CN111861808A - Implementation method of informed consent, informed receiving end and system - Google Patents

Implementation method of informed consent, informed receiving end and system Download PDF

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CN111861808A
CN111861808A CN202010691110.2A CN202010691110A CN111861808A CN 111861808 A CN111861808 A CN 111861808A CN 202010691110 A CN202010691110 A CN 202010691110A CN 111861808 A CN111861808 A CN 111861808A
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informed
receiving end
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content
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张发宝
李欣梅
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Shanghai Medsci Medical Technology Co ltd
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Shanghai Medsci Medical Technology Co ltd
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    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06QINFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
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    • HELECTRICITY
    • H04ELECTRIC COMMUNICATION TECHNIQUE
    • H04LTRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
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    • H04L67/10Protocols in which an application is distributed across nodes in the network
    • HELECTRICITY
    • H04ELECTRIC COMMUNICATION TECHNIQUE
    • H04LTRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
    • H04L67/00Network arrangements or protocols for supporting network services or applications
    • H04L67/01Protocols
    • H04L67/12Protocols specially adapted for proprietary or special-purpose networking environments, e.g. medical networks, sensor networks, networks in vehicles or remote metering networks

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Abstract

The invention provides a realization method of informed consent, an informed receiving end and a system, wherein the method comprises the following steps: the informed receiving end divides the informed consent acquired from the informed initiating end to obtain a plurality of paragraph contents and marks professional terms in each paragraph content; the informed receiving end plays the current paragraph contents according to the segmentation sequence, and initiates an informed inquiry to the party after playing the explanation contents of the professional terms selected by the party in the current paragraph contents; the informed receiving end determines whether to enter the playing of the next section of falling content according to the feedback result of the party on the informed inquiry; the informed receiving end repeats the content playing and feedback result obtaining process until the principal feeds back the determined informed state to all the paragraph contents. The invention realizes the signing of the informed consent through the internet or the terminal equipment, can store the content of the informed consent for a long time, and can better guarantee the benefits of both the informing party and the party by signing the informed consent by adopting the biological characteristic signature.

Description

Implementation method of informed consent, informed receiving end and system
Technical Field
The invention relates to the technical field of informed consent, in particular to an implementation method of informed consent, an informed receiving end and a system.
Background
The informed consent right refers to a right which can be chosen by a person and family members with independent judgment ability to understand the information informed by the person and family members and know the risks and consequences in the informed consent, and then decide the plan made by the informing party. The informed consent and notification of the party is a way to effectively solve the dispute between the party and the notifier, and the right obligation relationship between the two parties can be balanced.
Common informed consent notification modes are oral notification and written notification. The form of oral notification is often not uncommon and is common, as unanticipated emergencies before and during surgery can lead to disputes at a later date, and the notifying party can assume excessive legal liability due to the lack of written informed materials that can become valid legal evidence. Written notices usually require a party to sign some informed documents to achieve the purpose of formal, sufficient and comprehensive notices, but the signatures on traditional paper documents can appear, and the signed informed consent cannot be effective legal evidence because the signatures are stained or disseminated due to too long storage time or improper storage.
Disclosure of Invention
The invention aims to provide a realization method of informed consent, an informed receiving end and a system, which can realize the signing of an informed consent through the Internet or terminal equipment and can store the content of the informed consent for a long time so as to better guarantee the benefits of both an informing party and a party.
The technical scheme provided by the invention is as follows:
the invention provides a method for realizing informed consent, which comprises the following steps:
the informed receiving end divides the informed consent acquired from the informed initiating end to obtain a plurality of paragraph contents and marks professional terms in each paragraph content;
the informed receiving end plays the current paragraph contents according to the segmentation sequence, and initiates an informed inquiry to the party after playing the explanation contents of the professional terms selected by the party in the current paragraph contents;
the informed receiving end determines whether to play the next section of falling content according to the feedback result of the party on the informed inquiry;
and the informed receiving end repeats the content playing and feedback result obtaining process until the principal feeds back the determined informed information to all the paragraph contents.
Further, the step of the informed consent receiving end dividing the informed consent obtained from the informed initiating end to obtain a plurality of paragraph contents and marking the professional terms in each paragraph content includes:
The informed receiving end segments the acquired informed consent book through a preset punctuation mark or meaning group division rule to obtain a plurality of paragraph contents;
and the informed receiving terminal carries out word segmentation processing on the contents of each paragraph to obtain word segmentation results, screens out the professional terms from the word segmentation results and positions and marks the terms.
Further, the method for obtaining the word segmentation result by the receiving end of the knowledge to perform word segmentation processing on the contents of each paragraph and screening out the professional terms from the word segmentation result and positioning the marks comprises the following steps:
the informed receiving end trains to obtain a word segmentation dictionary, and the word segmentation result is obtained by segmenting the paragraph contents through the word segmentation dictionary;
the informed receiving end matches the word segmentation result with a preset professional term dictionary to screen out the professional terms;
and the informed receiving end carries out positioning marking on the screened professional terms through preset symbols.
Further, the step of the informed receiving end playing the current paragraph content according to the segmentation sequence, and after playing the explanation content of the professional term selected by the party in the current paragraph content, initiating an informed inquiry to the party includes:
the informed receiving end plays the current paragraph contents to the voice of the party from front to back according to the segmentation sequence and/or plays the current paragraph contents in a graph-text rolling way;
After the current paragraph content is played, the informed receiving end judges whether trigger operation information aiming at the current paragraph content and input by a party is acquired;
when the informed receiving end acquires the trigger operation information within a preset time after the playing is finished, determining that the words corresponding to the trigger operation information are selected professional terms, inquiring the description content of the selected professional terms, and playing the description content in a voice mode and/or in a picture-text rolling mode;
and the informed receiving end initiates an informed inquiry corresponding to the current paragraph content after the current paragraph content is played, if the duration of the trigger operation information is not obtained reaches the preset duration, or inquires the explanatory content of the selected professional term, and after the voice playing and/or image-text rolling playing of the explanatory content is finished, if the duration of the trigger operation information is not obtained reaches the preset duration.
Further, the step of deciding whether to enter the playing of the next paragraph content or not by the informed receiving end according to the feedback result of the party on the informed inquiry comprises the following steps;
the informed receiving end acquires a feedback result of the party on the informed inquiry;
If the feedback result is unclear or the party does not have the informed consent capability, the informed receiving end enters an informed assistance process;
and if the feedback result is clear, the informed receiving end plays the next paragraph content and the description content of the selected special terms from front to back to the party according to the segmentation sequence.
Further, the step of the informed receiving end obtaining the feedback result of the party to the informed inquiry comprises the following steps:
the informed receiving end triggers and acquires the input information of the party, and stops playing the current paragraph content and the description content of the special terms selected in the current paragraph content to the party when the triggering of acquiring the input information is started;
and the informed receiving end analyzes and identifies the input information to obtain a feedback result aiming at the informed inquiry.
Further, if the feedback result is unclear or the party does not have the ability of informed consent, the informed receiving end enters the step of the informed assistance flow:
if the feedback result is that the party does not have the informed consent capability, the informed receiving end initiates a request to be assisted by the guardian to sign informed consent; or the like, or, alternatively,
And if the feedback result is unclear, the informed receiving end sends the paragraph contents which are fed back to be unclear to the informed starting end so as to obtain the explanation of the informing party from the informed starting end.
Further, the method for obtaining the content playback and feedback result by the informed receiving end repeatedly comprises the following steps until the feedback of the client on all the paragraph contents is obtained as the determined informed state:
the informed receiving end prompts whether the party confirms agreement or not, and if yes, the biological characteristic signature input by the party is obtained;
the informed receiving end generates an electronic edition informed consent according to the biological characteristic signature;
and the informed receiving end carries out encryption and modification prevention processing on the electronic edition informed consent, then stores the electronic edition informed consent, and sends the electronic edition informed consent after the encryption and modification prevention processing to the corresponding informed issuing end.
Further, the step of dividing the informed consent obtained from the informed originator by the informed receiving end to obtain a plurality of paragraph contents and marking the professional terms in each paragraph content by the informed receiving end includes:
the informed consent template is obtained by the informed consent initiating terminal, and a corresponding informed consent is generated according to the informed consent template;
And the informed consent is sent to the corresponding informed receiving end by the informed initiating end.
The invention also provides an informed receiving end, which is applied to the implementation method of informed consent, and comprises the following steps:
the communication module is used for acquiring the informed consent form from the informed initiating terminal;
the segmentation marking module is used for dividing the informed consent form to obtain a plurality of paragraph contents and marking professional terms in each paragraph content;
the playing inquiry module is used for playing the current paragraph contents according to the segmentation sequence, initiating an informed inquiry to the party after the explanation contents of the professional terms selected by the current paragraph contents are played by the party, and switching the next paragraph contents to carry out playing inquiry until all the paragraph contents are played and inquired;
and the processing module is used for determining whether to enter the playing of the next paragraph of content according to the feedback result of the principal on the informed inquiry, and switching to obtain the feedback result of the next paragraph of content until the principal feeds back all the paragraph of content as the confirmed informed.
The invention also provides a system for realizing the informed consent, which is applied to the method for realizing the informed consent, and comprises the following steps: an informed-onset end and an informed-receiving end;
The informed consent terminal is used for sending an informed consent to the informed receiving terminal;
the informed receiving end is used for dividing the informed consent obtained from the informed initiating end to obtain a plurality of paragraph contents and marking professional terms in each paragraph content;
the informed receiving end is used for playing the current paragraph contents according to the segmentation sequence, and initiating an informed inquiry to the party after playing the explanation contents of the professional terms selected by the party in the current paragraph contents;
the informed receiving end is used for determining whether to play the next section of falling content according to the feedback result of the party on the informed inquiry;
and the informed receiving end is used for repeating the content playing and feedback result obtaining process until the principal feeds back the determined informed information to all the paragraph contents.
Through the implementation method, the informed consent receiving end and the system for informed consent provided by the invention, the signing of the informed consent can be realized through the Internet or terminal equipment, and the content of the informed consent can be stored for a long time so as to better guarantee the benefits of both the informing party and the party.
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The above features, technical features, advantages and implementations of a method, receiver and system for informed consent will be further described in the following detailed description of preferred embodiments with reference to the accompanying drawings.
FIG. 1 is a flow chart of one embodiment of a method of implementing informed consent of the present invention;
FIG. 2 is a flow chart of another embodiment of a method of implementing informed consent of the present invention;
fig. 3 is a flow chart of another embodiment of a method for implementing informed consent according to the present invention.
Detailed Description
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following description will be made with reference to the accompanying drawings. It is obvious that the drawings in the following description are only some examples of the invention, and that for a person skilled in the art, other drawings and embodiments can be derived from them without inventive effort.
For the sake of simplicity, the drawings only schematically show the parts relevant to the present invention, and they do not represent the actual structure as a product. In addition, in order to make the drawings concise and understandable, components having the same structure or function in some of the drawings are only schematically illustrated or only labeled. In this document, "one" means not only "only one" but also a case of "more than one".
One embodiment of the present invention, as shown in fig. 1, is a method for implementing informed consent, including:
s100, an informed receiving end divides an informed consent obtained from an informed initiating end to obtain a plurality of paragraph contents and marks professional terms in the paragraph contents;
specifically, the informed receiving end is a terminal device used by the party, and of course, the informed receiving end may also be a self-service terminal placed in an office area where the informing party is located, such as a self-service terminal in an office area of a hospital, a court, a department office hall or a dispatch office. The estrus-aware terminal is a terminal device used by a notifying party (including, but not limited to, medical staff such as doctors and anesthetists, legal staff such as lawyers, and staff of a business entity such as a real estate administration). The informed receiving end and the informed starting end perform communication interaction in a wireless communication mode (including but not limited to Bluetooth, WIFI, 4G or 5G), so that the informing party uses the informed starting end to send the informed consent to the informed receiving end used by the party. The informed consent receiving end segments the informed consent according to the character arrangement sequence of the informed consent to obtain a plurality of paragraph contents with different sizes, namely the informed consent consists of a first paragraph content P1, a second paragraph content P2, … … and an nth paragraph content Pn according to the character arrangement sequence, wherein n is larger than 1 and n belongs to a positive integer. Then, the informed receiving end searches the professional terms of the content of each paragraph and carries out positioning marking.
S200, an informed receiving end plays the current paragraph contents according to the segmentation sequence, and initiates an informed inquiry to the party after playing the explanation contents of the professional terms selected by the party in the current paragraph contents;
specifically, after the informed receiving end divides and obtains a plurality of paragraph contents, the current paragraph contents are played to the principal from front to back according to the segmentation sequence, then the principal determines whether the explanation of the professional term in the current paragraph contents needs to be known or not according to the understanding of the principal on the played current paragraph contents, if so, the explanation content of the professional term selected by the principal on the current paragraph contents is played, and then the informed inquiry is initiated to the principal. For example, after playing the first paragraph of content P1, if the principal is to understand the first paragraph of content P1, the first term D1 in the first paragraph of content P1 is selected, the receiving end immediately plays the explanation content of the selected first target term D1 to the principal, and then plays the explanation content of the selected second target term D2 to the principal. Here, the first target term D1 is not the first term in the first paragraph of content P1 that is marked and arranged in text, but is a term that the user first needs to explain for any selected one of the first paragraph of content P1. Other objective nomenclature D2 is the same as above, and is not repeated here.
S300, the informed receiving end determines whether to play the next section of falling content according to the feedback result of the client on the informed inquiry;
s400, the informed receiving end repeats the content playing and feedback result obtaining process until the principal feeds back the determined informed information to all the paragraph contents.
Specifically, after acquiring the corresponding informed query, the party feeds back whether to clearly determine the paragraph content played before the informed query is initiated according to the subjective intention of the party and the knowledge of the played content, and then receives the feedback result of the party on the informed query through the informed receiving end, and then the informed receiving end determines whether to play the next paragraph content according to the feedback result input by the party. Continuing with the above embodiment, if the feedback result is a deterministic conclusion, the informed receiving end plays the second episode of content P2 and the explanatory contents of the specific terms selected for the second episode of content P2 to the principal in sequence from front to back in the segment precedence order, and then initiates a second informed query for the second episode of content P2 to the principal. The above steps are repeated until the party feeds back the playing of all the paragraph contents as certain knowledge.
In this embodiment, the informed receiving end plays the current paragraph content to the party each time according to the segmentation order, and after the explanation content of the professional term selected in the current paragraph content, initiates an informed inquiry to the party, and after the party feeds back and determines the informed inquiry in this round, the party enters the next round of playing and informed inquiry, so that the party can comprehensively and carefully know the content of the whole informed consent form, and fully know the purpose, measure content, risk and benefit condition of the participation activity (e.g., medical activities such as special inspection, special treatment and experimental clinical medical treatment, and legal activities such as civil complaint).
For example, the traditional paper edition informed consent has the problems of irregular filling, unqualified signature and blurred handwriting which can not be recognized in the long-term storage process. There is also the phenomenon that some researchers replace their hands with stamps. In addition, there are too many professional terms in the informed consent mode, and the traditional mode is to sign an informed consent form face to face, so that a lot of time is required for communication between doctors and patients, and whether the patients sign on the basis of understanding the content of the informed consent cannot be proved. In addition, due to serious inconsistency of medical professional knowledge between the two doctors and the patient, the patient or family members may consider worrying about acquaintance doctors under the psychological pressure, and the like, so that the problems of medical complaints and tense relationship between the doctors and the patient caused by the problem of the informed consent occur, and the remote (or non-face-to-face) informed consent mode can avoid the false 'informed consent' caused by the psychological pressure to a great extent, and is beneficial to guaranteeing the benefits of the two doctors and the patient.
The invention can avoid the phenomenon that the family members sign the paper informed consent books through the self-service terminal and the informed issuing end which are arranged in the office area where the informing party is positioned, and reduce the problem of after-deeding so as to provide effective legal evidence. Moreover, the problem that the traditional paper file is not beneficial to storage is avoided, the purpose of long-time storage is easily achieved, and the benefits of both the known party and the party are guaranteed. In addition, the work load of workers participating in activity signing of the informed consent book can be greatly reduced by signing the informed consent book through the Internet, the process of signing the informed consent book is simplified, and the signing efficiency of the informed consent book is improved. In addition, repeated communication interaction between the informing party and the party is avoided, and the understanding degree and the signing efficiency of the informed consent are further greatly improved. In addition, the invention can implement remote informed consent signing, and the parties can basically fill in the informed consent at any time, thereby further improving the efficiency of signing the informed consent. Due to the serious inequality of professional knowledge of both the informing party and the party, the remote mode can avoid the situation that the party signs an informed consent unwillingly caused by psychological pressure when facing the face to a great extent, and is beneficial to guaranteeing the benefits of both the informing party and the party. In addition, the signing of the informed consent is realized through digitization, so that the purpose of long-time storage is easily achieved, and the problems that the informed consent is difficult to store and query and trace due to the traditional signing of paper are avoided.
In an embodiment of the present invention, a method for implementing informed consent includes:
s110, the informed receiving end segments the acquired informed consent book by presetting punctuation marks or meaning group division rules to obtain a plurality of paragraph contents;
specifically, the informed receiving end can perform sentence-breaking judgment through the preset punctuation marks to segment the informed consent book to obtain a plurality of paragraph contents. The predetermined punctuation marks used include, but are not limited to, commas, periods, pause signs, exclamation marks, question marks, spaces. And gradually dividing the preset punctuation informed consent into a plurality of paragraph contents, wherein punctuation follows the previous paragraph content. The continuity of the text semantics of the informed consent is considered by dividing the preset punctuation marks, so that the semantics are prevented from being broken by cutting, the paragraph contents are ensured to belong to a complete semantic segment as much as possible, and the generation of unusual words and sentences caused by cutting is avoided.
In addition, the informed receiving end can segment the informed consent book through the meaning group division rule to obtain a plurality of paragraph contents. The meaning group is each component divided according to meaning and structure in the sentence, each component is called a meaning group, and the words in the same meaning group are closely related to each other and cannot be randomly split, otherwise misunderstanding can be caused. The sense group division rule is a division rule that is split according to semantics and structure, for example, the sense group division rule is exemplified by division according to articles and nouns and division according to adjectives and names. The meaning group division rule is used for division, continuity of the text semantics of the informed consent is considered, the semantic breaking caused by cutting is avoided, the paragraph content is ensured to belong to a complete semantic segment as much as possible, and generation of unusual words and sentences caused by division is avoided.
S120, the informed receiving end carries out word segmentation processing on the contents of each paragraph to obtain word segmentation results, and professional terms are screened out from the word segmentation results and are marked in a positioning mode;
specifically, word segmentation models are set in advance according to word segmentation algorithms (including but not limited to a shortest path algorithm, a new word discovery algorithm, and a Chinese word segmentation method for constructing words from words), and words are segmented for contents of each paragraph through the word segmentation models. Illustratively, a rule of word segmentation (referred to as training) is learned by using a statistical machine learning model, so as to segment unknown texts. The main statistical machine learning models are: n-gram (N-gram), Hidden Markov Model (HMM), etc. It should be noted that the paragraph contents may include pure chinese characters, and may also include other characters such as numbers and english characters, which are not limited in this application. After the word segmentation is finished at the informed receiving end, the professional terms are screened out from a large number of word segmentation results, and the marks are located.
S200, the informed receiving end plays the paragraph contents and the explanation contents of the professional terms selected in the current paragraph contents to the party from front to back in sequence according to the segmentation sequence and initiates an informed inquiry to the party;
S300, the informed receiving end determines whether to enter the playing of the next paragraph content and the description content thereof according to the feedback result of the inquiry of the informed by the party, and repeats the content playing and feedback result obtaining process until the feedback of the party on the playing of all the paragraph contents and the description content thereof is obtained as the confirmed informed.
Specifically, the same portions of this embodiment as those of the above embodiment are referred to the above embodiment, and are not described in detail here. In this embodiment, the informed consent is segmented, the informed consent can be segmented into a plurality of complete paragraph contents with a small number of words, then, the paragraph contents are segmented to obtain segmentation results, and after professional terms are screened from the segmentation results, the positioning and marking are performed, so that a person can select the paragraph contents based on the marked professional terms, and further, the description contents of the selected professional terms are queried to play and explain the paragraph contents. By means of segmentation processing and word segmentation processing, paragraph contents and description contents of the selected professional terms can be played to the party in batches according to the segmentation sequence, and then informed inquiry is carried out, so that the party does not need to memorize the whole informed consent and description contents, and the use experience of the party is improved.
An embodiment of the present invention, as shown in fig. 2, is a method for implementing informed consent, including:
s110, the informed receiving end segments the acquired informed consent book by presetting punctuation marks or meaning group division rules to obtain a plurality of paragraph contents;
s121, training a cognitive receiving end to obtain a word segmentation dictionary, and segmenting the paragraph contents through the word segmentation dictionary to obtain a word segmentation result;
specifically, the informed receiving end obtains a large amount of corpus, removes stop words collected manually from the corpus, and then cuts the corpus from which the stop words are removed into relatively small text segments. Stop words generally have no special meaning, and are often combined with other words to form words or phrases, which mainly comprise punctuation marks, pronouns, language-atmosphere words, auxiliary words, conjunctions and the like. Extracting candidate words from the text segments, counting the occurrence probability of the candidate words and each single word in all the text segments, if the occurrence probability is greater than a preset threshold value, retaining the candidate words, otherwise, deleting the candidate words, and then merging the screened candidate words to obtain a word segmentation dictionary. Then, the informed receiving end carries out word segmentation on the current paragraph content through the word segmentation dictionary to obtain a word segmentation result.
The word segmentation dictionary is constructed based on the statistical method, syntactic and semantic information is not needed, the word segmentation dictionary is not limited to a special field, any resource is not depended on, the universality is strong, and the word segmentation requirements of different fields can be effectively met by adopting the word segmentation dictionary for word segmentation.
S122, the informed receiving end matches the word segmentation result with a preset professional term dictionary to screen out professional terms;
s123, the informed receiving end carries out positioning marking on the screened professional terms through preset symbols;
in particular, common words and terminology are present in the word segmentation result. Common words such as "pre-pregnancy", "bed rest" and the like are clear words, but professional terms such as "coronary artery", "perinatal depression" and the like are not clear words. Therefore, a preset professional term dictionary (including a dictionary of professional terms) and a general dictionary (including a dictionary of common words) can be established in advance according to the linguistic data in the professional field by referring to the above-mentioned way of establishing the segmentation dictionary, the segmentation result is matched with the preset professional term dictionary first, the segmentation result which is the same as the segmentation result of the professional terms in the preset professional term dictionary is screened out to obtain a first screening word set, the segmentation result is matched with the general dictionary, the segmentation result which is different from the common words in the general dictionary is screened out to obtain a second screening word set, and the first screening word set and the second screening word set are combined to obtain a final word set, so that each word included in the final word set is the final professional term. Then, the informed receiving end carries out positioning marking on the professional terms screened from the word segmentation result in an underline mode, a highlight marking mode or an annotation mode. Since an informed consent includes a plurality of paragraph contents and professional terms, and since the professional terms may only appear in a certain paragraph content or a plurality of paragraph contents, all the professional terms appearing in all the paragraph contents are marked.
Illustratively, the following paragraphs of a given informed consent form A are included:
"make the anesthesia work according to the general full force of the anesthesia operation with high responsibility. Anesthesia is generally safe, but due to individual differences, anesthesia accidents and complications are also likely to occur, and although the occurrence probability is low, current medical technology cannot be absolutely avoided, and the following are reported, including but not limited to: (this is paragraph content Pn)
1. According to the general operation of anesthesia, after various anesthetics are used according to the requirements of pharmacopoeia of the people's republic of China, reactions such as poisoning, allergy, hypersensitiveness, neurotoxicity, high fever and the like can occur, and the life is threatened when the reactions are serious. (this is paragraph content Pn +1)
2. In general anesthesia, although protective measures are taken before anesthesia, complications such as vomiting, aspiration, respiratory obstruction, aspiration pneumonia, asphyxia, respiratory failure, etc. may occur. (this is paragraph content Pn +2)
3. When the anesthetic is used in a prescribed dose during basal anesthesia or spinal block anesthesia, a decrease in respiratory blood pressure or an excessively high level of anesthesia may still occur, and complications such as drug sensitivity due to muscle relaxation, delayed or no recovery from respiration, aspiration, respiratory obstruction, and the like may still occur even after active treatment. (this is paragraph content Pn +3) ". All the specialized terms of the paragraph contents Pn, Pn +1, Pn +2 and Pn +3 (including but not limited to hypersensitiveness, neurotoxicity, aspiration, respiratory obstruction, aspiration pneumonia, muscle relaxation drug allergy, delayed or no recovery from respiration) are positioned and marked, the positions of the marked specialized terms in the informed consent (including in which paragraph contents and which line of the paragraph contents to wait) are recorded, the description contents of the same specialized term can be associated with the marked specialized terms at different positions, and after the person selects the specialized terms at different positions, the description contents can be directly called without repeatedly inquiring and storing the description contents of the same specialized term.
S210, the informed receiving end plays the current paragraph contents to the voice of the party from front to back according to the sequence of the segmentation, and/or plays the current paragraph contents in a text-text rolling way;
specifically, there are various ways for the receiving end to play the paragraph content to the party, one is text scrolling playing, the other is voice playing and displaying, and the other is playing and informing the party by combining the voice playing and the text scrolling playing. After the informed receiving end performs segmentation to obtain a plurality of segmented contents according to the above embodiment, the current paragraph contents are played to the party by voice and/or the current paragraph contents are played by scrolling through images and texts from front to back according to the segmentation sequence.
S220, judging whether trigger operation information aiming at the current paragraph content input by a party is acquired or not after the current paragraph content is played;
specifically, after the current paragraph content is played, the informed receiving end reserves a period of time, that is, a preset time length, to wait for obtaining trigger operation information of the party for the current paragraph content, where the trigger operation includes, but is not limited to, voice input, manual click, and the like.
S230, when the informed receiving end acquires the trigger operation information within a preset time length after the playing is finished, determining a word corresponding to the trigger operation information as a selected professional term, inquiring the description content of the selected professional term, and playing the description content in a voice mode and/or in a picture-text rolling mode;
Specifically, if the informed receiving end acquires the trigger operation information within a preset time length after the current paragraph content is played, determining that the word corresponding to the trigger operation information is the selected professional term, and then accessing the Baidu document, the professional document website (corresponding to the medical document website when the informed consent form of the medical activity is signed and corresponding to the legal document website when the informed consent form of the legal activity is signed) and the network interface of the knowledge sharing server by the informing party to search the professional term and acquire the vocabulary explanation (including but not limited to the text description and the picture description) of the professional term to query the description content of the selected professional term, and playing the description content of the selected professional term in a voice mode and/or in a picture-text scrolling mode.
Certainly, if the informed receiving end determines that the word corresponding to the trigger operation information is the selected professional term when the trigger operation information is acquired within the preset time after the playing of the current paragraph content is finished, the informed receiving end can initiate a popup window (for example, a chat interface of a remote informed consent signing APP or a chat interface of a remote informed consent signing website) to realize online interactive communication so as to inquire a notification party using the informed initiating end, the informed receiving end acquires the description content of the selected professional term sent by the notification party through the informed initiating end on line, and then the informed receiving end plays the description content of the selected professional term in a voice playing mode and/or in a picture and text rolling mode.
In addition, after the informed receiving end selects and plays the description content of the current professional term, timing is started after the description content of the current professional term is played, and if the next selected professional term is selected within the preset time length, the above mode is continued to be inquired and played until the current paragraph content is clear to all parties. For example, in the above-mentioned anesthesia example, the receiving end is configured to play the paragraph content Pn +2 to the party, count the time from the stop of the playing, click the labeled technical term "respiratory tract obstruction" on the party within a preset time period, query and play the explanatory content corresponding to the "respiratory tract obstruction" to the party, count the time from the stop of the playing, click the labeled technical term "aspiration pneumonia" on the party within a preset time period, and query and play the explanatory content corresponding to the "aspiration pneumonia" to the party.
S240, after the playing of the current paragraph content is finished, if the duration of the trigger operation information is not acquired to reach the preset duration, the informed receiving end initiates an informed inquiry corresponding to the current paragraph content;
s250, the informed receiving end inquires the description content of the selected professional term, and initiates an informed inquiry corresponding to the current paragraph content if the duration of the trigger operation information is not acquired to reach the preset duration after the voice playing and/or the image-text rolling playing of the description content is finished.
Specifically, if the informed receiving end starts timing after the playing of the current paragraph content is finished, and the trigger operation information is not acquired when the timing reaches a preset time length, an informed query corresponding to the current paragraph content is initiated. Or, if the informed receiving end starts timing after the current paragraph content is played, and acquires the trigger operation information when the timing does not reach the preset time length, the word corresponding to the trigger operation information is determined to be the selected specific term when the trigger operation information is acquired, then the informed receiving end starts timing after the description content of the current specific term is selected and played, and if the timing reaches the preset time length and still does not select the next selected specific term, the informed inquiry corresponding to the current paragraph content is initiated.
S300, the informed receiving end determines whether to play the next section of falling content according to the feedback result of the client on the informed inquiry;
s400, the informed receiving end repeats the content playing and feedback result obtaining process until the principal feeds back the determined informed information to all the paragraph contents.
Specifically, there are various ways for the receiving end to play the paragraph content and the description content of the selected special term to the party, one is text scrolling play, the other is voice play display, and the other is a combination of voice play and text scrolling play to play and inform the party. The informed receiving end performs segmentation to obtain a plurality of segmented contents with reference to the above embodiment, and after querying to obtain explanatory contents corresponding to the segmented contents, the explanatory contents of the first paragraph content P1 and the specific terms selected in the first paragraph content P1 are played to the party by voice from front to back according to the segmentation order, and/or the explanatory contents of the first paragraph content P1 and the specific terms selected in the first paragraph content P1 are played by scrolling through images and texts. The informed receiver then initiates a first informed query a1 for the first paragraph of content P1 to the principal. If the principal has determined the feedback from the first informed query A1, a second informed query A2 is initiated after the second story content P2 and the narrative contents of the specific terms selected in the second story content P2 are played back to the principal by voice and/or after the second story content P2 and the narrative contents of the specific terms selected in the second story content P2 are played back by scrolling. The above steps are repeated until the party feeds back the playing of all the paragraph contents as certain knowledge.
Specifically, the same portions of this embodiment as those of the above embodiment are referred to the above embodiment, and are not described in detail here. In this embodiment, after performing voice or scrolling playing on the current paragraph content and the explanation content of the professional term selected by the principal in the current paragraph content each time according to the segmentation order, the informed query is initiated to the principal by the informed receiving end, and after the principal determines the feedback of the informed query in this round, the next round of playing and informed query is entered. In addition, the informed receiving end or the online interaction mode can obtain the description content of the selected professional term, avoid causing troubles to the understanding of the parties on the informed consent, enable the parties to comprehensively and carefully understand the content of the whole informed consent, and fully understand the purpose, measure content, risk and benefit condition of the participation activity. In addition, or the on-line interaction mode is realized to obtain the description content of the selected special terms, the fact that the party goes to the scene to face and inquires the informing party is not needed, repeated communication interaction between the informing party and the party is avoided, and the understanding degree and the signing efficiency of the informed consent are greatly improved.
Illustratively, the contents of the section of a certain informed consent form b at which a proxy contract is signed are as follows:
payment of imported contract payment, imported customs duty, value added tax and other fees: the first party pays the payment of the imported contract, the imported customs duty, the added value tax and other expenses (including booking, customs declaration, commodity inspection, quarantine inspection, port expenses, transportation, insurance, bank expenses and the like) required by the second party agency import according to the fifth rule of the agency contract in time, such as delayed payment or refusal payment of the first party for the money, and all losses caused by the delayed payment or refusal payment of the first party are borne by the first party; if the party B agrees to pay related money, the party A pays off the money information paid by the party B before taking the goods (the interest is calculated according to the interest rate of the contemporary bank loan), otherwise the party B has the right to reserve and process the imported goods by self, and all the loss caused by the loss is borne by the party A. (this is paragraph content Pn)
And (4) commodity inspection and quarantine: if the quality, quantity and the like of goods are found to be inconsistent with the import contract, the first party applies for the inspection of the inspection bureau immediately, issues an inspection certificate and a loss certificate, and directly puts a claim to the responsible party or the entrusted second party, wherein the first party is required to bear the judgment result and pay the arbitration or the loss of lawsuit cost (including lawyer cost) caused by the delay of the first party by the first party. (this is paragraph content Pn +1)
If the state declares that the goods under the contract item related to the agency import are subjected to inverse reimbursement plan investigation, inverse subsidy plan investigation or implementation of similar behaviors such as temporary guarantee terms of the domestic market, etc., the first party should add the deposit according to the requirements of the second party. For example, the state collects the behavior of inverse tax on the goods under the contract item, and all the cost and loss caused by the behavior are borne by the first party. (this is paragraph content Pn +2)
All the professional terms (including but not limited to booking, closing, business inspection, anti-tipping plan survey and anti-subsidy plan survey) of the paragraph contents Pn, Pn +1 and Pn +2 are located and marked, and the positions of the marked professional terms in the informed consent (including which paragraph contents are included and which line of the paragraph contents is waiting) are recorded, the description contents of the same professional term can be associated with the marked professional terms at different positions, and after the party selects the professional terms at different positions, the description contents can be directly called without repeatedly inquiring and storing the description contents of the same professional term.
In an embodiment of the present invention, as shown in fig. 3, a method for implementing informed consent includes:
S010 an informed consent template is obtained by an informed consent initiating terminal, and a corresponding informed consent is generated according to the informed consent template;
s020 an informed consent end sends an informed consent to a corresponding informed receiving end;
specifically, informed consent is an answer or consent of a party with complete knowledge of certain internal information. Three processes are actually involved: knowing the information; understanding; an informed consent is a certificate for the informed record and the party's decision process, either granted or denied. Informed consent included: usage information, descriptive information (including activity participant information, terms, control measures, and possible benefits, etc.), risk information (including foreseeable risks and possible adverse events, etc.), cost information, confidential information, party information (including party identity information, contact information, etc.), party signature completion location, activity participant signature completion location, and date completion location.
Illustratively, the informed consent form of a medical activity includes the knowledge of the basic situation of the medical institution, the knowledge of the basic situation of the treated medical staff, and then the selection and decision of the medical measures taken by the medical party, and generally, the content of the informed consent form includes. Informed consent is composed of both informed consent, in the form of a physician's notice, which typically includes sufficient and necessary instructions regarding the therapeutic (or diagnostic) method employed and its benefits or risks, the control measures to be employed and the risks that may arise,
And through calling the designed template, an informed consent meeting the specifications and requirements of the field to which the participation activity belongs is designed in an auxiliary way. The informed parties generate different types of informed consent templates according to the specifications, and the informed consent templates are selected by the informed initiation end according to the required intention of the parties. And the informed consent template is automatically filled by the informed initiation end according to the pre-stored use information, the description information, the risk information, the cost information and the confidential information, and then the activity participants review the informed template filled with the information and sign to generate a corresponding informed consent after determining that no problem exists. And finally, sending the generated informed consent to an informed receiving end through a contact address reserved by the party through a server. For example, the informed consent templates for a medical activity include, but are not limited to, clinical treatment informed consent templates, clinical trial informed consent templates, and the informed consent templates corresponding to the patient's needs for a visit and the trial participation intent may be selected by the informed originating end.
S100, an informed receiving end divides an informed consent obtained from an informed initiating end to obtain a plurality of paragraph contents and marks professional terms in the paragraph contents;
S200, an informed receiving end plays the current paragraph contents according to the segmentation sequence, and initiates an informed inquiry to the party after playing the explanation contents of the professional terms selected by the party in the current paragraph contents;
s310, an informed receiving end acquires a feedback result of the party on the informed inquiry;
s320, if the feedback result is unclear or the party does not have the informed consent capability, the informed receiving end enters an informed assistance process;
s330, if the feedback result is clear, the informed receiving end plays the next paragraph content and the explanation content of the selected special terms from front to back to the party according to the segmentation sequence.
S400, the informed receiving end repeats the content playing and feedback result obtaining process until the principal feeds back the determined informed information to all the paragraph contents;
specifically, after the informed receiving end plays the current paragraph content and the explanation content of the professional term selected by the party in the current paragraph content in a voice playing and/or image-text rolling way, the informed receiving end initiates an informed inquiry to the party, and after the party obtains the informed inquiry, the party determines whether to switch to play the next current paragraph content according to the played current paragraph content and the understanding of the explanation content of the selected professional term and the subjective intention of the party. And after the party determines the switching, the informed receiving end acquires the input information of the party and identifies whether the input information needs to be switched for playing.
The input information includes, but is not limited to, voice information, key input, and manually input text information, and the feedback result is determined to be clear if a positive keyword such as "yes" or "ok" is parsed from the input information, and is determined to be unclear if a negative keyword such as "no" or "no" is parsed from the input information.
If the feedback of the current paragraph content and the explanation content of the professional term selected by the principal in the current paragraph content is determined to be clear, the informed receiving end switches to play the next current paragraph content. If the feedback of the explanation content of the current paragraph content and the professional term selected by the principal in the current paragraph content is determined to be unclear, the informed receiving end enters an informed assistance flow. The informed receiving end repeats the content playing and feedback result obtaining process until the principal feeds back the determined informed state to all the paragraph contents.
S500, the informed receiving end prompts whether the party confirms agreement or not, and if yes, the biological characteristic signature input by the party is obtained;
specifically, the informed receiving end completes the playing of all paragraph contents and description contents of the party according to the segmentation sequence, and when the feedback results of each round of initiated informed inquiry of the party are clear, the content of the whole informed consent book is clearly known by the party, the informed receiving end sends prompt information to prompt the party to enter the consent signing process, and if the party agrees to sign according to the subjective intention of the party, the party obtains the input biological characteristic signature of the party through the receiving end. If the party refuses to sign according to own subjective intention, the party feeds back a notification message of refusing to sign to the estrus initiating end through the receiving end.
The informed receiving end can intelligently analyze and record the voiceprint characteristics of the patient, the voiceprint characteristics serve as one of the biological identification characteristics of the person concerned, and a biological characteristic signature is generated. The informed receiver can also record the fingerprint of the party as one of the biological identification characteristics of the party by collecting and recording the fingerprint of the party and generate a biological characteristic signature. The informed receiver can also record the face information of the party as one of the biological identification characteristics of the party and generate a biological characteristic signature.
S600, an informed receiving end generates an electronic edition informed consent according to the biological characteristic signature;
s700, the informed receiving end encrypts and prevents modifying the electronic edition informed consent, stores the encrypted and prevented modifying electronic edition informed consent, and sends the encrypted and prevented modifying electronic edition informed consent to the corresponding informed issuing end.
Specifically, the preset encryption algorithm includes, but is not limited to, a SM2 algorithm, a hash algorithm, and other cryptographic algorithms. And the informed receiving end generates an electronic edition informed consent according to the biological characteristic signature, and encrypts the electronic edition informed consent to prevent modification, wherein the modification prevention processing mode is to switch the attribute of the electronic edition informed consent into read-only and encrypt the electronic edition informed consent with the read-only attribute by a preset encryption algorithm. And then, the informed receiving end stores the electronic edition informed consent subjected to the encryption and modification prevention processing into a local storage area. And sending the electronic edition informed consent subjected to encryption and modification prevention processing to a corresponding informed issuing end.
Specifically, the same portions of this embodiment as those of the above embodiment are referred to the above embodiment, and are not described in detail here. By using the biological characteristic signature, the informed consent can be stored for a long time without damage, and the rights and interests of the informed consent on the informing party and the party are protected. The electronic edition informed consent encrypting and modifying prevention processing can effectively realize 'what you see is what you sign', fully guarantee the informed right and the control right of the informing party and the party to the informed consent signed each time, prevent the content of the informed consent from being tampered, and once the information is updated, only one new informed consent can be signed again, thus greatly guaranteeing the benefits of the informing party and the party.
In an embodiment of the present invention, a method for implementing informed consent includes:
s100, an informed receiving end divides an informed consent obtained from an informed initiating end to obtain a plurality of paragraph contents and marks professional terms in the paragraph contents;
s200, an informed receiving end plays the current paragraph contents according to the segmentation sequence, and initiates an informed inquiry to the party after playing the explanation contents of the professional terms selected by the party in the current paragraph contents;
S311, the informed receiving end triggers to acquire the input information of the party and terminates playing the current paragraph content and the description content of the special term selected in the current paragraph content to the party when the triggering of acquiring the input information is started;
s312, the informed receiving end analyzes and identifies the input information to obtain a feedback result aiming at the informed inquiry;
specifically, the input information includes, but is not limited to, voice information, key input, and manually input text information, and it is determined that the explanation is required only when a positive keyword such as "yes" or "ok" is parsed from the input information, and it is determined that the explanation is not required when a negative keyword such as "no" or "no" is parsed from the input information. The informed receiving end triggers the acquisition of the input information of the party and terminates the playing of the current paragraph content and the description content of the professional term selected in the current paragraph content to the party when the acquisition of the input information is triggered to start,
s321, if the feedback result is that the party does not have the informed consent capability, the informed receiving end initiates a request to be assisted by the guardian to sign informed consent; or the like, or, alternatively,
specifically, the informed receiving end plays the paragraph content and the description content of the professional term selected in the current paragraph content to the party, and if the feedback result indicates that the party does not have the informed consent capability, the informed receiving end sends the informed consent and the authorization principal to the bound monitor terminal, and the monitor assists the party in signing the informed consent.
S322, if the feedback result is unclear, the informed receiving end sends the paragraph content which is fed back as unclear to the informed initiating end so as to obtain the explanation of the informing party from the informed initiating end;
specifically, the informed receiving end plays the paragraph content and the explanation content of the professional term selected in the current paragraph content to the party, if the feedback result is that the party does not know the played paragraph content and the explanation content corresponding to the paragraph content, the fed back unclear paragraph content is sent to the corresponding informed initiating end, after the informed initiating end receives the unclear paragraph content sent by the informed receiving end, the informed initiating end pops up a window to display the unclear paragraph content, prompts the informing party to explain the unclear paragraph content by adopting popular and understandable words according to the professional knowledge and experience of the informing party, and then feeds back the explanation to the informed receiving end, so that the party can conveniently know the clearly unaccepted paragraph content.
S340, if the feedback result is clear, the informed receiving end plays the next paragraph content and the description content of the selected special terms from front to back to the party according to the segmentation sequence;
s400, the informed receiving end repeats the content playing and feedback result obtaining process until the principal feeds back the determined informed information to all the paragraph contents.
Specifically, the same portions of this embodiment as those of the above embodiment are referred to the above embodiment, and are not described in detail here. According to the embodiment, the guardian assists in signing informed consent by initiating the request, so that the method can effectively help the old or the disabled and other parties without informed consent, realize signing of the informed consent, and improve the application range of remote signed informed consent. In addition, only when the user feeds back that the played paragraph content is unclear, the informed receiving end sends the paragraph content fed back as unclear to the informed initiating end to obtain the explanation of the informing party, and the rest of the explanation content is automatically inquired and searched through the crawler program, so that the informing party does not need to respectively explain each unclear paragraph content, the workload of the staff participating in activity signing and deciding the informed consent is greatly reduced, the informed consent bookmark signing process is simplified, and the signing and signing efficiency of the informed consent is improved.
Preferably, the text content explained by the informing party for the unclear paragraph content is uploaded to the informing party self-use knowledge sharing server each time, so that the explanation information of the professional words by the informing party self-use knowledge sharing server can be greatly expanded, and the work load of the staff of the informing party for explaining each unclear paragraph content in person is reduced.
Illustratively, internet hospitals are a new medical model. The method relies on an internet platform, gradually changes the traditional medical service mode under the support of emerging information technologies such as cloud computing, big data and the internet of things, and is a product of integration and innovation of the traditional medical mode and the emerging medical mode by crossing the traditional medical mode. However, the internet diagnosis and treatment behavior is different from that of the entity hospital, and the party does not necessarily see a doctor on site. For example, clinical trials of drugs are a necessary verification link before the drugs are marketed, and researchers collect, collate and analyze data about the safety and effectiveness of new drugs during clinical trials on human subjects, thereby providing important judgment basis for approval and marketing of new drugs. With the continuous development of medical technology, the guarantee of the rights and interests of the subjects begins to become an international discussion topic, medical ethics becomes a prerequisite to be considered in clinical tests, and a clinical test of the drug which can be accepted by the society and benefits the society is not only scientifically reliable, but also ethically acceptable.
The implementation of a clinical trial of a drug requires the recruitment of eligible subjects, i.e., patients, and in order to ensure the benefit of the patients, it is necessary to inform the patients of various risks and rights during the period before the trial begins, which mainly includes: (1) studying the background; (2) (ii) project purpose; (3) testing process; (4) the test period; (5) possible benefit of the test; (6) testing grouping conditions; (7) the risk of possible trials; (8) test confidentiality and subject privacy protection; (9) testing insurance and compensation; (10) subject's rights were informed (voluntary, free participation and withdrawal).
The clinical trial recruits patients, the trial can be completed only by a designated organization, and the follow-up process can be performed after the patients are willing after the remote informed consent. So as to avoid the time waste of the patient and the doctor due to the fact that the patient does not receive informed consent after coming. Remote informed consent lacks specifications and thus remains controversial. With the development of internet technology and artificial intelligence technology, the functions of remotely implementing informed consent, reading the informed consent form, replacing a professional term part in a doctor explaining the informed consent form, intelligently identifying and storing the voice of a patient and converting the voice into a character record, storing the informed consent implementation record for a long time, recording a digital signature, recording biological identification characteristics of the patient and the like can be realized. The present embodiments may be implemented by software installed into a smartphone or wearable device.
The software functions as follows:
(1) the content of each paragraph can be read by voice or manually through TTS technology for the informed consent;
(2) the patient can be guided to carry out step-by-step confirmation, whether the patient understands or not is confirmed by software or manual work when the contents of each paragraph and the description end to read, and the patient confirms the understanding by voice response and then continues to read the contents of the next paragraph and the description;
(3) a biometric signature may be generated, which may be an acquired voice print, fingerprint, facial image, etc. of the patient.
(4) The information in the local database can be retrieved and utilized, the device for installing the software is connected with the Internet for searching, each term in the informed consent form is automatically marked, the attention of the patient is prompted, and the patient can click to view the corresponding explanation or know the term by completing reading by the device (such as a mobile phone) for installing the software.
The invention can greatly reduce the workload of staff in signing and approving the informed consent in clinical tests and also reduce the risk. In addition, remote informed consent can be implemented, and patients can basically fill in the informed consent at any time, so that the signing efficiency of the informed consent is improved. The invention can also be applied to other fields and scenes which need to be informed and agreed and need to sign contracts, such as the matters of court work, the work contract approval of enterprises and the like.
The doctor end (namely the informed consent initiating end) can design an informed consent in accordance with the specification according to different requirements, and patients with requirements download and install the informed consent software to the patient end (namely the informed consent receiving end) according to the requirements of doctors (patients participating in clinical tests or clinical treatments are according to the requirements of doctors) and register. The registration adopts a mobile phone number registration mode, a WeChat registration mode and the like, and can also be identified and registered by a face by opening a camera. The doctor uses the informed consent software installed at the doctor end to send the informed consent designed for the patient to the corresponding patient end in a single-sending mode or a group-sending mode. And starting and operating the informed consent software installed at the patient terminal by the patient, then opening the appointed informed consent, automatically reading the informed consent by voice after the informed consent is opened, and entering an informed consent process after the reading is finished. Specifically, software can automatically read the first paragraph content and the description content of an informed consent through a TTS speech synthesis technology, the software judges to read a paragraph or a group according to periods, spaces, word segmentation and other modes, then a pause is executed, a first informed query is inserted (for example, do you understand the above information. After the first paragraph content and the description content thereof are read and confirmed by the patient, the next paragraph content and the description content thereof are read and queried, and the specific process refers to the reading and querying process of the first paragraph content and the description content thereof.
When the patient inputs an answer aiming at the informed inquiry in a voice interaction mode, the software records a voice signal and transmits the voice signal to the server, and the server analyzes the voice signal, extracts and records voiceprint characteristics and generates a biological characteristic signature as one of biological identification characteristics. Of course, patients without the ability to consent to informed consent require family members or agents to assist in completing informed consent.
After repeating the steps to finish the reading of the whole content of the informed consent and the informed inquiry, the software plays the prompted information by voice and simultaneously displays the prompted information on a screen, so as to prompt the patient to determine whether to sign, wherein the signing mode is to collect any one or more of fingerprints, head images and voice, and if the patient agrees to sign the informed consent and signs in a voice mode, the patient needs to repeat the specified sentences by voice (for example, the patient confirms to understand and agrees the information, or the like). After the signing of the patient is finished, an electronic informed consent form of a biological characteristic signature version is generated, the electronic informed consent form comprises information content, term explanation, patient voiceprint characteristics, fingerprints, head portrait digital characteristics and the like, then software immediately encrypts the electronic informed consent form file, only can consult the electronic informed consent form file after the timestamp is effective, but cannot modify the electronic informed consent form file, and then the electronic informed consent form file and the electronic consent form file are respectively stored or stored by a proper third party.
Illustratively, the non-face-to-face communication between the informing party and the non-face-to-face signing of the informed consent can be realized by the informed receiving end and the informed issuing end of the invention during the epidemic situation (such as new coronary pneumonia, SARS, plague and the like), so that the infection probability is greatly reduced, and the infection is prevented to a certain extent.
The invention also provides an informed receiving end, which is applied to an implementation method of informed consent, and comprises the following steps:
the communication module is used for acquiring the informed consent form from the informed initiating terminal;
the segmentation marking module is used for dividing the informed consent to obtain a plurality of paragraph contents and marking professional terms in each paragraph content;
the playing inquiry module is used for playing the current paragraph contents according to the segmentation sequence, initiating an informed inquiry to the party after the explanation contents of the professional terms selected by the party in the current paragraph contents are played, and switching the next paragraph contents to carry out playing inquiry until all the paragraph contents are played and inquired;
and the processing module is used for determining whether to enter the playing of the next paragraph of content according to the feedback result of the principal on the informed inquiry, and switching to obtain the feedback result of the next paragraph of content until the principal feeds back all the paragraph of content as the confirmed informed.
Specifically, this embodiment is a device embodiment corresponding to the method embodiment, and specific effects refer to the method embodiment, which is not described in detail herein.
The invention also provides a system for realizing informed consent, which comprises: an informed-onset end and an informed-receiving end;
the informed consent terminal is used for sending an informed consent to the informed receiving terminal;
the informed receiving end is used for dividing the informed consent obtained from the informed initiating end to obtain a plurality of paragraph contents and marking professional terms in each paragraph content;
the informed receiving end is used for playing the current paragraph contents according to the segmentation sequence and initiating an informed inquiry to the party after playing the explanation contents of the professional terms selected by the party in the current paragraph contents;
the informed receiving end is used for determining whether to enter the playing of the next section of falling content according to the feedback result of the client on the informed inquiry;
and the informed receiving end is used for repeating the content playing and feedback result obtaining process until the principal feeds back the determined informed information to all the paragraph contents.
Specifically, this embodiment is a system embodiment corresponding to the above method embodiment, and specific effects refer to the above method embodiment, which is not described in detail herein.
It will be apparent to those skilled in the art that, for convenience and brevity of description, only the above-described division of program modules is illustrated, and in practical applications, the above-described distribution of functions may be performed by different program modules, that is, the internal structure of the apparatus may be divided into different program units or modules to perform all or part of the above-described functions. Each program module in the embodiments may be integrated in one processing unit, or each unit may exist alone physically, or two or more units are integrated in one processing unit, and the integrated unit may be implemented in a form of hardware, or may be implemented in a form of software program unit. In addition, the specific names of the program modules are only used for distinguishing the program modules from one another, and are not used for limiting the protection scope of the application.
The informed receiving end and the informed starting end can be desktop computers, notebooks, palm computers, tablet computers, mobile phones, human-computer interaction screens and other equipment. It will be understood by those skilled in the art that the foregoing are merely examples of the informed receiving end and the informed initiating end, and are not intended to limit the informed receiving end, and may include more or less components than the foregoing embodiments, or may combine some components, or different components, for example: the informed receiving end may further include an input/output interface, a display device, a network access device, a communication bus, a communication interface, and the like. A communication interface and a communication bus, and may also include an input/output interface.
In the above embodiments, the descriptions of the respective embodiments have respective emphasis, and reference may be made to the related descriptions of other embodiments for parts that are not described or recited in detail in a certain embodiment.
Those of ordinary skill in the art will appreciate that the various illustrative elements and algorithm steps described in connection with the embodiments disclosed herein may be implemented as electronic hardware or combinations of computer software and electronic hardware. Whether such functionality is implemented as hardware or software depends upon the particular application and design constraints imposed on the implementation. Skilled artisans may implement the described functionality in varying ways for each particular application, but such implementation decisions should not be interpreted as causing a departure from the scope of the present application.
In the embodiments provided in the present application, it should be understood that the disclosed apparatus/informed receiving end and method may be implemented in other ways. For example, the above-described apparatus/notification sink embodiments are merely illustrative, and for example, the division of the modules or units is only one logical division, and there may be other divisions when the actual implementation is performed, for example, multiple units or components may be combined or integrated into another system, or some features may be omitted, or not executed. In addition, the shown or discussed mutual coupling or direct coupling or communication connection may be an indirect coupling or communication connection of some interfaces, devices or units, and may be in an electrical, mechanical or other form.
The units described as separate parts may or may not be physically separate, and parts displayed as units may or may not be physical units, may be located in one place, or may be distributed on a plurality of network units. Some or all of the units can be selected according to actual needs to achieve the purpose of the solution of the embodiment. In addition, functional units in the embodiments of the present application may be integrated into one processing unit, or each unit may exist alone physically, or two or more units are integrated into one unit. The integrated unit can be realized in a form of hardware, and can also be realized in a form of a software functional unit.
The integrated modules/units, if implemented in the form of software functional units and sold or used as separate products, may be stored in a computer readable storage medium. Based on such understanding, all or part of the flow of the method according to the embodiments of the present invention may also be implemented by sending instructions to relevant hardware through a computer program, where the computer program may be stored in a computer-readable storage medium, and when the computer program is executed by a processor, the steps of the method embodiments may be implemented. Wherein the computer program comprises: computer program code which may be in the form of source code, object code, an executable file or some intermediate form, etc. The computer-readable storage medium may include: any entity or device capable of carrying the computer program code, recording medium, usb disk, removable hard disk, magnetic disk, optical disk, computer Memory, Read-Only Memory (ROM), Random Access Memory (RAM), electrical carrier wave signals, telecommunications signals, software distribution medium, and the like. It should be noted that the content of the computer-readable storage medium can be increased or decreased according to the requirements of the legislation and patent practice in the jurisdiction, for example: in certain jurisdictions, in accordance with legislation and patent practice, the computer-readable medium does not include electrical carrier signals and telecommunications signals.
It should be noted that the above embodiments can be freely combined as necessary. The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and decorations can be made without departing from the principle of the present invention, and these modifications and decorations should also be regarded as the protection scope of the present invention.

Claims (11)

1. A method for realizing informed consent is characterized by comprising the following steps:
the informed receiving end divides the informed consent acquired from the informed initiating end to obtain a plurality of paragraph contents and marks professional terms in each paragraph content;
the informed receiving end plays the current paragraph contents according to the segmentation sequence, and initiates an informed inquiry to the party after playing the explanation contents of the professional terms selected by the party in the current paragraph contents;
the informed receiving end determines whether to play the next section of falling content according to the feedback result of the party on the informed inquiry;
and the informed receiving end repeats the content playing and feedback result obtaining process until the principal feeds back the determined informed information to all the paragraph contents.
2. The method for implementing informed consent according to claim 1, wherein the informed consent receiving end divides the informed consent form obtained from the informed initiating end to obtain a plurality of paragraph contents and marks the professional term in each paragraph content comprises the steps of:
The informed receiving end segments the acquired informed consent book through a preset punctuation mark or meaning group division rule to obtain a plurality of paragraph contents;
and the informed receiving terminal carries out word segmentation processing on the contents of each paragraph to obtain word segmentation results, screens out the professional terms from the word segmentation results and positions and marks the terms.
3. The method for implementing informed consent according to claim 2, wherein the informed receiving end performs word segmentation processing on each paragraph content to obtain a word segmentation result, and screens out a professional term from the word segmentation result and locates a mark, comprising the steps of:
the informed receiving end trains to obtain a word segmentation dictionary, and the word segmentation result is obtained by segmenting the paragraph contents through the word segmentation dictionary;
the informed receiving end matches the word segmentation result with a preset professional term dictionary to screen out the professional terms;
and the informed receiving end carries out positioning marking on the screened professional terms through preset symbols.
4. The method for implementing informed consent according to claim 1, wherein the informed receiving end plays the current paragraph contents according to the segmentation precedence order, and after playing the explanatory content of the professional term selected by the party in the current paragraph contents, initiates an informed query to the party, comprising the steps of:
The informed receiving end plays the current paragraph contents to the voice of the party from front to back according to the segmentation sequence and/or plays the current paragraph contents in a graph-text rolling way;
after the current paragraph content is played, the informed receiving end judges whether trigger operation information aiming at the current paragraph content and input by a party is acquired;
when the informed receiving end acquires the trigger operation information within a preset time after the playing is finished, determining that the words corresponding to the trigger operation information are selected professional terms, inquiring the description content of the selected professional terms, and playing the description content in a voice mode and/or in a picture-text rolling mode;
and the informed receiving end initiates an informed inquiry corresponding to the current paragraph content after the current paragraph content is played, if the duration of the trigger operation information is not obtained reaches the preset duration, or inquires the explanatory content of the selected professional term, and after the voice playing and/or image-text rolling playing of the explanatory content is finished, if the duration of the trigger operation information is not obtained reaches the preset duration.
5. The method for implementing informed consent according to claim 1, wherein the informed receiving end determines whether to enter the playing of the next paragraph content according to the feedback result of the party to the informed inquiry;
The informed receiving end acquires a feedback result of the party on the informed inquiry;
if the feedback result is unclear or the party does not have the informed consent capability, the informed receiving end enters an informed assistance process;
and if the feedback result is clear, the informed receiving end plays the next paragraph content and the description content of the selected special terms from front to back to the party according to the segmentation sequence.
6. The method for implementing informed consent according to claim 5, wherein the informed receiving end obtaining feedback result of the party to the informed inquiry comprises the steps of:
the informed receiving end triggers and acquires the input information of the party, and stops playing the current paragraph content and the description content of the special terms selected in the current paragraph content to the party when the triggering of acquiring the input information is started;
and the informed receiving end analyzes and identifies the input information to obtain a feedback result aiming at the informed inquiry.
7. The method for implementing informed consent according to claim 6, wherein if the feedback result is unclear or the party does not have the ability of informed consent, the informed receiving end proceeds to the step of informed assistance flow:
If the feedback result is that the party does not have the informed consent capability, the informed receiving end initiates a request to be assisted by the guardian to sign informed consent; or the like, or, alternatively,
and if the feedback result is unclear, the informed receiving end sends the paragraph contents which are fed back to be unclear to the informed starting end so as to obtain the explanation of the informing party from the informed starting end.
8. The method for implementing informed consent according to claim 1, wherein the informed receiving end repeats the content playing and feedback result obtaining process until obtaining the determined informed consent of the party for all paragraph contents feedback, comprising the steps of:
the informed receiving end prompts whether the party confirms agreement or not, and if yes, the biological characteristic signature input by the party is obtained;
the informed receiving end generates an electronic edition informed consent according to the biological characteristic signature;
and the informed receiving end carries out encryption and modification prevention processing on the electronic edition informed consent, then stores the electronic edition informed consent, and sends the electronic edition informed consent after the encryption and modification prevention processing to the corresponding informed issuing end.
9. The method for implementing informed consent according to any one of claims 1-8, wherein the receiving end for receiving informed consent performs a division process on the informed consent obtained from the initiating end for receiving informed consent to obtain several paragraph contents and marks professional terms in each paragraph content, and the method comprises the following steps:
The informed consent template is obtained by the informed consent initiating terminal, and a corresponding informed consent is generated according to the informed consent template;
and the informed consent is sent to the corresponding informed receiving end by the informed initiating end.
10. An informed receiving end, which is applied to the implementation method of informed consent according to any one of claims 1 to 8, and comprises:
the communication module is used for acquiring the informed consent form from the informed initiating terminal;
the segmentation marking module is used for dividing the informed consent form to obtain a plurality of paragraph contents and marking professional terms in each paragraph content;
the playing inquiry module is used for playing the current paragraph contents according to the segmentation sequence, initiating an informed inquiry to the party after the explanation contents of the professional terms selected by the current paragraph contents are played by the party, and switching the next paragraph contents to carry out playing inquiry until all the paragraph contents are played and inquired;
and the processing module is used for determining whether to enter the playing of the next paragraph of content according to the feedback result of the principal on the informed inquiry, and switching to obtain the feedback result of the next paragraph of content until the principal feeds back all the paragraph of content as the confirmed informed.
11. An implementation system of informed consent, which is applied to the implementation method of the informed consent of any one of claims 1 to 9, and comprises: an informed-onset end and an informed-receiving end;
the informed consent terminal is used for sending an informed consent to the informed receiving terminal;
the informed receiving end is used for dividing the informed consent obtained from the informed initiating end to obtain a plurality of paragraph contents and marking professional terms in each paragraph content;
the informed receiving end is used for playing the current paragraph contents according to the segmentation sequence, and initiating an informed inquiry to the party after playing the explanation contents of the professional terms selected by the party in the current paragraph contents;
the informed receiving end is used for determining whether to play the next section of falling content according to the feedback result of the party on the informed inquiry;
and the informed receiving end is used for repeating the content playing and feedback result obtaining process until the principal feeds back the determined informed information to all the paragraph contents.
CN202010691110.2A 2020-07-17 2020-07-17 Implementation method of informed consent, informed receiving end and system Pending CN111861808A (en)

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Application publication date: 20201030