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Downloadable Templates and Tools for Clinical Research

Welcome to global health trials' tools and templates library. please note that this page has been updated for 2015 following a quality check and review of the templates, and many new ones have been added. please click on the orange text to download each template., the templates below have been shared by other groups, and are free to use and adapt for your researchstudies. please ensure that you read and adapt them carefully for your own setting, and that you reference global health trials and the global health network when you use them. to share your own templates and sops, or comment on these, please email [email protected]. we look forward to hearing from you.

These templates and tools are ordered by category, so please scroll down to find what you need.

 

 

 

 

 
    

 

 

 

            

 

 

 

 
    

 

 

 

 

 

 

 

 
  

 

   

 

         

 

 

 

 

 

 
     

 

 

 

 

 
  

 
   

 

 

 

 

 

         

 

 

 

 

 

 

 

 

 
 

  

 
         

 

 

 

 

 

 

 

 

 

 

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To share your own templates and SOPs, or comment on these, please email [email protected]. We look forward to hearing from you!

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Trial Operations    Trial Management    Ethics and Informed Consent    Resources    Trial Design    Data Management and Statistics   

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shewitdege

This is Degena Bahrey Tadesse from Tigray, Ethiopia. I am new for this web I am assistant professor in Adult Health Nursing Could you share me the sample/templet research proposal for Global Research Nurses Pump-priming Grants 2023: Research Project Award

jo8281968517

I have learned lot..Thanks..

yfarzi

i was wondering why there is no SOP on laboratory procedures ?

kirannn14

Hi, Can you provide me the SOP for electronic signatures in Clinical trial

anupambendre

Do you have an "SOP for Telephonic site selection visit". Kindly Share on my registered mail ID

sguteta

Thank you for sharing the resources. It is very kind of you.

ericdortenzio

Hi These tolls are very useful! Thank you

Do you have a task and responsability matrix template for clinical trial managment ? Best

abdulkamara1986

I am very much happy to find myself here as a clinician

GHN_Editors

Dear Getrude

We have a free 14-module course on research ethics on our training centre; you'll receive a certificate if you complete all the modules and quizzes. You can take it in your own time. Just visit 'Training centre' in the tabs above, then 'short courses'.

Kind regards The Editorial Team

gamanyagg

need modules on free online gcp course on research ethics

antropmcdiaz

Estimados: me parece excelente el aporte que han hecho dado que aporta. por un lado a mejorar la transparencia del trabajo como a facilitar el seguimiento y supervisión de los mismos. Muchas gracias por ello

We also have an up to date list of global health events available here: https://globalhealthtrials.tghn.org/community/training-events/

Dear Nazish

Thank you, I am glad you found the seminars and the training courses useful. We list many training events (all relevant to Global Health, and as many of them as possible are either free or subsidised) on the 'community' web pages above. Keep an eye on those for events and activities which you can get involved with. Also, if you post an 'introduction' on the introduction group stating where you are from and your research interests, we can keep you updated of relevant local events.

ndurran

Thanks so much. These are very helpful seminars. Please let me know any other websites/links that provide free or inexpensive lectures on clinical Research. Appreciate your help.

Hi Nazish, and welcome to the Network. The items here are downloadable templates for you to use; it sounds like you may be seeking lectures and eLearning courses? If so - no problem! You can find free seminars with sound and slides here: https://globalhealthtrainingcentre.tghn.org/webinars/ , and you can find free, certified eLearning courses here: https://globalhealthtrials.tghn.org/elearning . Certificates are awarded for the eLearning courses for those scoring over 80% in the quiz at the end of each course. If you need anything else, do ask! Kind regards The Editorial Team

Hi, I am new to this website and also to the Clinical Research Industry for that matter I only am able to see the PDF of these courses, just wanted to know are these audio lectures and also happen to have audio clips that go with the pdf?

amanirak

This site is impeccable and very useful for my job!!!!

Thank you for your kind comments.

shailajadr

Fantastic resources

dralinn

I am delighted you found this website. I earlier introduced it to you because of your prolific interest in health care information and resource sharing....

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If you are submitting an article to BMC Medicine, check AJE's helpful tool for authors.

Updated on July 15, 2020

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If you are submitting an article to BMC Medicine , AJE has a helpful tool for authors to get started. The AJE template below is designed to help you with preparing your article for submission. For more detailed information about BMC Medicine and its submission guidelines, please go to the journal's official website.

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JAY SIWEK, M.D., MARGARET L. GOURLAY, M.D., DAVID C. SLAWSON, M.D., AND ALLEN F. SHAUGHNESSY, PHARM.D.

Am Fam Physician. 2002;65(2):251-258

Traditional clinical review articles, also known as updates, differ from systematic reviews and meta-analyses. Updates selectively review the medical literature while discussing a topic broadly. Nonquantitative systematic reviews comprehensively examine the medical literature, seeking to identify and synthesize all relevant information to formulate the best approach to diagnosis or treatment. Meta-analyses (quantitative systematic reviews) seek to answer a focused clinical question, using rigorous statistical analysis of pooled research studies. This article presents guidelines for writing an evidence-based clinical review article for American Family Physician . First, the topic should be of common interest and relevance to family practice. Include a table of the continuing medical education objectives of the review. State how the literature search was done and include several sources of evidence-based reviews, such as the Cochrane Collaboration, BMJ's Clinical Evidence , or the InfoRetriever Web site. Where possible, use evidence based on clinical outcomes relating to morbidity, mortality, or quality of life, and studies of primary care populations. In articles submitted to American Family Physician , rate the level of evidence for key recommendations according to the following scale: level A (randomized controlled trial [RCT], meta-analysis); level B (other evidence); level C (consensus/expert opinion). Finally, provide a table of key summary points.

American Family Physician is particularly interested in receiving clinical review articles that follow an evidence-based format. Clinical review articles, also known as updates, differ from systematic reviews and meta-analyses in important ways. 1 Updates selectively review the medical literature while discussing a topic broadly. An example of such a topic is, “The diagnosis and treatment of myocardial ischemia.” Systematic reviews comprehensively examine the medical literature, seeking to identify and synthesize all relevant information to formulate the best approach to diagnosis or treatment. Examples are many of the systematic reviews of the Cochrane Collaboration or BMJ's Clinical Evidence compendium. Meta-analyses are a special type of systematic review. They use quantitative methods to analyze the literature and seek to answer a focused clinical question, using rigorous statistical analysis of pooled research studies. An example is, “Do beta blockers reduce mortality following myocardial infarction?”

The best clinical review articles base the discussion on existing systematic reviews and meta-analyses, and incorporate all relevant research findings about the management of a given disorder. Such evidence-based updates provide readers with powerful summaries and sound clinical guidance.

In this article, we present guidelines for writing an evidence-based clinical review article, especially one designed for continuing medical education (CME) and incorporating CME objectives into its format. This article may be read as a companion piece to a previous article and accompanying editorial about reading and evaluating clinical review articles. 1 , 2 Some articles may not be appropriate for an evidence-based format because of the nature of the topic, the slant of the article, a lack of sufficient supporting evidence, or other factors. We encourage authors to review the literature and, wherever possible, rate key points of evidence. This process will help emphasize the summary points of the article and strengthen its teaching value.

Topic Selection

Choose a common clinical problem and avoid topics that are rarities or unusual manifestations of disease or that have curiosity value only. Whenever possible, choose common problems for which there is new information about diagnosis or treatment. Emphasize new information that, if valid, should prompt a change in clinical practice, such as the recent evidence that spironolactone therapy improves survival in patients who have severe congestive heart failure. 3 Similarly, new evidence showing that a standard treatment is no longer helpful, but may be harmful, would also be important to report. For example, patching most traumatic corneal abrasions may actually cause more symptoms and delay healing compared with no patching. 4

Searching the Literature

When searching the literature on your topic, please consult several sources of evidence-based reviews ( Table 1 ) . Look for pertinent guidelines on the diagnosis, treatment, or prevention of the disorder being discussed. Incorporate all high-quality recommendations that are relevant to the topic. When reviewing the first draft, look for all key recommendations about diagnosis and, especially, treatment. Try to ensure that all recommendations are based on the highest level of evidence available. If you are not sure about the source or strength of the recommendation, return to the literature, seeking out the basis for the recommendation.

The AHRQ Web site includes links to the National Guideline Clearinghouse, Evidence Reports from the AHRQ's 12 Evidence-based Practice Centers (EPC), and Preventive Services. The AHCPR released 19 Clinical Practice Guidelines between 1992 and1996 that were not subsequently updated.
evaluates evidence in individual articles. Commentary by ACP author offers clinical recommendations. Access to the online version of is a benefit for members of the ACP-ASIM, but will be open to all until at least the end of 2001.
Features short evaluations/discussions of individual articles dealing with evidence-based clinical practice.
The University of Oxford/Oxford Radcliffe Hospital Clinical School Web site includes links to CEBM within the Faculty of Medicine, a CATbank (Critically Appraised Topics), links to evidence-based journals, and EBM-related teaching materials.
The AHRQ began the Translating Research into Practice (TRIP) initiative in 1990 to implement evidence-based tools and information. The TRIP Database features hyperlinks to the largest collection of EBM materials on the internet, including NGC, POEM, DARE, Cochrane Library, CATbank, and individual articles. A good starting place for an EBM literature search.
,
Searches BMJ's compendium for up-to-date evidence regarding effective health care. Lists available topics and describes the supporting body of evidence to date (e.g., number of relevant randomized controlled trials published to date). Concludes with interventions “likely to be beneficial” versus those with “unknown effectiveness.” Individuals who have received a free copy of Issue 5 from the United Health Foundation are also entitled to free access to the full online content.
Systematic evidence reviews that are updated periodically by the Cochrane Group. Reviewers discuss whether adequate data are available for the development of EBM guidelines for diagnosis or management.
Structured abstracts written by University of York CRD reviewers (see NHS CRD). Abstract summaries review articles on diagnostic or treatment interventions and discuss clinical implications.
Bi-monthly, peer-reviewed bulletin for medical decision-makers. Based on systematic reviews and synthesis of research on the clinical effectiveness, cost-effectiveness and acceptability of health service interventions.
Bimonthly publication launched in 1995 by the BMJ Publishing Group. Article summaries include commentaries by clinical experts. Subscription is required.
Newsletter (including Patient-Oriented Evidence that Matters [POEM])*
This newsletter features up-to-date POEM, Disease-Oriented Evidence (DOE), and tests approved for Category 1 CME credit. Subscription required.
Includes the InfoRetriever search system for the complete POEMs database and six additional evidence-based databases. Subscription is required.
ICSI is an independent, nonprofit collaboration of health care organizations, including the Mayo Clinic, Rochester, Minn. Web site includes the ICSI guidelines for preventive services and disease management.
Comprehensive database of evidence-based clinical practice guidelines from government agencies and health care organizations. Describes and compares guideline statements with respect to objectives, methods, outcomes, evidence rating scheme, and major recommendations.
Searches CRD Databases (includes DARE, NHS Economic Evaluation Database, Health Technology Assessment Database) for EBM reviews. More limited than TRIP Database.
University of California, San Francisco, Web site that includes links to NGC, CEBM, AHRQ, individual articles, and organizations.
This Web site features updated recommendations for clinical preventive services based on systematic evidence reviews by the U.S. Preventive Services Task Force.

In particular, try to find the answer in an authoritative compendium of evidence-based reviews, or at least try to find a meta-analysis or well-designed randomized controlled trial (RCT) to support it. If none appears to be available, try to cite an authoritative consensus statement or clinical guideline, such as a National Institutes of Health Consensus Development Conference statement or a clinical guideline published by a major medical organization. If no strong evidence exists to support the conventional approach to managing a given clinical situation, point this out in the text, especially for key recommendations. Keep in mind that much of traditional medical practice has not yet undergone rigorous scientific study, and high-quality evidence may not exist to support conventional knowledge or practice.

Patient-Oriented vs. Disease-Oriented Evidence

With regard to types of evidence, Shaughnessy and Slawson 5 – 7 developed the concept of Patient-Oriented Evidence that Matters (POEM), in distinction to Disease-Oriented Evidence (DOE). POEM deals with outcomes of importance to patients, such as changes in morbidity, mortality, or quality of life. DOE deals with surrogate end points, such as changes in laboratory values or other measures of response. Although the results of DOE sometimes parallel the results of POEM, they do not always correspond ( Table 2 ) . 2 When possible, use POEM-type evidence rather than DOE. When DOE is the only guidance available, indicate that key clinical recommendations lack the support of outcomes evidence. Here is an example of how the latter situation might appear in the text: “Although prostate-specific antigen (PSA) testing identifies prostate cancer at an early stage, it has not yet been proved that PSA screening improves patient survival.” (Note: PSA testing is an example of DOE, a surrogate marker for the true outcomes of importance—improved survival, decreased morbidity, and improved quality of life.)

Antiarrhythmic therapyAntiarrhythmic drug X decreases the incidence of PVCs on ECGsAntiarrhythmic drug X is associated with an increase in mortalityPOEM results are contrary to DOE implications
Antihypertensive therapyAntihypertensive drug treatment lowers blood pressureAntihypertensive drug treatment is associated with a decrease in mortalityPOEM results are in concordance with DOE implications
Screening for prostate cancerPSA screening detects prostate cancer at an early stageWhether PSA screening reduces mortality from prostate cancer is currently unknownAlthough DOE exists, the important POEM is currently unknown

Evaluating the Literature

Evaluate the strength and validity of the literature that supports the discussion (see the following section, Levels of Evidence). Look for meta-analyses, high-quality, randomized clinical trials with important outcomes (POEM), or well-designed, nonrandomized clinical trials, clinical cohort studies, or case-controlled studies with consistent findings. In some cases, high-quality, historical, uncontrolled studies are appropriate (e.g., the evidence supporting the efficacy of Papanicolaou smear screening). Avoid anecdotal reports or repeating the hearsay of conventional wisdom, which may not stand up to the scrutiny of scientific study (e.g., prescribing prolonged bed rest for low back pain).

Look for studies that describe patient populations that are likely to be seen in primary care rather than subspecialty referral populations. Shaughnessy and Slawson's guide for writers of clinical review articles includes a section on information and validity traps to avoid. 2

Levels of Evidence

Readers need to know the strength of the evidence supporting the key clinical recommendations on diagnosis and treatment. Many different rating systems of varying complexity and clinical relevance are described in the medical literature. Recently, the third U.S. Preventive Services Task Force (USPSTF) emphasized the importance of rating not only the study type (RCT, cohort study, case-control study, etc.), but also the study quality as measured by internal validity and the quality of the entire body of evidence on a topic. 8

While it is important to appreciate these evolving concepts, we find that a simplified grading system is more useful in AFP . We have adopted the following convention, using an ABC rating scale. Criteria for high-quality studies are discussed in several sources. 8 , 9 See the AFP Web site ( www.aafp.org/afp/authors ) for additional information about levels of evidence and see the accompanying editorial in this issue discussing the potential pitfalls and limitations of any rating system.

Level A (randomized controlled trial/meta-analysis): High-quality randomized controlled trial (RCT) that considers all important outcomes. High-quality meta-analysis (quantitative systematic review) using comprehensive search strategies.

Level B (other evidence): A well-designed, nonrandomized clinical trial. A nonquantitative systematic review with appropriate search strategies and well-substantiated conclusions. Includes lower quality RCTs, clinical cohort studies, and case-controlled studies with non-biased selection of study participants and consistent findings. Other evidence, such as high-quality, historical, uncontrolled studies, or well-designed epidemiologic studies with compelling findings, is also included.

Level C (consensus/expert opinion): Consensus viewpoint or expert opinion.

Each rating is applied to a single reference in the article, not to the entire body of evidence that exists on a topic. Each label should include the letter rating (A, B, C), followed by the specific type of study for that reference. For example, following a level B rating, include one of these descriptors: (1) nonrandomized clinical trial; (2) nonquantitative systematic review; (3) lower quality RCT; (4) clinical cohort study; (5) case-controlled study; (6) historical uncontrolled study; (7) epidemiologic study.

Here are some examples of the way evidence ratings should appear in the text:

“To improve morbidity and mortality, most patients in congestive heart failure should be treated with an angiotensin-converting enzyme inhibitor. [Evidence level A, RCT]”

“The USPSTF recommends that clinicians routinely screen asymptomatic pregnant women 25 years and younger for chlamydial infection. [Evidence level B, non-randomized clinical trial]”

“The American Diabetes Association recommends screening for diabetes every three years in all patients at high risk of the disease, including all adults 45 years and older. [Evidence level C, expert opinion]”

When scientifically strong evidence does not exist to support a given clinical recommendation, you can point this out in the following way:

“Physical therapy is traditionally prescribed for the treatment of adhesive capsulitis (frozen shoulder), although there are no randomized outcomes studies of this approach.”

Format of the Review

Introduction.

The introduction should define the topic and purpose of the review and describe its relevance to family practice. The traditional way of doing this is to discuss the epidemiology of the condition, stating how many people have it at one point in time (prevalence) or what percentage of the population is expected to develop it over a given period of time (incidence). A more engaging way of doing this is to indicate how often a typical family physician is likely to encounter this problem during a week, month, year, or career. Emphasize the key CME objectives of the review and summarize them in a separate table entitled “CME Objectives.”

The methods section should briefly indicate how the literature search was conducted and what major sources of evidence were used. Ideally, indicate what predetermined criteria were used to include or exclude studies (e.g., studies had to be independently rated as being high quality by an established evaluation process, such as the Cochrane Collaboration). Be comprehensive in trying to identify all major relevant research. Critically evaluate the quality of research reviewed. Avoid selective referencing of only information that supports your conclusions. If there is controversy on a topic, address the full scope of the controversy.

The discussion can then follow the typical format of a clinical review article. It should touch on one or more of the following subtopics: etiology, pathophysiology, clinical presentation (signs and symptoms), diagnostic evaluation (history, physical examination, laboratory evaluation, and diagnostic imaging), differential diagnosis, treatment (goals, medical/surgical therapy, laboratory testing, patient education, and follow-up), prognosis, prevention, and future directions.

The review will be comprehensive and balanced if it acknowledges controversies, unresolved questions, recent developments, other viewpoints, and any apparent conflicts of interest or instances of bias that might affect the strength of the evidence presented. Emphasize an evidence-supported approach or, where little evidence exists, a consensus viewpoint. In the absence of a consensus viewpoint, you may describe generally accepted practices or discuss one or more reasoned approaches, but acknowledge that solid support for these recommendations is lacking.

In some cases, cost-effectiveness analyses may be important in deciding how to implement health care services, especially preventive services. 10 When relevant, mention high-quality cost-effectiveness analyses to help clarify the costs and health benefits associated with alternative interventions to achieve a given health outcome. Highlight key points about diagnosis and treatment in the discussion and include a summary table of the key take-home points. These points are not necessarily the same as the key recommendations, whose level of evidence is rated, although some of them will be.

Use tables, figures, and illustrations to highlight key points, and present a step-wise, algorithmic approach to diagnosis or treatment when possible.

Rate the evidence for key statements, especially treatment recommendations. We expect that most articles will have at most two to four key statements; some will have none. Rate only those statements that have corresponding references and base the rating on the quality and level of evidence presented in the supporting citations. Use primary sources (original research, RCTs, meta-analyses, and systematic reviews) as the basis for determining the level of evidence. In other words, the supporting citation should be a primary research source of the information, not a secondary source (such as a nonsystematic review article or a textbook) that simply cites the original source. Systematic reviews that analyze multiple RCTs are good sources for determining ratings of evidence.

The references should include the most current and important sources of support for key statements (i.e., studies referred to, new information, controversial material, specific quantitative data, and information that would not usually be found in most general reference textbooks). Generally, these references will be key evidence-based recommendations, meta-analyses, or landmark articles. Although some journals publish exhaustive lists of reference citations, AFP prefers to include a succinct list of key references. (We will make more extensive reference lists available on our Web site or provide links to your personal reference list.)

You may use the following checklist to ensure the completeness of your evidence-based review article; use the source list of reviews to identify important sources of evidence-based medicine materials.

Checklist for an Evidence-Based Clinical Review Article

The topic is common in family practice, especially topics in which there is new, important information about diagnosis or treatment.

The introduction defines the topic and the purpose of the review, and describes its relevance to family practice.

A table of CME objectives for the review is included.

The review states how you did your literature search and indicates what sources you checked to ensure a comprehensive assessment of relevant studies (e.g., MEDLINE, the Cochrane Collaboration Database, the Center for Research Support, TRIP Database).

Several sources of evidence-based reviews on the topic are evaluated ( Table 1 ) .

Where possible, POEM (dealing with changes in morbidity, mortality, or quality of life) rather than DOE (dealing with mechanistic explanations or surrogate end points, such as changes in laboratory tests) is used to support key clinical recommendations ( Table 2 ) .

Studies of patients likely to be representative of those in primary care practices, rather than subspecialty referral centers, are emphasized.

Studies that are not only statistically significant but also clinically significant are emphasized; e.g., interventions with meaningful changes in absolute risk reduction and low numbers needed to treat. (See http://www.cebm.net/index.aspx?o=1116 .) 11

The level of evidence for key clinical recommendations is labeled using the following rating scale: level A (RCT/meta-analysis), level B (other evidence), and level C (consensus/expert opinion).

Acknowledge controversies, recent developments, other viewpoints, and any apparent conflicts of interest or instances of bias that might affect the strength of the evidence presented.

Highlight key points about diagnosis and treatment in the discussion and include a summary table of key take-home points.

Use tables, figures, and illustrations to highlight key points and present a step-wise, algorithmic approach to diagnosis or treatment when possible.

Emphasize evidence-based guidelines and primary research studies, rather than other review articles, unless they are systematic reviews.

The essential elements of this checklist are summarized in Table 3 .

Choose a common, important topic in family practice.
Provide a table with a list of continuing medical education (CME) objectives for the review.
State how the literature search and reference selection were done.
Use several sources of evidence-based reviews on the topic.
Rate the level of evidence for key recommendations in the text.
Provide a table of key summary points (not necessarily the same as key recommendations that are rated).

Siwek J. Reading and evaluating clinical review articles. Am Fam Physician. 1997;55:2064-2069.

Shaughnessy AF, Slawson DC. Getting the most from review articles: a guide for readers and writers. Am Fam Physician. 1997;55:2155-60.

Pitt B, Zannad F, Remme WJ, Cody R, Castaigne A, Perez A, et al. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. N Engl J Med. 1999;341:709-17.

Flynn CA, D'Amico F, Smith G. Should we patch corneal abrasions? A meta-analysis. J Fam Pract. 1998;47:264-70.

Slawson DC, Shaughnessy AF, Bennett JH. Becoming a medical information master: feeling good about not knowing everything. J Fam Pract. 1994;38:505-13.

Shaughnessy AF, Slawson DC, Bennett JH. Becoming an information master: a guidebook to the medical information jungle. J Fam Pract. 1994;39:489-99.

Slawson DC, Shaughnessy AF. Becoming an information master: using POEMs to change practice with confidence. Patient-oriented evidence that matters. J Fam Pract. 2000;49:63-7.

Harris RP, Helfand M, Woolf SH, Lohr KN, Mulrow CD, Teutsch SM, et al. Methods Work Group, Third U.S. Preventive Services Task Force. Current methods of the U.S. Preventive Services Task Force. A review of the process. Am J Prev Med. 2001;20(3 suppl):21-35.

CATbank topics: levels of evidence and grades of recommendations. Retrieved November 2001, from: http://www.cebm.net/ .

Saha S, Hoerger TJ, Pignone MP, Teutsch SM, Helfand M, Mandelblatt JS. for the Cost Work Group of the Third U.S. Preventive Services Task Force. The art and science of incorporating cost effectiveness into evidence-based recommendations for clinical preventive services. Am J Prev Med. 2001;20(3 suppl):36-43.

Evidence-based medicine glossary. Retrieved November 2001, from: http://www.cebm.net/index.aspx?o=1116 .

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medical research article template

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Research Paper Template

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What It Covers

This template’s structure is based on the tried and trusted best-practice format for academic research papers. Its structure reflects the overall research process, ensuring your paper has a smooth, logical flow from chapter to chapter. Here’s what’s included:

  • The title page/cover page
  • Abstract (or executive summary)
  • Section 1: Introduction 
  • Section 2: Literature review 
  • Section 3: Methodology
  • Section 4: Findings /results
  • Section 5: Discussion
  • Section 6: Conclusion
  • Reference list

Each section is explained in plain, straightforward language , followed by an overview of the key elements that you need to cover within each section. 

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FAQs: Research Paper Template

What format is the template (doc, pdf, ppt, etc.).

The research paper template is provided as a Google Doc. You can download it in MS Word format or make a copy to your Google Drive. You’re also welcome to convert it to whatever format works best for you, such as LaTeX or PDF.

What types of research papers can this template be used for?

The template follows the standard best-practice structure for formal academic research papers, so it is suitable for the vast majority of degrees, particularly those within the sciences.

Some universities may have some additional requirements, but these are typically minor, with the core structure remaining the same. Therefore, it’s always a good idea to double-check your university’s requirements before you finalise your structure.

Is this template for an undergrad, Masters or PhD-level research paper?

This template can be used for a research paper at any level of study. It may be slight overkill for an undergraduate-level study, but it certainly won’t be missing anything.

How long should my research paper be?

This depends entirely on your university’s specific requirements, so it’s best to check with them. We include generic word count ranges for each section within the template, but these are purely indicative. 

What about the research proposal?

If you’re still working on your research proposal, we’ve got a template for that here .

We’ve also got loads of proposal-related guides and videos over on the Grad Coach blog .

How do I write a literature review?

We have a wealth of free resources on the Grad Coach Blog that unpack how to write a literature review from scratch. You can check out the literature review section of the blog here.

How do I create a research methodology?

We have a wealth of free resources on the Grad Coach Blog that unpack research methodology, both qualitative and quantitative. You can check out the methodology section of the blog here.

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Yes, you’re welcome to share this template. If you want to post about it on your blog or social media, all we ask is that you reference this page as your source.

Can Grad Coach help me with my research paper?

Within the template, you’ll find plain-language explanations of each section, which should give you a fair amount of guidance. However, you’re also welcome to consider our private coaching services .

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How to Write a Medical Abstract for Publication

medical research article template

Preparing Your Study, Review, or Article for Publication in Medical Journals

The majority of social, behavioral, biological, and clinical journals follow the conventional structured abstract form with the following four major headings (or variations of these headings):

OBJECTIVE   (Purpose; Aim; Goal) : Tells reader the purpose of your research and the questions it intends to answer

METHODS   (Setting; Study Design; Participants) : Explains the methods and process so that other researchers can assess, review, and replicate your study.

RESULTS (Findings; Outcomes) : Summarizes the most important findings of your study

CONCLUSIONS   (Discussion; Implications; Further Recommendations) : Summarizes the interpretation and implications of these results and presents recommendations for further research

Sample Health/Medical Abstract

medical research article template

Structured Abstracts Guidelines *

  • Total Word Count: ~200-300 words (depending on the journal)
  • Content: The abstract should reflect only the contents of the original paper (no cited work)

*   Always follow the formatting guidelines of the journal to which you are submitting your paper.

Useful Terms and Phrases by Abstract Section

Objective:  state your precise research purpose or question (1-2 sentences).

  • Begin with “To”: “We aimed to…” or “The objective of this study was to…” using a verb that accurately captures the action of your study.
  • Connect the verb to an object phrase to capture the central elements and purpose of the study, hypothesis , or research problem . Include details about the setting, demographics, and the problem or intervention you are investigating.
 analyze, ascertain, assess, characterize, collect, describe, determine, establish, evaluate, examine, explain, identify, investigate, measure, present, produce, validate
 The role of [method/item], a reliable and valid measure of [item/quality], the process undertaken in [procedure], the degree of [item/quality being measured], the amount/number of [item], the outcome of [therapy/procedure], the differences in the quality of [variable being measured]

METHODS : Explain the tools and steps of your research (1-3 sentences)

  • Use the past tense if the study has been conducted; use the present tense if the study is in progress.
  • Include details about the study design, sample groups and sizes, variables, procedures, outcome measures, controls, and methods of analysis.
ElementExamples
We conducted a qualitative analysis of…”; “A three-year longitudinal study of diabetic patients was performed…”; “We conducted a systematic review searching databases for…”; “We interviewed 34 Dutch general practitioners…”
All cancer patients >40 years of age were eligible for the study”; “We analyzed data of the American Project on Patient Evaluation of Palliative Practice Care (APPEPPC)”; “Elderly patients with late-stage Alzheimer’s disease were identified…”; “Sample groups were limited to patients with a history of smoking”
 “…in hospitals around the State of New York…”; “…at urgent care centers in three hospitals in Taipei, Taiwan…”; “…at Pyeongchang Regional Care Facility…”
“We surveyed 2,136 patients over the course of three years…”; “The frequency of consultations, symptoms, presentations, referrals, and prescription data during the four years prior to diagnosis were recorded…”
“Age- and sex-matched controls were identified…”

  RESULTS : Summarize the data you obtained (3-6 sentences)

  • Use the past tense when describing the actions or outcomes of the research.
  • Include results that answer the research question and that were derived from the stated methods; examine data by qualitative or quantitative means.
  • State whether the research question or hypothesis was proven or disproven.
ElementExamples
“participated in the study/completed the treatment”; “changed/did not change significantly”; “had greater/lesser odds of…”; “were associated with…”; “response rate was…”; “The likelihood of ____ was found to be increased by…”; “adverse events occurred…”; “[number/kind of outcomes] were identified, including…”; “was/was not associated with…”
“Symptoms of…were reported by 3,811 (80%) of 4,764 patients”; “Patients refusing antibiotics increased 23% from 2013 to 2016”; “One in four infants were kept at the hospital longer than two days”
“Many patients reported a long history of chest infection”; “Doctors reported generally high levels of workplace satisfaction”; “The results of the physiotherapy analysis were reproduced”

CONCLUSIONS : Describe the key findings (2-5 sentences)

ElementExamples
“This study confirms that…”; “[Result] indicates that…”; “…leads to fewer prescriptions for…;” “…was reliable/accurate”; “…is safe/well-tolerated/effective
 “…valid and reliable for routine use”; “…is drastically decreased after transplantation”; “…may result in functional improvement of the…”; “Our preliminary results indicate potential benefits of using [procedure/drug] in this group of patients”
“…which could increase the number of potential liver donors”; “antibiotic-resistant strains are an emerging threat”
“Additional studies on [area of study] are recommended to [aim of additional research]”; “However, this evidence should be further assessed in larger trials”; “This diagnostic accuracy may not be generalizable to all office laboratories”
  • Use the present tense to discuss the findings and implications of the study results.
  • Explain the implications of these results for medicine, science, or society.
  • Discuss any major limitations of the study and suggest further actions or research that should be undertaken.

Before submitting your abstract to medical journals, be sure to receive proofreading services from Wordvice, including journal manuscript editing and paper proofreading , to enhance your writing impact and fix any remaining errors.

Related Resources

  • 40 Useful Words and Phrases for Top-Notch Essays  (Oxford Royale Academy)
  • 100+ Strong Verbs That Will Make Your Research Writing Amazing  (Wordvice)
  • Essential Academic Writing Words and Phrases  (My English Teacher.eu)
  • Academic Vocabulary, Useful Phrases for Academic Writing and Research Paper Writing  (Research Gate)
  • How to Compose a Journal Submission Cover Letter  (Wordvice/YouTube)
  • How to Write the Best Journal Submission Cover Letter  (Wordvice)

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How to Write Case Reports and Case Series

Ganesan, Prasanth

Department of Medical Oncology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India

Address for correspondence: Dr. Prasanth Ganesan, Medical Oncology, 3 rd Floor, SSB, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantari Nagar, Puducherry - 605006, India. E-mail: [email protected]

Received March 13, 2022

Received in revised form April 10, 2022

Accepted April 10, 2022

This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.

Case reports are considered the smallest units of descriptive studies. They serve an important function in bringing out information regarding presentation, management, and/or outcomes of rare diseases. They can also be a starting point in understanding unique associations in clinical medicine and can introduce very effective treatment paradigms. Preparing the manuscript for a case report may be the first exposure to scientific writing for a budding clinician/researcher. This manuscript describes the steps of writing a case report and essential considerations when publishing these articles. Individual components of a case report and the “dos and don'ts” while preparing these components are detailed.

INTRODUCTION

A case report describes several aspects of an individual patient's presentation, investigations, management decisions, and/or outcomes. This is a type of observational study and has been described as the smallest publishable unit in medical literature.[ 1 ] A case series involves a group of patients with similar presentations or treatments. In modern medicine [ Figure 1 ], these publications are categorized as the “lowest level of evidence”.[ 2 ] However, they serve several essential functions. For example, there are rare diseases where large, randomized trials, or even observational studies may not be possible. Medical practice, in these conditions, is often guided by well-presented case reports or series. There are situations where a single case report has heralded an important therapy change.[ 3 ] Further, case reports are often a student's first exposure to manuscript writing. Hence, these serve as training for budding scholars to understand scientific writing, learn the process of manuscript submission, and receive and respond to reviewer comments. This article explains the reasons why case reports are published and provides guidance for writing such type of articles.

F1-11

WHY ARE CASE REPORTS PUBLISHED?

A case report is often published to highlight the rarity of a particular presentation. However, it may be of much more value if it also informs some aspects of management. This could be in the form of rare expressions of a common disease so that clinicians who read will be aware and can consider additional possibilities and differential diagnoses when encountering similar situations. A new form of evaluation of a patient, either to facilitate the diagnostics or to improve understanding of the disease condition, may stimulate a case report. Novel treatments may be tried, and the results might be necessary to disseminate. This may be encountered either in rare diseases or conditions where treatment options are exhausted. Moreover, randomized trials report outcomes of a group and often do not inform about the individual patient. [ Table 1 ] describes a few examples of case reports/case series which have had a remarkable impact on medical practice.

T1-11

ETHICAL ISSUES

If there is a possibility of patient identification from the report, it is mandatory to obtain informed consent from the patient while approval from the institutional ethics committee (IEC) may also be needed depending on institutional policies.[ 7 ] If identifying information is absent (or if suitable steps are taken to remove identifying information or hide the identity, (such as by covering the eyes), it may still be required by some journals to obtain ethics committee approval for certain types of case reports. If a case series involves retrospective chart review, “waiver-of-consent” may be sought from the ethics committee. Indian Ethical Guidelines do not separately address this issue in case reports.[ 8 ] The Committee on Publication Ethics has described best practices for journals when publishing case reports which also gives links to model consent forms.[ 9 ]

HOW TO START?

If you are a beginner and you have identified an interesting case which you want to report, the first step would be to sit with your team and discuss the aspects of the case you want to highlight in your publication.[ 10 ] Do a literature search and try to summarize available information before writing the draft. It would also be a good idea to understand which journal you are targeting; this will assist in determining the number of figures, the word limits, and ethical requirements (such as informed consent). Discussions with senior faculty about the authors and their order should also be done at this point to avoid issues later. For a beginner, it would be a good practice to present the case in the department or in an institutional scientific forum before writing up the manuscript.

COMPONENTS OF a CASE REPORT

A case report usually has the following sections: an abstract, a brief introduction, the actual description of the case, and finally, the discussion which highlights the uniqueness of the case and includes a conclusion statement. Many journals these days publish case reports only as a letter to editor; in such cases, an abstract is not usually required.

The title must be informative about the problem being reported. It may refer to the particular issue being highlighted in the report, or it may refer to the educational aspect of that particular report. Catchy titles are often used by authors to trigger interest among the readers and make them want to read the article. Authors may remember to use titles which will help people locate the article when searching the literature.

When writing a title, it may be best to avoid terms such as “case report,” “review of literature,” “unique,” “rare,” “first-report”; these do not add value to the presentation.

Introduction

This must introduce the condition and clearly state why the case report is worth reading. It may also contain a brief mention of the current status of the problem being described with supporting references.

Describing the case

The case must be presented succinctly, in a chronological order, clearly highlighting the salient aspects of the case being reported. Relevant negative findings may be provided. For example, if a case is being reported for elaborating a new type of treatment, then more attention must be given to treatment aspects (e.g., name of the drug, dosage, schedule, dose modifications, or the type of surgery, duration, and type of anesthesia) after briefly describing the presentation and diagnostics. The idea is that the reader must be able to apply the treatment in his/her practice if required.

However, if the case is being presented for diagnostic rarity/unusual clinical features/pathological aspects, then more attention must be given to these aspects. For example, if the emphasis is on tissue pathology, then the description must include details about tissue processing, types of stains, and immunohistochemistry details.

Figures and tables

Figures, as in any publication, should be self-explanatory. A properly constructed figure legend can be used for describing certain aspects of the case much better than long-winded text in the main manuscript. This will also help to reduce the word count in the main manuscript. If there are multiple figures (e.g., follow-up radiology series and response to treatment images), these can be combined as [ Figure 1 ]a, [ Figure 1 ]b, [ Figure 1c ] or [ Figure 1 ]a, [ Figure 1 ]b, [ Figure 1 ]c, [ Figure 1d ]. This will help conform to the figure number limits prescribed by the journal. While preparing the figures, one must ensure that the quality of the art/photograph is not compromised. Further, patient identifying features must be masked, unless necessary to show.

Tables are usually not part of case reports but may be used. One example is presenting the baseline investigations in a tabular format which can facilitate assimilation as well as reduce the word count. Tables are more often used in case series. The most common is a type of table where the features of all the cases included are summarized with each row referring to an individual patient. This usually works for a series of up to ten patients; beyond that, the table may become crowded and difficult to understand. Tables may also be used in the discussion section to summarize related, published reports to date.

Discussion including review

A case report may help to alter the approach to patient management in the clinic or it may even stimulate original research evaluating a new treatment. Thus, the discussion must summarize the unique aspects of the case (why is the case different?) and the essential learning points/implications (how will it change management?/What further research needs to be done?). In addition to stating the differences from existing literature, the discussion should also attempt to explain these differences.

If the condition or treatment approach being focused on is sufficiently rare, reviewing all available cases published until that point is critical. This review may be presented in a table with each case described briefly. A more nuanced study might attempt to summarize the relevant demographics and clinical details of the various cases published to date in the form of a table (e.g., median age, gender distribution, and survival outcomes).

CASE SERIES - WHAT IS DIFFERENT?

There is no formal definition as to what is case series and what would be considered a retrospective cohort study. In general, a case series comprises <10 cases; beyond that, it may be feasible to apply formal statistics and may be considered a cohort study.

Both case reports and case series are descriptive studies. Case series must have similar cases and hence the inclusion must be clearly defined. The interventions must be documented in a way that is reproducible and follow-up of each individual in the report must be available. Although formal statistical analyses are usually not a part of case series, authors may attempt to summarize baseline demographic parameters using descriptive statistics.

ABSTRACT OF a CASE REPORT

As explained earlier, a few journals do not require abstracts for case report submissions. When required, one should try to highlight the salient aspects of the case presented and the reason for the publication within the abstract word limit, which may be as short as 100–200 words. Spend time and effort in writing a good abstract as this is a portion which is usually read by the editor during manuscript screening and may have implications for whether the article progresses to the next stage of editorial processing.

REFERENCES IN a CASE REPORT

One may only cite key references in a case report or series as there is limited scope for elaborate literature search. Most journals have a limit of 10–15 references for case reports; when publishing as a letter to editor (or correspondence), the allowed reference limit may be even lower (five or less for some journals).

CHOOSING THE RIGHT JOURNAL

Many journals have recently stopped publishing case reports and series. This is often an attempt by journals to optimize their resources (space and reviewer time) to attain the highest possible impact. Although this is unfortunate, it is a reality which must be acknowledged. Nonetheless, the advent of online-only journals has led to more options for aspiring authors. Some journals accept case series, whereas others have “sister” journals created to accept case reports and other, less definitive, contributions to the literature.[ 11 ] It is an important exercise to study all available journals accepting case reports of the type being written. The case report must be tailored to the journal's requirements. Many journals may charge an article processing fee; author(s) must consider whether they are willing to pay and publish. Some of these may be predatory journals; authors must be wary of them and scrupulously avoid publishing in such journals as they can permanently stain the publication records of a researcher.

PUBLISHING THE CASE REPORT/SERIES AS a LETTER TO EDITOR/IMAGE SERIES

When the matter to be conveyed is very minimal or is being published mainly for its rarity, letters to editor may be an alternate route to publish case report data. Interesting images may be published in the form of “images” series which is now a part of many journals. The flexibility of web-based publishing also allows interesting videos to be published online.

GUIDELINES FOR CASE REPORTS

There are guidelines which help authors in the preparation and submission of case reports. The CAse REports (CARE) checklist is one such popular guideline. It provides a “checklist” and other resources for authors that can help navigate the process of writing a case report, especially when a person is doing it for the first time.[ 12 ]

AUTHORSHIP IN CASE REPORTS

Although there are no separate guidelines for authorship in “case reports,” general authorship rules follow that for any manuscript. “Gift” authorship must be avoided. All authors must have contributed to the creation of the manuscript in addition to being involved in some aspect of care of the patient being reported. Authorship order should be ideally predecided based on mutual consensus.

CONCLUSIONS

A case report is a useful starting point for one's scientific writing career. There are useful online resources which describe the steps for a newbie writer.[ 13 14 ] [ Table 2 ] summarizes the important components to follow and understand when writing case reports. Although many frontline journals have reduced their acceptance of case reports, these publications continue to serve an essential scientific and academic role.

T2-11

Financial support and sponsorship

Conflicts of interest.

There are no conflicts of interest.

Case reports; manuscript writing; case series; references

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Preparing the Research Presentation

If you have never presented a paper at a scientific meeting, you should read this article. Even if you have presented before, it is likely that this article contains information that will improve your presentation. This article contains a set of practical, proven steps that will guide your preparation of the presentation. Our assumptions are that you will schedule appropriate planning and preparation time, are interested in doing the best job possible, and know that a quality presentation is a combination of good research and communication skills. This and subsequent articles will focus on planning, preparation, creating visual aids (slides), and presentation skills for a scientific presentation. The intent of this series of articles is to help you make a favorable impression at the scientific meeting and reap the rewards, personal and professional, of a job well done.

To begin with, you need to create an outline of the topics you might present at the meeting. Your outline should follow the IMRAC format (introduction, methods, results, and conclusion). This format is chosen because your audience understands it and expects it. If you have already prepared a paper for publication, it can be a rich source of content for the topic outline.

To get you started, we have prepared a generic outline  to serve as an example. We recognize that a generic outline does not necessarily adapt to all research designs, but we ask you to think, "How can I adapt this to my situation?" To help you visualize the content you might include in the outline, two types of examples have been included, one that describes a cross-sectional study using a survey methodology (example A), and a second using a combination of a case-control and cohort designs (example B).

Use the Preparing the Research Presentation Checklist  to assist you in preparing the topic outline.

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How to write a review article?

In the medical sciences, the importance of review articles is rising. When clinicians want to update their knowledge and generate guidelines about a topic, they frequently use reviews as a starting point. The value of a review is associated with what has been done, what has been found and how these findings are presented. Before asking ‘how,’ the question of ‘why’ is more important when starting to write a review. The main and fundamental purpose of writing a review is to create a readable synthesis of the best resources available in the literature for an important research question or a current area of research. Although the idea of writing a review is attractive, it is important to spend time identifying the important questions. Good review methods are critical because they provide an unbiased point of view for the reader regarding the current literature. There is a consensus that a review should be written in a systematic fashion, a notion that is usually followed. In a systematic review with a focused question, the research methods must be clearly described. A ‘methodological filter’ is the best method for identifying the best working style for a research question, and this method reduces the workload when surveying the literature. An essential part of the review process is differentiating good research from bad and leaning on the results of the better studies. The ideal way to synthesize studies is to perform a meta-analysis. In conclusion, when writing a review, it is best to clearly focus on fixed ideas, to use a procedural and critical approach to the literature and to express your findings in an attractive way.

The importance of review articles in health sciences is increasing day by day. Clinicians frequently benefit from review articles to update their knowledge in their field of specialization, and use these articles as a starting point for formulating guidelines. [ 1 , 2 ] The institutions which provide financial support for further investigations resort to these reviews to reveal the need for these researches. [ 3 ] As is the case with all other researches, the value of a review article is related to what is achieved, what is found, and the way of communicating this information. A few studies have evaluated the quality of review articles. Murlow evaluated 50 review articles published in 1985, and 1986, and revealed that none of them had complied with clear-cut scientific criteria. [ 4 ] In 1996 an international group that analyzed articles, demonstrated the aspects of review articles, and meta-analyses that had not complied with scientific criteria, and elaborated QUOROM (QUality Of Reporting Of Meta-analyses) statement which focused on meta-analyses of randomized controlled studies. [ 5 ] Later on this guideline was updated, and named as PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). [ 6 ]

Review articles are divided into 2 categories as narrative, and systematic reviews. Narrative reviews are written in an easily readable format, and allow consideration of the subject matter within a large spectrum. However in a systematic review, a very detailed, and comprehensive literature surveying is performed on the selected topic. [ 7 , 8 ] Since it is a result of a more detailed literature surveying with relatively lesser involvement of author’s bias, systematic reviews are considered as gold standard articles. Systematic reviews can be diivded into qualitative, and quantitative reviews. In both of them detailed literature surveying is performed. However in quantitative reviews, study data are collected, and statistically evaluated (ie. meta-analysis). [ 8 ]

Before inquring for the method of preparation of a review article, it is more logical to investigate the motivation behind writing the review article in question. The fundamental rationale of writing a review article is to make a readable synthesis of the best literature sources on an important research inquiry or a topic. This simple definition of a review article contains the following key elements:

  • The question(s) to be dealt with
  • Methods used to find out, and select the best quality researches so as to respond to these questions.
  • To synthetize available, but quite different researches

For the specification of important questions to be answered, number of literature references to be consulted should be more or less determined. Discussions should be conducted with colleagues in the same area of interest, and time should be reserved for the solution of the problem(s). Though starting to write the review article promptly seems to be very alluring, the time you spend for the determination of important issues won’t be a waste of time. [ 9 ]

The PRISMA statement [ 6 ] elaborated to write a well-designed review articles contains a 27-item checklist ( Table 1 ). It will be reasonable to fulfill the requirements of these items during preparation of a review article or a meta-analysis. Thus preparation of a comprehensible article with a high-quality scientific content can be feasible.

PRISMA statement: A 27-item checklist

Title
Title1 Identify the article as a systematic review, meta-analysis, or both
Summary
Structured summary2 Write a structured summary including, as applicable, background; objectives; data sources; study eligibility criteria, participants, treatments, study appraisal and synthesis methods; results; limitations; conclusions and implications of key findings; and systematic review registration number
Introduction
Rationale3 Explain the rationale for the review in the context of what is already known
Objectives4 Provide an explicit statement of questions being addressed with reference to participants, interventions, comparisons, outcomes, and study design (PICOS)
Methods
Protocol and registration5 Indicate if a review protocol exists, if and where it can be accessed (such as a web address), and, if available, provide registration information including the registration number
Eligibility criteria6 Specify study characteristics (such as PICOS, length of follow-up) and report characteristics (such as years considered, language, publication status) used as criteria for eligibility, giving rationale
Sources of Information7 Describe all information sources in the survey (such as databases with dates of coverage, contact with study authors to identify additional studies) and date last searched
Survey8 Present the full electronic search strategy for at least one major database, including any limits used, such that it could be repeated
Study selection9 State the process for selecting studies (that is, for screening, for determining eligibility, for inclusion in the systematic review, and, if applicable, for inclusion in the meta-analysis)
Data collection process10 Describe the method of data extraction from reports (such as piloted forms, independently by two reviewers) and any processes for obtaining and confirming data from investigators
Data items11 List and define all variables for which data were sought (such as PICOS, funding sources) and any assumptions and simplifications made
Risk of bias in individual studies12 Describe methods used for assessing risk of bias in individual studies (including specification of whether this was done at the study or outcome level, or both), and how this information is to be used in any data synthesis
Summary measures13 State the principal summary measures (such as risk ratio, difference in means)
Synthesis of outcomes14 For each meta-analysis, explain methods of data use, and combination methods of study outcomes, and if done consistency measurements should be indicated (ie P test)
Risk of bias across studies15 Specify any assessment of risk of bias that may affect the cumulative evidence (such as publication bias, selective reporting within studies).
Additional analyses16 Describe methods of additional analyses (such as sensitivity or subgroup analyses, meta-regression), if done, indicating which were pre-specified.
Results
Study selection17 Give numbers of studies screened, assessed for eligibility, and included in the review, with reasons for exclusions at each stage, ideally with a flow diagram.
Study characteristics18 For each study, present characteristics for which data were extracted (such as study size, PICOS, follow-up period) and provide the citation.
Risk of bias within studies19 Present data on risk of bias of each study and, if available, any outcome-level assessment (see item 12)
Results of individual studies20 For all outcomes considered (benefits and harms), present, for each study, simple summary data for each intervention group and effect estimates and confidence intervals, ideally with a forest plot (a type of graph used in meta-analyses which demonstrates relat, ve success rates of treatment outcomes of multiple scientific studies analyzing the same topic)
Syntheses of resxults21 Present the results of each meta-analyses including confidence intervals and measures of consistency
Risk of bias across studies22 Present results of any assessment of risk of bias across studies (see item 15).
Additional analyses23 Give results of additional analyses, if done such as sensitivity or subgroup analyses, meta-regression (see item 16)
Discussion
Summary of evidence24 Summarize the main findings, including the strength of evidence for each main outcome; consider their relevance to key groups (such as healthcare providers, users, and policy makers)
Limitations25 Discuss limitations at study and outcome level (such as risk of bias), and at review level such as incomplete retrieval of identified research, reporting bias
Conclusions26 Provide a general interpretation of the results in the context of other evidence, and implications for future research
Funding
Funding27 Indicate sources of funding or other support (such as supply of data) for the systematic review, and the role of funders for the systematic review

Contents and format

Important differences exist between systematic, and non-systematic reviews which especially arise from methodologies used in the description of the literature sources. A non-systematic review means use of articles collected for years with the recommendations of your colleagues, while systematic review is based on struggles to search for, and find the best possible researches which will respond to the questions predetermined at the start of the review.

Though a consensus has been reached about the systematic design of the review articles, studies revealed that most of them had not been written in a systematic format. McAlister et al. analyzed review articles in 6 medical journals, and disclosed that in less than one fourth of the review articles, methods of description, evaluation or synthesis of evidence had been provided, one third of them had focused on a clinical topic, and only half of them had provided quantitative data about the extend of the potential benefits. [ 10 ]

Use of proper methodologies in review articles is important in that readers assume an objective attitude towards updated information. We can confront two problems while we are using data from researches in order to answer certain questions. Firstly, we can be prejudiced during selection of research articles or these articles might be biased. To minimize this risk, methodologies used in our reviews should allow us to define, and use researches with minimal degree of bias. The second problem is that, most of the researches have been performed with small sample sizes. In statistical methods in meta-analyses, available researches are combined to increase the statistical power of the study. The problematic aspect of a non-systematic review is that our tendency to give biased responses to the questions, in other words we apt to select the studies with known or favourite results, rather than the best quality investigations among them.

As is the case with many research articles, general format of a systematic review on a single subject includes sections of Introduction, Methods, Results, and Discussion ( Table 2 ).

Structure of a systematic review

IntroductionPresents the problem and certain issues dealt in the review article
MethodsDescribes research, and evaluation process
Specifies the number of studies evaluated orselected
ResultsDescribes the quality, and outcomes of the selected studies
DiscussionSummarizes results, limitations, and outcomes of the procedure and research

Preparation of the review article

Steps, and targets of constructing a good review article are listed in Table 3 . To write a good review article the items in Table 3 should be implemented step by step. [ 11 – 13 ]

Steps of a systematic review

Formulation of researchable questionsSelect answerable questions
Disclosure of studiesDatabases, and key words
Evaluation of its qualityQuality criteria during selection of studies
SynthesisMethods interpretation, and synthesis of outcomes

The research question

It might be helpful to divide the research question into components. The most prevalently used format for questions related to the treatment is PICO (P - Patient, Problem or Population; I-Intervention; C-appropriate Comparisons, and O-Outcome measures) procedure. For example In female patients (P) with stress urinary incontinence, comparisons (C) between transobturator, and retropubic midurethral tension-free band surgery (I) as for patients’ satisfaction (O).

Finding Studies

In a systematic review on a focused question, methods of investigation used should be clearly specified.

Ideally, research methods, investigated databases, and key words should be described in the final report. Different databases are used dependent on the topic analyzed. In most of the clinical topics, Medline should be surveyed. However searching through Embase and CINAHL can be also appropriate.

While determining appropriate terms for surveying, PICO elements of the issue to be sought may guide the process. Since in general we are interested in more than one outcome, P, and I can be key elements. In this case we should think about synonyms of P, and I elements, and combine them with a conjunction AND.

One method which might alleviate the workload of surveying process is “methodological filter” which aims to find the best investigation method for each research question. A good example of this method can be found in PubMed interface of Medline. The Clinical Queries tool offers empirically developed filters for five different inquiries as guidelines for etiology, diagnosis, treatment, prognosis or clinical prediction.

Evaluation of the Quality of the Study

As an indispensable component of the review process is to discriminate good, and bad quality researches from each other, and the outcomes should be based on better qualified researches, as far as possible. To achieve this goal you should know the best possible evidence for each type of question The first component of the quality is its general planning/design of the study. General planning/design of a cohort study, a case series or normal study demonstrates variations.

A hierarchy of evidence for different research questions is presented in Table 4 . However this hierarchy is only a first step. After you find good quality research articles, you won’t need to read all the rest of other articles which saves you tons of time. [ 14 ]

Determination of levels of evidence based on the type of the research question

ISystematic review of Level II studiesSystematic review of Level II studiesSystematic review of Level II studiesSystematic review of Level II studies
IIRandomized controlled studyCrross-sectional study in consecutive patientsInitial cohort studyProspective cohort study
IIIOne of the following: Non-randomized experimental study (ie. controlled pre-, and post-test intervention study) Comparative studies with concurrent control groups (observational study) (ie. cohort study, case-control study)One of the following: Cross-sectional study in non-consecutive case series; diagnostic case-control studyOne of the following: Untreated control group patients in a randomized controlled study, integrated cohort studyOne of the following: Retrospective cohort study, case-control study (Note: these are most prevalently used types of etiological studies; for other alternatives, and interventional studies see Level III
IVCase seriesCase seriesCase series or cohort studies with patients at different stages of their disease states

Formulating a Synthesis

Rarely all researches arrive at the same conclusion. In this case a solution should be found. However it is risky to make a decision based on the votes of absolute majority. Indeed, a well-performed large scale study, and a weakly designed one are weighed on the same scale. Therefore, ideally a meta-analysis should be performed to solve apparent differences. Ideally, first of all, one should be focused on the largest, and higher quality study, then other studies should be compared with this basic study.

Conclusions

In conclusion, during writing process of a review article, the procedures to be achieved can be indicated as follows: 1) Get rid of fixed ideas, and obsessions from your head, and view the subject from a large perspective. 2) Research articles in the literature should be approached with a methodological, and critical attitude and 3) finally data should be explained in an attractive way.

Medical Research: Forms & Consent Templates

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See  consent template updates  for recent changes.

RegularFor greater than minimal risk research
[03/2024]

[03/2024]

[01/2024]
Regular without HIPAAUse VA Form 10-0493N/AN/A
[01/2024]
ExpeditedFor minimal risk research (e.g., blood draws, non-invasive specimen collection, interviews, surveys, behavioral interventions, etc.)
[03/2024]

[03/2024]

[01/2024]
Expedited without HIPAAUse VA Form 10-0493N/AN/A
[01/2024]
Somatic cell donationFor stem cell research
[09/2023]

[09/2023]
N/A
Adults (18+) unable to provide consentUse legally authorized representative (LAR) consent for adults (18+)
[01/2023]

[01/2023]
N/A
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[04/2024]
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Children, age 7-12 yearsUse for children age 7-12
[04/2024]

[04/2024]
N/A
Expedited research information sheetUse for waiver of documentation (i.e., waiver of signature) for minimal risk procedures
[09/2023]

[09/2023]
N/A
Exempt research information sheetFor exempt research
[09/2023]

[09/2023]
N/A
Screening script, level 1aUse for waiver of documentation for screening
[01/2023]

[01/2023]
N/A
Screening script, level 1bUse for waiver of documentation for screening and retaining contact information for future research
[01/2023]

[01/2023]
N/A
VA HIPAA Authorization (VA Form 10-0493)Use regular or expedited consent without HIPAAN/AN/A
[09/2015]
Schedule of Procedures tableUse or insert into consent when standard of care procedures overlap with research procedures
[10/2017]

[10/2017]
N/A
General Data Protection Regulation (GDPR) consent form languageInsert into consent when study takes place in the European Union/European Economic Area (EU/EEA)
[01/2023]

[01/2023]
N/A

Other Forms:

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SIR Self-Assessment Checklist - IND/IDE

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•   
•   
 
•   
• Non-Medical:  
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is used to submit: 
  •  applications - see examples above. 
      - Complete and attach supplemental required attachments as needed (see above) 
  •   to approved protocols (need prior IRB approval to implement). 
  •   applications. 
  •   unanticipated problems, events/information requiring prompt reporting. 
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  • Introduction
  • Article Information

Data are from Epic Systems Corporation peer benchmarking. Center horizontal lines represent medians; lower and upper bounds of the boxes, 25th and 75th percentiles; vertical lines, 5th to 95th percentile; and dashed horizontal line, 4-hour standard set by The Joint Commission.

Data are from Epic Systems Corporation peer benchmarking. A, Hospital occupancy is the percentage of staffed beds; ED visits are from January 2020.

eTable. Sample Site Characteristics from the Epic Peer Benchmarking Service

  • Monthly Rates of Patients Who Left Before Accessing Care in US Emergency Departments JAMA Network Open Research Letter September 30, 2022 This cross-sectional study investigates rates of patients who left emergency departments without being seen from 2017 to 2021. Alexander T. Janke, MD; Edward R. Melnick, MD, MHS; Arjun K. Venkatesh, MD, MBA, MHS

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Janke AT , Melnick ER , Venkatesh AK. Hospital Occupancy and Emergency Department Boarding During the COVID-19 Pandemic. JAMA Netw Open. 2022;5(9):e2233964. doi:10.1001/jamanetworkopen.2022.33964

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Hospital Occupancy and Emergency Department Boarding During the COVID-19 Pandemic

  • 1 Department of Emergency Medicine, Yale University School of Medicine, New Haven, Connecticut
  • 2 VA Ann Arbor, University of Michigan, National Clinician Scholars Program, Ann Arbor
  • 3 Center for Outcomes Research and Evaluation, Yale University, New Haven, Connecticut
  • Research Letter Monthly Rates of Patients Who Left Before Accessing Care in US Emergency Departments Alexander T. Janke, MD; Edward R. Melnick, MD, MHS; Arjun K. Venkatesh, MD, MBA, MHS JAMA Network Open

Emergency department (ED) boarding refers to holding admitted patients in the ED, often in hallways, while awaiting an inpatient bed. The Joint Commission identified boarding as a patient safety risk that should not exceed 4 hours. 1 Downstream harms include increased medical errors, compromises to patient privacy, and increased mortality. 2 Boarding is a key indicator of overwhelmed resources and may be more likely to occur when hospital occupancy exceeds 85% to 90%. 3

Hospital resource constraints have become more salient during the COVID-19 pandemic and have been associated with excess mortality. 4 Existing federal data fail to capture a comprehensive view of resource limitations inclusive of ED strain. 5 We used a national benchmarking database to examine hospital occupancy and ED boarding during the COVID-19 pandemic.

This cross-sectional study used aggregated hospital measures available through a voluntary peer benchmarking service offered by Epic Systems Corporation, an electronic health record vendor. Measures were collected monthly from January 2020 to December 2021. Annual ED visit volumes and total hospital beds for participating sites were included (eTable in the Supplement ). We reported median and 5th to 95th percentile for hospital occupancy (percentage of staffed inpatient beds occupied, calculated hourly and averaged over the month), ED boarding time (median time from admission order to ED departure to an inpatient bed), and ED visit count. The study was classified as exempt by the institutional review board at Yale University because the study did not use patient data. This study followed the STROBE reporting guideline.

Distribution of ED boarding time was examined across hospital occupancy levels, with a threshold of 85% or greater based on Kelen et al. 3 We plotted all 3 measures with new national daily COVID-19 cases. 6 The difference in median ED boarding time between high-occupancy and low-occupancy hospital-months was evaluated using the Wilcoxon rank sum test .Analyses were performed using R, version 4.0.2.

Hospitals reporting benchmarking data increased from 1289 in January 2020 to 1769 in December 2021. Occupancy rates and boarding time had a threshold association: when occupancy exceeded 85%, boarding exceeded The Joint Commission 4-hour standard for 88.9% of hospital-months ( Figure 1 ). In those hospital-months, median ED boarding time was 6.58 hours compared with 2.42 hours in other hospital-months ( P  < .001). Across all hospitals, the median ED boarding time was 2.00 hours (5th-95th percentile, 0.93-7.88 hours) in January 2020, 1.58 hours (5th-95th percentile, 0.90-3.51 hours) in April 2020, and 3.42 hours in December 2021 (5th-95th percentile, 1.27-9.14 hours). Median hospital occupancy was highest in January 2020 (69.6%; 5th-95th percentile, 44.3%-69.6%), 48.7% (5th-95th percentile, 28.7%-69.9% hours) in April 2020, and 65.8% (5th-95th percentile, 42.7%-84.8%) in December 2021 ( Figure 2 ).

We found that hospital occupancy greater than 85% was associated with increased ED boarding beyond the 4-hour standard. Throughout 2020 and 2021, ED boarding increased even when hospital occupancy did not increase above January 2020 levels. The harms associated with ED boarding and crowding, long-standing before the pandemic, may have been further entrenched. Study limitations were the inability to differentiate occupancy for specific services, median measures of boarding likely underestimated actual burden, and the sample was anchored to specific data fields within the Epic peer benchmarking service. Future research should explore more complex measures like staffing variability and local outbreak burden. Policy makers should address acute care system strain in future pandemic waves and other disasters to avoid further hospital system capacity strain and unsafe patient care conditions.

Accepted for Publication: June 30, 2022.

Published: September 30, 2022. doi:10.1001/jamanetworkopen.2022.33964

Open Access: This is an open access article distributed under the terms of the CC-BY License . © 2022 Janke AT et al. JAMA Network Open .

Corresponding Author: Alexander T. Janke, MD, VA Ann Arbor, University of Michigan, National Clinician Scholars Program, NCRC Building 14, G100, 2800 Plymouth Rd, Ann Arbor MI 48109 ( [email protected] ).

Author Contributions: Dr Janke had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: All authors.

Acquisition, analysis, or interpretation of data: Janke, Melnick.

Drafting of the manuscript: Janke, Melnick.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Janke.

Obtained funding: Janke.

Administrative, technical, or material support: Melnick, Venkatesh.

Supervision: Melnick, Venkatesh.

Conflict of Interest Disclosures: Dr Janke reported receiving support from the Veterans Affairs (VA) Office of Academic Affiliations through the VA/National Clinician Scholars Program and the University of Michigan and funding from an Emerging Infectious Diseases and Preparedness grant from the Society for Academic Emergency Medicine Foundation. Dr Melnick reported receiving grants from the National Institute on Drug Abuse, the American Medical Association, and the Agency for Healthcare Research & Quality outside the submitted work. Dr Venkatesh reported receiving grants from the Centers for Medicare & Medicaid Services and the American College of Emergency Physicians outside the submitted work; receiving funding from an Emerging Infectious Diseases and Preparedness grant from the Society for Academic Emergency Medicine Foundation; and having committee leadership roles with the American College of Emergency Physicians and the Society for Academic Emergency Medicine. No other disclosures were reported.

Funding/Support: Dr Venkatesh was supported by the American Board of Emergency Medicine–National Academy of Medicine Fellowship.

Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Disclaimer: The contents of this article do not represent the views of the US Department of Veterans Affairs or the US Government.

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Brief State Non-Medical Exemptions from School Immunization Requirements

All 50 states and Washington D.C. have laws requiring certain vaccines for students to attend school. Many states align their vaccine requirements with recommendations from the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices . All states allow exemptions from school immunization requirements for children who are unable to receive vaccines for medical reasons. State laws vary regarding non-medical exemptions, for religious or personal reasons. Personal exemptions are also referred to as "philosophical exemptions" by some states.

Thirty states and Washington D.C. allow exemptions for people who have religious objections to immunizations. Thirteen 13 states allow exemptions for either religious or personal reasons. Two states, Louisiana and Minnesota, do not specify whether the non-medical exemption must be for religious or personal reasons. Five states do not allow any type of non-medical exemption.

The map below indicates each state's non-medical exemption policy. The map also links to the statutes for each state regarding school vaccine requirements and exemptions. Below the map is a table which provides more information about state exemption laws including exemption exceptions, requirements to obtain a non-medical exemption and information on states that have removed certain exemption policies.

Modal title

Map Source: Adapted from the LexisNexis StateNet Database and the Immunization Action Coalition.

State

Personal Exemption

Religious Exemption

Additional Details On Exemption Exceptions & Educational Requirements

No

Yes

 

No

Yes

 

Yes

Yes

Parent/guardian must complete an online educational course to receive a non-medical exemption.

Yes

Yes

Parent/guardian must complete an educational module to receive a non-medical exemption.

No

No

California removed its personal and religious exemption option in 2015.

Yes

Yes

Parent/guradian must complete an online educational module to receive a non-medical exemption.

No

No

Connecticut removed its religious exemption option in 2021. If a religious exemption was granted prior to April 28, 2021, the exemption will be honored through 12th grade.

No

Yes

 

No

Yes

A personal exemption is allowed for the HPV (human papillomarvirus) vaccine only.

No

Yes

 

Georgia

No

Yes

 

No

Yes

Parent/guardian must submit a Certificate of Religious Exemption signed by a health care provider to receive a religious exemption.

Yes

Yes

 

No

Yes

 

No

Yes

 

No

Yes

 

No

Yes

 

No

Yes

 

Yes

No

Parent/guardian may obtain an exemption through written dissent - no personal or religious reason is listed in statute.

No

No

Maine removed its relgious and personal exemption options in 2019. A student with a philosohpical or religious exemption prior to September 1, 2021 may continue to attend school under exemption if certain requirments are met.

No

Yes

 

No

Yes

 

Yes

Yes

 

Yes

No

A notarized statement must be submited requesting an exemption for consientiously held beliefs to obtain an personal exemption.

No

Yes

A federal district court order entered in April 2023 required Mississippi to allow a religious exemption. Parent/guardian must watch an educational video at a county health department to receive an exemption.

No

Yes

 

No

Yes

 

No

Yes

 

No

Yes

 

No

Yes

 

No

Yes

 

No

No

New York removed its religious exemption option in 2019.

No

Yes

 

No

Yes

 

Yes

Yes

 

Yes

Yes

 

Yes

Yes

 

Yes

Yes

Parent/guardian must submit request signed by a health care provider or obtain a certificate after viewing an educational module to receive a non-medical exemption.

Yes

Yes

 

No

Yes

 

No

Yes

 

Yes

Yes

 

Yes

Yes

 

No

Yes

 

Yes

Yes

 

No

Yes

Parent/gurdaian must review evidence-based educational material to receive a religious exemption.

No

Yes

A personal exemption is allowed for HPV (human papillomarvirus) vaccine only.

Yes

Yes

Washington removed the personal belief exemption for measles, mumps and rubella (MMR) in 2019.

No

No

 

Yes

Yes

 

No

Yes

 

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