever possible. On the other hand, extensive lists of references to original work on a topic can use excessive space on the printed page. Small numbers of references to key original papers will often serve as well as more exhaustive lists, particularly since references can now be added to the electronic version of published papers, and since electronic literature searching allows readers to retrieve published literature efficiently.

Avoid using abstracts as references. References to papers accepted but not yet published should be designated as "in press" or "forthcoming"; authors should obtain written permission to cite such papers as well as verification that they have been accepted for publication. Information from manuscripts submitted but not accepted should be cited in the text as "unpublished observations" with written permission from the source.

        Avoid citing a "personal communication" unless it provides essential information not available from a public source, in which case the name of the person and date of communication should be cited in parentheses in the text. For scientific articles, authors should obtain written permission and confirmation of accuracy from the source of a personal communication.

Some journals check the accuracy of all reference citations, but not all journals do so, and citation errors sometimes appear in the published version of articles. To minimize such errors, authors should therefore verify references against the original documents.

IV.A.9.b. Reference Style and Format

The Uniform Requirements style is based largely on an ANSI standard style adapted by the National Library of Medicine (NLM) for its databases. (7) For samples of reference citation formats, authors should consult http://www.nlm.nih.gov/bsd/ uniform_requirements.html.

        References should be numbered consecutively in the order in which they are first mentioned in the text. Identify references in text, tables, and legends by Arabic numerals in parentheses. References cited only in tables or figure legends should be numbered in accordance with the sequence established by the first identification in the text of the particular table or figure. The titles of journals should be abbreviated according to the style used in Index Medicus. Consult the List of Journals Indexed in Index Medicus, published annually as a separate publication by the library and as a list in the January issue of Index Medicus. The list can also be obtained through the library's web site (http://www.nlm.nih.gov).

        Journals vary on whether they ask authors to cite electronic references within parentheses in the text or in numbered references following the text. Authors should consult with the journal that they plan to submit their work to.

IV.A.10. Tables

Tables capture information concisely, and display it efficiently; they also provide information at any desired level of detail and precision. Including data in tables rather than text frequently makes it possible to reduce the length of the text.

        Type or print each table with double spacing on a separate sheet of paper. Number tables consecutively in the order of their first citation in the text and supply a brief title for each. Do not use internal horizontal or vertical lines. Give each column a short or abbreviated heading. Authors should place explanatory matter in footnotes, not in the heading. Explain in footnotes all nonstandard abbreviations. For footnotes use the following symbols, in sequence: *,†,‡,§,||,¶,**,††,‡‡

        Identify statistical measures of variations, such as standard deviation and standard error of the mean.

        Be sure that each table is cited in the text.

        If you use data from another published or unpublished source, obtain permission and acknowledge them fully.

        Additional tables containing backup data too extensive to publish in print may be appropriate for publication in the electronic version of the journal, deposited with an archival service, or made available to readers directly by the authors. In that event an appropriate statement will be added to the text. Submit such tables for consideration with the paper so that they will be available to the peer reviewers.

IV.A.11. Illustrations (Figures)

Figures should be either professionally drawn and photographed, or submitted as photographic quality digital prints. In addition to requiring a version of the figures suitable for printing, some journals now ask authors for electronic files of figures in a format (e.g., JPEG or GIF) that will produce high quality images in the web version of the journal; authors should review the images of such files on a computer screen before submitting them, to be sure they meet their own quality standard.

        For x-ray films, scans, and other diagnostic images, as well as pictures of pathology specimens or photomicrographs, send sharp, glossy, black-and-white or color photographic prints, usually 127 × 173 mm (5 × 7 inches). Although some journals redraw figures, many do not. Letters, numbers, and symbols on Figures should therefore be clear and even throughout, and of sufficient size that when reduced for publication each item will still be legible. Figures should be made as self-explanatory as possible, since many will be used directly in slide presentations. Titles and detailed explanations belong in the legends, however, not on the illustrations themselves.

        Photomicrographs should have internal scale markers. Symbols, arrows, or letters used in photomicrographs should contrast with the background.

If photographs of people are used, either the subjects must not be identifiable or their pictures must be accompanied by written permission to use the photograph (see Section III.D.4.a). Whenever possible permission for publication should be obtained.

        Figures should be numbered consecutively according to the order in which they have been first cited in the text. If a figure has been published, acknowledge the original source and submit written permission from the copyright holder to reproduce the material. Permission is required irrespective of authorship or publisher except for documents in the public domain.

For illustrations in color, ascertain whether the journal requires color negatives, positive transparencies, or color prints. Accompanying drawings marked to indicate the region to be reproduced might be useful to the editor. Some journals publish illustrations in color only if the author pays for the extra cost.

        Authors should consult the journal about requirements for figures submitted in electronic formats.

IV.A.12. Legends for Illustrations (Figures)

Type or print out legends for illustrations using double spacing, starting on a separate page, with Arabic numerals corresponding to the illustrations. When symbols, arrows, numbers, or letters are used to identify parts of the illustrations, identify and explain each one clearly in the legend. Explain the internal scale and identify the method of staining in photomicrographs.

IV.A.13. Units of Measurement

Measurements of length, height, weight, and volume should be reported in metric units (meter, kilogram, or liter) or their decimal multiples.

Temperatures should be in degrees Celsius. Blood pressures should be in millimeters of mercury, unless other units are specifically required by the journal.

        Journals vary in the units they use for reporting hematological, clinical chemistry, and other measurements. Authors must consult the information for authors for the particular journal and should report laboratory information in both the local and International System of Units (SI). Editors may request that the authors before publication add alternative or non-SI units, since SI units are not universally used. Drug concentrations may be reported in either SI or mass units, but the alternative should be provided in parentheses where appropriate.

IV.A.14. Abbreviations and Symbols

Use only standard abbreviations; the use of non-standard abbreviations can be extremely confusing to readers. Avoid abbreviations in the title. The full term for which an abbreviation stands should precede its first use in the text unless it is a standard unit of measurement.

IV.B Sending the Manuscript to the Journal

An increasing number of journals now accept electronic submission of manuscripts, whether on disk, as attachments to electronic mail, or by downloading directly onto the journal website. Electronic submission saves time as well as postage costs, and allows the manuscript to be handled in electronic form throughout the editorial process (for example, when it is sent out for review). When submitting a manuscript electronically, authors should consult with the instructions for authors of the journal they have chosen for their manuscript.

        If a paper version of the manuscript is submitted, send the required number of copies of the manuscript and figures; they are all needed for peer review and editing, and editorial office staff cannot be expected to make the required copies.

        Manuscripts must be accompanied by a cover letter, which should include the following information.

·         A full statement to the editor about all submissions and previous reports that might be regarded as redundant publication of the same or very similar work. Any such work should be referred to specifically, and referenced in the new paper. Copies of such material should be included with the submitted paper, to help the editor decide how to handle the matter.

·         A statement of financial or other relationships that might lead to a conflict of interest, if that information is not included in the manuscript itself or in an authors' form

·         A statement that the manuscript has been read and approved by all the authors, that the requirements for authorship as stated earlier in this document have been met, and that each author believes that the manuscript represents honest work, if that information is not provided in another form (see below); and

·         The name, address, and telephone number of the corresponding author, who is responsible for communicating with the other authors about revisions and final approval of the proofs, if that information is not included on the manuscript itself.

        The letter should give any additional information that may be helpful to the editor, such as the type or format of article in the particular journal that the manuscript represents. If the manuscript has been submitted previously to another journal, it is helpful to include the previous editor's and reviewers' comments with the submitted manuscript, along with the authors' responses to those comments. Editors encourage authors to submit these previous communications and doing so may expedite the review process.

        Many journals now provide a pre-submission checklist that assures that all the components of the submission have been included. Some journals now also require that authors complete checklists for reports of certain study types (e.g., the CONSORT checklist for reports of randomized controlled trials). Authors should look to see if the journal uses such checklists, and send them with the manuscript if they are requested.

        Copies of any permission to reproduce published material, to use illustrations or report information about identifiable people, or to name people for their contributions must accompany the manuscript.

V. REFERENCES

A. References Cited in this Document

1.     Davidoff F for the CSE Task Force on Authorship. . Who's the Author? Problems with Biomedical Authorship, and Some Possible Solutions. Science Editor. July-August 2000: Volume 23 - Number 4: 111-119.

2.     Yank V, Rennie D. Disclosure of researcher contributions: a study of original research articles in The Lancet. Ann Intern Med. 1999 Apr 20;130(8):661-70.

3.     Flanagin A, Fontanarosa PB, DeAngelis CD. Authorship for research groups. JAMA. 2002;288:3166-68.

4.     Peer Review in Health Sciences. F Godlee, T Jefferson. London: BMJ Books, 1999.

5.     World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2000 Dec 20;284(23):3043-5.

6.     Pitkin RM, Branagan MA, Burmeister LF. Accuracy of data in abstracts of published research articles. JAMA. 1999 Mar 24-31;281(12):1110-1.

7.     Patrias K. National Library of Medicine recommended formats for bibliographic citation. Bethesda (MD): The Library; 1991.

B. Other Sources of Information Related to Biomedical Journals

World Association of Medical Editors (WAME) www.WAME.org

Council of Science Editors (CSE) www.councilscienceeditors.org

European Association of Science Editors (EASE) www.ease.org.uk

Society for Scholarly Publishing (SSP) www.ssp.net

Cochrane Collaboration www.cochrane.org

The Mulford Library, Medical College of Ohio www.mco.edu/lib/instr/libinsta.html

VI.   ABOUT THE INTERNATIONAL COMMITTEE OF MEDICAL JOURNAL EDITORS

The International Committee of Medical Journal Editors (ICMJE) is a group of general medical journal editors whose participants meet annually and fund their work on the Uniform Requirements for Manuscripts. The ICMJE invites comments on this document and suggestions for agenda items.

VII. AUTHORS OF THE UNIFORM REQUIREMENTS FOR MANUSCRIPTS SUBMITTED TO BIOMEDICAL JOURNALS

The ICMJE participating journals and organizations and their representatives who approved the revised Uniform Requirements for manuscripts in June 2003 include Annals of Internal Medicine, Canadian Medical Association Journal, Croatian Medical Journal, Journal of the American Medical Association, Nederlands Tijdschrift voor Geneeskunde, New England Journal of Medicine, New Zealand Medical Journal, The Lancet, The Medical Journal of Australia,Tidsskrift for Den Norske Llegeforening, Ugeskrift for Laeger, and the U.S. National Library of Medicine.

VIII. USE, DISTRIBUTION, AND TRANSLATION OF THE UNIFORM REQUIREMENTS

Users may print, copy, and distribute this document without charge for not-for-profit, educational purpose. The ICMJE does not stock paper copies (reprints) of this document.

        The ICMJE policy is for interested organizations to link to the official English language document at www.ICMJE.org. The ICMJE does not endorse posting of the document on web sites other than www.ICMJE.org.

        The ICMJE welcomes organizations to translate this document into languages other than English for non-profit purposes. However, the ICMJE does not have the resources to translate, to back translate, or to approve translated versions of the document. Thus, any translations should prominently include the following statement: "This is a (insert language name) language translation of the ICMJE Uniform Requirements for Manuscripts Submitted to Biomedical Journals. (insert name of organization) prepared this translation with support from (insert name of funding source, if any). The ICMJE has not endorsed nor approved the contents of this translation. The official version of the Uniform Requirements for Manuscripts Submitted to Biomedical Journals is located at www.ICMJE.org."

IX. INQUIRIES

Inquiries about the Uniform Requirements should be sent to Christine Laine, MD, MPH at the ICMJE Secretariat office, American College of Physicians, 190 N. Independence Mall West, Philadelphia, PA 19106-1572, USA. phone, 215-351-2660; fax 215-351-2644; e-mail claine@acponline.org. Please do not direct inquiries about individual journal styles or policies to the ICMJE secretariat office.


-0001-11-30

INITIATION OF BREASTFEEDING


MONITORING THE PRACTICE AND PROGRESS OF INITIATION OF BREASTFEEDING WITHIN HALF AN HOUR TO ONE HOUR AFTER BIRTH, IN THE LABOR ROOM OF KING KHALID UNIVERSITY HOSPITAL

Fawzia Ahmed Habib, MD, Arab Board Obstetrics & Gynecology 

College of Medicine, King Khalid University Hospital, Riyadh, Saudi Arabia

_____________________________________________________________________________________

هدف الدراسة:   أجريت الدراسة لمعرفة التطور في عملية إرضاع المواليد حديثي الولادة خلال نصف ساعة إلى ساعة من الولادة وتحديد الأسباب التي تمنع الأمهات من إرضاع أطفالهن بعد الولادة.

طريقة الدراسة:   هذه دراسة وصفية أجريت بغرفة الولادة بمستشفى الملك خالد الجامعي خلال شهر جمادي الأولى وشهر ذي القعدة 1422هـ .  ضمت هذه الدراسة602 سيدة و طفلها لمعرفة مدى رغبتهن لإرضاع أطفالهن بعد الولادة مباشرة وما هي الأسباب التي تمنعهن من ذلك.

نتائج الدراسة: النتائج كانت مشجعة للغاية حيث أن أكثر من 60% من السيدات قمن بإرضاع أطفالهن خلال نصف ساعة إلى ساعة بعد الولادة مباشرة .  كانت الأسباب لعدم الإرضاع راجعة إلى سببين رئيسيين هما أن تكون الأم متعبة لا تستطيع الإرضاع وترفض ذلك أو بسبب العملية القيصرية، إلى جانب أسباب أخرى.

الخــلاصـــــة:   هناك حاجة ماسة إلى  توعية الأمهات بأهمية الرضاعة الطبيعية وتحسين العناية بالأم والطفل وذلك لبناء  جيل من الأطفال الأصحاء

الكلمات المرجعية : الرضاعة الطبيعية ، الطفل حديث الولادة، مستشفى الملك خالد الجامعي ، غرفة الولادة.

_____________________________________________________________________________________

Purpose:  To monitor the progress in the practice of early breastfeeding of newborn babies within half an hour to one hour after delivery, and to identify the reasons for not breastfeeding the babies in the labor room.

Patients and methods: This is a descriptive study conducted in the labor and delivery rooms of King Khalid University Hospital during the months(5) of Jumada I and (11) Dhulqada 1422H.  A total of 602 women were included in the study.  A structured form was used to assess the extent of feeding and the reasons for not breastfeeding in the first 1/2 to 1 hour after birth. The frequency and the percentage were used to compare the data.

Results: It was encouraging to find that 60% of the women breastfed their babies within 1/2 an hour to 1 hour after birth.  Of the reasons for not breastfeeding the

___________________________________________________________________________

Correspondence to:

Dr. Fawzia A. Habib, Associate Professor & Consultant Obstetric & Gynecologist, Department of Obstetrics & Gynecology (36), College of Medicine & King Saud University, King Khalid University Hospital, P.O. Box 7805, Riyadh 11472 


babies early, two were of the greatest concern.  The first is that 13% of the women were   either too tired to breastfeed or refused to do so at this early stage.  Secondly, the majority of the mothers who had had cesarean sections did not breastfeed their babies.

Conclusion:  Mothers and their families play a very vital role in building the health of the nation.  This can be achieved by early breastfeeding, which contributes to the rearing of healthy babies, increase in intelligence and the building of strong future generations.  The health care professional must have continuous education and be frequently updated on breastfeeding standards.

Key words:  Breastfeeding, newborn, King Khalid University Hospital, labor room

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INTRODUCTION

Breast milk is considered a uniquely superior infant feed, providing various medical and psychological advantages over formula feeding. It is not only important for health, nutrition and the development of a baby’s trust and sense of security, but also enhances brain development and learning readiness.1  Breastfed babies have fewer attacks of ear infections, which have been associated with hearing loss and learning delays.2

BACKGROUND OF THE STUDY

Healthy newborn infants are often separated from their mothers after delivery and may not be put to the breast for hours, or sometimes for days while waiting for the milk to come in.  This can happen with both hospital and home deliveries, in traditional and modern settings.  The practice is potentially detrimental to both breastfeeding and the development of mother/infant relationship often referred to as “bonding”. The American Academy of Pediatrics recommends that breast-feeding should begin within the first hour of life, rather than hours after birth.3  Early skin to skin contact and the opportunity to suckle within the first hour or so after birth are both important.  Some contact is inevitable when attempting to breastfeed but contact itself does not necessarily result in immediate suckling.  However, contact and suckling are so closely interrelated that most studies reviewed have used the terms interchangeably, and few researchers distinguish clearly between them.4,5  Several randomized studies have examined the influence of early postnatal contact on the initiation and continuation of breastfeeding.  Widstrom et al,5 suggested that early touch of the  nipple and areola (within 30 minutes) might positively influence maternal/infant relationship during the first days after birth.  Early suckling can increase postpartum uterine activity and may reduce the risk of postpartum hemorrhage.  Chua et al,6  in Singapore, recorded uterine activity in 11 women immediately after delivery of the placenta before, during and after breastfeeding or manual nipple stimulation.  The median increase with manual stimulation was 66%, and with breast-feeding was 93%.   A meta-analysis of these seven studies by perez-Escamilla et al,7  concluded that early contact had a positive effect on the duration of breast-feeding at 2 or 3 months (P<0.05).  A cross-sectional study conducted on 726 Primi para women and their babies in  the USA revealed that mothers were less likely to breastfeed exclusively in hospitals if the first feed occurred 7 to 12 hours postpartum or more than 12 hours postpartum.8

    The objective of this study is to encourage the Obstetrics & Gynecology Unit of King Khaled University Hospital (KKUH) in its endeavor to follow the ten policies of Baby Friendly Hospital Initiative.  Accordingly, the nurses were taught about breastfeeding in detail and the mothers were given assistance to breastfeed their babies within one hour of life.  The reaction of the nurses and others involved during the initial stage of implementing this new practice was that, (1) it was not possible, (2) the women would not agree, (3) the babies would not suck etc.  Gradually the nurses came to understand that it was possible to help women breastfeed their newborns within half an hour of birth.  The nurses now assist women to breastfeed their babies; a practice which started few months ago. This descriptive study was undertaken to find out the extent to which women breastfed their babies in the labor room and what the reasons were for not breastfeeding. This survey is to be repeated every six months to monitor progress and based on the findings of the study to plan strategies to improve the practice of breastfeeding. 

CASES  AND METHODS

A descriptive study design was used. Early breastfeeding was instituted by  assisting the mother to breastfeed her baby within 1/2 an hour to 1 hour of birth. The setting was the labor and delivery room of KKUH which had 17 beds.  The delivery rooms of 8 beds have an annex of 5 beds and a  1st stage room with four beds.  There is an operating theatre and two rooms for the resuscitation of babies. The majority of the patients were delivered normally, (85%) by forceps, ventouse and the remaining (15%) were delivered by lower segment cesarean section.  More than 70% of our patients were high-risk patients. The majority of the nurses working in delivery room were midwives.  All the women who delivered in the labor and delivery unit of KKUH during the months (5) of Jumada I and (11) Dhulqada formed the target population.  The sample size was 287 in the month (5) of Jumada I 1422H and 315 in the month of (11) Dhulqada 1422H.  All the available samples for both  months were included in this study.  A concurrent audit was done to collect the data for the study.  A structured form was used to assess the extent of feeding and the reasons for not breast-feeding.  Data will be collected the same way every six months till 100% of the women delivering in the hospital breastfeed their babies in the Labor room.  The frequency and the percentage were used to compare the data.  The statistical tests of significance will be used after 2 years of data collection.

RESULTS AND DISCUSSION

The majority of the women who were included in the study, 42.5% of 287 in Jumada I (J1) and 45.6 % of 318 in Dhulqda (Dq), were multigravidae. The primigravidae (26.7%) were fewer in Dq than those (37.6%) in J1,  whereas the percentage of grand multigravidae (above gravida six) were more (27.7%) in Dq than in J1(19.9%) as shown in Figure I.  The percentage of those women who were delivered by caesarean section was more in Dhulqada than in Jumada I.  However, the

Figure 1: Demographic Data – Gravida

number of women who had spontaneous vaginal delivery, ventouse and assisted breech deliveries were fewer in Dhulqada than in Jumada I, as shown in Figure 2. It is very encouraging to see that there is a definite improvement in the initiation of breastfeeding in the labor room. In Dhulqada, 60% of women initiated breastfeeding in the labor room as compared to 54% Jumada I, as shown in Figure 3.  Though the percentage of women who initiated breastfeeding seems low (6%), it was not easy to encourage them to breastfeed, considering the shortage of staff, the language barrier, between new nurses with very little knowledge of Arabic and the refusal of the majority of patients to breastfeed their babies. Despite these problems, nurses still made the effort and to some extent the patients were cooperative.

Figure 2: Demographic data – Mode of delivery

Figure 3: Comparison on initiation of breast-feeding within half-an-hour of delivery in Jumad-I & Dhulqada

Figure 4: Comparison on initiation of breastfeeding on gravida

Figure 5: Comparison on initiation of breastfeeding on mode of delivery

Figure 4 explains that in Jumada I, there was no difference between the primi, multi, or grand multigravidae but in Dhulqada the multigravidae showed an improvement (11.9%) in initiating breastfeeding as compared to primigravidae (1.9%) and the grand multigravidae (3.1%).

        This shows that primigravidae and the grand multigravidae need more encouragement and education during the antenatal period.  Much effort should be focused on the primigravidae, since women tend to repeat whatever they do in the first pregnancy in the subsequent ones. There are many factors related to the noncompliance of the initiation of breastfeeding within 1/2 an hour of birth. Some of these are the lack of knowledge, coming to labor room without enough nourishment as a result of which they are tired, lack of motivation and



 

Figure 6: Comparison of reasons for not initiating breastfeeding in labor room


 

the lack of family support.  Figure 5 shows that in both months a majority (almost all) of women who had caesarean section did not breastfeed their babies though most of them underwent caesarean section under spinal anesthesia, and were fully conscious post delivery. There was not much   difference in the initiation of breastfeeding in the other two groups, i.e., spontaneous vaginal delivery (70.2%) and ventouse (66.6%) in the month (11) of Dhulqada. Whereas there was a vast difference in terms of noncompliance in the mothers who were delivered by ventouse (33.3%) as compared to those who delivered spontaneously (60.7%) in the month (5) of Jumada I, it is interesting and encouraging to note that the women who delivered by ventouse in Dhulqada (66.6%) were more compliant as compared to those who delivered by the same means in Jumada I.  Whether this increase is accidental or the result of increased awareness in this group remains to be seen since there is little difference between spontaneous vaginal delivery and ventouse, for both groups are able to perform the same functions post delivery. However, the nurses should continue to educate and encourage all new mothers to breastfeed their babies irrespective of the mode of delivery.  The variety of reasons given for not initiating breast-feeding within 1/2 an hour to 1 hour after birth are shown in Figure 6.  It was obvious from the study that none of the patients who underwent cesarean section breastfed their babies though cesarean birth is not a contraindication for breastfeeding.  Breastfeeding provides some advantages to the mother who has had cesarean section. For instance, suckling stimulates the mother’s uterus to contract more quickly and speed her healing. Breastfeeding brings mother and baby emotionally closer, which may be especially important if they are in separate rooms or the birth was traumatic.

        The establishment of the practice of initiating breastfeeding within 1/2 an hour to 1 hour for women in the recovery room requires a lot of education for the health team members, as well as the patients. It is gratifying that the number of women who refused to breastfeed their babies fell from 13.2% in Jumada I 1422H and by an additional (4.1%) in Dhulqada.  This may be the result of the education they had in the antenatal clinic and the wards.  The percentage of women who said they were tired and therefore could not feed their babies in Jumada I was 10.8 % as compared to 8.5% in Dhulqadqa.  Though there was some reduction after 6 months, the educators should persist in teaching the patients how to prepare themselves for delivery.  Some women take only fluids from the time contractions start and some neither eat nor drink anything from the start of contractions.  Some women waste their energy by bearing down unnecessarily and so feel very tired after delivery.  There is a great need therefore, for formal parenthood classes in the antenatal clinics.  The majority of women who were given pethidine during labor did not initiate breast-feeding in labor room.  The medication given during labor may have interfered with the early development of breastfeeding and delayed the first breastfeed. In addition, these women also felt dizzy and so refused to feed their babies in the labor room.

CONCLUSIONS AND RECOMMENDATIONS

It is encouraging to note there has been a 60% improvement in the half a year.  In the year 2001, no babies were breastfed by their mothers  within one hour of birth.  Now, however, there is a steady improvement in the number of women who breastfeed their babies in the  labor room.  It is gratifying that the number of women refusing to breastfeed has fallen considerably.

        Our recommendations are: (1) Prepared parenthood classes must be conducted in the antenatal clinics regularly, so that every expectant mother can be taught and prepared to breastfeed her baby early. (2) All patients on admission to the labor room must be informed that they  should expect to breastfeed their  babies  within 1/2 an hour to 1 hour after birth. (3) The Obstetrics Departments must have health educators and lactation nurses to promote and achieve the baby friendly hospital policies. (4) All the health team members must encourage women to breastfeed their babies.

ACKNOWLEDGMENT

The author is grateful to Sister Rajakumari Ravi, Associate Director of Nursing in the Obstetrics and Gynecology Department, King Khalid University Hospital, for her help in making King Khalid University Hospital a Baby Friendly Hospital.

REFERENCES

1.     Ryan AS, Wenjun Z, Acosta A. Breastfeeding continues to increase into the new millennium.  Pediatrics 2002; 110:1103-09

2.     Saarinen UM.  Prolonged breastfeeding as prophylaxis for recurrent otitis media.  Acta Paediatr Scand 1982; 71:567-71.

3.     American Academy of Pediatrics.  Policy statement:  Breastfeeding and the use of human milk.  Pediatrics 1997; 100(6): 1035-9.

4.     Taylar PM, Maloni JA, Brawn DR. Early sucking and prolonged breastfeeding. Am J Dis of Children 1986; 140:151-54.

5.     Widstrom AM, Wahlberg V, Metthiesen AS, et al .  Short  term effects of early suckling and touch of the nipple on maternal behavior.  Early Hum Dev 1990;21:153-63.

6.     Chua S, Arulkumaran S, Lim I, et al. Influence of breastfeeding and nipple stimulation on post partum uterine activity. Br J Obstet Gynecol 1994, 101: 804-5.

7.     Perez-Escamilla R, Pollitt E, Lonnerdal B, et al.  Infant feeding polices in maternity wards and their  effect ion breastfeeding success: an analytical overview.  Am J Public Health 1994; 84: 89-97.

8.     Kurini JN, Shiono PH. Early formula supplementation of breastfeeding. Pediatrics 1991; 88 (4): 745-50.


-0001-11-30

THE EMPEROR'S CLOTHES


THE EMPEROR'S CLOTHES

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Weighing of young children is an activity that goes on in clinics throughout the developed world and less privileged countries.  In the latter, it is considered important as a step to prevent or identify early under nutrition which in some areas is almost universal and plays a major part in infant and child mortality.  In the 60’s, the author designed a home-based weight chart which with some variation was adopted by WHO, UNICEF and governments worldwide. Weighing and the plotting of weight for the age curve became known as Growth Monitoring (GM).  In using these weight charts the health worker is expected to read off a weight, usually from a dial scale, and insert this as the next entry on the weight for age growth chart. 

        Almost all doctors and politicians assume that this graphic representation of the child’s weight, increasing with age can be created by health workers and be understood and interpreted by them and the mothers.  This is not so. For years, just like the ‘Emperor’s Clothes’, failure has been accepted as due to a lack of instruction in the use of charts. Weight for age graphs are rarely created and even where created their meaning is not understood nor are decisions taken from variations in the growth curve.  To discover the reason for this, we must have discussions with colleagues responsible for primary and secondary education.  Piaget (1896-1980) suggested that the graphic representation of number is difficult and is best taught at the primary school age.  Few primary schools in less privileged countries teach the graphic representation of number.  A colleague teaching in a secondary school told me it took a term to teach her students to grasp the concept of graphs. 

        Should growth monitoring then be abandoned?  Certainly it cannot be justified unless decisions on the health of the child are taken from a source other than the weight for age growth curve.  The Alma Ata conference in 1978 defined primary health care as: “Essential health care made universally accessible to individuals and acceptable to them through their full participation at a cost that the community and country can afford”.

        Research suggests that if the weighing of children is undertaken by their own mothers using a simple, low cost, easily understood Direct Recording Scale1 things can change.  This scale has no needle moving against numbers but a large spring which the mother sees stretching up her child’s chart as she, in her own home, lowers her child into the trousers below the scale. She then inserts the next point on the weight for age curve.  Such an indestructible scale used in their home by a group mothers leads them to an understanding of the meaning of the growth curve and enable them to take action when faltering occurs2.  If resources are limited, the scale can be made locally in wood using an imported spring.  Its cost is low3 and leaves the health workers time required for other activities by saving them the time spent weighing babies at the clinic.

        This is not to suggest that the Direct Recording Scale is the only answer. It needs much more research, but it may be the direction in which research in GM should move. This weighing scale will enable the family and community health worker to recognise changes in the child’s growth and if their resources allow take appropriate action.

Professor David Morley*

Emeritus Professor of Tropical Child Health

University of London, UK

1.     Morley D, Nickson P, Brown R.  TALC Direct Recording Scale. Lancet 1991; 338: 1600.

2.     Meegan M, Morley D. Growth monitoring family participation: effective community development.  Tropical Doctor 1999; 29 23-27.

3.     Teaching Aids at Low Cost (TALC) will provide more information and is a source for the Direct Recording Scale. POB.49. St. Albans. AL1  5TX.  UK. talc@talcuk.org  www talcuk.org

*Professor David Morley is a world figure and authority on tropical child health.  He devoted himself to promoting health of children in the 'developing world'. His famous book 'Paediatric Priorities in the Developing World' was described in one of the British Paediatric Association meetings as the "most important book ever written in medicine in the 20th century." Professor Morley was the winner of the first King Faisal International Prize in Medicine in the early 80's. His students – many of them now decision makers and university teachers – are found all over the developing world. The Editor of this journal is one such.

        Professor Morley has had a lifelong interest and concern for the growth of children in the 'third world'. He designed the growth chart (Road-to-Health chart) in the 60's. He is indeed the 'father of growth monitoring'. He continually researched and tried to improve growth monitoring.  He has always been keen on the use of appropriate, affordable and cost-effective technology. This led him to invent the Direct Recording Scale for growth monitoring. Professor Morley has always preached the bridging of the current gap between available life saving technology and its use where it is desperately needed. He has always called for a social breakthrough to institute the scientific breakthroughs in health institutions and homes of the people.

        Over the past few years, he, and upon assessing results of collaborative research, he seems to be convinced that growth monitoring is proving cost-ineffective. The reasons for this he summarized in this special communication. However, on answering whether growth monitoring should be abandoned, Prof. Morley is suggesting restricting its use to situations where decisions on the child's health are taken from the weight-for-age growth curve. Hopefully this communication would stimulate further research and discussion of the subject.

Professor Hassan Bella

Editor-in-Chief



-0001-11-30

FAITH HEALERS' VIEWS


A PILOT STUDY OF FAITH HEALERS' VIEWS ON EVIL EYE, JINN POSSESSION, AND MAGIC IN THE KINGDOM OF SAUDI ARABIA

Tariq A. Al-Habeeb, KSUF Psych, College of Medicine, King Saud University, Riyadh, Saudi Arabia

_______________________________________________________________________________________

مقدمة :في غالب الأحوال يقوم المعالجون بالقرأن باستخدام وسائل غير مألوفة في علاج مراجعيهم ممن يعانون من مجموعة من الأعراض النفسية والجسدية التي ربما توحي لهم بوجود عين حاسدة أو تلبس الجن للإنس أو السحر.

هدف الدراسة:تهدف هذه الدراسة إلى تحليل نموذج تلك الأعراض التشخيصية ووسائل العلاج المستخدمة لتلك الاضطرابات.

طريقة الدراسة: لقد تمت هذه الدراسة في منطقة القصيم بالسعودية بدراسة خمسة وأربعين معالجاً بالقرآن من خلال توزيع استبانة مصممة لهذا الغرض.

نتائج الدراسة: لوحظ أن أكثر المعالجين بالقرآن ليس لديهم تصور واضح للأعراض النفسية التي تفرق بشكل جلي بين تلك الاضطرابات الروحية التي اعتاد المعالجون بالقرآن أن يوصوا مرضاهم التداوي منها بطرق علاجية مستمدة من المفاهيم الدينية التي لاحظوا أنها تؤدي إلى تحسن ملحوظ في المعاناة العقلية.

الاستنتاج : إن الأعراض الظاهرة للاضطرابات الروحية المذكورة ليست ذات خصوصية ، ولكنها تساعد المعالجين بالقرآن في تشخيص تلك العلل ووصف الدواء المناسب لها. ولذا أرى أن الأبحاث القادمة يجب أن تركز على طرق التشخيص المستخدمة.

الكلمات المرجعية :المعالجون بالقرآن ، الاضطرابات الروحية ، العلاجات غير المألوفة ، تلبس الجن ، العين الحاسدة ، السحر. 

__________________________________________________________________________________________________________________

Background: Faith healers usually offer unorthodox therapies to their clients who present with an array of physical and psychological symptoms suggestive of the evil eye, jinn possession, and magic.

Objective: This exploratory pilot study aims to analyse the pattern of narrated symptoms and treatments given by faith healers practising in the Al-Qassim region, Saudi Arabia.

Method: Forty five faith healers who consented to this study were given  a predesigned, self-administered, semistructured  questionnaire to collect the relevant data. 

Results:  Notably, most faith healers have a poor repertoire of psychiatric symptoms, which could not specifically differentiate the three spiritual disorders. They tend to recommend an array of therapies rooted in religious concepts for the treatment of their clients who, they claim, show substantial improvement  in their mental suffering.

Conclusion: The revealed symptomatology of each disorder alone may not be specific but it certainly helps them not only to identify these disorders but also to prescribe unconventional therapies. Future research should look systematically into the diagnostic and treatment methods for these disorders.

Key Words:Faith healers, spiritual disorders, unorthodox therapies, jinn possession, evil eye, magic.

______________________________________________________________________________________________________________________________

Correspondence to:

Dr. Tariq A. Al-Habeeb, P.O. Box 7805, Riyadh 11472, Saudi Arabia


INTRODUCTION

Muslims all over the world, strongly believe, according to Islamic teaching, in the existence of supernatural forces such as jinns, magic and the evil eye. The beliefs in such spiritual forces coupled with fear are passed on from one generation to another for many reasons, namely: (i) the existence of these forces as documented in the Holy Quran, (ii) the belief in demons, witchcraft, and the evil eye by followers of other major religions; approximately 90% of the world's societies believe in demonic possession, (iii) the support given by transcultural literature for such disorders.1-3 In  folk psychiatry in all cultures and societies, faith healers (FHs) usually evoke supernatural powers in the etiology of mental disorders4-6 and identify spiritual disorders. In addition, FHs also make diagnoses such as psychosis (majnoon/wushra), extreme anger, and jealousy that are attributable to spiritual forces.7 Likewise, the majority of contemporary psychiatrists also believe in supernatural spirits, but rarely do they consider spiritual diagnoses or explain their causes by means of religion. Thus, they tend to ignore the therapeutic value of culture in spiritual or other mental disorders. However, psychiatrists now ascribe diagnoses underpinning demonic possession;2 and in recognition of cultural factors even the Diagnostic and Statistical Manual of Mental Disorder (DSM-IV)8 has inserted a cultural dimension to each mental disorder. To give more impetus to transcultural psychiatry, world leaders in psychiatry must remove the seven sins of international psychiatry.9

        From fire, the almighty Allah created both male and female jinn (spirit in English) who invisibly live with and share human activities. Jinn, good or bad due to  their beneficial or harmful effects could be believers or nonbelievers in Allah and could take any shape and form. Like jinn, the evil eye and magic also mentioned in the Holy Quran have disastrous effects on human health and behavior. The followers of Islam believe in jinn who can see and watch humans and bedevil them. The study of these forces has epidemiological, etiological, diagnostic, and psychotherapeutic and health promotion implications.2,6,10 To the FHs the possessed patients often report that they had perceived jinn entering their bodies and moving in different organs. This is followed by bizarre, multiple  behaviour and odd movements that may imply psychotic and nonpsychotic disorders.2 These disorders are also largerly diagnosed in female patients who are particularly weak, misinformed, uneducated and of poor backgrounds suffering both from the evil eye and magic, who also present with an array of somatic symptoms, interpersonal conflicts, and alleged misfortunes. The trance and possession states, explained by the theories of dissociation, conflictual communication, and sociocultural sanctions2 are recognized in the International Classification of Disorders (ICD-10)11 (F44.3) and DSM-IV (300.15). The latter suggests further research into dissociative trance disorders in order to refine the diagnostic criteria. FHs, who use special methods for diagnosing jinn possession, evil eye, and magic are reported to treat such patients mostly  by reading from the Holy Quran and the sayings of Prophet Mohammed (PBUH),6,7 but these patients ultimately need extensive assessment by psychiatrists.  Notably, FHs also use other treatment6,7 and protective4 strategies such as amulets and charms against these disorders.4

AIMS

In Saudi Arabia, more than 50% of patients first consult the FHs for a variety of psychiatric reasons.7 Nonetheless, there is a dearth of literature on cultural psychiatry in the Arabian Gulf countries. This pilot research has the following goals (1) to find out any association between sociodemographic variables of FHs and the reports of symptoms (2) to examine the symptom pattern – psychological, physical and other symptoms of jinn possession, evil eye, and magic as narrated by FHs, and (3) to describe their prescribed modes of  therapy.  The author hypothesized that (i) The FHs with higher education and a practice in urban areas would reveal more symptoms of these three disorders (ii) the FHs would reveal a poor repertoire of psychopathological symptoms of these spiritual disorders, and (iii) they would prescribe several modes of religious therapies.  To meet these objectives, 45 FHs who finally agreed to this research were requested to complete a simple self-administered, semistructured questionnaire.

MATERIAL AND METHOD

The study sample was composed of 45 male FHs in Al-Qassim region, which is  the most conservative province of Saudi Arabia with urban and rural areas. At the time of this study, the total number of FHs in that province was 72, but only 45 of them (62.5%) a statistically acceptable number agreed to participate. However, that 37.5% refused to participate reflects a chance occurrence rather than any differences in personality, attitudes or practices. Although there is no exhaustive registry of the FHs, which would be a good thing to have, the established practising FHs are easily seen to be knowledgeable, and from the Al-Qassim region like the author. There were no known female FHs in this health region.  The objectives of the study were explained clearly to the FHs before they gave verbal consent to participate.

        A predesigned, semistructured questionnaires with some open-ended questions in Arabic were distributed by a social worker who was made familiar with the questionnaire by the author himself. This questionnaire was simple enough to be answered by the FHs regardless of their educational level. Moreover, the knowledge of basic Arabic reading and writing was enough to answer questions and give information on the following sociodemographic variables: age, educational level, marital status, and residence. This questionnaire also collected separate data about the evil eye, jinn possession, and magic as revealed by FHs on these similar items, (1) their sources of information, with five options out of which one or more could be chosen, (2) physical symptoms, (3) psychological symptoms, (4) other symptoms, (5) prescribed treatment modalities, (6) other possible therapies, and (7) additional remarks. Item-6 had six options and the respondents could select one or more items; Items 2-5 and 7 were open-ended, so the FHs could enumerate as many symptoms and therapies and practice as they liked with any additional information they wanted to give. Some of the FHs left only item number 4 unanswered, e.g., other symptoms, because most of them had reported some symptoms on items 2 and 3.

Data Analysis

The data were entered into the computer and apart from frequency distribution, chi- square test and descriptive statistics were used for the analysis. The Statistical package for Social Sciences (SPSS) 10.0 for Windows was used and p value of 0.05 or less was considered significant.

RESULTS

Sociodemographic parameters of FHs

The mean age of FHs was 49.44±17.30 years (range: 28 to 85). The majority of FHs (75.6%) were literate, having had primary to advanced education, married (88.9%) and living in cities (71.1%). When age, educational level, and residential status of FHs was related to number of symptoms (<12 and 12)  (Table 1), a significant association was observed only between frequency of symptoms and the residential background of FHs (?2=4.02, d.f=1, p<0.04). The cutoff point of 12 was chosen arbitrarily by the author after a long association and experience with FHs. Moreover, all symptoms of three spiritual disorders reported by FHs were also taken into account. This dichotomization served a simple purpose of finding out some association between age, education and residence and reported symptoms, e.g. or < 12 symptoms. FHs practising in urban areas signficantly reported more symptoms than those in the villages. Conceivably, urban patients consulting FHs might have reported a large number of symptoms, thus enriching the symptom repositories of urban FHs. This explanation certainly needs further corroboration. There was a trend towards the reporting of more symptoms by FHs with higher education.

Sources of information of FHs

The FHs gathered knowledge about the evil eye, jinn possession, and magic from five main sources in decreasing frequency: books including Holy Koran (92.8%), treated patients (76%), personal experiences (72%), lectures (45%), and mass media, in particular, recorded casettes (10.4%).

Symptomatology of evil eye, jinn, and magic

The FHs revealed symptoms of these disorders, which could be categorized mainly into somatic and psychological (Table 2). There were multiple bodily symptoms more or less common to all the three spiritual disorders. The most frequently reported somatic symptoms were headache, chest pain, abdominal pain, leg pain, eyeache, earache, pain in all joints, and backache. Other less common somatic symptoms were vomiting, tiredness, paralysis, giddiness, tremors, anorexia, abortions, and dyspnea. In addition to these apparently somatic symptoms, there were some psychological symtoms that overlay all three disorders, and these included anxiety, fear/doubt of developing disease, and obsessive thinking. Other important psychological symptoms were insomnia, hate, depression, feeling of having a weight on the chest, talkativeness, hyperactivity, estrangement between wife and husband and also between two/three wives, persistent conflict among family members,


Table 1: Age and education by quantity of reported symptoms by faith healers

Variable

<12 symptoms

12 symptoms

X2

d.f.

p-value

Age in years:

<29

5

3

30-50

9

22

<50

2

4

3.12

2

0.209*

Education:

Illiterate

8

3

<8th level

7

9

8th level

5

13

5.59

2

0.061*

Residence:

Village

9

4

Urban

10

22

4.02

1

0.045†

*not significant, †significant

Table 2: Distribution of symptoms by three disorders as revealed by faith healers

Symptoms

Evil eye

Jinn possession

Magic

No. (%)

No. (%)

No. (%)

Somatic:

Multiple bodyaches

45 (100)

45 (100)

45 (1000

Paralysis

  5 (11.1)

   15 (33.0)*

  7 (15.5)

Giddiness

  6 (13.3)

12 (26.6)

10 (22.2)

Tremors

4 (8.8)

    9 (20.0)*

6 (13.3)

Anorexia

   8 (17.7)*

4 (8.8)

7 (15.5)

Abortions

13 (28.8)*

  6 (13.3)

18 (40.0)*

Dyspnea

4 (8.8)

  7 (15.5)

6 (13.3)

Psychological:

Anxiety

45 (100)

45 (100)

45 (100)

Doubt of diseases

34 (75.5)

   42 (93.3)*

40 (88.8)

Obsession†

44 (97.7)

  40 (88.8)

42 (93.3)

Insomnia

12 (26.6)

   19 (42.2)*

14 (31.1)

Hatredness‡

34 (75.5)

  11 (24.4)

  42 (93.3)*

Depressive ideas

17 (37.7)*

   8 (17.7)

11 (24.4)

Abnormal movements

3 (6.6)

24 (53.3)*

14 (31.1)

Estrangement§

24 (53.3)

14 (31.1)

37 (82.2)

Seizure-like state

2 (4.4)

38 (84.4)*

12 (26.6)

Psychotic disturbance

3 (6.6)

21 (46.6)*

  6 (13.3)

Imagination

5 (11.1)

7 (15.5)

10 (22.2)*

Altered consciouness

2 (4.4)

24 (53.3)*

7 (15.5)

*most frequently observed, †or increased thinking/preoccupation, ‡mainly among husband and wife plus wife-wife, §husband and wife pulis wife-wife

Table 3: Distribution of treatment by three disorders as recommended by faith healers

Treatments

Evil eye

Jinn possession

Magic

No. (%)

No. (%)

No. (%)

Roqaya

45 (100)

45 (100)

45 (100)

Reading Hadith

38 (84.4)

43 (95.5)

45 (100)

Prayers

45 (100)

45 (100)

45 (100)

Saaout

  6 (13.3)

  15 (33.3)*

   9 (20.0)

Herbs

24 (53.3)

18 (40.0)

26 (57.7)

Exorcism

-

45 (100)*

-

Physical punishment

-

  21 (46.6)*

-

Strangulation

-

19 (40.0)*

-

Cautery

8 (17.7)

5 (11.1)

12 (26.6)*

Read-in-water†

9 (20.0)

21 (46.6)

34 (75.5)*

Non-psychotropics

6 (13.3)

  8 (17.7)

12 (26.6)

Psychotropics

9 (20.0)

17 (37.7)*

11 (24.4)

Referral to psychiatrist

4 (8.80)

12 (26.6)*

7 (15.5)

*most frequently observed, †paper with written Quranic verses mixed in water or oil for drinking and/or local applications.


seizure-like state, psychotic disturbance and violent behaviour, aggression, bizarre movements and imaginations, aphonia, blindness, altered consciousness, and economic loss.

Therapeutic modalities prescribed by FHs

The unorthodox modes of therapies (Table 3) most frequently prescribed by FHs to the patients with evil eye, jinn possession, and magic were roqaya (reading specific verses from holy Quran, soothing sayings by the Prophet Mohammed (PBUH), regular performance of prayers, exorcism (Jinn and other devious supernatural spirits), physical punishment, temporary strangulation, cautery, saaout (snuff - inhalation of a herb powder), local application of a paste made of different types of herbs, drinking water mixed with herbs, water mixed with paper with written Quranic verses, and local application of oil and drinking some oils. Saaout may also imply the use of herbal nasal drops or a similar material mixed with oil or oily substance used as a nasal spray.  Some FHs (77.3%) advise their clients to consult psychiatrists for further psychiatric treatment. Lastly, most FHs (96%) stated that their patients showed marked improvement and that they the FHs wished to have specific knowledge about psychiatric disorders, drugs, and modern treatment methods.                        

DISCUSSION

Besides sociodemographic parameters and sources of knowledge, this study examined the symptomatology of jinn possession, evil eye, and sorcery as narrated by FHs together with their prescribed treatments for such disorders. The majority of FHs  are  religious and conservative by nature. As revealed in the present study, they enhance their knowledge by reading holy books including Koran and Hadith, attending religious lectures and gatherings, and listening to recorded audiocasettes. This finding may not be consistent with western culture where health providers use the mass media including television, video casettes, and the internet to increase their specific knowledge on spiritual disorders and healing.12 In this regard, the author suggests that there should be some cultural psychiatric programs on television that FHs target to encourage them to participate in such transcultural psychiatric activities in the Middle East countries and other parts of the world.

        Conventional wisdom suggests that older  FHs with higher education and more experience should have significantly better knowledge of the symptoms of spiritual disorders. The findings of the present study did not confirm this hypothesis. There could be many reasons for this, including their lack of a medical background and relatively little experience in psychiatric disorders as compared to physical disorders, and the absence of formal psychiatric training of  FHs. However,  FHs practising in urban settings reported significantly more psychopathological symptoms as compared to traditional practitioners in the rural areas. This finding may be because urban clients were better at communicating their complaints to the  FHs than the rural patients.

        According to the present study, somatic presentation, common to all three spiritual disorders, indicates clearly that the patients report their stresses through body language. This type of somatic-cum-symbolic communication is also reported to be common among patients with similar and other psychiatric disorders in developing countries13 but to a lesser degree in Western countries. In contrast, the triad of  somatic symptoms such as apparent paralysis, dyspnea and tremors may indicate jinn psychopathology, while anorexia and abortions may anchor the diagnosis of evil eye and magic. Like somatic symptoms, few  psychological symptoms including anxiety, denial of diseases, obsessive ruminations and preoccupations and depressive thoughts were common among all three disorders, and this is consistent with the clinical fact  that these non-specific symptoms are commonly reported by patients with other neurotic disorders. An assortment of psychological symptoms, reported by  FHs, such as abnormal movements, seizure-like state, transient psychotic disturbance, and reversible altered consciousness was partly compatible with the diagnostic criteria of possession state as laid down in major classifications. While the three most frequently observed symptoms such as repugnance, emotional distance, and fantasy emanate from the same background, though there is still no official representation in major psychiatric classifications for the evil eye and magic disorders despite the abundance of literature (DSM-IV&ICD-10).4,13,14

        According to this study, all  FHs, and as expected, prescribed treatment modalities based on their strong Islamic cultural background which is consistent with an earlier study.15 Reading from the holy Quran and Hadith were the most commonly prescribed means of healing the spiritual suffering. Likewise, unique unorthodox therapies in agreement with the respective cultures can be traced in other major religious groups in other parts of the world.4,16-18 The use of physical punishment and strangulation during exorcism of a jinn is a very offensive practice that should be discouraged since it is associated with complications such as severe suffocation6  and even death.19 As in other cultures,4 the use of different types of herbal preparations is legitimate and is in line with the doctrine of alternative medicine. Cautery, which may give rise to serious complications, is a traditional invasive therapy prescribed by  FHs for patients not only suffering from the evil eye and magic disorders, but also other psychiatric and physical diseases.20 In Islam, cautery is recommended as a last treatment option. Lastly, the results of the current study show that faith healers were not in favor of patients using  non-psychotropic and psychotropic drugs. This reflects their lack of knowledge of modern psychiatry.  FHs are not allowed to prescribe modern drugs, but like other clinicians they do advise their clients to consult mental health professionals.

        This preliminary study has some caveats. The design of this research is exploratory rather than analytical and more advanced statistical analyses may have revealed more definite conclusions. The sample of the study was not large yet reasonably good.  However, studied FHs revealed comprehensive but restricted responses. A multi-regional study may be needed to expand the sample for the data to yield more substantial results.  This will also entail designing more structured and comprehensive questionnaire as well as personal interviews with faith healers. The results of this study should therefore be interpreted cautiously and not generalized to other provinces.

        In summary,  FHs practising in urban areas were found to report more symptoms compared to those working in rural areas and they prescribed an array of unorthodox therapies for clients suffering from spiritual disorders. Although the revealed somatic and pychological symptoms were not very specific to the corresponding disorders, a variety of symptoms indicated the possible diagnosis of the state of jinn possession. In contrast, the symptomatology of evil eye and magic disorders heavily overlapped. Future researches should explore the assessment techniques and diagnostic methods that faith healers employ in making the diagnosis of these spiritual and other mental disorders.

REFERENCES

1.     Campion J, Bhugra D. Experiences of religious healing in psychiatric patients in south India. Soc Psychiatry Psychiatr Epidemiology 1997;32:215-21.

2.     Pereira S, Bhui K, Dein S. Making sense of ‘possession states’: psychopathology and differential diagnosis. British J Hosp Med 1995;53:582-6

3.     Pfeifer S. Belief in demons and exorcism in psychiatric patients in Switzerland. Br J Med Psychol 1994;67:247-58.

4.     Jacobson L, Merdasa F. Traditional perceptions and treatment of mental disorders in Western Ethiopia before the 1974 revolution. Acta Psychiatr Scand 1991;84:475-81

5.     Razali SM, Khan UA, Hasanah CI. Belief in supernatural causes of mental ilness among Malay patients: impact on treatment. Acta Psychiatr Scand 1996;94:229-33.

6.     Younis YO. Possession and exorcism: an illustrative case. The Arab J Psychiatry 2000;11:56-9

7.     Hussein FM. A study of the role of unorthodox treatments of psychiatric illnesses. Arab J Psychiatry 1991;2:170-84

8.     American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 4th ed. Washington DC: American Psychiatric Association 1994.

9.     Fabrega Jr H. Culture, spirituality and psychiatry. Curr Opinion Psychiatry 2000;13:525-30

10.   Hawks SR, Hull ML, Thalman RL, Richins PM. Review of spiritual health: definition, role, and intervention strategies in health promotion. Am J Health Promot 1995;9:371-8.

11. World Health Organization. The ICD-10 Classification of Mental and Behavioral Disorder 1992; Geneva: WHO.

12.   Christensen H, Griffiths K. The Internet and mental health literacy. Aust N Z J Psychiatry 2000;34:975-9

13.   Keshavan MS, Narayanan HS, Gangadhar BN. ‘Bhanmati’sorcery and psychopathology in south  India. Brit J Psychiatry 1989;154:218-20

14.   Krawietz B. Islamic conceptions of the evil eye. Med Law 2002;21:339-55.

15.   Sayed M, Abosinaina B, Rahim SIA. Traditional healing of psychiatric patients in Saudi Arabia. Current Psychiatry 1999;6:11-23

16.   Hopkins PE. Pastoral counseling as spiritual healing: a credo. J Pastoral Care1999;53:145-51

17.   Schlitz M, Braud W. Distant intentionality and healing: assessing the evidence. Altern Ther Health Med 1997;3:62-73

18.   Levin JS. How prayer heals: a theoretical model. Altern Ther Health Med 1996:2:66-73

19.   Vendura K, Geserick G. Fatal exorcism. A case report. Arch Kriminol 1997;200:73-8

20.   Qureshi NA, Al-Amri AH, Abdelgadir MH, El-Haraka EA. Traditional cautery among psychiatric patients in Saudi Arabia. Transcultural Psychiatry 1998;35:76-83

21.   Qureshi N A, Al-Habeeb TA, Al-Ghamdy YS, Magzoub MMA, Schmidt H. Psychiatric referrals: psychiatric symptomatology in primary care and general hospitals, Al-Qassim region, Saudi Arabia. Saudi Medical J 2001;22:619-24.



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HEARING IMPAIRMENT HYPERTENSION


HEARING IMPAIRMENT AND HYPERTENSION AMONG LONG DISTANCE BUS DRIVERS

Ismail Abdelmoneim, MSc, Dr.PH, College of Medicine & Medical Sciences, King Khalid University, Abha, Saudi Arabia

_______________________________________________________________

هدف الدراسة:دراسة مدى انتشار ارتفاع ضغط الدم والإعاقة السمعية لدى سائقي حافلات نقل الركاب بين المدن بالمقارنة مع سائقي حافلات نقل الركاب داخل مدينة أبها

طريقة البحث: اشتملت هذه الدراسة المقطعية على فحص عدد 108 سائق حافلة ركاب منهم 62 سائق حافلات بين المدن و 46 سائق حافلات داخل المدينة . تم خلالها دراسة الحالة الاجتماعية والاقتصادية للسائقين بواسطة استبيان ، ثم تلا ذلك فحص ضغط الدم ومقياس سمعي لكل سائق. وذلك خلال الفترة من أكتوبر 2001م إلى مارس 2002م.

النتائج: أظهرت الدراسة أن سائقي الحافلات بين المدن يتحملون عبء عمل أكبر من نظرائهم داخل المدن (64 ساعة أسبوعياً بالمتوسط + 14.3 مقارنة بـ 46.7 + 5,5 ساعة أسبوعياً).      كذلك يعانون من إعاقة سمعية في الترددات 250  ،  500  ،  1000  ،  2000 هيرتز أكثر من زملائهم وذلك رغم احتساب التأثير العمري. أما ضغط الدم المرتفع فقد عانت منه هذه الفئة أكثر من سائقي الحافلات داخل المدن.

الخلاصة والتوصيات: أثبتت الدراسة إعاقة سمعية أكثر وارتفاع ضغط الدم لدى سائقي حافلات بين المدن أكثر من سائقي الحافلات داخل المدن وبناءً على ذلك يوصى بعمل اختبار سمعي قبل وأثناء سنوات العمل للمتابعة مع العمل على تجنب الضغوط الناتجة عن هذه المهمة بتحسين      ظروف العمل والكشف الصحي المنتظم بما في ذلك فحص ضغط الدم.

الكلمات المرجعية : الإعاقة السمعية - عبء العمل - ارتفاع ضغط الدم - سائقي حافلات الركاب.

_________________________________________________________

Objectives: To investigate the prevalence of possible hearing impairment and hypertension in long distance bus drivers compared to the city bus drivers in Abha city.

Methods: This was a cross-sectional study involving 62 long distance bus drivers and 46 city bus drivers from October 2001 to March 2002. A specially-designed questionnaire was administered to the drivers to explore some of their socioeconomic backgrounds. A pure tone air conduction audiometry and blood pressure measurements were performed.

Results: Long distance bus drivers’ workload is significantly higher than that of city drivers (total weekly hours 64.0+14.3 compared to 46.7+5.5). Hearing impairment was significantly more among long distance drivers in the frequencies of 250, 500, 1000 and 2000 Hz especially in the left ear even after age corrections. The prevalence of mild hearing loss and hypertension were also higher among the long distance drivers (19.4% vs 4.5% and 38.7% vs 13% respectively).

Conclusion and recommendations: This study showed more hearing affection and a higher prevalence of hypertension among long distance bus drivers than their

___________________________________________________________________________

Correspondence to:

Dr. Ismail Abdelmoneim, P.O. Box 11698, Abha 61321, Saudi Arabia

counterparts operating in the city. Their hearing acuity should be tested before they start work and regularly afterwards. The stresses and strains of the job should be further studied and relieved; and regular health checks including blood pressure monitoring are to be instituted.

Key Words:Hearing impairment, workload, hypertension, bus drivers.

___________________________________________________________________________


INTRODUCTION

Bus drivers are known to be a high risk group. They have to deal with the pressure of time, the responsibility of the passengers’ welfare and safety, as well as other demands relating to passenger complaints.1 In some longitudinal and cross-sectional studies, it was shown that bus drivers had a high risk for cardiovascular morbidity and mortality.2,3 Studies have shown a significant positive relation between psychological job stress and strain indices and levels of adrenaline, noradrenaline and serum triglycerides levels in a group of shift work drivers.4 Thus, the extra load of shift work during unusual hours strengthened the relation between the experiences of external demands and physiologic reactivity.5 Literature on studies concerning the hearing affection of bus drivers, especially the long distance drivers are scarce.

        The aim of this study was to investigate the prevalence of hypertension and the possible hearing affection in long distance bus drivers compared to city bus drivers.

SUBJECTS AND METHODS

This study aimed at measuring the prevalence of hearing impairment and hypertension in bus drivers. It included 108 bus drivers, 62 of whom were long distance drivers traveling across cities in the kingdom and 46 drivers working in the city commuting service in Abha. This represents the total number of drivers covering these services at the Khamis Mushayat station. After completing the necessary administrative procedures, the long distance drivers were interviewed and examined in the main bus station of Khamis Mushayat. They were examined in 3 consecutive weeks to cover all working shifts. Each worker was individually interviewed after at least 12 hours of rest using a specially designed questionnaire that addressed his social and economic characteristics such as age, marital status, education, years of service and weekly hours of work, past occupation and salary. Questions on some habits such as smoking and practice of physical exercise were also asked. There were questions on history of diseases and medications. His blood pressure was checked and classified as high or normal according to WHO guidelines.6 Following the interview, the worker was examined in a separate quiet room in the administration building for his hearing acuity. After an inspection of the external ear and meatus to exclude any obstruction in the external ear, a pure tone air conduction audiogram was performed for each ear using the impedance audiometer AT22t from Interacoustics, Denmark. No driver was excluded from this study. Calibration was done before every measuring session.

Age corrections were made for the 1000, 2000, 3000, 4000 and 6000 Hz for both ears.7 The degree of hearing handicap was calculated as follows:8 (1) The average of the hearing threshold levels at 500, 1000, 2000 and 3000 Hz is calculated for each ear. (2) The percent impairment for each ear is calculated by multiplying the amount by which the above mentioned average exceeds 25 dB. (3) The binaural impairment assessment is then calculated by multiplying the smaller percentage (better ear) by 5 and adding the product to the larger percentage (poorer ear) and dividing the total by 6.

       The degree of impairment was afterwards arbitrarily categorized into mild (up to 10% loss, moderate (to 50% loss) and severe bilateral hearing loss (above 50% loss). Following this, the in-city drivers were similarly examined in the early morning at the main garage for three consecutive weeks.

        Both groups were statistically compared using the SPSS package version 10. The significance level chosen was 5% for the student’s t, X2 or Fisher exact tests and the odds ratio.

RESULTS

Table 1 shows that the length of service was significantly greater among the long distance drivers than the city drivers (16.2+7.4 years compared to 13.0+8.1 years, p<=0.04). Moreover, their weekly working hours significantly exceeded that of the city drivers (64.0+14.3 hours/week compared to 46.7+5.5 hours/week, p=0.001). However, they were paid significantly less than the city drivers (1408+291.5 SR/month versus 1766+654.8 SR/month, p=0.002). There was no significant difference in age between the 2 groups. About 38% of the long distance drivers had hypertension compared to only 13% of the city drivers; this difference was statistically significant (p=0.003).


Table 1: Demographic characteristics of both groups of drivers

Variables

Long Distance Drivers

City Drivers

p-value

(n=62) ± SD

(n=46) ± SD

Age (years)

40.4 ±6.4

40.5 ± 8.3

NS

Duration of work (years)

16.2 ± 7.4

13.0 ± 8.1

0.04

Hours/week

64.0 ± 14.3

46.7 ± 5.5

0.001

Salary / month (SR)

1408 ± 291.5

1766 ± 656.8

0.002

No. (%)

No. (%)

Marital status

NS

Unmarried

3 (4.8)

  5 (10.9)

Married

59 (95.2)

41 (89.1)

Education

NS

Primary

30 (48.4)

29 (63.0)

Intermediate

10 (16.1)

13 (28.2)

Secondary

22 (35.5)

4 (8.8)

Smoking (yes)

28 (45.1)

22 (47.8)

NS

Physical exercise (yes)

3 (4.8)

8 (17.4)

0.03

Hypertension

24 (38.7)

6 (13.0)

0.003

NS=Not significant

Table 2: Threshold hearing levels (in dBA) for both groups of drivers using the pure tone air conduction audiometry

Group

Frequencies

250 Hz

500 Hz

1 KHz

2 KHz

3 KHz

4 KHz

6 KHz

8 KHz

Right ear:

LDD (n=62)

43.1±12.5*

39.6±7.6*

22.6±8.2

18.8±9.1

18.5±12.1

16.4±13.2

22.4±12.8

34.5±6.3

CD (n=46)

38.6±9.9

35.2±9.5

20.7±8.9

15.6±9.9

21.3±17.2

20.6±20.8

24.7±20.3

42.2±36.3

Left ear:

LDD (n=62)

38.9±12.2*

36.5±9.3

  29.5±8.1*

  17.6±8.3*

18.7±12.7

19.3±13.9

36.8±16.5

34.1±17.6

CD (n=46)

33.8±8.9

33.4±10.3

25.2±8.4

14.2±9.2

18.8±16.7

18.2±18.8

37.5±23.0

35.5±22.4

LDD=Long distance drivers,  CD=City drivers *significant at 5% level

Table 3: Frequency of degree of hearing loss in both groups of drivers

Degree of hearing loss

Long distance

drivers (n=62)

No. (%)

City drivers (n=46)

No. (%)

Significance

Mild

12 (19.4)

2 (4.5)

OR (95% CI) =

5.28 (1.03-36.25)*

Moderate

7 (11.3)

1 (2.2)

OR (95% CI) = 5.73 (0.66-128.47)

Severe

             2 (3.2)

              0

Fisher exact test = p=0.506

*Significant at 5% level


        Table 2 describes the hearing threshold in dBA for both groups at the different frequencies. It was evident that the long distance drivers had significantly higher mean loss than the city drivers in the 250 Hz and 500 Hz frequencies in the right ear (mean 43.1+12.5 dBA compared to 38.6+9.9 dBA and 39.6+7.6 dBA compared to 35.2+9.5 dBA respectively). Similarly, the left ear showed significantly higher  impairment in the 250, 1000 and 2000 Hz frequencies (38.9+12.2 dBA compared to 33.8+8.9 dBA and 29.5+8.1 dBA compared to 25.2+8.4 dBA and 17.6+8.3dBA compared to 14.2+9.2 dBA respectively for the 3 frequencies).

        Table 3 shows the number of drivers in both groups suffering from mild, moderate or severe hearing loss. It was noticed that the only significant difference was in the mild hearing loss category where the long distance drivers had an odds ratio (95% CI) of 5.28 (1.03-36.25) than the city drivers for this degree of impairment.

DISCUSSION

Urban bus drivers have long been known to be high risk to many long-term somatic effects.9,10 Although their main work is to drive, long distance bus drivers are thought to be under a lot of stress because of the long working hours, fatigue and unfavorable physical and climatic factors.11 The aim of this study was to investigate the prevalence of hypertension as a stress indicator, as well as hearing impairment in this group of workers as compared to the city bus drivers.

        The overall workload marked in the total number of working hours per week was significantly more for the long distance drivers group, as was the length of service. Thus, it can be assumed that differences in prevalence of either hypertension or hearing impairment between the two groups are more related to this difference in workload.

        The incidence of hypertension was significantly higher (38.7%) among long distance drivers. This has also been reported in several other studies involving the higher frequencies of hypertension12 or cardiovascular affections and mortality13 among this group of workers. The probable cause as pointed out previously is the higher levels of adrenaline and noradrenaline in drivers as a result of the stress of driving.4

        Bus drivers usually work in a noisy environment. Some studies have shown that the noise level at the driver seat exceeds the 90 dBA  Threshold limit value.14. Occupational hearing loss is usually characterized by maximum loss in the high frequencies especially the 4000 Hz frequency.15 This, however, is not applicable in early cases of occupational hearing impairment where the loss starts in the lower frequencies. The probable reason for more affection of the left ear might be the result of its proximity to the window through which a lot of noise penetrates. The serious implication of the lower frequencies affections is that it affects the normal speech hearing range (500 to 2500 Hz) which might represent an occupational as well as a social handicap.15

        Similar to the finding in this study, other studies have found the incidence of both hypertension and hearing loss outstanding in this group of workers.16

CONCLUSION AND RECOMMENDATIONS

Bus drivers are susceptible to both hypertension and hearing impairment as indicated in this study, where the group with the higher workload (duration of work) suffered significantly more than the group with a lower workload. It is recommended that further in-depth studies of their working conditions be done and a means of improvement be found. Their hearing abilities should be tested before the assumption of duty, and regularly afterwards. The stresses and strains of the job should be further studied and conditions improved. Regular health check-ups including blood pressure monitoring should be instituted.

ACKNOWLEDGMENT

I am thankful Dr. Mohd Yunus Khan, my colleague in the Department who spared no effort to help me throughout the study.

REFERENCES

1.        Richter P, Wagner T, Heger R, Weiss G.  Psychophysiological analysis of mental load during driving on rural roads- a quasi experimental field study. Ergonomics 1998; 1(5): 93-609.

2.        Netterstrom B, Suadicami P.  Self assessed job satisfaction and ischaemic heart disease mortality: a 10 years follow up of urban bus drivers. Int J Epidemiol 1993; 22 (1): 51-6.

3.        Netterstrom B, Juel K. Impact of work related and psychosocial factors on the development of ischaemic heart disease among urban bus drivers in Denmark. Scandinavian J Work Environ Health 1988;14 (4): 231-8.

4.        Alfredsson L, Hammar N, Hogstedt C.  Incidence of myocardial infarction and mortality from specific causes among bus drivers in Sweden. Int J Epidemiol 1993; 22 (1): 57-61.

5.        Gobel M, Springer J, Scheiff J. Stress and strain of short haul bus drivers: psychophysiology as a design oriented method for analysis. Ergonomics 1998; 41(5): 563-0.

6.        Hypertension Control. Report of a WHO expert committee, Geneva 1996.

7.        American industrial Hygiene Association, Noise and Hearing Conservation Manual, 4th ed. Akron, OH: AIHA, 1986.

8.        Guide for evaluation of hearing handicap. American Academy of Otolaryngology committee on hearing and equilibrium and the American council of Otolaryngology Committee on the medical aspects of noise. JAMA 1979; 241: 2055-9.

9.        Morris JN, Crawford MD.  Coronary heart diseases and physical activity at work. BMJ 1958; 1485-92.

10.     Netterstrom B, Laursen P.  Incidence and prevalence of ischemic heart disease among urban bus drivers in Copenhagen. Scand J Soc Med 1981; 9: 75-9.

11.     Rydstedt LW, Johansson G, Evans GW.  The human side of the road: improving the working conditions of urban bus driving. J Occup Health Psychol 1998; 3 (2) 161-71.

12.     Ragland DR, Greiner BA, Holman BL, Fisher JM. Hypertension and years of driving in transit vehicle operators.  Scand J Soc Med 1997; 25 (4): 271-9.

13.     Wang PD, Lin RS.Coronary heart disease risk factors in urban bus drivers. Public Health  2001; 115 (4): 261-4.

14.     Patwardhan MS, Kolate MM, More TA. To assess effect of noise on hearing ability of bus drivers by audiometry. Indian J Physiol Pharmacol 1991; 35 (1): 35-8.

15.     Olishifski JB. Occupational hearing loss, noise, and hearing conservation. In: Occupational medicine, principles and practical applications. Carl Zenz (ed) 2nd edition 1988, Mosby Year Book p 296.

16.     Mikovic-Kraus S: Noise induced hearing loss and blod pressure. Int Arch Occup Environ Health 1990; 62 (3): 259-60




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