- Email: [email protected]
Instructions for Authors
INSTRUCTIONS FOR AUTHORS Manuscript Preparation and Submission Guidelines The Instructions for Authors are also available online at http://www.jfas.org/ in the “Author’s Corner” Section. All submissions to JFAS must be submitted electronically at http://www.jfas.org/. By selecting “Author’s Corner” and “Manuscript Submission” at the JFAS Web site, you will arrive at the Elsevier electronic submission page, the Elsevier Editing System at http://ees.elsevier. com/jfas/. Authors will be guided stepwise through the creation and uploading of the various files. When submitting a manuscript to Elsevier Editorial System (EES), authors need to provide an electronic version of their manuscript. For this purpose original source files, not PDF files, are preferred. The author should specify a category designation for the manuscript (full-length article or Tips, Quips and Pearls) and choose a set of classifications from the prescribed list provided online. Authors may send queries concerning the submission process, manuscript status, or journal procedures to the Editorial Office. Once the submission files are uploaded, the system automatically generates an electronic (PDF) proof, which is then used for reviewing. All correspondence, including the Editor’s decision and request for revisions, will be by e-mail, and logged in the EES. Copyright Transfer Agreement: The Journal of Foot & Ankle Surgery considers for publication original articles only. Manuscripts are accepted on the premise that they are submitted solely to this journal, and have not been published elsewhere. Work appearing in The Journal of Foot & Ankle Surgery is copyrighted by the American College of Foot and Ankle Surgeons (ACFAS). Each author will be required to sign a copyright transfer agreement (CTA). The form will be e-mailed once the manuscript is submitted on-line, and you can, at any time download the form by following the instruction described, below. The form states: “In consideration of The Journal of Foot & Ankle Surgery reviewing my (our) submission, the undersigned author(s) transfers, assigns, or otherwise conveys all copyright ownership to the American College of Foot and Ankle Surgeons (ACFAS) in the event the work is published. The undersigned authors(s) guarantee to the American College of Foot and Ankle Surgeons that the submission is the original work of the author(s). If any part of the submission is owned by another party, the authors(s) must attach to this statement an assignment of copyright to the American College of Foot and Ankle Surgeons signed by the owner.” ●
Every author, including the corresponding author and all co-authors, must submit a signed CTA to the Journal
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office as soon as possible following submission of a manuscript for editorial consideration. The CTA can be downloaded from the “Author’s Corner” section of the JFAS webpage (www.jfas.org/), by clicking on the “Manuscript Submission” option, which links to the Elsevier Editorial System (http:// ees.elsevier.com/jfas/ ), where the form can be procured by clicking on the “Copyright Transfer Agreement” option. The signed agreement/s can be returned to D. Scot Malay, Editor, JFAS, via electronic mail (after scanning or digitally photographing the signed CTA) at [email protected], via telefax at (215) 967-4463, or via standard mail at 2314 Waverly Street, Philadelphia, PA 19146, USA. No manuscript can be published without first having the signed CTA/s on file in the Journal office, and authors are instructed to attend to this matter as soon as your manuscript has been accepted for editorial consideration. In the event that a manuscript has only a single author, and that author does not submit a signed CTA prior to the publication preparation deadline, then publication of the manuscript will be delayed until the required signed CTA/s are on file in the Journal office. The Editor also reserves the right to discontinue editing a manuscript, and hold peer review, if the signed Copyright Transfer Agreement/s is/are not on file in the Journal offices. All accepted manuscripts become the permanent property of ACFAS and may not be published elsewhere without written permission from both the author and ACFAS. Transfer of copyright to ACFAS implies transfer of all worldwide rights, including printed, electronic, microfilm, and facsimile publication, unless specified otherwise.
Financial Disclosure and Conflict of Interest Statement: Every author, including the corresponding author and all co-authors, must submit a signed conflict of interest statement to the Journal office, at the time of submission of a manuscript for editorial consideration. Authors should disclose any financial arrangements they may have with any company whose product is pertinent to the submitted manuscript, or with a company making a competing product. The information will be held in confidence while the paper is under review and will not influence the blind peer review process. If the article is accepted for publication, a disclosure statement will appear with the article. The conflict of interest statement can be downloaded from the “Author’s Corner” section of the JFAS webpage (www.jfas.org/), by clicking on the “Manuscript Submission” option, which links to the
Elsevier Editorial System (http://ees.elsevier.com/jfas/ ), where the form can be procured by clicking on the “Conflict of Interest Disclosure” option. The completed and signed statement/s can be returned to D. Scot Malay, Editor, JFAS, via electronic mail (after scanning or digitally photographing the completed and signed statement/s) at [email protected], via telefax at (215) 967-4463, or via standard mail at 2314 Waverly Street, Philadelphia, PA 19146, USA. No manuscript can be published without first having the conflict of interest disclosures on file in the Journal office. General Format: Each page should be numbered consecutively, in the bottom right corner, with the title page designated as page 1. The manuscript should be doublespaced, line-numbered, and left margin justified. The contents of your manuscript should include the following sections in the following order: For a full-text manuscript reporting a clinical trial, cohort study, or any other original research, or a case series or case report: 1) 2) 3) 4) 5)
6) 7) 8) 9)
Title Page Abstract Level of Clinical Evidence Key Words Text, consisting of a) Introduction b) Patients/ Materials and Methods c) Results and d) Discussion Acknowledgments References Tables Figures For a Tips, Quips and Pearls manuscript:
1) 2) 3) 4)
5) 6) 7) 8)
Title Page Abstract Key Words Text, consisting of: a) Introduction b) Technique c) Discussion Acknowledgments References Tables Figures
The main segments are to be identified by bold, leftmargin headings, capitalizing the first letter of each named section. As a general rule, when describing activities that were part of the investigation, as well as the observed outcomes, use the past tense. Present tense is reserved for discussions
of states of knowledge, which are considered ongoing (for example, “Open reduction and internal fixation is the treatment of choice for displaced, unstable fractures . . .”). Whenever uncertainty arises in regard to format, authors are encouraged to consult the following text: AMA Manual of Style: A Guide for Authors and Editors, 10th Edition, edited by JAMA & Archives Journals. Title Page: The title page, which is to be submitted as a separate electronic file, should include the following items: ● ●
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title of the manuscript, authors, and their credits, including academic degrees (Do not use initials to designate diplomate status in any organization. Fellowship status in an organization can be designated using the appropriate initials.) The corresponding author should be clearly identified and the telephone and telefax numbers, as well as the electronic and standard mailing addresses, should be provided. name of affiliated institutions (hospital/university/organization or private practice), if applicable, including city, state, and country (if not from the United States).
The title, as provided in the title page, will be used in any publication related to the article, as will the order of the authors submitted. Abstract: Submit an abstract summarizing the contents of the article on a page separate from the title and manuscript (this is done in a text box during the online submission process). We request that the abstract be no longer than 250 words, since PubMed truncates longer abstracts at 250 words, resulting in an uncontrolled loss of information that could adversely influence online searching efforts. ●
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The Abstract for a manuscript is to be written as continuous prose, without subheadings for each section of the manuscript. The Abstract for a report of research should reflect the format of the manuscript itself, describing pertinent information for each section of the manuscript (without subheadings). It should briefly introduce the research problem, explain methods, summarize results, and provide a conclusion. The Abstract for a case study should state the condition of interest, and include a brief summary of the specific clinical situation, the uniqueness or rarity of the diagnosis or the novelty of an intervention, and a statement regarding the clinical significance of the case. Do not use any abbreviations or bibliographic reference citations in the Abstract. If necessary, parts of the Abstract may be written as phrases, rather than as complete sentences.
Level of Clinical Evidence: Immediately following the Abstract section, the author is to designate the paper in accordance with the Level of Clinical Evidence as depicted in Table 1. It is important to understand that all levels of clinical evidence
Table 1.
Levels of Evidence for Primary Research Question* Types of Studies
Therapeutic Studies—Investigating the Results of Treatment Level I
Level II
● High-quality randomized controlled trial with statistically significant difference or no statistically significant difference but narrow confidence intervals ● Systematic review2 of Level-I randomized controlled trials (and study results were homogeneous3) ● Lesser-quality randomized controlled trial (eg, ⬍80% follow-up, no blinding, or improper randomization) ● Prospective4 comparative study5 ● Systematic review2 of Level-II studies or Level-I studies with inconsistent results
Prognostic Studies— Investigating the Effect of a Patient Characteristic on the Outcome of Disease ● High-quality prospective study4 (all patients were enrolled at the same point in their disease with ⱖ80% follow-up of enrolled patients) ● Systematic review2 of Level-I studies ● Retrospective6 study ● Untreated controls from a randomized controlled trial ● Lesser-quality prospective study (e.g. patients enrolled at different points in their disease or ⬍80% follow-up) ● Systematic review of Level-II studies Case-control study7
Level III
Case-control study7 ● Retrospective6 comparative study5 ● Systematic review2 of Level-III studies
Level IV
Case series8
Case series
Level V
Expert opinion
Expert opinion
Diagnostic Studies—Investigating a Diagnostic Test
Economic and Decision Analyses—Developing an Economic or Decision Model
● Testing of previously developed diagnostic criteria in series of consecutive patients (with universally applied reference “gold” standard) ● Systematic review2 of Level-I studies ● Development of diagnostic criteria on basis of consecutive patients (with universally applied reference “gold” standard) ● Systematic review2 of Level-II studies
● Sensible costs and alternatives; values obtained from many studies; multiway sensitivity analyses ● Systematic review2 of Level-I studies
● Study of nonconsecutive patients (without consistently applied reference “gold” standard) ● Systematic review2 of LevelIII studies ● Case-control study ● Poor reference standard Expert opinion
● Analyses based on limited alternatives and costs; poor estimates ● Systematic review2 of LevelIII studies
● Sensible costs and alternatives; values obtained from limited studies multiway sensitivity analyses ● Systematic review2 of LevelII studies
● No sensitivity analyses Expert opinion
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A complete assessment of the quality of individual studies requires critical appraisal of all aspects of the study design. A combination of results from two or more prior studies. 3 Studies provided consistent results. 4 Study was started before the first patient enrolled. 5 Patients treated one way (e.g., with cemented hip arthroplasty) compared with patients treated another way (e.g., with cementless hip arthroplasty) at the same institution. 6 Study was started after the first patient enrolled. 7 Patients identified for the study on the basis of their outcome (e.g., failed total hip arthroplasty), called “cases,” are compared with those who did not have the outcome (e.g.,had a successful total hip arthroplasty), called “controls.” 8 Patients treated one way with no comparison group of patients treated another way. *This chart was adapted from material published by the Centre for Evidence-Based Medicine, Oxford, UK. For more information, please see www.cebm.net. 2
can be meaningful and interesting to readers, and authors are encouraged to submit all types of investigations. Key Words: Provide 3–5 key words or phrases for indexing purposes. Keep in mind that electronic searches of the biomedical literature depend to a large degree on key words. Refer to PubMed’s Medical Subject Heading (MeSH) webpage (http:// www.ncbi.nlm.nih.gov) for help selecting key words. Key words are to be spelled in lower case letters, unless representative of a proper name, and listed in alphabetical order separated by a comma between each word/term. Avoid abbreviations in the key words, unless a proprietary name uses an abbreviation. If a proprietary name is used, be sure to include the appropriate symbol indicating registered trademark. In general, proper names are not used as key words. Text: The text should be comprised of the following four
sections: Introduction, Patients and Methods or Materials and Methods, Results, and Discussion. Introduction: This section should provide a concise overview of the state of knowledge regarding the specific problem being studied. It should begin with a statement of the problem and its clinical/social importance, followed by an explanation of recent and important research related to the topic, supported by reference citations. The importance of the topic is best conveyed by means of statistics that indicate the prevalence and/or economic impact of the condition in the population/society. After an explanation of what is known, and what remains unknown in regard to the focus of the study, the author should concisely state the specific research question or hypothesis for the current investigation. Gener-
ally, the last sentence of the Introduction should include a statement that describes the specific study design (see Table 2, below) and reiterates the research question.
Patients and Methods (or Materials and Methods): If the study is a clinical investigation involving living, human participants (patients, subjects), then the heading for this section should be “Patients and Methods.” If the investigation involves animals, cadavers, or in vitro models of any sort, including computer models, then this section should be termed “Materials and Methods.” In general, the methods section should describe the following elements of the investigation: ● ●
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aims, assessors and other members of the investigational team, including surgeons of record if they are also authors of the paper or outcomes assessors, population or sample. intervention, endpoints (outcomes), statistical methods used to determine the meaning of the results
In essence, this section should describe the building blocks of good clinical evidence that were used in the investigation (see Table 3, below).
More detailed discussion of these important elements of biomedical investigation can be found at a number of evidence-based medicine websites, including the Centre for Health Evidence (http://www.cche.net/), the Centre for Evidence-based Medicine (http://www.cebm.utoronto.ca/), and the Oxford Centre for Evidence-based Medicine (http:// www.cebm.net/). Ideally, the methods section should provide enough detail to allow subsequent researchers to replicate the study. When reporting randomized controlled trials, a study flow diagram
in CONSORT format, as well as all of the information required by the CONSORT checklist, should be provided. The CONSORT statement, checklist, and study flow diagram are available at http://www.consort-statement.org. Authors submitting reports of clinical trials are encouraged to register their investigation with a public domain repository, such as ClinicalTrials.gov, available at http:// clinicaltrials.gov/. Please indicate in the methods section of your submission, the specific registration number and public domain repository where the study data can be found. The following elements of the investigation should be concisely described in the methods section: Aims: The primary aim of the investigation, as well as any secondary aims, should be clearly stated. A distinction should be made between primary and secondary aims. As a rule, the sample size should be adequate to identify a statistically significant difference in regard to the primary aim, if such a difference exists. Power and sample size calculations can be determined using any of a number of software programs, such as that found at: http://biostat. mc.vanderbilt.edu/twiki/bin/view/Main/PowerSampleSize. In describing the primary aim, many authors will restate, in some fashion, their hypothesis and research question, emphasizing that they undertook to answer the question. Assessors: • Members of the investigational team should be described in regard to their participation in the study; namely: * if they served as outcome assessors * if they performed an intervention * if they abstracted data from medical records, in the case of a retrospective study * If they performed statistical analyses of the data • For studies in which subjective measurements are determined, such as measurements of radiographic angles, a method should be described for breaking ties and determining an outcome when indecision or uncertainty existed. • If outcomes assessors were blind to treatment allocation, this must be stated. • If outcomes assessors were participants in the intervention, such as members of the surgical team or treating clinicians, this must also be stated. Study population: ●
The methods section should provide readers with an explicit description of the participant/patient population and the time period from which they were selected. The time period should delineate the day, month and year that the period started; and the day, month and year that the period ended (MM/DD/YYYY-MM/DD/YYYY). If the day that the time period started is not precisely known, then it is acceptable to state just the month and year that initiated and ended the period (MM/YYYY-MM/
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YYYY). This is a very important detail, since the duration of interest can be very different, and remains unclear, if only the year at the start and end of the time period is depicted. It is also important for the author to state whether or not treatment allocation was determined in a random fashion, and whether or not participants in a clinical trial were blind to treatment allocation. For case series and cohort studies, the author should state whether or not the participants were enrolled consecutively. The inclusion and exclusion criteria must be clearly stated, and it is best to simply list these in a fashion that would allow other interested investigators to repeat your study. Authors should also indicate whether or not the investigation was conducted with Institutional Review Board approval, and whether or not participants/patients volunteered and consented to be in the investigation. Participants in the investigation should be referred to as “participants” if the diagnostic test or intervention is experimental and not yet approved for use by the US Food and Drug Administration, and as patients for all other tests or interventions that are already known to be therapeutic, safe, and efficacious. Intervention:
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In any investigation, the intervention needs to be explicitly described. If participants were randomized to an active therapy that was compared to standard therapy, or to placebo, then each treatment arm needs to be described. Authors are encouraged to avoid presenting a detailed narrative report of an operative intervention for a standard procedure that can be referenced in any of a number of textbooks or published articles in peer-reviewed journals. Reference can be made, with an appropriate citation, to a standard procedure as it is described in a textbook; and variations on the procedure should be described in detail. We do not want to publish an entire operative report. Novel interventions, notable variations on standard procedures, decision points related to an intervention, and adjunct procedures should be thoroughly described. Generic drug names should be used wherever possible. When a brand name is used, the name and address of the manufacturer must be identified in parentheses immediately following the proprietary name. As a rule, the proprietary name should be used the first time that the medication or device is mentioned, and thereafter referred to in generic terms. Whenever medication use is described, complete dosing information (dose, method of administration, frequency and duration of use) should be included. Endpoints (outcomes):
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Outcome measures should be explicitly defined in terms of how the variable was measured, who made the mea-
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surement, and whether or not the assessor was blind to the intervention (for an intervention trial). Authors should clearly state if outcomes were based on physical examination, chart review, telephone interview, questionnaire or radiographic films, or some other method. As a rule, any variable that a reasonable clinician would consider important in regard the treatment of a patient, as it pertains to the investigation, should be considered in the analysis. In addition to the intervention/s or outcome/s of interest (dependent variable/s), typical independent variables include such things as age and age category, gender, activity level, body mass index (BMI) or BMI category, comorbidities, medications, duration of treatment, surgeon or clinical site, adjunct therapies, frequency and duration of follow-up, and post-intervention management procedures (immobilization, physical therapy, etc.). Items such as those listed above should be referred to as “variables” and not as “parameters,” since the term “parameter” should be reserved for statistical expressions that describe the data, such as the mean and standard deviation, or beta coefficients derived from a regression analysis. Whenever possible, it is preferable that “hard” endpoints be used, such as analytical measurements, clinical or microbiology laboratory results, and the like. Whenever “soft” endpoints, such as quality of life (QOL) or footrelated QOL, are considered, it is preferable to use health measurement instruments that have previously been shown to be reliable and to provide valid information. Keep in mind that a health measurement instrument in and of itself is not said to be valid, although the information gained from the use of the health measurement instrument may (and should) be. QOL instruments should be specific to the foot and ankle (ACFAS, AOFAS, Bristol Foot Score, Foot Function Index, etc.), as well as measures of general health (SF-36, etc). Whenever a health measurement instrument is used, the author should cite the reference wherein the reader can find the results of the reliability and validation study related to the instrument. Investigator derived questionnaires should be described in terms of reliability and validity, if such testing was undertaken by the investigators, or if it has been described in a previous publication. For scales that rank categories (e.g., mild, moderate, severe) an aggregate score should be used. For measurements of pain, the 10-cm visual analog scale (VAS) is recommended. Statistical methods:
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The statistical plan should be clearly described, and every investigation should include at least descriptive and inferential, as well as univariate and multiple variable, statistical analyses.
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The descriptive statistical analysis should define parameters such as the measure of central tendency (mean or median average), and measures of dispersion (standard deviation or range). The parameter, as well as the statistical test, should be selected based on the type and distribution of the data. Continuous numeric data that are normally distributed are suitable for representation using the mean and standard deviation, and may be analyzed using mean-based statistical tests (such as Student’s t-test). Categorical data, and data that are non-normally distributed, are suitable for representation using the median and range, and may be analyzed using median-based (nonparametric) methods such as the Wilcoxon matched-pairs signed-ranks test, sign test, Wilcoxon rank-sum test, and the Kruskal-Wallis equality-of-populations rank test, and other null hypothesis tests and methods of estimation. For categorical data, Fisher’s exact method should be used whenever possible. Univariate analyses should describe the association of independent variables with the outcome of interest (dependent variable), whereas multiple variable analyses should describe the association of all of the clinically important variables with the outcome of interest.
Results should be presented with only as much precision as is of scientific value. For example, measures of association (odds ratios, relative risks, risk differences, etc.) should typically be reported to two significant digits. As a rule, the terms “significant” and “significantly” should be reserved for use when describing statistical differences. The statement “no significant difference was found” between 2 or more groups should not be made unless a power analysis was done and the value of alpha (level of significance, typically 5%) or beta (the power to detect a statistically significant difference, usually 80% or 90%) is reported. Use of the word “significant” requires reporting of a P-value (probability) or, preferably, the 95% confidence interval about a point estimate. Ninety-five percent confidence intervals are preferred whenever the results of survivor analyses are given in the text, tables or graphs. Except when 1-sided tests are required by study methodology, such as in noninferiority trials, 2-sided P-values should be reported. By convention, P-values larger than 0.01 should be reported to 2 decimal places, those between 0.01 and 0.001 to 3 decimal places, and P-values smaller than 0.001 should be reported as P ⬍ 0.001. Probabilities should never be reported as P ⫽ 0.000. Furthermore, use of the word “correlation” or the term “correlates with” requires that a correlation coefficient be calculated and reported, otherwise terms such as “association” or “associated” should be used. Use the uppercase P as the symbol to indicate the probability. The results of a sensitivity analysis, such as that described by Greenland (Maldonado G, Greenland S: Simu-
lation study of confounder-selection strategies. Amer J Epidemiol. 138: 923–936, 1993), or that described by Rosenbaum (Rosenbaum PR. Sensitivity analysis for matched case-control studies. Biometrics. 47(1): 87–100, 1991; and, Rosenbaum PR. Discussing hidden bias in observational studies. Ann Intern Med. 1; 115(11): 901–5, 1991), should be presented for retrospective studies where unmeasured independent variables may have potentially influenced the results. Additional references that may be useful in regard to the description of the methods and the presentation of a statistical plan include: Bailar JC III, Mosteller F. Guidelines for statistical reporting in articles for medical journals: amplifications and explanations. Ann Intern Med 1988; 108: 266 –73. Altman DG, Machin D, Bryant TN, Gardner MJ (eds). Statistics with Confidence. 2nd edition. London: BMJ Books, 2000. Malay DS. Some thoughts about data type, distribution, and statistical significance. J Foot Ankle Surg 45: 57–9, 2006. Malay DS. Levels of clinical evidence. J Foot Ankle Surg 46: 63– 4, 2007. Results: The results section should provide quantitative information about the data collected, in the form of descriptive and inferential statistics. ●
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Relevant information on the study population includes demographic information for each subgroup (control group and study groups), exclusions and attrition. Inferential statistics should be used to compare groups using appropriate statistical tests based on the size of the study population, type of variables under study (discrete vs. categorical), and the distribution of the data collected. Quantitative information should be summarized in the text, and readers should be referred to relevant tables for more detailed information. As a rule, a minimum of three results tables should be presented, and designated Tables 1, 2, and 3. Table 1 typically depicts the baseline demographic characteristics of the sample population, often categorizing the patients/participants by intervention or outcome, and showing whether or not statistically significant differences existed between the groups. For randomized controlled trials, it is not necessary to depict statistically significant differences at baseline, since randomization distributes the characteristics by chance. Table 2 generally depicts the results of the univariate analyses, and Table 3 generally depicts the results of the multiple variable analyses. Additional tables can be helpful when the data warrant such detail. Figures and tables used to report the results need to be complete with enough detail to stand alone, without the need for the reader to refer to the detailed text in order to fully understand the results. Therefore, the
table title, headings and legends need to be thoughtfully phrased so that there is no ambiguity or lack of information (sample size, units of measurement, statistical test used to calculate the P-value, etc.). Discussion: The discussion section offers the authors’ interpretation of the results of their investigation. Authors should consider how their results fit into the general state of knowledge on the subject, as well as their clinical relevance. In addition, authors should acknowledge the limitations of their investigation that may have introduced bias, and they should discuss how the results may have been affected by bias. Finally, suggestions for clinical applications and/or further research may be appropriate. Do not include a separate “Conclusion” subsection, as the final paragraph of the discussion should describe the authors’ conclusions (and the paragraph can start with a sentence that states: “In conclusion, we found . . .” or something to this effect). Acknowledgement: Acknowledgments should be made to those who have informally contributed their expertise or assisted in the investigation, rather than to those who have contributed to the manuscript while performing the role of their regular occupation. References: References are cited in the body of the text by means of numeric citations listed parenthetically in the appropriate sentence, prior to the end of the sentence (usually just before the period ending the sentence, or immediately following mention of a specific author or previous publication). Reference citations are to appear in sequential numeric order, beginning with the number “1” and continuing in order the first time that a particular reference is cited, until the last citation is noted. In other words, supply references numbered in the exact order they appear in the text (not alphabetically). Do not use superscripts, and do not submit a document with endnotes embedded via software algorithms (macros) that link items on the reference page to the in-text citation. If you use such macros to write your paper, please disable the macro, or convert the references cited to text only, prior to submitting your manuscript. This is important because embedded macros impede the editorial process, and greatly slow down the turnaround time related to reviewing and editing a manuscript. Begin the list of references on a new page. The references should be double-spaced. Sources not identified in the text should not be listed. Unpublished sources must be included in parentheses within the body of the text, not in the Reference Section. Abbreviations for journal titles should conform to those used by Medline (www.ncbi.nlm.nih.gov/ sites/entrez?db⫽pubmed). If Medline does not index a journal, then spell out the entire journal name in addition to listing the author name/s, title of the article, volume number, page numbers, and year of publication. Always list all authors, and do not use “et al” when listing your references. The term “et al” may be used in the body
of the text; however, it is generally reserved for mentioning papers written by more than three authors. Textbook references must include the specific page or pages used. Web site references must include the date when the site was last accessed. Examples of reference citations include: For a journal article: 1. Mendicino RW, Orsini RC, Whitman SE, Cantanzariti AR. Fibular groove deepening for recurrent peroneal subluxation. J Foot Ankle Surg 40:252–263, 2001. For a textbook: 2. Trevino SG. Disorders of the hallucal sesamoids. In Foot and Ankle Disorders, pp 379 –398, edited by MS Myerson, WB Saunders, Philadelphia, 2000. For an electronic version of a print journal: 3. Gardner MJ, Boraiah S, Hentel KD, Helfet DL, Lorich DG. The hyperplantarflexion ankle fracture variant. J Foot Ankle Surg [serial on the Internet] 46:256 –260, 2007. Available at: http://www.jfas.org/issues/contents. For a Web page: 4. Clinical Practice Guideline Heel Pain Panel. Diagnosis and Treatment of Heel Pain. American College of Foot and Ankle Surgeons Web site. September/October 2001. Available at: http://www.acfas.org/pubresearch/cpg/heelpaincpg.htm. Accessed July 20, 2007. For a personal communication: 5. John A. Ruch, DPM; personal communication, dd/mm/ yyyy. For a thesis or dissertation: 6. Malay DS. “The Incidence and Risks of Failure to Heal After Lower Extremity Amputation for the Treatment of Neuropathic Foot Ulcer in Diabetic Patients” (MA thesis, The University of Pennsylvania, 2006), 2– 4. Tables: Tables should be clear and support the specific points mentioned in the text. ●
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Black and white lines and text are preferred. The “insert table” function of the toolbar of most word processors works well for this. Tables and their accompanying legends should be able to stand alone, communicating the meaning of the information without reference to the main text. In the text, tables are cited using parentheses about the table-reference being cited. For example: “(Table 1)”. You do not need to state: “(see Table 1).” Each table should be titled, and accompanied by a table legend. The table title should be formatted as in the following example: “Table 1 The dataset.” Do not use abbreviations in either the title or the table legend, unless the abbreviation is defined in the legend. Table titles and legends must be submitted for each figure, in consecutive order, double-spaced, on a separate
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page from the text, typically following the list of references cited. Abbreviations or footnotes should be explained in lower case alphabetical superscripts in the legend beneath the table. Each table may be submitted as a separate page (file), or included sequentially in the body of the text (preferable). All tables must be original, unless indicated otherwise. Tables previously published in other sources should be accompanied by a letter from that publishing company and author, granting permission for their use.
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Figures: Photographs and illustrations should be clear and support the specific points mentioned in the text. ●
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Figures and their accompanying legends should be able to stand alone, communicating the meaning of the information without reference to the main text. In the text, figures should be cited using parentheses about the figure-reference being cited. For example: “(Figure 1)”. Each figure should be titled, and accompanied by a figure legend. The figure title should be formatted as in the following example: “Figure 1 The gastrocnemius recession.” Do not use abbreviations in either the figure title or the figure legend, unless the abbreviation is defined in the legend. Abbreviations or footnotes should be explained in lower case alphabetical superscripts in the legend beneath the figure. Figure titles and legends must be submitted for each figure, in consecutive order, double-spaced, on a separate page from the text. Each figure must be submitted as a separate page (file), in other words, do not submit multiple figures embedded in a Word file. Images should be provided in TIF, GIF or EPS format, per the instructions for online submission at http:// ees.elsevier.com/jfas. Manuscripts that describe a pathological entity must be accompanied by a photomicrograph depicting the histopathology, with magnification power and staining technique indicated. Radiographic images should be submitted in grayscale format. Black and white line drawings are acceptable only if they are of professional quality. All figures must be original, unless indicated otherwise. Figures previously published in other sources should be accompanied by a letter from that publishing company and author, granting permission for their use. Illustrations and figures will not be returned to the authors.
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Any and every time that a proprietary substance (such as a medication), device, equipment, or software program is mentioned in the manuscript, it must be accompanied by either of the following symbols: “®” or “™”, indicating that the substance or device is a registered trademark. The following information must be provided in parentheses, immediately following mention of the proprietary item: proprietor’s name (the name of the company that owns the registered trademark), city and state wherein the proprietor’s headquarters are located, and the country if other than the United States. Authors should use the proprietor’s precise terminology (exact name and registered trademark symbol, “®” or “™”) when referring to a specific proprietary substance, device or procedure. This information is usually available at the proprietor’s Web site. If copyrighted material is mentioned, then the “©” symbol should accompany the item. The use of copyrighted material requires that the author obtain explicit permission from the owner of the copyright (publisher), and the author, for such use.
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Do not use abbreviations in the Title, Abstract, or Key Words section of the manuscript, because information from these portions of the paper is used in the process of electronically indexing the biomedical literature. If a proper or proprietary name entails the use of an abbreviation, only then can it be used in the Title, Abstract or Key Words sections. Abbreviations can be used in the Introduction, as well as any area of the manuscript thereafter. Abbreviations are not to be used unless the term has first been spelled in full, and the abbreviation noted in parentheses immediately following the initial use of the full term. For example: “. . . deep peroneal nerve (DPN).” Abbreviations that are part of a proprietary name are to be used in accordance with the guidelines noted for registered trademarks and copyrights.
Permissions: Permission requests to reprint material from The Journal of Foot & Ankle Surgery should be addressed to: Permissions Editor, The Journal of Foot & Ankle Surgery, PO Box 1239, Brooklandville, MD 21022. Reprints: Reprint order forms are included at the time the edited manuscript and page proof are sent to the corresponding author. One gratis copy of the issue in which the article appears will be sent to the primary author. The Instructions for Authors are also available online at http://www.jfas.org/ in the “Author’s Corner” Section.
Every author, including the corresponding author and all co-authors, must submit a signed CTA to the Journal
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office as soon as possible following submission of a manuscript for editorial consideration. The CTA can be downloaded from the “Author’s Corner” section of the JFAS webpage (www.jfas.org/), by clicking on the “Manuscript Submission” option, which links to the Elsevier Editorial System (http:// ees.elsevier.com/jfas/ ), where the form can be procured by clicking on the “Copyright Transfer Agreement” option. The signed agreement/s can be returned to D. Scot Malay, Editor, JFAS, via electronic mail (after scanning or digitally photographing the signed CTA) at [email protected], via telefax at (215) 967-4463, or via standard mail at 2314 Waverly Street, Philadelphia, PA 19146, USA. No manuscript can be published without first having the signed CTA/s on file in the Journal office, and authors are instructed to attend to this matter as soon as your manuscript has been accepted for editorial consideration. In the event that a manuscript has only a single author, and that author does not submit a signed CTA prior to the publication preparation deadline, then publication of the manuscript will be delayed until the required signed CTA/s are on file in the Journal office. The Editor also reserves the right to discontinue editing a manuscript, and hold peer review, if the signed Copyright Transfer Agreement/s is/are not on file in the Journal offices. All accepted manuscripts become the permanent property of ACFAS and may not be published elsewhere without written permission from both the author and ACFAS. Transfer of copyright to ACFAS implies transfer of all worldwide rights, including printed, electronic, microfilm, and facsimile publication, unless specified otherwise.
Financial Disclosure and Conflict of Interest Statement: Every author, including the corresponding author and all co-authors, must submit a signed conflict of interest statement to the Journal office, at the time of submission of a manuscript for editorial consideration. Authors should disclose any financial arrangements they may have with any company whose product is pertinent to the submitted manuscript, or with a company making a competing product. The information will be held in confidence while the paper is under review and will not influence the blind peer review process. If the article is accepted for publication, a disclosure statement will appear with the article. The conflict of interest statement can be downloaded from the “Author’s Corner” section of the JFAS webpage (www.jfas.org/), by clicking on the “Manuscript Submission” option, which links to the
Elsevier Editorial System (http://ees.elsevier.com/jfas/ ), where the form can be procured by clicking on the “Conflict of Interest Disclosure” option. The completed and signed statement/s can be returned to D. Scot Malay, Editor, JFAS, via electronic mail (after scanning or digitally photographing the completed and signed statement/s) at [email protected], via telefax at (215) 967-4463, or via standard mail at 2314 Waverly Street, Philadelphia, PA 19146, USA. No manuscript can be published without first having the conflict of interest disclosures on file in the Journal office. General Format: Each page should be numbered consecutively, in the bottom right corner, with the title page designated as page 1. The manuscript should be doublespaced, line-numbered, and left margin justified. The contents of your manuscript should include the following sections in the following order: For a full-text manuscript reporting a clinical trial, cohort study, or any other original research, or a case series or case report: 1) 2) 3) 4) 5)
6) 7) 8) 9)
Title Page Abstract Level of Clinical Evidence Key Words Text, consisting of a) Introduction b) Patients/ Materials and Methods c) Results and d) Discussion Acknowledgments References Tables Figures For a Tips, Quips and Pearls manuscript:
1) 2) 3) 4)
5) 6) 7) 8)
Title Page Abstract Key Words Text, consisting of: a) Introduction b) Technique c) Discussion Acknowledgments References Tables Figures
The main segments are to be identified by bold, leftmargin headings, capitalizing the first letter of each named section. As a general rule, when describing activities that were part of the investigation, as well as the observed outcomes, use the past tense. Present tense is reserved for discussions
of states of knowledge, which are considered ongoing (for example, “Open reduction and internal fixation is the treatment of choice for displaced, unstable fractures . . .”). Whenever uncertainty arises in regard to format, authors are encouraged to consult the following text: AMA Manual of Style: A Guide for Authors and Editors, 10th Edition, edited by JAMA & Archives Journals. Title Page: The title page, which is to be submitted as a separate electronic file, should include the following items: ● ●
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title of the manuscript, authors, and their credits, including academic degrees (Do not use initials to designate diplomate status in any organization. Fellowship status in an organization can be designated using the appropriate initials.) The corresponding author should be clearly identified and the telephone and telefax numbers, as well as the electronic and standard mailing addresses, should be provided. name of affiliated institutions (hospital/university/organization or private practice), if applicable, including city, state, and country (if not from the United States).
The title, as provided in the title page, will be used in any publication related to the article, as will the order of the authors submitted. Abstract: Submit an abstract summarizing the contents of the article on a page separate from the title and manuscript (this is done in a text box during the online submission process). We request that the abstract be no longer than 250 words, since PubMed truncates longer abstracts at 250 words, resulting in an uncontrolled loss of information that could adversely influence online searching efforts. ●
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The Abstract for a manuscript is to be written as continuous prose, without subheadings for each section of the manuscript. The Abstract for a report of research should reflect the format of the manuscript itself, describing pertinent information for each section of the manuscript (without subheadings). It should briefly introduce the research problem, explain methods, summarize results, and provide a conclusion. The Abstract for a case study should state the condition of interest, and include a brief summary of the specific clinical situation, the uniqueness or rarity of the diagnosis or the novelty of an intervention, and a statement regarding the clinical significance of the case. Do not use any abbreviations or bibliographic reference citations in the Abstract. If necessary, parts of the Abstract may be written as phrases, rather than as complete sentences.
Level of Clinical Evidence: Immediately following the Abstract section, the author is to designate the paper in accordance with the Level of Clinical Evidence as depicted in Table 1. It is important to understand that all levels of clinical evidence
Table 1.
Levels of Evidence for Primary Research Question* Types of Studies
Therapeutic Studies—Investigating the Results of Treatment Level I
Level II
● High-quality randomized controlled trial with statistically significant difference or no statistically significant difference but narrow confidence intervals ● Systematic review2 of Level-I randomized controlled trials (and study results were homogeneous3) ● Lesser-quality randomized controlled trial (eg, ⬍80% follow-up, no blinding, or improper randomization) ● Prospective4 comparative study5 ● Systematic review2 of Level-II studies or Level-I studies with inconsistent results
Prognostic Studies— Investigating the Effect of a Patient Characteristic on the Outcome of Disease ● High-quality prospective study4 (all patients were enrolled at the same point in their disease with ⱖ80% follow-up of enrolled patients) ● Systematic review2 of Level-I studies ● Retrospective6 study ● Untreated controls from a randomized controlled trial ● Lesser-quality prospective study (e.g. patients enrolled at different points in their disease or ⬍80% follow-up) ● Systematic review of Level-II studies Case-control study7
Level III
Case-control study7 ● Retrospective6 comparative study5 ● Systematic review2 of Level-III studies
Level IV
Case series8
Case series
Level V
Expert opinion
Expert opinion
Diagnostic Studies—Investigating a Diagnostic Test
Economic and Decision Analyses—Developing an Economic or Decision Model
● Testing of previously developed diagnostic criteria in series of consecutive patients (with universally applied reference “gold” standard) ● Systematic review2 of Level-I studies ● Development of diagnostic criteria on basis of consecutive patients (with universally applied reference “gold” standard) ● Systematic review2 of Level-II studies
● Sensible costs and alternatives; values obtained from many studies; multiway sensitivity analyses ● Systematic review2 of Level-I studies
● Study of nonconsecutive patients (without consistently applied reference “gold” standard) ● Systematic review2 of LevelIII studies ● Case-control study ● Poor reference standard Expert opinion
● Analyses based on limited alternatives and costs; poor estimates ● Systematic review2 of LevelIII studies
● Sensible costs and alternatives; values obtained from limited studies multiway sensitivity analyses ● Systematic review2 of LevelII studies
● No sensitivity analyses Expert opinion
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A complete assessment of the quality of individual studies requires critical appraisal of all aspects of the study design. A combination of results from two or more prior studies. 3 Studies provided consistent results. 4 Study was started before the first patient enrolled. 5 Patients treated one way (e.g., with cemented hip arthroplasty) compared with patients treated another way (e.g., with cementless hip arthroplasty) at the same institution. 6 Study was started after the first patient enrolled. 7 Patients identified for the study on the basis of their outcome (e.g., failed total hip arthroplasty), called “cases,” are compared with those who did not have the outcome (e.g.,had a successful total hip arthroplasty), called “controls.” 8 Patients treated one way with no comparison group of patients treated another way. *This chart was adapted from material published by the Centre for Evidence-Based Medicine, Oxford, UK. For more information, please see www.cebm.net. 2
can be meaningful and interesting to readers, and authors are encouraged to submit all types of investigations. Key Words: Provide 3–5 key words or phrases for indexing purposes. Keep in mind that electronic searches of the biomedical literature depend to a large degree on key words. Refer to PubMed’s Medical Subject Heading (MeSH) webpage (http:// www.ncbi.nlm.nih.gov) for help selecting key words. Key words are to be spelled in lower case letters, unless representative of a proper name, and listed in alphabetical order separated by a comma between each word/term. Avoid abbreviations in the key words, unless a proprietary name uses an abbreviation. If a proprietary name is used, be sure to include the appropriate symbol indicating registered trademark. In general, proper names are not used as key words. Text: The text should be comprised of the following four
sections: Introduction, Patients and Methods or Materials and Methods, Results, and Discussion. Introduction: This section should provide a concise overview of the state of knowledge regarding the specific problem being studied. It should begin with a statement of the problem and its clinical/social importance, followed by an explanation of recent and important research related to the topic, supported by reference citations. The importance of the topic is best conveyed by means of statistics that indicate the prevalence and/or economic impact of the condition in the population/society. After an explanation of what is known, and what remains unknown in regard to the focus of the study, the author should concisely state the specific research question or hypothesis for the current investigation. Gener-
ally, the last sentence of the Introduction should include a statement that describes the specific study design (see Table 2, below) and reiterates the research question.
Patients and Methods (or Materials and Methods): If the study is a clinical investigation involving living, human participants (patients, subjects), then the heading for this section should be “Patients and Methods.” If the investigation involves animals, cadavers, or in vitro models of any sort, including computer models, then this section should be termed “Materials and Methods.” In general, the methods section should describe the following elements of the investigation: ● ●
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aims, assessors and other members of the investigational team, including surgeons of record if they are also authors of the paper or outcomes assessors, population or sample. intervention, endpoints (outcomes), statistical methods used to determine the meaning of the results
In essence, this section should describe the building blocks of good clinical evidence that were used in the investigation (see Table 3, below).
More detailed discussion of these important elements of biomedical investigation can be found at a number of evidence-based medicine websites, including the Centre for Health Evidence (http://www.cche.net/), the Centre for Evidence-based Medicine (http://www.cebm.utoronto.ca/), and the Oxford Centre for Evidence-based Medicine (http:// www.cebm.net/). Ideally, the methods section should provide enough detail to allow subsequent researchers to replicate the study. When reporting randomized controlled trials, a study flow diagram
in CONSORT format, as well as all of the information required by the CONSORT checklist, should be provided. The CONSORT statement, checklist, and study flow diagram are available at http://www.consort-statement.org. Authors submitting reports of clinical trials are encouraged to register their investigation with a public domain repository, such as ClinicalTrials.gov, available at http:// clinicaltrials.gov/. Please indicate in the methods section of your submission, the specific registration number and public domain repository where the study data can be found. The following elements of the investigation should be concisely described in the methods section: Aims: The primary aim of the investigation, as well as any secondary aims, should be clearly stated. A distinction should be made between primary and secondary aims. As a rule, the sample size should be adequate to identify a statistically significant difference in regard to the primary aim, if such a difference exists. Power and sample size calculations can be determined using any of a number of software programs, such as that found at: http://biostat. mc.vanderbilt.edu/twiki/bin/view/Main/PowerSampleSize. In describing the primary aim, many authors will restate, in some fashion, their hypothesis and research question, emphasizing that they undertook to answer the question. Assessors: • Members of the investigational team should be described in regard to their participation in the study; namely: * if they served as outcome assessors * if they performed an intervention * if they abstracted data from medical records, in the case of a retrospective study * If they performed statistical analyses of the data • For studies in which subjective measurements are determined, such as measurements of radiographic angles, a method should be described for breaking ties and determining an outcome when indecision or uncertainty existed. • If outcomes assessors were blind to treatment allocation, this must be stated. • If outcomes assessors were participants in the intervention, such as members of the surgical team or treating clinicians, this must also be stated. Study population: ●
The methods section should provide readers with an explicit description of the participant/patient population and the time period from which they were selected. The time period should delineate the day, month and year that the period started; and the day, month and year that the period ended (MM/DD/YYYY-MM/DD/YYYY). If the day that the time period started is not precisely known, then it is acceptable to state just the month and year that initiated and ended the period (MM/YYYY-MM/
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YYYY). This is a very important detail, since the duration of interest can be very different, and remains unclear, if only the year at the start and end of the time period is depicted. It is also important for the author to state whether or not treatment allocation was determined in a random fashion, and whether or not participants in a clinical trial were blind to treatment allocation. For case series and cohort studies, the author should state whether or not the participants were enrolled consecutively. The inclusion and exclusion criteria must be clearly stated, and it is best to simply list these in a fashion that would allow other interested investigators to repeat your study. Authors should also indicate whether or not the investigation was conducted with Institutional Review Board approval, and whether or not participants/patients volunteered and consented to be in the investigation. Participants in the investigation should be referred to as “participants” if the diagnostic test or intervention is experimental and not yet approved for use by the US Food and Drug Administration, and as patients for all other tests or interventions that are already known to be therapeutic, safe, and efficacious. Intervention:
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In any investigation, the intervention needs to be explicitly described. If participants were randomized to an active therapy that was compared to standard therapy, or to placebo, then each treatment arm needs to be described. Authors are encouraged to avoid presenting a detailed narrative report of an operative intervention for a standard procedure that can be referenced in any of a number of textbooks or published articles in peer-reviewed journals. Reference can be made, with an appropriate citation, to a standard procedure as it is described in a textbook; and variations on the procedure should be described in detail. We do not want to publish an entire operative report. Novel interventions, notable variations on standard procedures, decision points related to an intervention, and adjunct procedures should be thoroughly described. Generic drug names should be used wherever possible. When a brand name is used, the name and address of the manufacturer must be identified in parentheses immediately following the proprietary name. As a rule, the proprietary name should be used the first time that the medication or device is mentioned, and thereafter referred to in generic terms. Whenever medication use is described, complete dosing information (dose, method of administration, frequency and duration of use) should be included. Endpoints (outcomes):
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Outcome measures should be explicitly defined in terms of how the variable was measured, who made the mea-
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surement, and whether or not the assessor was blind to the intervention (for an intervention trial). Authors should clearly state if outcomes were based on physical examination, chart review, telephone interview, questionnaire or radiographic films, or some other method. As a rule, any variable that a reasonable clinician would consider important in regard the treatment of a patient, as it pertains to the investigation, should be considered in the analysis. In addition to the intervention/s or outcome/s of interest (dependent variable/s), typical independent variables include such things as age and age category, gender, activity level, body mass index (BMI) or BMI category, comorbidities, medications, duration of treatment, surgeon or clinical site, adjunct therapies, frequency and duration of follow-up, and post-intervention management procedures (immobilization, physical therapy, etc.). Items such as those listed above should be referred to as “variables” and not as “parameters,” since the term “parameter” should be reserved for statistical expressions that describe the data, such as the mean and standard deviation, or beta coefficients derived from a regression analysis. Whenever possible, it is preferable that “hard” endpoints be used, such as analytical measurements, clinical or microbiology laboratory results, and the like. Whenever “soft” endpoints, such as quality of life (QOL) or footrelated QOL, are considered, it is preferable to use health measurement instruments that have previously been shown to be reliable and to provide valid information. Keep in mind that a health measurement instrument in and of itself is not said to be valid, although the information gained from the use of the health measurement instrument may (and should) be. QOL instruments should be specific to the foot and ankle (ACFAS, AOFAS, Bristol Foot Score, Foot Function Index, etc.), as well as measures of general health (SF-36, etc). Whenever a health measurement instrument is used, the author should cite the reference wherein the reader can find the results of the reliability and validation study related to the instrument. Investigator derived questionnaires should be described in terms of reliability and validity, if such testing was undertaken by the investigators, or if it has been described in a previous publication. For scales that rank categories (e.g., mild, moderate, severe) an aggregate score should be used. For measurements of pain, the 10-cm visual analog scale (VAS) is recommended. Statistical methods:
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The statistical plan should be clearly described, and every investigation should include at least descriptive and inferential, as well as univariate and multiple variable, statistical analyses.
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The descriptive statistical analysis should define parameters such as the measure of central tendency (mean or median average), and measures of dispersion (standard deviation or range). The parameter, as well as the statistical test, should be selected based on the type and distribution of the data. Continuous numeric data that are normally distributed are suitable for representation using the mean and standard deviation, and may be analyzed using mean-based statistical tests (such as Student’s t-test). Categorical data, and data that are non-normally distributed, are suitable for representation using the median and range, and may be analyzed using median-based (nonparametric) methods such as the Wilcoxon matched-pairs signed-ranks test, sign test, Wilcoxon rank-sum test, and the Kruskal-Wallis equality-of-populations rank test, and other null hypothesis tests and methods of estimation. For categorical data, Fisher’s exact method should be used whenever possible. Univariate analyses should describe the association of independent variables with the outcome of interest (dependent variable), whereas multiple variable analyses should describe the association of all of the clinically important variables with the outcome of interest.
Results should be presented with only as much precision as is of scientific value. For example, measures of association (odds ratios, relative risks, risk differences, etc.) should typically be reported to two significant digits. As a rule, the terms “significant” and “significantly” should be reserved for use when describing statistical differences. The statement “no significant difference was found” between 2 or more groups should not be made unless a power analysis was done and the value of alpha (level of significance, typically 5%) or beta (the power to detect a statistically significant difference, usually 80% or 90%) is reported. Use of the word “significant” requires reporting of a P-value (probability) or, preferably, the 95% confidence interval about a point estimate. Ninety-five percent confidence intervals are preferred whenever the results of survivor analyses are given in the text, tables or graphs. Except when 1-sided tests are required by study methodology, such as in noninferiority trials, 2-sided P-values should be reported. By convention, P-values larger than 0.01 should be reported to 2 decimal places, those between 0.01 and 0.001 to 3 decimal places, and P-values smaller than 0.001 should be reported as P ⬍ 0.001. Probabilities should never be reported as P ⫽ 0.000. Furthermore, use of the word “correlation” or the term “correlates with” requires that a correlation coefficient be calculated and reported, otherwise terms such as “association” or “associated” should be used. Use the uppercase P as the symbol to indicate the probability. The results of a sensitivity analysis, such as that described by Greenland (Maldonado G, Greenland S: Simu-
lation study of confounder-selection strategies. Amer J Epidemiol. 138: 923–936, 1993), or that described by Rosenbaum (Rosenbaum PR. Sensitivity analysis for matched case-control studies. Biometrics. 47(1): 87–100, 1991; and, Rosenbaum PR. Discussing hidden bias in observational studies. Ann Intern Med. 1; 115(11): 901–5, 1991), should be presented for retrospective studies where unmeasured independent variables may have potentially influenced the results. Additional references that may be useful in regard to the description of the methods and the presentation of a statistical plan include: Bailar JC III, Mosteller F. Guidelines for statistical reporting in articles for medical journals: amplifications and explanations. Ann Intern Med 1988; 108: 266 –73. Altman DG, Machin D, Bryant TN, Gardner MJ (eds). Statistics with Confidence. 2nd edition. London: BMJ Books, 2000. Malay DS. Some thoughts about data type, distribution, and statistical significance. J Foot Ankle Surg 45: 57–9, 2006. Malay DS. Levels of clinical evidence. J Foot Ankle Surg 46: 63– 4, 2007. Results: The results section should provide quantitative information about the data collected, in the form of descriptive and inferential statistics. ●
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Relevant information on the study population includes demographic information for each subgroup (control group and study groups), exclusions and attrition. Inferential statistics should be used to compare groups using appropriate statistical tests based on the size of the study population, type of variables under study (discrete vs. categorical), and the distribution of the data collected. Quantitative information should be summarized in the text, and readers should be referred to relevant tables for more detailed information. As a rule, a minimum of three results tables should be presented, and designated Tables 1, 2, and 3. Table 1 typically depicts the baseline demographic characteristics of the sample population, often categorizing the patients/participants by intervention or outcome, and showing whether or not statistically significant differences existed between the groups. For randomized controlled trials, it is not necessary to depict statistically significant differences at baseline, since randomization distributes the characteristics by chance. Table 2 generally depicts the results of the univariate analyses, and Table 3 generally depicts the results of the multiple variable analyses. Additional tables can be helpful when the data warrant such detail. Figures and tables used to report the results need to be complete with enough detail to stand alone, without the need for the reader to refer to the detailed text in order to fully understand the results. Therefore, the
table title, headings and legends need to be thoughtfully phrased so that there is no ambiguity or lack of information (sample size, units of measurement, statistical test used to calculate the P-value, etc.). Discussion: The discussion section offers the authors’ interpretation of the results of their investigation. Authors should consider how their results fit into the general state of knowledge on the subject, as well as their clinical relevance. In addition, authors should acknowledge the limitations of their investigation that may have introduced bias, and they should discuss how the results may have been affected by bias. Finally, suggestions for clinical applications and/or further research may be appropriate. Do not include a separate “Conclusion” subsection, as the final paragraph of the discussion should describe the authors’ conclusions (and the paragraph can start with a sentence that states: “In conclusion, we found . . .” or something to this effect). Acknowledgement: Acknowledgments should be made to those who have informally contributed their expertise or assisted in the investigation, rather than to those who have contributed to the manuscript while performing the role of their regular occupation. References: References are cited in the body of the text by means of numeric citations listed parenthetically in the appropriate sentence, prior to the end of the sentence (usually just before the period ending the sentence, or immediately following mention of a specific author or previous publication). Reference citations are to appear in sequential numeric order, beginning with the number “1” and continuing in order the first time that a particular reference is cited, until the last citation is noted. In other words, supply references numbered in the exact order they appear in the text (not alphabetically). Do not use superscripts, and do not submit a document with endnotes embedded via software algorithms (macros) that link items on the reference page to the in-text citation. If you use such macros to write your paper, please disable the macro, or convert the references cited to text only, prior to submitting your manuscript. This is important because embedded macros impede the editorial process, and greatly slow down the turnaround time related to reviewing and editing a manuscript. Begin the list of references on a new page. The references should be double-spaced. Sources not identified in the text should not be listed. Unpublished sources must be included in parentheses within the body of the text, not in the Reference Section. Abbreviations for journal titles should conform to those used by Medline (www.ncbi.nlm.nih.gov/ sites/entrez?db⫽pubmed). If Medline does not index a journal, then spell out the entire journal name in addition to listing the author name/s, title of the article, volume number, page numbers, and year of publication. Always list all authors, and do not use “et al” when listing your references. The term “et al” may be used in the body
of the text; however, it is generally reserved for mentioning papers written by more than three authors. Textbook references must include the specific page or pages used. Web site references must include the date when the site was last accessed. Examples of reference citations include: For a journal article: 1. Mendicino RW, Orsini RC, Whitman SE, Cantanzariti AR. Fibular groove deepening for recurrent peroneal subluxation. J Foot Ankle Surg 40:252–263, 2001. For a textbook: 2. Trevino SG. Disorders of the hallucal sesamoids. In Foot and Ankle Disorders, pp 379 –398, edited by MS Myerson, WB Saunders, Philadelphia, 2000. For an electronic version of a print journal: 3. Gardner MJ, Boraiah S, Hentel KD, Helfet DL, Lorich DG. The hyperplantarflexion ankle fracture variant. J Foot Ankle Surg [serial on the Internet] 46:256 –260, 2007. Available at: http://www.jfas.org/issues/contents. For a Web page: 4. Clinical Practice Guideline Heel Pain Panel. Diagnosis and Treatment of Heel Pain. American College of Foot and Ankle Surgeons Web site. September/October 2001. Available at: http://www.acfas.org/pubresearch/cpg/heelpaincpg.htm. Accessed July 20, 2007. For a personal communication: 5. John A. Ruch, DPM; personal communication, dd/mm/ yyyy. For a thesis or dissertation: 6. Malay DS. “The Incidence and Risks of Failure to Heal After Lower Extremity Amputation for the Treatment of Neuropathic Foot Ulcer in Diabetic Patients” (MA thesis, The University of Pennsylvania, 2006), 2– 4. Tables: Tables should be clear and support the specific points mentioned in the text. ●
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Black and white lines and text are preferred. The “insert table” function of the toolbar of most word processors works well for this. Tables and their accompanying legends should be able to stand alone, communicating the meaning of the information without reference to the main text. In the text, tables are cited using parentheses about the table-reference being cited. For example: “(Table 1)”. You do not need to state: “(see Table 1).” Each table should be titled, and accompanied by a table legend. The table title should be formatted as in the following example: “Table 1 The dataset.” Do not use abbreviations in either the title or the table legend, unless the abbreviation is defined in the legend. Table titles and legends must be submitted for each figure, in consecutive order, double-spaced, on a separate
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page from the text, typically following the list of references cited. Abbreviations or footnotes should be explained in lower case alphabetical superscripts in the legend beneath the table. Each table may be submitted as a separate page (file), or included sequentially in the body of the text (preferable). All tables must be original, unless indicated otherwise. Tables previously published in other sources should be accompanied by a letter from that publishing company and author, granting permission for their use.
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Figures and their accompanying legends should be able to stand alone, communicating the meaning of the information without reference to the main text. In the text, figures should be cited using parentheses about the figure-reference being cited. For example: “(Figure 1)”. Each figure should be titled, and accompanied by a figure legend. The figure title should be formatted as in the following example: “Figure 1 The gastrocnemius recession.” Do not use abbreviations in either the figure title or the figure legend, unless the abbreviation is defined in the legend. Abbreviations or footnotes should be explained in lower case alphabetical superscripts in the legend beneath the figure. Figure titles and legends must be submitted for each figure, in consecutive order, double-spaced, on a separate page from the text. Each figure must be submitted as a separate page (file), in other words, do not submit multiple figures embedded in a Word file. Images should be provided in TIF, GIF or EPS format, per the instructions for online submission at http:// ees.elsevier.com/jfas. Manuscripts that describe a pathological entity must be accompanied by a photomicrograph depicting the histopathology, with magnification power and staining technique indicated. Radiographic images should be submitted in grayscale format. Black and white line drawings are acceptable only if they are of professional quality. All figures must be original, unless indicated otherwise. Figures previously published in other sources should be accompanied by a letter from that publishing company and author, granting permission for their use. Illustrations and figures will not be returned to the authors.
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Any and every time that a proprietary substance (such as a medication), device, equipment, or software program is mentioned in the manuscript, it must be accompanied by either of the following symbols: “®” or “™”, indicating that the substance or device is a registered trademark. The following information must be provided in parentheses, immediately following mention of the proprietary item: proprietor’s name (the name of the company that owns the registered trademark), city and state wherein the proprietor’s headquarters are located, and the country if other than the United States. Authors should use the proprietor’s precise terminology (exact name and registered trademark symbol, “®” or “™”) when referring to a specific proprietary substance, device or procedure. This information is usually available at the proprietor’s Web site. If copyrighted material is mentioned, then the “©” symbol should accompany the item. The use of copyrighted material requires that the author obtain explicit permission from the owner of the copyright (publisher), and the author, for such use.
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Do not use abbreviations in the Title, Abstract, or Key Words section of the manuscript, because information from these portions of the paper is used in the process of electronically indexing the biomedical literature. If a proper or proprietary name entails the use of an abbreviation, only then can it be used in the Title, Abstract or Key Words sections. Abbreviations can be used in the Introduction, as well as any area of the manuscript thereafter. Abbreviations are not to be used unless the term has first been spelled in full, and the abbreviation noted in parentheses immediately following the initial use of the full term. For example: “. . . deep peroneal nerve (DPN).” Abbreviations that are part of a proprietary name are to be used in accordance with the guidelines noted for registered trademarks and copyrights.
Permissions: Permission requests to reprint material from The Journal of Foot & Ankle Surgery should be addressed to: Permissions Editor, The Journal of Foot & Ankle Surgery, PO Box 1239, Brooklandville, MD 21022. Reprints: Reprint order forms are included at the time the edited manuscript and page proof are sent to the corresponding author. One gratis copy of the issue in which the article appears will be sent to the primary author. The Instructions for Authors are also available online at http://www.jfas.org/ in the “Author’s Corner” Section.