paper documentation corrections should

Good Clinical Practice Study Documentation

The Department of Medicine Clinical Research Unit has prepared this document is to provide guidance to all faculty and staff involved in the conduct of research on the  best practices related to documentation .

Good study documentation will allow for an individual with basic knowledge of the particular project to recreate the events of the study.

General Information

• Maintain records of all data and observations pertinent to the research subject.  These records should be identifiable to a particular participant.
• Remember that source documents are where the information is first recorded.
• All data must be verifiable.
• Study documentation should be able to recreate the study for any reviewer.
• Attributable – Can you tell who wrote and/or did this
• Legible – Can it be read?
• Contemporaneous- – Is the data current, and in the correct time frame?  The notation, signature and date should occur at the same time.
• Original – Has the data been altered?
• Accurate – Are there conflicting data elsewhere?  Content should precisely reflect the event.
• Use a signed Note to File to explain any discrepancies, missing or incomplete data.
• The same standards maintained for medical documentation should be followed for research documentation
• All documents require 2 identifiers on each page. 
• All entries are to be signed and dated in real time.
• Error corrections are made by drawing a single line through the incorrect entry, initial and date.
• Never obliterate entries that require correction.
• Subject records need to be secure but accessible.
• Do not alter past-dated notes by writing alongside or adding to prior entries.  Updates may be made through addenda.
• Use dark ink, do not use pencil.
• Never use whiteout.
• If the source data is incomplete or deficient, it may be completed or corrected using an addendum.  This late entry must be signed and dated at the time it is created.

Note to File

• May be used to correct errors, or as an explanation to a departure from the protocol.  Reasons for any departure should be documented and attempts to correct or prevent in the future should be included.
• This should not be used as a panacea to correct any error.

Informed Consent

• The process requires documentation and should reflect the process approved by the IRB in a narrative form or through the use of a checklist.
• Signature and date and time must be of the person obtaining the consent, at the time of the process. (Not added later)

Case Report Forms as Source

Case report forms may be used as source only when this practice is clearly outlined in the protocol, and they represent the data collected for the research are where the data were initially recorded.   

Medical Records From Outside Source

• Copies of records from an outside source may be used if they support endpoints, inclusion/exclusion criteria or adverse events.
• Attempts to obtain medical records should be recorded in the research chart.

Questionnaires

• Documentation must reflect who completed the questionnaire, in compliance with the protocol.
• For questionnaires completed by staff, a note should reflect how the information was obtained ie: direct interview with participant, phone call, chart abstraction.

Document Format, Documentation Style, and Proofreading

Document Format

Make sure that you have formatted your document as required for the writing task. If you are writing an essay in MLA or APA style, make sure that you have checked for the correct margins, header, first page heading, cover page if required, page numbering, spacing, and other formatting details. If you are writing for the web, make sure that you know where to find the style guide or guidelines for the type of document you are working on. Writing a personal blog has different requirements than writing a professional blog for a website.

Here are some resources to help you:

• To learn more about MLA essay format, see the Purdue OWL article, “ MLA General Format .”
• To learn more about APA essay format, see the Purdue OWL article, “ APA General Format .”
• Also, see the “Using MLA to Format Your Documents” portion of the “ Resources for Working with MLA ” appendix of this text.

Documentation Style

Whenever you use material from another source, whether that means images, text, ideas, or media, you must do so ethically by giving credit to the originator. If you are writing a college essay, that usually means using either MLA or APA style. For academic writing, citing within your essay and also providing a bibliography are required. When writing for the web, you may be providing links to the original source and/or a list of sources.

• To learn more about MLA documentation, see the Purdue OWL article, “ MLA Formatting and Style Guide .”
• To learn more about APA documentation, see the Purdue OWL article, “ APA Formatting and Style Guide .”
• Also, see the “Four-Step Process for Working with Sources” portion of the “ Resources for Working with MLA ” appendix of this text

Proofreading

Proofreading is the final step, and it means using a system to ensure you’ve made all the corrections necessary.

Using a System

Circle, highlight, underline : Select one method to mark all the corrections you want to make. You might choose to circle, underline, or highlight all errors you find. Check off each circle, highlight, or underline when you make the correction in the electronic document.

Check marks and checkboxes : Some writers make a check mark in the margin for every error they find in a line of typing, then put a slash through the check mark once it is corrected. You can also make checkboxes and then check the box once the correction is made.

Using editor’s marks : You may have certain marks that you have learned to make for some kinds of errors, either from an instructor or from professional editing marks. If so, feel free to use those. For an extensive list of editing marks, consult the NY Book Editor’s Guide to Copyediting Marks (at nybookeditors.com).

The Word on College Reading and Writing Copyright © by Carol Burnell, Jaime Wood, Monique Babin, Susan Pesznecker, and Nicole Rosevear is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License , except where otherwise noted.

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Entries in Medical Records: Amendments, Corrections and Addenda

Entering information into patients’ medical records in a timely manner is important for many reasons. The Centers for Medicare & Medicaid Services (CMS) provides some guidance regarding what is considered timely for Medicare purposes.

We strongly encourage all health care providers to enter information into the patient’s medical record at the time the service is provided to the patient — that is, contemporaneously. 

CMS recently published established recordkeeping principles to provide further guidance regarding the timeliness of entries in medical records. These principles apply to all Medicare contractors that review medical records, including Medicare Administrative Contractors (MACs), the Comprehensive Error Rate Testing (CERT) review contractors, Recovery Audit Contractors (RACs), and Unified Program Integrity Contractors (UPICs). In all cases, regardless of whether the documentation is maintained or submitted in paper or electronic form, any medical records that contain amendments, corrections, or addenda must:

• Clearly and permanently identify any amendment, correction or delayed entry as such
• Clearly indicate the date and author of any amendment, correction, or delayed entry
• Not delete, but instead, clearly identify all original content

For paper medical records:

• Making corrections, in keeping with these principles, generally entails using a single line strike-through so the original content is still legible
• The author of the alteration must sign and date the revision
• Amendments or delayed entries must also be signed and dated by the author upon entry

For electronic medical records:

• Amendments, corrections and delayed entries must be distinctly identified as such
• The record must provide a reliable means of clearly identifying the original content, the modified content, and the date and author of each modified record

Medicare contractors, including Palmetto GBA, cannot consider entries in medical records that do not comply with the established recordkeeping principles described above. For example, we must disregard undated or unsigned entries handwritten in the margins of a document. 

Reference:  CMS Change Request 8105  (PDF), which updates the CMS Program Integrity Manual (PDF) (Pub. 100-08), chapter 3, section 3.3.2.5.

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Best Practices for Amending Electronic Health Record Documentation

Electronic health records (EHRs) are designed to provide a legible, comprehensive, and lasting record of a patient’s medical history and treatment. Medical transcription companies play a key role in helping physicians maintain consistent, HIPAA compliant documentation. However, errors can creep into EHRs due to data entry mistakes caused by system design or user error, importing of inaccurate medication lists, confusing interfaces and complicated navigation, the copy-paste function, etc. Since physicians utilize EHR data to make decisions about the patient’s care, such mistakes could lead to medication errors, wasteful duplication, incorrect or unnecessary treatment, and delayed diagnosed, and result in malpractice litigation. The reality is that errors can occur when documenting medical records, but correcting the mistakes the right way and reporting them in a consistent and timely manner will make it easier to defend malpractice claims.

Take the first step towards optimizing your EHR record documentation.

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Types of Corrections made in Medical Records

The principles for amending EHRs are the same as those for paper records, according to MedPro, and include:

• not concealing the original documentation
• making timely corrections, and
• signing all entries

However, the EHR differs in terms of how it displays and records information and its ability to track user actions through metadata and audit trails.

Capstone Performance Systems lists four types of changes that can be made in medical records:

Addendum : This involves adding omitted information to an existing document without modifying the original document, along with the current date and reason for the additional information being added to the record. The added information should be connected to the original report and both should bear the signature of the same provider. Amendment : After the original documentation has been completed by the provider, an amendment clarifies information presented in the original document without altering it. Amendments should bear the current date. Correction : Corrections refer to changes in the information in the document to correct mistakes after the original document has been signed or completed. Deletion : Incorrect information is removed or deleted from a closed/finalized document without replacing it with new information.

Best Practices and Tips for Amending Medical Documentation

The EHR is a healthcare organization’s most important business and legal record and physicians need to understand what they can and cannot do with regard to making changes in it. Following these best practices and tips can help organizations protect themselves when making changes to documentation:

• Ensure that overall documentation policies and procedures include a clear process for amending patient records.
• Follow state laws on amending medical records. Some states may have specific record amendment rules.
• Verify if your EHR allows error correction and can track corrections or changes once the original entry has been entered or authenticated. Work with your EHR vendor on this.
• Avoid deleting relevant information permanently. Line out and rewrite incorrect entries in the written medical record instead of obscuring them.
• The altered EHR record should be flagged to indicate that a change has been made.
• Make a narrative entry in the medical record statement indicating that an error has been made, and is being corrected.
• Have a system in place to retain and easily access copies of the original data.
• Clearly document both the original error and the correction for future reference.
• Ensure that the record amendment policy specifies the precise information that should be included when a correction, addendum, or late entry is made (such as the date and time of revision, name of the person who made the change, what information is being changed, and the reason for the alteration).
• The record amendment policy should state the appropriate timeframe for making corrections, addendums, and late entries.
• Notify the original author of the content about the correction, addendum, or late entry so that they can verify that the amendment is necessary.
• Educate providers and staff about documentation amendment procedures and the potential consequences of deliberate or inadvertent record falsification (www.medpro.com).
• Conduct routine audits to ensure that providers and staff are complying with organizational documentation policies and procedures.

Physicians should focus on ensuring complete, accurate and concise medical records and the best way to do this is to document the patient encounter real-time, or shortly afterwards. Outsourcing medical transcription to an experienced transcription company can ensure that physician dictation is accurately transcribed in quick turnaround time.

For affordable and accurate medical transcription services in the US, call us today at 1-800 670 2809 .

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Editing and Proofreading

What this handout is about.

This handout provides some tips and strategies for revising your writing. To give you a chance to practice proofreading, we have left seven errors (three spelling errors, two punctuation errors, and two grammatical errors) in the text of this handout. See if you can spot them!

Is editing the same thing as proofreading?

Not exactly. Although many people use the terms interchangeably, editing and proofreading are two different stages of the revision process. Both demand close and careful reading, but they focus on different aspects of the writing and employ different techniques.

Some tips that apply to both editing and proofreading

• Get some distance from the text! It’s hard to edit or proofread a paper that you’ve just finished writing—it’s still to familiar, and you tend to skip over a lot of errors. Put the paper aside for a few hours, days, or weeks. Go for a run. Take a trip to the beach. Clear your head of what you’ve written so you can take a fresh look at the paper and see what is really on the page. Better yet, give the paper to a friend—you can’t get much more distance than that. Someone who is reading the paper for the first time, comes to it with completely fresh eyes.
• Decide which medium lets you proofread most carefully. Some people like to work right at the computer, while others like to sit back with a printed copy that they can mark up as they read.
• Try changing the look of your document. Altering the size, spacing, color, or style of the text may trick your brain into thinking it’s seeing an unfamiliar document, and that can help you get a different perspective on what you’ve written.
• Find a quiet place to work. Don’t try to do your proofreading in front of the TV or while you’re chugging away on the treadmill. Find a place where you can concentrate and avoid distractions.
• If possible, do your editing and proofreading in several short blocks of time. Your concentration may start to wane if you try to proofread the entire text at one time.
• If you’re short on time, you may wish to prioritize. Make sure that you complete the most important editing and proofreading tasks.

Editing is what you begin doing as soon as you finish your first draft. You reread your draft to see, for example, whether the paper is well-organized, the transitions between paragraphs are smooth, and your evidence really backs up your argument. You can edit on several levels:

Have you done everything the assignment requires? Are the claims you make accurate? If it is required to do so, does your paper make an argument? Is the argument complete? Are all of your claims consistent? Have you supported each point with adequate evidence? Is all of the information in your paper relevant to the assignment and/or your overall writing goal? (For additional tips, see our handouts on understanding assignments and developing an argument .)

Overall structure

Does your paper have an appropriate introduction and conclusion? Is your thesis clearly stated in your introduction? Is it clear how each paragraph in the body of your paper is related to your thesis? Are the paragraphs arranged in a logical sequence? Have you made clear transitions between paragraphs? One way to check the structure of your paper is to make a reverse outline of the paper after you have written the first draft. (See our handouts on introductions , conclusions , thesis statements , and transitions .)

Structure within paragraphs

Does each paragraph have a clear topic sentence? Does each paragraph stick to one main idea? Are there any extraneous or missing sentences in any of your paragraphs? (See our handout on paragraph development .)

Have you defined any important terms that might be unclear to your reader? Is the meaning of each sentence clear? (One way to answer this question is to read your paper one sentence at a time, starting at the end and working backwards so that you will not unconsciously fill in content from previous sentences.) Is it clear what each pronoun (he, she, it, they, which, who, this, etc.) refers to? Have you chosen the proper words to express your ideas? Avoid using words you find in the thesaurus that aren’t part of your normal vocabulary; you may misuse them.

Have you used an appropriate tone (formal, informal, persuasive, etc.)? Is your use of gendered language (masculine and feminine pronouns like “he” or “she,” words like “fireman” that contain “man,” and words that some people incorrectly assume apply to only one gender—for example, some people assume “nurse” must refer to a woman) appropriate? Have you varied the length and structure of your sentences? Do you tends to use the passive voice too often? Does your writing contain a lot of unnecessary phrases like “there is,” “there are,” “due to the fact that,” etc.? Do you repeat a strong word (for example, a vivid main verb) unnecessarily? (For tips, see our handouts on style and gender-inclusive language .)

Have you appropriately cited quotes, paraphrases, and ideas you got from sources? Are your citations in the correct format? (See the UNC Libraries citation tutorial for more information.)

As you edit at all of these levels, you will usually make significant revisions to the content and wording of your paper. Keep an eye out for patterns of error; knowing what kinds of problems you tend to have will be helpful, especially if you are editing a large document like a thesis or dissertation. Once you have identified a pattern, you can develop techniques for spotting and correcting future instances of that pattern. For example, if you notice that you often discuss several distinct topics in each paragraph, you can go through your paper and underline the key words in each paragraph, then break the paragraphs up so that each one focuses on just one main idea.

Proofreading

Proofreading is the final stage of the editing process, focusing on surface errors such as misspellings and mistakes in grammar and punctuation. You should proofread only after you have finished all of your other editing revisions.

Why proofread? It’s the content that really matters, right?

Content is important. But like it or not, the way a paper looks affects the way others judge it. When you’ve worked hard to develop and present your ideas, you don’t want careless errors distracting your reader from what you have to say. It’s worth paying attention to the details that help you to make a good impression.

Most people devote only a few minutes to proofreading, hoping to catch any glaring errors that jump out from the page. But a quick and cursory reading, especially after you’ve been working long and hard on a paper, usually misses a lot. It’s better to work with a definite plan that helps you to search systematically for specific kinds of errors.

Sure, this takes a little extra time, but it pays off in the end. If you know that you have an effective way to catch errors when the paper is almost finished, you can worry less about editing while you are writing your first drafts. This makes the entire writing proccess more efficient.

Try to keep the editing and proofreading processes separate. When you are editing an early draft, you don’t want to be bothered with thinking about punctuation, grammar, and spelling. If your worrying about the spelling of a word or the placement of a comma, you’re not focusing on the more important task of developing and connecting ideas.

The proofreading process

You probably already use some of the strategies discussed below. Experiment with different tactics until you find a system that works well for you. The important thing is to make the process systematic and focused so that you catch as many errors as possible in the least amount of time.

• Don’t rely entirely on spelling checkers. These can be useful tools but they are far from foolproof. Spell checkers have a limited dictionary, so some words that show up as misspelled may really just not be in their memory. In addition, spell checkers will not catch misspellings that form another valid word. For example, if you type “your” instead of “you’re,” “to” instead of “too,” or “there” instead of “their,” the spell checker won’t catch the error.
• Grammar checkers can be even more problematic. These programs work with a limited number of rules, so they can’t identify every error and often make mistakes. They also fail to give thorough explanations to help you understand why a sentence should be revised. You may want to use a grammar checker to help you identify potential run-on sentences or too-frequent use of the passive voice, but you need to be able to evaluate the feedback it provides.
• Proofread for only one kind of error at a time. If you try to identify and revise too many things at once, you risk losing focus, and your proofreading will be less effective. It’s easier to catch grammar errors if you aren’t checking punctuation and spelling at the same time. In addition, some of the techniques that work well for spotting one kind of mistake won’t catch others.
• Read slow, and read every word. Try reading out loud , which forces you to say each word and also lets you hear how the words sound together. When you read silently or too quickly, you may skip over errors or make unconscious corrections.
• Separate the text into individual sentences. This is another technique to help you to read every sentence carefully. Simply press the return key after every period so that every line begins a new sentence. Then read each sentence separately, looking for grammar, punctuation, or spelling errors. If you’re working with a printed copy, try using an opaque object like a ruler or a piece of paper to isolate the line you’re working on.
• Circle every punctuation mark. This forces you to look at each one. As you circle, ask yourself if the punctuation is correct.
• Read the paper backwards. This technique is helpful for checking spelling. Start with the last word on the last page and work your way back to the beginning, reading each word separately. Because content, punctuation, and grammar won’t make any sense, your focus will be entirely on the spelling of each word. You can also read backwards sentence by sentence to check grammar; this will help you avoid becoming distracted by content issues.
• Proofreading is a learning process. You’re not just looking for errors that you recognize; you’re also learning to recognize and correct new errors. This is where handbooks and dictionaries come in. Keep the ones you find helpful close at hand as you proofread.
• Ignorance may be bliss, but it won’t make you a better proofreader. You’ll often find things that don’t seem quite right to you, but you may not be quite sure what’s wrong either. A word looks like it might be misspelled, but the spell checker didn’t catch it. You think you need a comma between two words, but you’re not sure why. Should you use “that” instead of “which”? If you’re not sure about something, look it up.
• The proofreading process becomes more efficient as you develop and practice a systematic strategy. You’ll learn to identify the specific areas of your own writing that need careful attention, and knowing that you have a sound method for finding errors will help you to focus more on developing your ideas while you are drafting the paper.

Think you’ve got it?

Then give it a try, if you haven’t already! This handout contains seven errors our proofreader should have caught: three spelling errors, two punctuation errors, and two grammatical errors. Try to find them, and then check a version of this page with the errors marked in red to see if you’re a proofreading star.

Works consulted

We consulted these works while writing this handout. This is not a comprehensive list of resources on the handout’s topic, and we encourage you to do your own research to find additional publications. Please do not use this list as a model for the format of your own reference list, as it may not match the citation style you are using. For guidance on formatting citations, please see the UNC Libraries citation tutorial . We revise these tips periodically and welcome feedback.

Especially for non-native speakers of English:

Ascher, Allen. 2006. Think About Editing: An ESL Guide for the Harbrace Handbooks . Boston: Wadsworth Cengage Learning.

Lane, Janet, and Ellen Lange. 2012. Writing Clearly: Grammar for Editing , 3rd ed. Boston: Heinle.

For everyone:

Einsohn, Amy. 2011. The Copyeditor’s Handbook: A Guide for Book Publishing and Corporate Communications , 3rd ed. Berkeley: University of California Press.

Lanham, Richard A. 2006. Revising Prose , 5th ed. New York: Pearson Longman.

Tarshis, Barry. 1998. How to Be Your Own Best Editor: The Toolkit for Everyone Who Writes . New York: Three Rivers Press.

You may reproduce it for non-commercial use if you use the entire handout and attribute the source: The Writing Center, University of North Carolina at Chapel Hill

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Roberts Academic Medicine Handbook pp 149–154 Cite as

How to Maintain Excellent Clinical Documentation

• Sharon E. Williams 2  
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Clinical documentation is an important part of clinical care. It serves as a record of the care provided and the excellence in clinical service. Documentation should be clear, concise, thorough, and well organized to meet the clinical standard of care for your patients as well as the needs of your colleagues, institution, and governing compliance and financial agencies. The use of the electronic health record (EHR) can aid in documentation efficiency, particularly when it is personalized to your clinic workflow patterns, but can also create burden and contribute to work burnout when not optimized. Team-based models of care and additional advances in technology can also improve efficient documentation practices. Finally, challenges to maintaining documentation standards and solutions are discussed.

• Clinical documentation
• Electronic health record
• Productivity

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Williams, S.E. (2020). How to Maintain Excellent Clinical Documentation. In: Roberts, L. (eds) Roberts Academic Medicine Handbook. Springer, Cham. https://doi.org/10.1007/978-3-030-31957-1_16

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Do’s and Don’ts of Electronic Documentation

• Denise Neal , B.S.N., M.J., C.P.H.R.M.

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Documentation that is not up to date may lead to errors in patient care, harm to the patient, and potential liability.

The medical record, whether on paper or via an electronic system, is a communication tool used for care coordination and provides up-to-date information regarding the patient’s diagnosis, treatment, and services provided and is used to justify the reimbursement of services, according to the Centers for Medicare and Medicaid Services. The medical record serves as the legal record to provide evidence of adherence to the standard of care as well as federal and state regulations.

Electronic health records (EHR) and electronic medical records (EMR) both contain digital patient health information. An EMR is a digital version of a patient chart that is designed for internal use by one practice, clinic, or hospital and may need to be printed out to share the information. An EHR collects information from all clinicians involved in the patient’s care and can be shared among many settings. Poor documentation in an EMR or EHR can impact patient safety and quality of care, create compliance concerns, and lead to medical and/or civil liability.

Psychiatrists can mitigate liability risk by keeping the following do’s and don’ts in mind when documenting electronically.

Be aware of “metadata,” which are computerized data that identify how an electronic document has been manipulated. Metadata can be discovered through an audit trail and identify users who accessed the record; date and time of access; and information viewed, added, deleted, or changed. Metadata may be requested by plaintiff counsel in a malpractice case.

BDocument at the time services are provided or as soon as possible after the visit/communication.

Document pertinent clinical information communicated by phone, email, text, or other electronic means.

Confirm accuracy of drop-down selections before signing the record.

Ensure that information that automatically populates in the medical record is accurate.

Review all medication orders for selection errors (drug, dose, frequency, route).

Use only approved abbreviations, acronyms, and symbols.

Recognize that templates do not address all elements of care and add narrative.

Individualize each patient note and expand as needed.

Correct medical record errors in accordance with federal and state laws, the Privacy and Security Standards under the Health Insurance Portability and Accountability Act (HIPAA), and your organization’s record-keeping guidelines.

Document late entries or additions to an original entry as an addendum. Include the date and time of the addendum and a brief reason for the addition/late entry. Make it clear that the information you are adding is not part of the original entry.

Make corrections to clarify inaccuracies as an amendment. Never delete the original entry. The “strikethrough” feature is often used in the EHR/EMR. Date and time the amendment, state a brief reason for the clarification/change, and reference the original note.

Maintain psychotherapy notes in a separate, secured section of the EMR/EHR to receive additional confidentiality protections under HIPAA.

Do not add or change a medical record after a claim or safety event has occurred without first consulting an attorney or risk manager.

Do not copy and paste/clone notes. This practice can undermine the quality of the medical record; may increase the risk of inaccurate, redundant, outdated, and unnecessary information being included; and lead to clinical errors, potential attestation of care provided by another physician, and overbilling of services.

Ensuring documentation integrity through accurate and timely medical recordkeeping helps to improve patient safety and quality of care while reducing the risk of medical and/or civil liability. ■

This information is provided as a risk management resource for Allied World policyholders and should not be construed as legal or clinical advice. This material may not be reproduced or distributed without the express, written permission of Allied World Assurance Company Holdings Ltd., a Fairfax company (“Allied World”). Risk management services are provided by or arranged through AWAC Services Company, a member company of Allied World. © 2021 Allied World Assurance Company Holdings, Ltd. All Rights Reserved.

Denise Neal, B.S.N., M.J., C.P.H.R.M., is a risk management consultant in the Risk Management Group of AWAC Services Company, a member company of Allied World. Risk Management services are provided as an exclusive benefit to insureds of the APA-endorsed American Professional Agency Inc. liability insurance program.

• Aseptic Technique
• Hand-Over Tools
• Instruments
• OR for Infection Preventionists
• Positioning
• Procedures in Action
• A Glimpse into Infection Prevention
• An Inside Look at OR Efficiencies
• ASC Infection Prevention Policies and Procedures
• Resources for Cardiac Catheterization
• Resources for Endoscopy
• Guidelines and Tools for the Sterile Processing Team
• Core Curriculum for the RNFA
• Perioperative Care of the COVID-19 Patient
• Joint Commission Standards Ambulatory Critical Access Hospital Hospital Office Based Surgery Sterile Processing
• AAAHC Standards Accreditation for Ambulatory Health Care Accreditation for Medicare Deemed Status
• Equipment and Supplies Finder Device Video Instructions

Information Management

• Full Guideline

The Guideline for Patient Information Management was approved by the AORN Guidelines Advisory Board and became effective as of April 19, 2022. The recommendations in the guideline are intended to be achievable and represent what is believed to be an optimal level of practice. Policies and procedures will reflect variations in practice settings and/or clinical situations that determine the degree to which the guideline can be implemented. AORN recognizes the many diverse settings in which perioperative nurses practice; therefore, this guideline is adaptable to all areas where operative or other invasive procedures may be performed.

designing patient health care record (HCR) information systems (eg, electronic medical record [EMR], electronic health record [EHR], medical record documentation ) and tools,

evaluating health information technology (HIT),

documenting patient care information, and

using perioperative patient information management for the safe delivery of perioperative care and quality improvement. 1  

Highly reliable data collection processes are necessary not only to chronicle a patient’s response to nursing interventions and clinical improvement related to the patient’s health care, but also to demonstrate the health care organization’s progress in and dedication to improving health care outcomes, including those for individuals (ie, patient-centered care) and those for populations (ie, community health and national systems). 2  

Federal regulations govern patient information management in the United States. The Privacy, Security, and Enforcement Rules in the Health Insurance Portability and Accountability Act (HIPAA) of 1996 3,4   include national standards for electronic transmission of health information, and the simplification provision requires protections for health information while reducing paperwork and streamlining business processes. With advancements in HIT, federal regulations including the Genetic Information Nondiscrimination Act of 2008, which prohibits employer discrimination based on health, and the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009, which prohibits selling of health information, were enacted to protect health care professionals and patients from intentional or unintentional misuse of health information. 5  

Even after the passage of the HITECH Act, there has been inconsistency among health care settings related to advanced use of HIT capabilities. This can be seen in the ways that advanced EHR functions are accessed and used by personnel in different types of health care organizations (eg, critical access hospitals compared to urban hospitals) and by patients. 6   Continuous modifications are being made to privacy, security, and enforcement rules and breach notification rules, and these rule modifications require health care organizations to update HCR data capture and maintenance processes. 5   The 21st Century Cures Act of 2016 includes provisions to advance interoperability and support the access, exchange, and use of electronic health information by health care professionals and patients. 7  

This guideline represents a conceptual outline for a comprehensive perioperative documentation plan that includes nursing workflow, data capture, required components, and electronic platforms. It is not inclusive of all required HCR documentation elements, nor should it be seen as the only guideline to be followed when developing or revising clinical perioperative documentation policies and procedures.

This guideline is specific to patient information documentation guidelines; therefore, the following topics are outside the scope of this document: access to personal health information; accreditation requirements; HIT certification criteria ; certification processes for EHR systems; data analytic requirements, EHR human factors science; EHR adoption processes; general or non-perioperative-specific nursing documentation; hand-over communication requirements and perioperative team communication (see the AORN Guideline for Team Communication 8   ); health data reporting for the purpose of reimbursement; health information exchanges and interoperability requirements and facilitation; the processes used for obtaining informed consent (eg, shared decision making) or consent education aids (eg, audio-visual); information that is recorded or communicated outside of the patient HCR; mandatory quality reporting criteria and submission; nurse informaticists’ scope of practice and aspects of their job description (eg, use of the EHR to predict outcomes or treatments by developing clinical decision support [CDS] or use of artificial intelligence [AI], machine learning , and big data ); patient information tracking devices; and verbal communication of the patient care plan.

Evidence Review

A medical librarian with a perioperative background conducted a systematic search of the databases Ovid MEDLINE, Ovid Embase, EBSCO CINAHL, and the Cochrane Database of Systematic Reviews. The search was limited to literature published in English from June 2015 through June 2020. At the time of the initial search, weekly alerts were created on the topics included in that search. Results from these alerts were provided to the lead author until July 2021. The lead author requested additional articles that either did not fit the original search criteria or were discovered during the evidence appraisal process. The lead author and the medical librarian also identified relevant guidelines from government agencies, professional organizations, and standards-setting bodies.

Search terms included Affordable Care Act, ambulatory facility, American Recovery and Reinvestment Act, ambulatory surgery center, analytics, big data, charting, charting by exception, clinical decision support systems, computer-assisted decision making, computerized patient records, consent (research), data analytics, data collection, data mining, data storage and retrieval, decision making (computer-assisted), decision support systems (clinical), documentation, electronic data interchange, electronic health records, electronic medical record, electronic signature, forms and records control, government regulations, Health Care Reform Act, health informatics, health information exchange, health information interoperability, health information system interoperability, HIT for economic and clinical health, Health Insurance Assistance for the Unemployed Act of 2009, Health Insurance Portability and Accountability Act, Health Level 7, Health Level Seven, Health Level Seven (organization), Health Level Seven International, HIPAA, HITECH Act, HL7, hospital information systems, information management, information retrieval, information storage, information storage and retrieval, informed consent, interoperability, Kassebaum Kennedy Act, machine learning, meaningful use, medical informatics, medical information exchange, medical records, Medicare and Medicaid electronic HCR, Medicare and Medicaid Health Information Technology for Economic and Clinical Health Act, multi hospital information systems, nursing informatics, Obamacare, office-based surgery, operating room, operating room information systems, operating suite, operating theater, paper charting, Patient Protection and Affordable Care Act, Public Law 104-191, Public Law 111-148, Public Law 111-5, records management, same day surgery, surg*, systems integration, TAA Health Coverage Improvement Act of 2009, and variance charting.

Included were research and non-research literature in English, complete publications, and publications with dates within the time restriction when available. Excluded were non-peer-reviewed publications and older evidence within the time restriction when more recent evidence was available. Editorials, news items, and other brief items were excluded. Low-quality evidence was excluded when higher-quality evidence was available, and literature outside the time restriction was excluded when literature within the time restriction was available ( Figure 1 ).

Flow Diagram of Literature Search Results

Adapted from Moher D, Liberati A, Tetzlaff J, Atman DG; The PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: The PRISMA Statement. PLoS Med. 2009;6(6):e1000097.

Articles identified in the search were provided to the project team for evaluation. The team consisted of the lead author and one evidence appraiser. The lead author and the evidence appraiser reviewed and critically appraised each article using the AORN Research or Non-Research Evidence Appraisal Tools as appropriate. The literature was independently evaluated and appraised according to the strength and quality of the evidence. Each article was then assigned an appraisal score. The appraisal score is noted in brackets after each reference as applicable.

Each recommendation rating is based on a synthesis of the collective evidence, a benefit-harm assessment, and con­sideration of resource use. The strength of the recommen­dation was determined using the AORN Evidence Rating Model and the quality and consistency of the evidence sup­porting a recommendation. The recommendation strength rating is noted in brackets after each recommendation.

Note: The evidence summary table is available at http://www.aorn.org/evidencetables/ .

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The Impact of Structured and Standardized Documentation on Documentation Quality; a Multicenter, Retrospective Study

1 Department of Otorhinolaryngology and Head and Neck Surgery, Radboud University Medical Center, Nijmegen, Netherlands

Rudolf B. Kool

3 Radboud University Medical Center, Radboud Institute for Health Sciences, IQ Healthcare, Nijmegen, Netherlands

Ludi E. Smeele

2 Department of Head and Neck Oncology and Surgery, Antoni Van Leeuwenhoek, Amsterdam, Netherlands

Richard Dirven

Chrisje a. den besten, luc h. e. karssemakers, tim verhoeven.

4 Department of Oromaxillofacial Surgery and Head and Neck Surgery, Radboud University Medical Center, Nijmegen, Netherlands

Jasmijn M. Herruer

Guido b. van den broek, robert p. takes, associated data.

Data is available upon reasonable request.

The reuse of healthcare data for various purposes will become increasingly important in the future. To enable the reuse of clinical data, structured and standardized documentation is conditional. However, the primary purpose of clinical documentation is to support high-quality patient care. Therefore, this study investigated the effect of increased structured and standardized documentation on the quality of notes in the Electronic Health Record. A multicenter, retrospective design was used to assess the difference in note quality between 144 unstructured and 144 structured notes. Independent reviewers measured note quality by scoring the notes with the Qnote instrument. This instrument rates all note elements independently using and results in a grand mean score on a 0–100 scale. The mean quality score for unstructured notes was 64.35 (95% CI 61.30–67.35). Structured and standardized documentation improved the Qnote quality score to 77.2 (95% CI 74.18–80.21), a 12.8 point difference (p < 0.001). Furthermore, results showed that structured notes were significantly longer than unstructured notes. Nevertheless, structured notes were more clear and concise. Structured documentation led to a significant increase in note quality. Moreover, considering the benefits of structured data recording in terms of data reuse, implementing structured and standardized documentation into the EHR is recommended.

Supplementary information

The online version contains supplementary material available at 10.1007/s10916-022-01837-9.

Introduction

Clinical documentation is the process of creating a text record that summarizes the interaction between patients and healthcare providers during clinical encounters [ 1 ]. The quality of clinical documentation is important as it impacts quality of patient care, patient safety, and the number of medical errors [ 2 – 4 ]. Furthermore, clinical documentation is increasingly used for other purposes, such as quality measurement, finance, and research. Additionally, regulatory requirements regarding documentation have increased [ 5 , 6 ]. Consequently, physicians are spending more and more time on documentation [ 7 ].

In recent years, various tools and techniques have been developed to increase documentation efficiency and decrease the time physicians need to spend on documentation. These techniques are known as content importing technology (CIT). Examples of CIT are copy and paste functions (CPF), automated data import from other parts of the electronic health record (EHR), templates, or macros. These tools seem to have multiple benefits, primarily faster documentation during patient visits. However, Weis and Levy described that the use of CIT has multiple risks. Incorrect insertion of data from other parts of the record, or excessively long, bloated notes can distract a reader from key, essential facts and data [ 8 ]. However, when used correctly, it should be possible to limit these risks.

In addition to the need to increase documentation efficiency, documentation needs to be accurate. Cohen et al. stated that variation in EHR documentation between physicians impedes effective and safe use of EHRs, emphasizing the need for increased standardization of documentation [ 9 ]. However, some studies have suggested that structured and standardized documentation (hereafter: structured documentation) can impede expressivity in notes. Rosenbloom explored this tension between flexible, narrative documentation and structured documentation and recommended that healthcare providers can choose how to document patient care based on workflow and note content needs [ 1 ]. This implies that structured documentation is preferred when reuse of data is desirable. On the other hand, narrative documentation can be used when reuse of information is not required.

Research has shown that structured documentation can improve provider efficiency and decrease documentation time [ 10 ]. Unfortunately, little is known about the effects that a transition from primarily unstructured, free-text EHR documentation to structured and standardized EHR documentation has on the quality of EHR notes. To date, research on this topic has mainly focused on the difference between paper-based and electronic documentation [ 11 – 13 ]. Although reuse of data, for which structured documentation is essential, will become increasingly important, the primary goal of EHR documentation is supporting high-quality patient care [ 14 ]. Therefore, the primary objective was to investigate the effect of increased standardized and structured documentation on the quality of EHR notes.

Since 2009, the Radboudumc Center for Head and Neck Oncology developed and implemented a highly structured care pathway. A care pathway is a complex intervention for the mutual decision-making and organization of care processes for a well-defined group of patients during a well-defined period [ 15 ]. In 2017, for all stages of the care pathway (e.g. first visit consultation, multidisciplinary tumor board, diagnostic results consultation, treatment, follow-up consultation) the patient information that had to be entered into the EHR was defined. Structured and standardized forms using different types of CIT, automated documentation and standardized response options were developed in Epic EHR (EPIC, Verona Wisconsin). These forms allowed physicians to enter all patient information efficiently into the EHR. This resulted in structured and standardized notes while simultaneously storing structured data elements into the EHR database. These data elements can be reused in other stages of the care pathway, automatically compute referral letters, trigger standardized ordersets, or other tools to make the care process more efficient. Ultimately, this data is used to populate real-time quality dashboards. Furthermore, data can be extracted from the EHR and sent to third parties, such as quality and cancer registries or other health care centers when referring patients. Besides structured data recording, these forms support additional narrative documentation if needed or preferred. Recently, a similar highly structured care pathway with structured documentation based on the previously developed care pathway in Radboudumc, was implemented at the Head and Neck Oncology department in Antoni van Leeuwenhoek. In this center, HiX EHR (Chipsoft, Amsterdam) is used. Because of the difference in EHR vendor and the resulting variation in technical possibilities of the EHRs, there were slight differences in structured forms and notes in both centers. However, the structured forms that were built in center B remain highly similar to the forms used in Center A, as the forms and notes of Center A were shared with center B and were subsequently used in the development phase.

A multicenter, retrospective design was used to assess the difference in note quality in two tertiary HNC care centers. In center A, structured documentation has gradually increased in recent years. Therefore, the EHR notes of patients seen between January and December 2013 were compared with those of patients seen between January and December 2019. The transition to structured documentation in center B was more immediate due to implementing an EHR embedded care path that supports structured documentation. Therefore, the notes of patients seen between March and July 2020 were compared with those seen between January and April 2021. This shorter interval added to internal validity because it is less likely that other, time-related factors influenced the outcome. Notes of consultations of adult patients that completed at least one initial oncological consultation (IOC) or follow-up consultation (FUC) during the study period were eligible for inclusion. In both centers, a list of eligible notes was extracted from the EHR and for each consultation type and each documentation method, 36 notes were randomly drawn. In total, 288 notes were included. Subsequently, notes were carefully anonymized. All names, dates, and other identifying information were replaced with < name > , < date > , or otherwise masked. A translated example of a structured note is available as Electronic Supplementary Material (Online Resource 1 ). HNC care providers from center A were recruited to rate the notes collected in center B, and HNC care providers in center B were recruited to rate notes from center A to minimize bias. Each physician was assigned a random group of notes. However, unstructured and structured notes were evenly distributed among raters. Subsequently, notes were scored in a secured digital environment created in CastorEDC (Castor, Amsterdam), an electronic data capture platform.

The quality of the notes was assessed using the Qnote instrument, a validated measurement method for the quality of clinical documentation [ 16 ]. This instrument rates every element of a note individually, by using one or more of seven components (Table ​ (Table1 1 ).

Elements and components of Qnote instrument

The primary outcomes of this study were the quality of notes and note elements, measured by the Qnote instrument on a 100-point scale. Secondary outcomes included length of notes in words, mean component scores per note, and subjective quality measured by a general score given on a scale of 1–10.

Data were notated and analyzed using SPSS version 25 (IBM Corp, Armonk, NY, USA). Two-way ANOVA was used to assess differences in note quality between before and after implementation of structured documentation. The Qnote grand mean score and element scores were outcome variables. The type of note, the originating center, and a dummy variable indicating the period in which the note was written were added as fixed factors. Two-tailed significance was defined as p < 0.05 or a 95% CI not including zero.

This study was approved by the Institutional Review Boards at Antoni van Leeuwenhoek Netherlands Cancer Institute and Radboud University Medical Center.

The grand mean score of all 144 EHR notes written before implementing structured documentation was 64.35 (95% CI 61.30–67.35). When comparing this score to all 144 EHR notes written with structured documentation, a 12.8 point difference (p < 0.001) was found. Structured documentation improved the grand mean score to 77.2 (95% CI 74.18–80.21). Subsequently, additional analysis was conducted on all element scores. The results are shown in Table ​ Table2 2 .

Estimated marginal means of Qnote scores and main effect of structured documentation

* difference significant (p < 0.05)

Table ​ Table3 3 shows descriptive results of element scores displayed per type of note. What can be observed from the data in Table ​ Table3 3 is that for structured documentation, the standard deviation decreases in most elements scores, indicating the variability in quality seems to be lower in structured notes. Furthermore, when comparing the grand mean score for IOC and FUC notes separately, an increase for both types of notes was found (Fig.  1 ). IOC Qnote score increased by 14.9 (95% CI 11.3–18.5) points from 67.3 to 82.3. FUC Qnote score increased by 10.8 (95% CI 4.6–17.0) from 61.3 to 72.1.

Descriptive results of Qnote element scores, per note type

* grey marked elements were not evaluated for this note because these elements were considered not relevant in this type of consultation

Boxplot of grand mean score per note type

Subsequently, analysis was conducted on data from both centers separately to determine whether structured documentation led to increased quality in both centers. In center B, an increase of 14.59 was found (95% CI 7.22–21.96) in IOC note quality, and a 16.36 point increase (95% CI 8.99–23.73) in FUC note quality was found. A significant improvement in IOC Qnote score by 15.10 (95% CI 8.26–22.10) was observed in center A. The 5.3 point increase in FUC note quality was not statistically significant (95% CI -1.61–12.14).

Analysis of secondary outcome measures showed a significant increase in note length for structured documentation in both note types. IOC notes increased from 442.1 to 639.6 words, with a mean difference of 197.5 (95% CI 146.9–248.1), translating to a 44.7% increase. A significant 53.3% increase was found in FUC notes, increasing with 46.5 words (95% CI 31.7–61.2) from 86.9 to 133.4. To evaluate whether this increase in note length led to unnecessary long notes containing excessive non-essential information, all scores for a given component were averaged. For example, the component concise was used to rate 9 of the 11 elements used to rate a note. The mean of all conciseness scores was calculated to get an overall indication of the conciseness of the note. Table ​ Table4 4 shows the difference in mean component scores. As can be seen from the data in Table ​ Table4, 4 , the mean conciseness score, indicating whether note elements were focused and brief, increased significantly. Furthermore, the mean clearness score, indicating whether note elements were understandable to clinicians, also increased significantly.

Mean component score difference between unstructured and structured documentation

When analyzing the scores of the general instrument that rated the notes on a scale of one to ten, a significant increase in documentation quality was also found. Mean scores increased from 6.83 to 7.52, which was an 0.68 increase (95% CI 0.44–0.94).

The study offers some important insights into the impact of increased structured and standardized documentation on EHR note quality in outpatient care. In this retrospective multicenter study, our results show that structured documentation is associated with higher quality documentation. In summary, our results show a 20.0% increase measured on a 0–100 scale. Furthermore, results showed that structured notes were significantly longer than unstructured notes, but were more concise nevertheless.

This study showed an overall increase in documentation quality after the implementation of structured and standardized recording. In 8 of the 11 elements measured with the Qnote instrument, a significant increase in quality was found. This result may be explained by the fact that relevant elements and items that have to be documented are presented to the health care provider in an intuitive, uniform way. Therefore, clinicians are less likely to forget certain elements and items within the note. Furthermore, repeatedly recording in the same format ensures the physician is trained to record properly and completely. The medication element showed a minor, insignificant increase. This might be because medications were not included in notes in one center and therefore did not contribute to the observed results on this element. Additionally, minor, insignificant increases were found in physical examination and plan of care. This could be explained by the fact that the score for these elements was already high in unstructured documentation.

A recent study found variation in the quality of documentation between healthcare providers [ 9 ]. This variation could lead to inefficient documentation and the risk of patient harm from missed or misinterpreted information. Therefore, reducing this variability may also be considered relevant. The descriptive data on element scores in this study showed a trend indicating that the variation in documentation quality decreases when using structured documentation. However, some elements still showed significant variation. Therefore, implementing solutions that reduce variation in documentation quality between encounters and healthcare providers should be encouraged.

In addition, when the notes were analyzed differentiated by center, a significant increase in the quality of IOC notes was observed. This was also the case for follow-up notes in one of the two centers. This supports the conclusion that structured and standardized recording increases documentation quality, independent of a specific center or EHR vendor.

The results also show notes were longer when structured documentation was used. This could be because structured documentation contributes to including all relevant elements, or because health care providers are more reliant on CIT. CIT can be a problem if it leads to unnecessary, unorganized, or unclear information in a note and distracts the reader from the essential information buried within the note. This is known as note bloat. When considering the results of this study, there is no evidence that the longer notes were the result of note bloat. Firstly, an increase in quality in almost all elements where CIT is mainly used (problem list, past medical history, adverse reaction, social and family history) was observed. Secondly, the analysis on components used to assess the individual elements showed significant increases in clearness and conciseness. Therefore, it is safe to assume that in this study, the longer notes were not associated with note bloat and are most likely the result of more complete, and therefore higher quality, documentation.

The reports in the literature to date have mainly focused on the effect of electronic documentation versus handwritten documentation. Some studies have shown a perceived decrease in quality after implementing EHRs, identifying copy-paste functions (CPF) and note clutter as the main reasons for this quality decrease [ 17 ]. Others claim that EHRs increase note quality compared to manual recording in inpatient and outpatient care [ 11 – 13 , 18 ]. A small number of studies have evaluated semi-structured templates that mainly use free-text documentation, comparing them to traditional templates or fully unstructured free-text notes. A small (n = 36) trial comparing outpatient notes written using a traditional template with an optimized template found mixed results, with no difference in overall quality [ 19 ]. However, the intervention notes were inferior in accuracy and usefulness, although better organized. Another study evaluating a quality improvement project to improve clinical documentation quality found no increase in quality [ 20 ]. A third, larger study did find a significant increase in inpatient documentation quality using a semi-structured template [ 21 ]. The abovementioned studies indicate that further research on this topic is warranted. However, our findings show compelling evidence that structured documentation can improve documentation quality.

This study has several strengths. This is the first study to use a validated measure instrument for outpatient notes to examine the impact of structured and standardized recording on outpatient note quality. Given the rising demand for reuse and exchange of healthcare data, structured and standardized data recording will become increasingly important. This study proves that structured documentation can also improve the quality of EHR notes. Furthermore, the increase in quality was found in two centers with different EHRs. These factors contribute to the generalizability of the results.

Another strength of this study is the method used to assess the quality of the notes. Of the instruments available in the literature that are used to assess the quality of documentation, most focus on the absence of data or only assess the global quality of the note, such as the PDSI-9 [ 22 ]. However, the Qnote instrument is based on a qualitative study in which relevant elements of an outpatient clinical note were identified [ 23 ]. Therefore, it is possible to rate the quality of all note elements independently and subsequently calculate a total score. This structured approach is likely to be more objective than other, more general rating instruments. Besides, rating elements individually benefit from being able to identify specific deficits in note quality. Because of this, improving the quality of clinical EHR notes can be conducted in a more targeted and effective way.

This study also has some limitations. Firstly, the main limitation of the retrospective nature of this study is that a causal relationship between the implementation of structured and standardized documenting cannot be established with certainty. In one center, the interval between the two study periods was several years. Therefore, the influence of other factors cannot be eliminated. In the other center, the interval between study periods is shorter, making it highly likely that implementing the standardized care pathway with structured documentation is the primary reason for the increase in note quality. Moreover, analyzing the data differentiated by center resulted in similar outcomes. Secondly, the Qnote instrument has been validated on a population of diabetic patients and not for oncological patients. However, the elements used are general and not disease- or setting-specific. Moreover, the general score given by the raters in this study showed similar or marginally lower scores than the Qnote instrument. This conclusion was also stated in the initial Qnote validation study [ 16 ]. Lastly, due to the visual similarity of structured and standardized notes, the complete blinding of study notes for raters was impossible. This might have led to an unconscious bias. However, the risk was minimized by recruiting note raters employed at another hospital.

The findings of this study support the assumption that structured documentation positively influences documentation quality. This is an important finding, given that the need for structured documentation will only increase in the near future because structured data is key in enabling the reuse of healthcare data. Data reuse will become increasingly important in health care, for various purposes, such as automated quality measurement, information exchange when referring patients to other health care centers, and less time-consuming data collection methods for scientific research. Furthermore, the use and implementation of decision support tools also require structured recording of healthcare data. The abovementioned applications of data reuse in healthcare can lead to increased efficiency and quality of healthcare. Nevertheless, there could be a concern that as data reuse becomes more important, healthcare providers are required to capture more data while providing care. This, in turn, might lead to an increased administrative burden. This should be avoided, as healthcare providers are unlikely to accept a documentation method that adds a significant burden to their workload [ 24 ]. Efforts should be made to to implement structured documentation methods within EHRs to enable data reuse while reducing the administrative burden. The results of this study raise further questions about the benefits and pitfalls of structured documentation systems, on which future studies should focus. These include the effect of the structured documentation systems on documentation time and effort, how physicians' perceptions regarding the documentation process and the EHR are influenced, and how these factors affect adoption, and how these factors affect adoption. As a result, we have started another study to answer such questions.

This study demonstrated that structured and standardized recording led to an increase in the quality of notes in the EHR. Additionally, a significant increase in note length was found. Moreover, the results showed that the longer notes were also considered more clear and concise. Considering the benefits of structured data recording in terms of data reuse, it is recommended to implement structured and standardized documentation into the EHR.

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