PATIENT RECRUITMENT PROCEDURES AND PATIENT RECRUITMENT SYSTEM

Description

State of the art

[0001] The invention relates to a method for patient recruitment according to the preamble of claim 1 and a patient recruitment system according to the preamble of claim 8.

[0002] From the prior art, e.g. the published US patent applications US 2005 / 182665 A1 and US 2014 / 316793 A1, patient databases are known in which patient data sets are stored that are used to recruit patients for clinical studies.

[0003] The object of the invention is, in particular, to achieve advantageous properties with regard to patient recruitment. Furthermore, the object of the invention is, in particular, to achieve high quality and / or efficiency. Furthermore, the object of the invention is, in particular, to achieve a high-quality selection of potential participants for clinical studies. This object is achieved according to the invention by the features of claims 1 and 8, while advantageous embodiments and further developments of the invention can be found in the subclaims. Advantages of the invention

[0004] The invention is based on a method, in particular a patient recruitment method, for patient recruitment for a study, in particular for at least one clinical study, wherein in at least one comparison step at least one patient parameter stored on a patient data server of at least one patient is compared mechanically, and in particular automatically, with at least one recruitment parameter stored on a study data server of at least one study, and wherein in at least one evaluation step at least one suitability parameter of a suitability of the patient for the study is determined mechanically, and in particular automatically, depending on the patient parameter and the recruitment parameter and stored on at least one server, in particular a patient recruitment server.

[0005] According to the invention, in at least one assignment step, at least one assignment between the patient and the study is carried out depending on the suitability parameter and at least one assignment information is stored on at least one server, in particular the patient recruitment server.

[0006] The method according to the invention can achieve advantageous properties with regard to patient recruitment, in particular with regard to its efficiency and / or quality. A high quality selection of suitable patients can advantageously be achieved. Furthermore, suitable patients can advantageously be encouraged to participate in clinical trials and / or recruitment costs can be reduced. Furthermore, a patient and / or clinical staff assigned to the patient can advantageously be informed about suitable trials and encouraged to participate actively. Furthermore, patient awareness of clinical trials can be raised, thereby reducing patient recruitment costs. Furthermore, high cost efficiency in patient recruitment can be achieved.In particular, patients can be efficiently recruited for studies related to the demonstration of efficacy of active substances and / or treatment methods that are to be approved in the future.

[0007] In addition, the invention comprises a patient recruitment system, in particular for recruiting patients for studies, advantageously for clinical studies, in particular provided for carrying out the method for patient recruitment, with at least one patient recruitment server which is provided for executing at least one comparison process for comparing at least one patient parameter of at least one patient with at least one recruitment parameter of at least one study and for executing at least one evaluation process for generating at least one suitability parameter of a suitability of the patient for the study depending on the patient parameter and the recruitment parameter.

[0008] It is proposed that the patient recruitment server is provided for executing at least one assignment process for generating at least one assignment between the study and the patient depending on the suitability parameter.

[0009] The inventive design of the patient recruitment system allows for advantageous properties with regard to patient recruitment, particularly with regard to its efficiency and / or quality. A high quality selection of suitable patients can advantageously be achieved. Furthermore, suitable patients can advantageously be encouraged to participate in clinical trials and / or recruitment costs can be reduced. Furthermore, a patient can advantageously be informed about suitable trials and encouraged to participate actively. Furthermore, patient awareness of clinical trials can be raised, thereby reducing patient recruitment costs. Furthermore, high cost efficiency in patient recruitment can be achieved.

[0010] In particular, the comparison process includes a particularly automated execution of the comparison step, and / or the evaluation process includes a particularly automated execution of the evaluation step, and / or the assignment process includes a particularly automated execution of the assignment step. In this context, a "process" is understood to mean, in particular, a machine routine and / or a machine subprogram or program execution, which is particularly executable by means of at least one computing unit and / or is carried out in at least one operating state. A "computing unit" is understood to mean, in particular, a unit with an information input, an information processing unit, and an information output.Advantageously, the computing unit comprises at least one processor, a memory, one or more input and output means, further electrical components, an operating program, control routines, control routines and / or calculation routines.

[0011] Preferably, the method is intended for patient recruitment. Particularly preferably, the method and / or the patient recruitment system is intended for recruiting patients for Phase III clinical trials. However, patient recruitment for clinical trials of a different phase and / or for other types of trials is also conceivable. In particular, patient recruitment can include the recruitment of patients in the medical and / or veterinary field, advantageously for corresponding, particularly clinical, trials. "Intended" is to be understood in particular as being specially programmed, designed, and / or equipped. The fact that an object is intended for a specific function is to be understood in particular as meaning that the object fulfills and / or executes this specific function in at least one application and / or operating state.The fact that a method is "intended" for a purpose should be understood in particular to mean that the method includes at least one method step that is specifically aimed at the purpose and / or that the method is specifically directed at the purpose and / or that the method serves to fulfill the purpose and is at least partially optimized for this fulfillment. The fact that a method step is "intended" for a purpose should be understood in particular to mean that the method step is specifically aimed at the purpose and / or that the method step is specifically directed at the purpose and / or that the method step serves to fulfill the purpose and is at least partially optimized for this fulfillment.

[0012] A "patient data server" is understood, in particular, to be a server on which patient data records can be stored and / or are stored. The patient data server can be configured as a dedicated server, but alternatively or additionally also as a virtual server and / or a cloud server and / or a shared server and / or as at least part of a content delivery network or another suitable server. The patient parameter is preferably at least part of at least one, in particular electronic, patient data record. In particular, the patient data record can comprise a plurality of different patient parameters.The patient parameter comprises, in particular, at least one value and / or at least one characteristic that characterizes at least one feature of the patient and, in particular, their state of health and / or their body, for example, at least an age, in particular a minimum age and / or a maximum age, a height, in particular a minimum height and / or a maximum height, a weight, in particular a minimum weight and / or a maximum weight, a BMI, in particular a minimum BMI and / or a maximum BMI, a gender, a medical history, a laboratory value, a measured value, medication information, a sensor value, addiction information, habit information, behavioral information, and / or the like, wherein any combinations are conceivable. It is also conceivable for the patient parameter and / or the patient data record to comprise at least one, in particular unique, patient ID.In particular, the patient data record comprises at least one case that includes at least one diagnosis and / or at least one piece of treatment information and / or at least one piece of medication information linked, in particular, to the treatment information and / or at least one course of illness or the like. In particular, the patient data record comprises several such cases and advantageously at least part of the patient's treatment and / or illness history.

[0013] A "study data server" is understood to mean, in particular, a server on which study data sets, in particular data sets relating to clinical studies, can be stored and / or are stored. The study data server can be configured as a dedicated server, but alternatively or additionally also as a virtual server and / or a cloud server and / or a shared server and / or as at least part of a content delivery network or another suitable server. Preferably, the recruitment parameter is at least part of at least one, in particular electronic, study data set, in particular a data set from a clinical study. In particular, the study data set can be a data set from a clinical study.For example, the study dataset may include at least one piece of contact information, for example, of a study coordinator, and / or at least one piece of information about a study duration and / or a study location and / or a study type and / or a study objective, or other such metadata. The recruitment parameter preferably includes at least one value and / or at least one value range and / or at least one parameter and / or at least one piece of categorization information, in particular multiple linked categorization information, and / or at least one keyword, in particular a combination of keywords, for example a hierarchical combination, based on which a patient's suitability can be determined, preferably by machine, particularly taking into account the patient parameter.For example, the recruitment parameter may include a gender, age, height, weight, BMI, medical history, a laboratory value, a measured value, corresponding minimum and / or maximum values, medication, a sensor value, addiction information, habit information, behavioral information, and / or the like, in particular in the form of a value range and / or in the form of a decision criterion such as a Boolean query and / or a categorical parameter. Furthermore, it is conceivable that the study parameter and / or the study data set includes at least one, in particular unique, study ID.

[0014] Patient parameters and / or study parameters can in principle comprise, for example, textual information and / or at least one reference to medical and / or clinical terminology, in particular in the form of a reference to a corresponding database and / or at least one piece of image information and / or audio information and / or video information and / or at least one time stamp and / or a chronology or the like.

[0015] A "patient recruitment server" is understood to mean, in particular, a server on which data, particularly electronic data, relating to the recruitment of specific patients for specific studies can be and / or is stored. The patient recruitment server can be configured as a dedicated server, but alternatively or additionally also as a virtual server and / or a cloud server and / or a shared server and / or as at least part of a content delivery network or another suitable server. Preferably, at least one allocation data set and / or at least one suitability data set is stored on the patient recruitment server. It is conceivable that the suitability data set contains a plurality of different suitability parameters. Advantageously, the suitability data set is a suitability data set assigned to the patient. Particularly advantageously, the suitability parameter is a suitability parameter assigned to the study and the patient.Preferably, a plurality of different suitability data sets are stored on the patient recruitment server, each of which is in particular assigned to a specific patient and / or each of which contains suitability parameters of a specific patient for at least one study.

[0016] In particular, the patient data server and / or the study data server and / or the patient recruitment server has at least one computing unit and / or at least one interface to a central computing unit and preferably at least one electronic data storage device for storing parameters and / or data sets or the like. Parameters and / or data sets stored on the data storage device are preferably encrypted. Particularly preferably, data is retrieved from the data storage device and / or stored therein only in anonymized and / or pseudonymized form. Advantageously, the patient data server and / or the study data server and / or the patient recruitment server are at least temporarily connected by means of at least one data connection. Preferably, the patient data server and / or the study data server and / or the patient recruitment server are at least partially formed as a single piece and / or identically.In particular, it is conceivable that the patient recruitment server comprises and / or forms the patient data server and / or the study data server. It is further conceivable that the patient data server and / or the study data server and / or the patient recruitment server are located at different locations or at the same location and / or are part of a cloud. Advantageously, the patient data server and / or the study data server and / or the patient recruitment server are integrated into an intranet of a healthcare institution, for example a hospital, a clinic, a medical center, or the like, and / or are connectable to an external network, in particular only for maintenance purposes, so that a high level of security and / or anonymity of personal data can be advantageously ensured.

[0017] In particular, the comparison step comprises a machine comparison of the patient parameter with the recruitment parameter and / or at least a machine retrieval and / or query of the patient parameter and the recruitment parameter. Preferably, the patient recruitment server is provided to carry out the comparison step. In particular, it is conceivable that in the comparison step, at least one patient data set and / or at least one study data set is queried and / or at least temporarily stored, in particular in preparation for the evaluation step. Preferably, the comparison step comprises a comparison of a set of patient parameters with a specific logical link between a plurality of recruitment parameters, which are used, for example, hierarchically and / or at least partially as inclusion and / or exclusion criteria for formulating the logical link.The logical link is advantageously created automatically and / or used to create at least one machine-executable decision-making and / or evaluation process.

[0018] Preferably, the evaluation step comprises at least one automated calculation and / or determination of the suitability parameter, for example in the form of a logical query, a numerical value comparison, an intersection, or the like, and preferably a combination of at least two of these. In particular, it is conceivable that the suitability parameter is determined automatically depending on a specific set of patient parameters and / or depending on a specific set of recruitment parameters. According to the invention, the suitability parameter is a quality measure for the patient's suitability for the study, i.e., a match score. It is conceivable that the suitability parameter is a Boolean parameter, for example, with the two states "patient suitable" and "patient unsuitable." According to the invention, the suitability parameter is a match parameter, i.e.,the match score, which, according to the invention, correlates with the quality of a match between the patient and the study. For example, the suitability parameter can be a percentage of suitability. Furthermore, it is conceivable that the suitability parameter can assume various discrete values, for example, values ​​between 0 and 5, between 0 and 10, between 0 and 100, or any other discrete values. Preferably, the suitability parameter is determined as a function of several patient parameters and several study parameters, whereby individual parameters and / or matches can be weighted differently. Furthermore, it is conceivable that certain parameters are treated as exclusion parameters.For example, it is conceivable that a patient is assessed as completely unsuitable if at least one patient parameter is not within a permitted value range according to a corresponding recruitment parameter and / or does not correspond to a specific recruitment parameter, such as gender and / or a specific medication, which, for example, makes a patient unsuitable for a corresponding study. Alternatively or additionally, it is conceivable that the suitability parameter depends on the number and / or extent of a match between patient parameters and corresponding recruitment parameters.

[0019] For example, the study may contain recruitment parameters that require a specific gender, an age within a specific range, the presence of a specific disease, and a laboratory value for a specific health-related parameter within a specific range for a potentially suitable patient. Of course, any other combinations deemed appropriate by the expert are conceivable. In this case, for example, the eligibility parameter could assume a medium value if the patient parameters regarding gender and the presence of the disease correspond to the recruitment parameters and the patient is of a suitable age, and assume a high value if, for example, a laboratory value of the patient also falls within the corresponding range.Furthermore, gender could be defined as an exclusion criterion, so that, for example, a patient with a gender that does not correspond to that required by the study would be assigned a suitability parameter indicating unsuitability, regardless of whether the other parameters match. Of course, any combinations and strategies for determining a suitability parameter that seem reasonable to the expert are also conceivable, and the examples given are entirely non-restrictive.

[0020] Preferably, the assignment comprises linking the patient to the study, in particular noting the suitability parameter. Preferably, several studies and, in particular, corresponding suitability parameters can be assigned to a specific patient. Likewise, several patients and, in particular, corresponding suitability parameters can be assigned to a specific study. Advantageously, the method comprises at least one pseudonymization step, in which at least one patient parameter and / or at least one patient data set is at least partially pseudonymized. Anonymization is also conceivable. In principle, all of the patient's personal data are advantageously pseudonymized and / or anonymized at a suitable point in the method.In particular, in the assignment step, the assignment to the patient takes place in pseudonymized and / or anonymized form and / or the assignment information is advantageously stored on the patient data server in pseudonymized and / or anonymized form.

[0021] According to the invention, in the assignment step, the study is assigned to the patient depending on the suitability parameter. According to the invention, the study is assigned to the patient if the suitability parameter indicates that the patient is suitable for the study by the suitability parameter exceeding or falling below a certain threshold. It is conceivable that the threshold is adjusted automatically depending on at least one piece of information stored on the patient recruitment server and / or on the study data server. For example, the threshold can be increased or decreased if the number of potentially suitable patients increases or decreases. It is also conceivable that the threshold can be specified, for example, by clinical staff and / or by the patient. It is also conceivable that the threshold can be stored as a recruitment parameter on the study data server and / or can be specified by a creator and / or person responsible for the study.This advantageously allows suitability information to be linked to a patient. This can advantageously lead to a simple and / or efficient identification of suitable patients.

[0022] According to the invention, a plurality of suitable studies are assigned to the patient in the assignment step. In particular, at least one study parameter and advantageously one corresponding suitability parameter are assigned to the patient, and a corresponding assignment function is advantageously stored on the patient recruitment server. Preferably, a patient suitability parameter is created for a specific selection of studies and / or for all studies for which study data is stored on the study data server, and suitable studies are advantageously then assigned to the patient. The selection of studies can be carried out automatically and / or on the basis of at least one predefinable parameter. This can advantageously result in time and / or cost savings when recruiting patients for suitable studies.

[0023] According to the invention, in the assignment step, the patient is assigned an ordered list of suitable studies, which is stored on at least one server, in particular the patient recruitment server. A study is particularly suitable if the patient is at least partially suitable or at least not unsuitable as a subject for the study. Furthermore, it is conceivable that a further, in particular ordered, list of currently unsuitable or partially suitable studies is created and assigned to the patient, in particular a list containing potentially suitable studies in the future.An automated decision regarding future potential suitability is conceivable, for example, based on a patient's current medication and / or health condition or similar, which currently renders the patient unsuitable for the study, but whose end is foreseeable and / or after which the patient would be suitable for the study. This advantageously allows the patient to be recruited for a study based on a specific patient, with the patient's basic willingness to participate in a study serving as a starting point, for example, before a suitable study is advantageously selected from the list.

[0024] According to the invention, the ordered list is created automatically according to at least one machine-determined and / or at least one predefinable criterion. Advantageously, the criterion can be specified, for example, by the patient and / or by a treating physician and / or by other clinical staff and / or by a study manager. According to the invention, the list is ordered according to an overall match score. Alternatively or additionally, it is conceivable for the list to be ordered according to a date, for example a start of a study and / or admission of the patient and / or according to a time period, for example a study duration, in particular of fundamentally suitable studies, and / or a patient's length of stay or the like. This can advantageously increase the probability of successful recruitment and / or reduce the effort involved in recruitment.

[0025] Furthermore, according to the invention, in at least one selection step, a list of studies to be compared is created, in particular depending on at least one piece of location information assigned to the patient and / or the study. Preferably, only studies that were added to the list of studies to be compared in the selection step are used in the comparison step. Preferably, the selection step takes place before the comparison step. The location information can be, for example, a location of a healthcare institution at which the patient is currently staying and / or which the patient preferably visits repeatedly, for example for outpatient treatment, and / or a place of residence and / or a location of a general practitioner and / or a location at which the study is conducted, in particular a location of a healthcare institution at which the study is conducted, and / or a location of a study manager or the like.It is advantageous to add studies to the list of studies to be compared that are being and / or are to be conducted at the same healthcare institution where the patient is currently staying and / or is expected to stay in the future.

[0026] For example, it is conceivable that when a patient is registered at the healthcare institution, which may in particular also include at least information regarding an expected length of stay and / or a room number of the patient and the like, available studies whose study data records are stored on the study data server are searched for studies to which suitable location information is assigned, in particular in order to create the list of studies to be compared. In particular, in the case that at least the study data server is designed as a local server of the healthcare institution, it is conceivable that only study data from studies conducted at the healthcare institution are stored and / or can be stored on it. However, it is also conceivable that study data for studies from different healthcare institutions are stored and / or can be stored on the study data server.

[0027] It is also conceivable that the list of studies to be compared is drawn up depending on at least one date and / or a period and / or a date or the like. For example, a patient may be unsuitable for participation in a particular study because they are already assigned to another study on certain dates and / or have a treatment appointment or the like, in which case the corresponding study should preferably not be added to the list of studies to be compared. It is also conceivable that a patient's stay at the healthcare institution is likely to be, in particular considerably, shorter than the duration of a study and therefore appears unsuitable for a particular study, which accordingly makes it advantageous not to add it to the list of studies to be compared.

[0028] In an advantageous embodiment of the invention, it is proposed that the selection step and / or the comparison step and / or the assignment step are carried out repeatedly. According to the invention, the list of studies to be compared is processed in order to create the ordered list of suitable studies and assign it to the patient. According to the invention, the list of studies to be compared is repeatedly updated in real time and / or repeatedly processed in real time. Advantageously, patient parameters are compared with recruitment parameters in real time and / or suitability parameters are determined in real time. According to the invention, the selection step, the comparison step and the assignment step are carried out automatically at certain regular and / or predeterminable time intervals, for example daily or weekly, for example in order to check newly added studies for the suitability of the patient for newly added studies.Furthermore, according to the invention, the selection step, the matching step, and the assignment step are performed again after additional patient parameters have been entered, in particular by the patient and / or clinical staff and / or a study coordinator. This advantageously allows for a high level of timeliness. Furthermore, this allows for a high probability of successful recruitment over the entire period of a patient's stay at a healthcare institution.

[0029] According to the invention, at least one piece of study information is output in at least one output step by means of at least one input and / or output unit. The input and / or output unit is preferably designed as an input and output unit which is provided to output at least one piece of information for a user and which is provided for input of at least one piece of information by a user, in particular the same user. According to the invention, study information for a study for which the patient is at least partially suitable is output. According to the invention, the input and / or output unit is provided to output and display study data from the studies in the ordered list of suitable studies in an ordered form.The input and / or output unit is advantageously provided to output a corresponding suitability parameter or a suitability criterion determined on the basis of these suitability parameters for each study output, for example in the form of a score, a star rating, a bar that is more or less filled depending on suitability, a match score, or the like. Furthermore, the input and / or output unit is advantageously provided to output the study information at different levels of detail, for example depending on a corresponding selection and / or preselection by the patient and / or the clinical staff. Furthermore, it is conceivable that the input and / or output unit is provided to push study information, for example in the event that a patient's suitability parameter for a specific study increases and / or that a new study with a high match score is added, or the like.According to the invention, the input and / or output unit is provided for arrangement in a patient room of at least one healthcare institution. In an alternative not according to the invention, the input and / or output unit could be provided for arrangement in at least one doctor's office and / or in at least one waiting room. Particularly preferably, the input and / or output unit is arranged and advantageously, in particular permanently, installed in at least one healthcare institution, in particular in at least one patient room and / or in at least one doctor's office and / or in at least one waiting room. The input and / or output unit can comprise a plurality of input and / or output devices, at least some of which can be identical or different. For example, the input and / or output unit can comprise different input and / or output devices for patient rooms, doctors' offices and / or waiting rooms.This makes it possible to provide study data, particularly on suitable studies, in a simple and / or efficient manner.

[0030] According to the invention, the input and / or output unit is part of the patient recruitment system. Particularly preferably, the input and / or output unit is connectable and / or connected to the patient recruitment server. In particular, the input and / or output unit is provided for inputting at least one patient parameter and / or an intention to participate and / or for outputting at least one piece of study information. The study information can, for example, comprise a textual and / or pictorial and / or acoustic and / or audiovisual description of a specific study and / or an objective of the study and / or participation requirements for the study and / or contact information for a responsible person or the like. The study information is preferably suitable for enabling the patient to obtain information about a specific study.In particular, at least one input and / or output device of the input and / or output unit intended for use by a patient is provided for entering the patient parameter. In this case in particular, the patient parameter can be, for example, patient-specific information that is suitable for supplementing a patient data record but is not yet stored on the patient data server. Alternatively or additionally, it is conceivable for the patient parameter to be entered by clinical personnel, for example a treating physician, using the input and / or output unit. Preferably, at least one piece of information relating to the patient's intention and / or willingness to participate in a specific study can be entered as the intention to participate using the input and / or output unit, in particular by the patient and / or by a clinical personnel assigned to the patient.This advantageously allows information regarding potentially suitable studies, in particular for a specific patient and / or for the clinical staff treating him / her, to be provided in an efficient and / or comprehensive manner.

[0031] According to the invention, the input and / or output unit comprises at least one display, which is arranged in a patient room, in particular in the patient's room. Alternatively or additionally, an arrangement in a doctor's office and / or in a waiting room is conceivable. In particular, the input and / or output unit can have a plurality of displays via which information from patients and / or clinical staff can be entered and / or retrieved. Particularly preferably, the display is at least part of an input and / or output device assigned to the patient. The display is preferably installed in the patient room. However, it is also conceivable for the display and / or the input and / or output device assigned to the patient to be designed to be removable, for example in the manner of a portable display and / or computer.Preferably, at least one location information of the input and / or output device assigned to the patient is stored on the patient data server, for example in the form of coordinates and / or in the form of a room number and / or floor information or the like.

[0032] It is also conceivable that the input and / or output unit comprises at least one mobile device. For example, the mobile device can be assigned to and / or belong to the patient and / or the clinical staff, in particular the attending physician. The mobile device can in particular be designed as a smartphone, a tablet PC, data glasses, a smartwatch, a smartband, a smart cloth, a smart ring, any other wearable, or the like. Preferably, the mobile device is provided for a connection at least to the patient recruitment server. In particular, the mobile device forms at least one input and / or output device of the input and / or output unit. This can advantageously achieve a high level of user convenience. Furthermore, high cost efficiency can be achieved if, for example, existing mobile devices are integrated into the patient recruitment system.

[0033] In an advantageous embodiment of the invention, it is proposed that at least one patient participation intention parameter be entered by means of the input and / or output unit and stored on at least one server, in particular on the patient recruitment server and / or on the patient data server. The participation intention parameter can be a Boolean parameter, which can, for example, assume the value "participation intended." It is conceivable that information regarding a patient's non-intended participation is stored automatically and / or as a default value on the patient recruitment server, in particular for all studies in the ordered list of suitable studies, and that this information is preferably deleted for a specific study if a corresponding participation intention parameter is entered for this specific study. It is also conceivable that the participation intention parameter contains a rating.For example, a patient preference can be stored for at least some studies in the ordered list of suitable studies, which preference is ordered in particular according to the patient's interest in participating. In particular, the participation intention parameter can advantageously be entered optionally by the patient and / or by clinical staff. Furthermore, it is conceivable that information regarding an intention to participate and / or a general interest of the patient is made available to clinical staff by means of the input and / or output unit. For example, a treating physician can be informed of a patient's general interest in a particular study and can preferably subsequently contact the patient regarding the study and / or inform a study coordinator. This can advantageously increase the probability of successful recruitment.

[0034] It is also proposed that at least one output parameter for outputting the study information be adapted, preferably automatically, depending on at least one patient characteristic, in particular at least one patient parameter. The patient characteristic can be, for example, an age and / or a gender and / or a level of education and / or a medical history and / or a personal preference and / or any suitable patient parameter. In particular, the patient recruitment system and / or the input and / or output unit are provided for a context-sensitive presentation of information, in particular the study information. Preferably, the output parameter is a presentation parameter, in particular of the display.For example, a font size and / or display brightness and / or language and / or detail and / or wording of content and / or volume and / or arrangement of partial information on an information area, for example on a display, or the like, is adjusted, in particular automatically. Furthermore, it is conceivable that technical terms, for example in study descriptions, are automatically replaced with patient-friendly language and / or with common terms, in particular depending on at least one patient parameter such as a patient preference. For example, the term "pneumonia" could optionally be replaced with the term "pneumonia," or the like. Furthermore, it is conceivable that at least one automated semantic analysis of a study description could create at least a simplified and / or more easily understandable and / or abbreviated study description.Furthermore, it is conceivable that the patient characteristic is recorded automatically, for example by means of at least one query of at least one patient parameter from the patient data server and / or by means of at least one query of information stored, for example, on an external server or the like. It is also conceivable that the input and / or output unit is provided for the input of at least one target output parameter by the patient and / or by the treating clinical staff, who determines the output parameter. This can advantageously achieve a presentation of information specifically tailored to a patient and, in particular, encourage the patient to participate in a study.

[0035] Furthermore, it is proposed that at least one hierarchical evaluation list with several evaluation criteria be created mechanically and / or automatically based on several recruitment parameters of the study, which are used to determine the eligibility parameter. In particular, the evaluation criteria are determined mechanically from the recruitment parameters. Of course, it is also conceivable that the evaluation list is at least partially created manually and / or can be specified, for example, by a study manager. Preferably, the evaluation list includes a hierarchically structured logical comparison rule for comparing the recruitment parameters with the patient parameters. As described above, evaluation criteria can be inclusion and / or exclusion criteria.It is also conceivable that evaluation criteria can generate several different, in particular continuously distributed, values, for example probabilities and / or scores and / or partial match scores or the like. Preferably, in the evaluation step, a match score, in particular depending on several partial match scores, and / or a number of matches between recruitment parameters and patient parameters is determined using the evaluation list as a suitability parameter. It is conceivable that the evaluation list and / or corresponding recruitment parameters are / are created at least partially automatically based on a textual description of a study. This advantageously allows even complex requirements that must be met for suitability for a study to be efficiently determined and / or verified.

[0036] In an advantageous embodiment of the invention, it is proposed that at least one weighting parameter be assigned to each evaluation criterion, in particular mechanically and / or automatically. It is conceivable that the weighting parameters are generated at least partially automatically, for example, in the form of automatically generated starting values, which can, in particular, be subsequently overwritten. For example, at least some of the weighting parameters can be adjusted by a study manager and / or a client and / or clinical personnel assigned to a corresponding study, or the like, in particular by means of the input and / or output unit.For example, a weighting parameter of a specific evaluation criterion can be changed to identify a larger or smaller number of patients as potentially suitable and / or to make adjustments in recruitment, for example, based on new findings and / or partial study results. Furthermore, it is conceivable that at least one weighting parameter is determined automatically based on at least one piece of study information, for example, by means of at least one semantic analysis of a textual description and / or an analysis of a study objective or the like. This can advantageously improve the quality of identifying suitable patients.

[0037] It is further proposed that at least one list of assessment criteria be created which requires at least one input from at least one clinical staff member. For example, this may be a list of automatically created assessment criteria which is made available to the clinical staff member for review and / or approval. Furthermore, it is conceivable that this is a list of assessment criteria which were not and / or cannot be added to the list of assessment criteria completely automatically and / or which were not and / or cannot be completed completely automatically. Alternatively or additionally, it is conceivable that the list of assessment criteria is reviewed and / or approved and / or edited and / or supplemented and / or reorganized by a study manager and / or clinical staff member, in particular by means of the input and / or output unit.This can advantageously achieve a high degree of flexibility with regard to the formulation of evaluation criteria and / or strategies.

[0038] Advantageous properties with regard to the provision of information for a patient interested in a study can be achieved in particular if at least one piece of contact information relating to the study is provided for the patient. In particular, contact information is provided for studies in which the patient has at least an intention to participate. Furthermore, contact information is advantageously provided for studies for which the patient and / or the clinical person has entered at least one piece of information relating to an interest in the study, in particular by means of the input and / or output unit. For example, the patient is provided with information on the studies in the ordered list of suitable studies which the patient decides on for closer examination, for example by at least entering a selection using the input and / or output unit.It is conceivable that the input and / or output unit is intended to additionally establish contact with a contact person of the study, for example in the form of a call and / or in the form of a notification or the like.

[0039] A high level of reliability with regard to determining suitability and / or recruiting suitable patients can be achieved in particular if at least one further patient parameter is queried and / or entered in at least one input step using at least one input and / or output unit. In particular, the further patient parameter is requested from the patient and / or from the clinical staff. Preferably, one type of further patient parameter is determined automatically, for example in the case of a partial match of a patient data set with a study data set, in particular for the complete or at least more complete determination of a suitability parameter. The further patient parameter can be any patient parameter that is in particular not yet stored on the patient data server and / or is advantageously stored on the patient data server after its input.

[0040] It is further proposed that at least one item of patient suitability information be made available to clinical staff assigned to the patient by means of the input and / or output unit, in particular by means of an input and / or output device assigned to the clinical staff. In particular, the input and / or output unit is provided to make available, in particular to output and / or display, the ordered list of studies as well as the suitability criteria and / or suitability parameters assigned to the studies. Preferably, the input and / or output unit is provided to process a selection of different patients by the clinical staff and preferably to make available corresponding suitability information assigned to a respectively selected patient as well as particularly advantageously associated study information, for example during a ward visit and / or when reviewing occupancy or the like.Furthermore, it is conceivable that the input and / or output unit is designed to provide and / or output at least one piece of study information to the patient based on at least one pre-selection by clinical staff, wherein the pre-selection can preferably be entered by the clinical staff after the patient's suitability information has been output to the clinical staff. This can advantageously achieve high cost efficiency and / or time savings, particularly since clinical staff can specifically encourage potentially suitable patients to participate in clinical studies.

[0041] According to the invention, at least one patient parameter is automatically recorded and mechanically processed by means of at least one sensor unit, in particular a sensor unit of the input and / or output unit. According to the invention, the patient recruitment system comprises the sensor unit. The sensor unit can, for example, be installed in a patient room and / or at a patient bed, in particular permanently. It is also conceivable for the sensor unit to be designed as a mobile sensor unit, which can be attached in particular at different positions and / or at different patient beds and / or in different patient rooms. Furthermore, it is conceivable for the sensor unit to be attachable to a patient's body, for example in the form of a band and / or a belt and / or a headgear and / or a contact point or the like. The sensor unit can also comprise at least part of a piece of clothing belonging to the patient.It is also conceivable that the sensor unit is at least part of the mobile device. The sensor unit can comprise a body temperature sensor and / or an image capture unit and / or a weight sensor and / or a body parameter sensor and / or a fingerprint scanner or the like. For example, the sensor unit can comprise a camera and / or a motion sensor and / or another sensor, for example a smartphone and / or data glasses and / or a wearable device or an input and / or output device arranged, in particular permanently installed, at the patient bed and / or in the patient room or the like. Preferably, the sensor unit is provided to transmit at least one detected parameter and / or at least one item of status information and / or any data to at least one server, in particular to the patient data server and / or to the study data server and / or to the patient recruitment server.The sensor unit can, for example, be provided for determining body weight and / or body temperature and / or a fingerprint and / or sleeping behavior and / or fatigue and / or any other patient parameters. It is also conceivable for the sensor unit to be provided for image capture. In this case in particular, it is conceivable for the patient recruitment server and / or the input and / or output unit and / or the sensor unit to be provided for image recognition, based on which, in particular, at least one patient parameter can be determined. For example, the sensor unit can capture at least one image, for example of the patient and / or a medication package and / or a wound and / or a body part and / or a bandage of the patient or the like, based on which at least one patient parameter can be determined.In particular, it is conceivable that the method comprises a method step for determining medication usage information of the patient, for example by asking the patient to scan and / or photograph prescriptions and / or medication packages and / or tablets or the like and / or in which method step the patient takes corresponding images and / or carries out scans and / or in which method step advantageously correspondingly captured images and / or scans are analyzed by machine in order to automatically record the corresponding patient parameters and / or store them on the patient data server.

[0042] A high degree of ease of use and / or effective recruitment based on a patient-specific presentation can be achieved, in particular, if at least one output parameter for outputting at least one piece of study information is adapted depending on the patient parameter detected by the sensor unit. For example, it is conceivable that the output parameter is adapted depending on a detected age and / or a detected impairment, for example, of the patient's vision, and / or depending on medications currently prescribed to the patient detected by the sensor unit, and / or a detected fatigue of the patient, or the like.According to the invention, the sensor unit is designed to recognize at least one unique feature of a patient, such as a fingerprint, a face, an eye, or even, for example, an RFID chip or the like, which the patient wears on their body and / or which is integrated into a piece of clothing belonging to the patient, in particular one provided by the healthcare institution. Alternatively or additionally, according to the invention, a feature that is not necessarily unique but is assigned to the patient, such as body weight, gender, estimated age, eye color, and / or the like, in particular also in combination, is stored and / or compared with current detections of the sensor unit in order to recognize a patient.For example, it can be detected if a patient other than the one intended according to an occupancy plan is lying in a particular patient bed and / or is using a particular input and / or output device and / or wishes to query certain study information intended for the correct patient, or the like. According to the invention, a display and / or another output means of the input and / or output unit is at least temporarily deactivated and / or blocked if a different patient than the patient and / or no patient is detected. This advantageously prevents the display of sensitive and / or personal data to unauthorized persons.

[0043] Advantageous properties with regard to ease of use and / or efficient patient recruitment can be achieved in particular with an input and / or output unit which is intended for use in a patient recruitment system according to the invention.

[0044] The invention further relates to a use of the method according to the invention and / or the patient recruitment system according to the invention for recruiting at least one patient for at least one study, in particular for a clinical study, advantageously for a Phase III clinical study, which, for example, aims to test the therapeutic effect of an active ingredient and, in particular, its approval. Of course, use for recruiting patients for any other, particularly clinical, study is also conceivable.

[0045] The method according to the invention or the patient recruitment system according to the invention should not be limited to the applications and embodiments described above. In particular, the method according to the invention or the patient recruitment system according to the invention can have a number of individual elements and / or components and / or units and / or method steps that differs from the number stated herein in order to fulfill a functionality described herein. In particular, the method according to the invention can include special method steps in which at least one of the above-described features of the patient recruitment system according to the invention or an associated functionality is at least partially implemented.Furthermore, for the value ranges specified in this disclosure, values ​​within the stated limits are also to be considered disclosed and can be used arbitrarily. Unless otherwise stated, it is further conceivable for all described method steps and / or processes to be carried out at least partially and advantageously entirely mechanically and / or automatically, and / or that the patient recruitment system is intended for an at least partially and advantageously entirely mechanically and / or automated execution thereof and / or comprises a corresponding process and / or is intended for its execution. Furthermore, "mechanically" in the context of this disclosure can in particular also include "automated," although non-automated mechanical processes are of course also conceivable. Drawings

[0046] Further advantages will become apparent from the following description of the drawings. The drawings illustrate an exemplary embodiment of the invention. The drawings, the description, and the claims contain numerous features in combination. Those skilled in the art will also expediently consider the features individually and combine them into useful further combinations.

[0047] They show: Fig. 1 shows a healthcare institution with a patient recruitment system in a schematic representation, Fig. 2 shows a schematic flow diagram of a method for patient recruitment, Fig. 3 shows a hierarchical evaluation list in a schematic representation and Fig. 4 shows an input and output device of an input and / or output unit of the patient recruitment system in a schematic representation. Description of the embodiments

[0048] Figure 1shows a healthcare institution 50 with a patient recruitment system 34 in a schematic representation. The healthcare institution 50 can be, for example, a doctor's office, a medical center, or preferably a hospital or the like. The patient recruitment system 34 is intended in the present case to carry out a method for patient recruitment for a clinical study. A schematic flow diagram of the patient recruitment method is shown in the Figure 2 The patient recruitment system 34 and / or the illustrated method for patient recruitment can be used to recruit at least one patient 14 for at least one study, in particular for a clinical study, advantageously for a Phase III clinical study, which, for example, aims to test a therapeutic effect of an active ingredient and, in particular, to obtain its approval.

[0049] The patient recruitment system 34 has at least one patient recruitment server 36. According to the invention, the patient recruitment system 34 further has at least one patient data server 12 and at least one study data server 16. In the present case, the patient data server 12, the study data server 16, and the patient recruitment server 36 are each part of a shared dedicated server 52, which is integrated into an intranet of the healthcare institution 50. In particular, the patient data server 12, the study data server 16, and the patient recruitment server 36 are interconnected and / or arranged in a shared network.However, it is of course conceivable that the patient data server 12, the study data server 16 and / or the patient recruitment server 36 are at least partially separate from one another and / or at least partially outside the healthcare institution 50 and / or its intranet and / or as a cloud or the like.

[0050] In the illustrated case, a patient 14 is in a patient room 54 of the healthcare institution 50. Patient 14 may, for example, be receiving and / or have received inpatient treatment. Clinical staff 30, such as an attending physician, is assigned to patient 14. Clinical staff 30 may, in particular, be composed of several individuals, such as physicians, nurses, and / or physiotherapists, or the like, such as in a shift system or the like.

[0051] In the present case, there are a number of clinical studies that are currently and / or will be conducted directly at the healthcare institution 50. In the present case, study data records for these studies are stored on the study data server 16. Preferably, only study data for studies at the healthcare institution 50 are stored on the study data server 16. However, it is also conceivable that, alternatively or additionally, study data for studies that are currently and / or will be conducted at other locations and / or healthcare institutions are stored. Study data and in particular study data records can, for example, be created by those responsible for the study and / or be and / or have been stored on the study data server 16. The creation of study data can be at least partially automated, for example based on entries in a corresponding input mask.In particular, incomplete study data sets can also be stored and / or stored on the study data server 16.

[0052] In addition, in the present case, a plurality of patient data records exists that are stored on the patient data server 12. Patient data records can be assigned to both former and current and / or future patients. Preferably, a specific patient data record contains at least parts of a treatment history of the respective patient 14, their gender, their age, their medication and / or any other patient data. Patient data can, for example, be based on entries and / or information from patients, from clinical staff, from a health insurance company of a corresponding patient and the like and / or can be and / or have been created at least partially automatically. In particular, incomplete patient data records can also be and / or can be stored on the patient data server 12.

[0053] In addition, in the present case, there are a plurality of recruitment data sets stored on the patient recruitment server 36. A recruitment data set advantageously contains at least one recruitment parameter. In particular, a recruitment data set for a specific study contains information regarding certain characteristics that a patient 14 should and / or must have in order to be suitable for participation in the specific study. For example, the age of subjects, their medication, their gender, their medical history, their weight, and the like can form corresponding recruitment parameters. Recruitment parameters can preferably be entered by a study manager. It is also conceivable for recruitment parameters to be created automatically, in particular based on at least one input.For this purpose, any desired formulation of such parameters is conceivable, for example, as a logical link, as input in a suitable input mask, or the like. Furthermore, an automated formulation of recruitment parameters is conceivable, for example, based on at least one semantic analysis of at least one study description and / or a requirements profile. In principle, even incomplete recruitment data sets can be stored and / or stored on the patient recruitment server 36.

[0054] According to the invention, patient data are generally exchanged in anonymized and / or pseudonymized form between the patient data server 12, the study data server 16 and the patient recruitment server 36.

[0055] The patient recruitment server 36 is provided for executing at least one comparison process for comparing at least one patient parameter of at least one patient 14 with at least one recruitment parameter of at least one study. Furthermore, the patient recruitment server 36 is provided for executing at least one evaluation process for generating at least one suitability parameter of the suitability of the patient 14 for the study depending on the patient parameter and the recruitment parameter. Furthermore, the patient recruitment server 36 is provided for executing at least one assignment process for generating at least one assignment between the study and the patient 14 depending on the suitability parameter.

[0056] As mentioned above, a procedure for patient recruitment for clinical studies is carried out by means of the patient recruitment system 34, the process of which is schematically shown in the Figure 2The depiction of process steps and / or procedures is purely exemplary and is not intended to be exhaustive. Furthermore, any process steps may be repeated and / or performed in a different order than that shown.

[0057] The method for patient recruitment comprises at least one comparison step 10, in which at least one patient parameter of at least one patient 14 stored on the patient data server 12 is automatically compared with at least one recruitment parameter of at least one study stored on the study data server 16. In particular, the comparison step 10 is carried out by means of the comparison process. In addition, the method for patient recruitment comprises at least one evaluation step 18, in which at least one suitability parameter of the suitability of the patient 14 for the study is automatically determined depending on the patient parameter and the recruitment parameter and stored on at least one server 20, in particular on the patient recruitment server 36. In particular, the evaluation step 18 is carried out by means of the evaluation process.In addition, the method for patient recruitment comprises at least one assignment step 22, in which at least one assignment between the patient 14 and the study is carried out depending on the suitability parameter and at least one assignment information is stored on at least one server, in particular on the patient recruitment server 36.

[0058] In the allocation step 22, the study is allocated to patient 14 based on the eligibility parameter. In particular, patient 14 serves as a starting point for the search for suitable studies, which are allocated to the patient if they are eligible.

[0059] In the assignment step 22, several suitable studies are assigned to the patient 14. In particular, a number of suitable studies assigned to several or all of the patients 14 located at the healthcare institution 50 are stored on the patient recruitment server 36. Preferably, information is stored on the patient recruitment server 36 for each patient 14, indicating for which studies, which are conducted in particular at the healthcare institution 50, the patient 14 appears to be fundamentally suitable, at least partially suitable, and / or at least not unsuitable.

[0060] In the present case, in the assignment step 22, an ordered list of suitable studies is assigned to the patient 14, which is stored on at least one server 20, in particular on the patient recruitment server 36. Preferably, an individual ordered list of suitable studies is stored on the patient recruitment server 36 for several or all patients 14 located in the healthcare institution 50. It is conceivable that a corresponding ordered list is created automatically for each patient 14 currently located in the healthcare institution 50, for example, for the first time upon registration and / or admission and / or admission. It is also conceivable that an ordered list of suitable studies is only created upon at least one approval, which is given, for example, by clinical staff 30 and / or by the patient 14 themselves.For example, it would be conceivable that patient 14 would have to agree upon admission that his suitability for studies may in principle be checked by the patient recruitment server 36.

[0061] The ordered list is created automatically according to at least one machine-determined and / or at least one predeterminable criterion, as also stated above in particular. According to the invention, the ordered list is ordered according to a match score of the patient 14 for the studies on the list, with a most suitable list advantageously forming a first or last entry in the list. If necessary, the list can also be ordered according to a date, for example a start date of the corresponding studies, according to a location where the studies are conducted, according to a study duration and / or the like. In particular, it is conceivable for the list to be ordered depending on at least one input from the patient 14 and / or the clinical staff 30. In particular, the patient 14 can have a correspondingly ordered list generated by entering a specific preference.

[0062] In at least one selection step 24, a list of studies to be compared is created. In particular, the list of studies to be compared is created depending on at least one piece of location information assigned to the patient 14 and / or the study. Furthermore, it is conceivable that the list of studies to be compared is created depending on a length of stay and / or a date of stay of the patient 14 and / or a start date and / or a duration of the study or the like. For example, it is conceivable that only studies that are started and / or conducted at the healthcare institution 50 during the patient 14's stay at the healthcare institution 50 are placed on the list of studies to be compared. However, it is also conceivable that studies that are conducted at other healthcare institutions are placed on the list of studies to be compared, for example for the purpose of referring the patient.

[0063] The patient recruitment system 34 has an input and / or output unit 28 that can be connected to the patient recruitment server 36 and is provided for inputting at least one patient parameter. The input and / or output unit 28 is in the Figure 1 shown schematically. In the present case, the input and / or output unit 28 is an input and output unit for inputting information, which can be stored, for example, on the patient recruitment server 36, and for outputting information, for example study data and / or patient data and / or suitability parameters, in particular for the patient 14 and / or for the clinical staff 30. Furthermore, the input and / or output unit 28 is provided for inputting at least one intention to participate, in particular an intention of the patient 14 to participate in the study. Furthermore, the input and / or output unit 28 is provided in the present case for outputting at least one piece of study information.

[0064] The input and / or output unit 28 is intended for installation in the healthcare institution 50. In particular, the input and / or output unit 28 is intended for installation in at least one patient room 54 and / or in at least one doctor's room 42 and / or in at least one waiting room 44.

[0065] In the present case, the input and / or output unit 28 comprises a first input and output device 56. The first input and output device 56 is arranged in the patient room 54. The first input and output device 56 can, for example, be permanently attached and / or installed on a patient bed 112 and / or on a wall and / or on a ceiling of the patient room 54. It is also conceivable for the input and output device 56 to be designed as a portable input and output device, for example in the manner of a portable computer, a tablet PC, headphones, data glasses, or the like. The patient 14 can use the first input and output device 56 to obtain information about studies currently underway at the healthcare institution 50, in particular studies from the list of suitable studies assigned to him or her. The input and / or output unit 28 comprises at least one display 46 arranged in the patient room 54.In the present case, the first input and output device 56 comprises the display 46. The display 46 can be configured as a touch display. In particular, the display 46 is provided for inputting and / or outputting information, in particular study data and / or eligibility data and / or patient data.

[0066] Furthermore, in the present case, the input and / or output unit 28 comprises a second input and output device 58, which is assigned to the clinical staff 30. The second input and output device 58 can differ in terms of functionality and / or design and / or actions that can be carried out with it, or it can also be identical. In the present case, the second input and output device 58 is designed, for example, in the manner of a tablet PC or an electronic paper or the like and can advantageously be used by the clinical staff 30 at different locations, for example during a round. In this case, it is particularly conceivable for the second input and output device 58 to have at least one sensor provided for the automated detection of a room number and / or for the recognition of patients 14.In particular, it is conceivable that information is provided to the clinical staff 30 depending on a detection of the sensor, for example, upon entering the patient room 54 of the patient 14, the list of suitable studies assigned to the patient 14.

[0067] Furthermore, the input and / or output unit 28 in the present case comprises a third input and output device 60. The third input and output device 60 can be arranged, for example, in a doctor's office 42 of the healthcare institution 50. In the present case, the third input and output device 60 is designed as a permanently installed touch display, via which study data and / or patient data and / or ordered lists of suitable studies for different patients 14 can be retrieved. In particular, it is conceivable that the third input and output device 60 is intended to output at least one notification, in particular without being prompted, for example, if a patient 14 has been admitted to the healthcare institution 50 who has a high match score with a specific study.

[0068] In addition, the input and / or output unit 28 in the present case comprises a fourth input and output device 62. The fourth input and output device 62 can be arranged, for example, in a waiting room 44. The fourth input and output device 62 can be provided to display study data to a patient 14, for example, during a waiting period, in particular upon registration of the patient 14, which allows retrieval of their patient data record from the patient data server 12.

[0069] It is also conceivable that the input and / or output unit 28 comprises at least one mobile device 48. In the present case, the input and / or output unit 28 comprises at least one mobile device 48 of the clinical staff 30, for example a work smartphone. The mobile device 48 advantageously forms at least one input and output device of the input and / or output unit 28. The mobile device 48 can, for example, be provided for executing at least one program, in particular an app, which enables integration into the patient recruitment system 34. For example, the mobile device 48 can also be a tablet PC, a smartwatch, a smart cloth, a smartband, any other wearable, a computer, or the like. It is also conceivable that the mobile device 48 is a mobile device of the patient 14.

[0070] In the following we will again refer to the Figure 2In at least one output step 26, at least one piece of study information is output by means of at least one input and / or output unit 28. The study information is displayed, for example, to the patient 14. Alternatively or additionally, it is conceivable that the study information is displayed to the clinical staff 30. Preferably, the study information is generated based on at least one study data record stored on the study data server 16, for example, using a study description and / or contact information and / or location information and / or a study duration or the like. It is conceivable that different study information is output to the patient 14 than to the clinical staff 30.In particular, the study information for patient 14 is prepared in a patient-friendly manner, for example with regard to language and / or detail and / or the use of further background information which, for example, patient 14 requires, but which, for clinical staff 30, represents general specialist knowledge.

[0071] In addition, in at least one method step 64, at least one participation intention parameter of the patient 14 is entered by means of the input and / or output unit 28 and stored on at least one server, in particular on the patient recruitment server 36. In particular, the participation intention parameter is a participation intention parameter assigned to the study. The participation intention parameter can, for example, assume the values ​​"participation intended" or "participation not intended." It is also conceivable that the participation intention parameter indicates that the patient 14 is fundamentally interested in the study but, for example, desires additional information, in particular provided by a study coordinator and / or clinical staff 30, and / or would like to be reminded of the study again, for example, to be given time to consider the study.It is conceivable that, after entering the intention to participate parameter, the patient 14 can be shown the ordered list of suitable studies supplemented by the intention to participate information, so that the patient 14 can obtain information about which studies he intends to participate in from a display.

[0072] Furthermore, at least one output parameter for the output of the study information is adapted, in particular in the output step 26, depending on at least one patient characteristic, in particular on at least one patient parameter.

[0073] For example, it is conceivable that patient 14 can adjust the type and / or scope of information displayed by means of inputs made, in particular, using the first input and output device 56 assigned to them. For example, it is conceivable that patient 14 is initially shown the ordered list of suitable studies and can then retrieve more detailed study information on individual studies, for example by tapping and / or clicking or selecting. Furthermore, it is conceivable that different study information, for example for different target groups, is stored for a specific study.It is then conceivable that a type and / or extent of a presentation of study information and / or wording and / or additional external links or the like is adapted depending on one or more patient parameters, in particular automatically, preferably independently of a patient input, for example depending on their native language and / or gender and / or age and / or any visual impairment or the like.

[0074] In addition, at least one piece of contact information relating to the study can be provided to the patient 14. For example, a name and / or a telephone number and / or a location of a study coordinator can be displayed. It is further conceivable that the input and / or output unit 28 is provided to provide at least one communication channel, for example, a telephone line and / or a video call line and / or a text message channel or the like, which is preferably provided for the patient 14 to contact a study coordinator.

[0075] In particular, in the evaluation step 18, at least one hierarchical evaluation list with several evaluation criteria is created automatically based on several recruitment parameters of the study, on the basis of which the suitability parameter is determined. The evaluation list can also be created, in particular as a whole, in advance, in particular automatically, and advantageously stored on the patient recruitment server 36 and / or on the study data server 16. It is conceivable that the evaluation list is created at least partially automatically using at least one semantic analysis of at least one textual description, in particular a study description. It is also conceivable that the input and / or output unit 28 is provided for input and / or support, in particular of a study manager, in the creation of the evaluation list.

[0076] The Figure 3shows a schematic representation of an exemplary evaluation list 66 of an exemplary study. The exemplary evaluation list 66 is based on a specific study protocol.

[0077] The exemplary evaluation list 66 includes several evaluation criteria 68, 70, 72 that could potentially lead to the inclusion of a patient 14. In the present case, the first evaluation criterion 68 is a diagnostic criterion. According to the study protocol, for a patient 14 who could potentially be eligible for the study, one of two possible diagnostic criteria 76, 78 should be met, i.e., one of two possible diagnoses should be present. In the present case, for example, patient 14 meets the first diagnosis. The first evaluation criterion is therefore assigned a partial match score of 84 out of 1.

[0078] A second assessment criterion 70 in the present case is medication. Patient 14 partially fulfills this criterion in the present case, for example, because he or she is taking a medication similar to one required by the second assessment criterion 70. Therefore, the second assessment criterion 70 is assigned a partial match score 86, for example, of 0.66.

[0079] For example, a third evaluation criterion 72 in this case is a demographic criterion. According to the study protocol, a patient 14 who could potentially be eligible for the study should meet one of two possible demographic criteria 80, 82. For example, a patient 14 should be female and older than 50 years, or male and older than 65 years. In this case, for example, the patient is male and 68 years old. The third evaluation criterion 72 is therefore assigned a partial match score of 88 out of 1.

[0080] In addition, the evaluation list 66 in the present case includes a fourth evaluation criterion 74, which can potentially lead to the exclusion of a patient 14. The fourth evaluation criterion 74 is an exclusion criterion in the present case. In the present case, the fourth evaluation criterion 74 leads, for example, to the exclusion of a patient 14 if they are already participating in another study. In the present case, for example, patient 14 is not currently participating in any other study. The fourth evaluation criterion 74 is therefore assigned a value of 90 out of 0. It is conceivable that fulfillment of an exclusion criterion leads to the exclusion of a patient 14, regardless of the assessment of other evaluation criteria.

[0081] In the case of the exemplary evaluation list 66, the evaluation criteria 68, 70, 72, 74 are each assigned a weighting parameter. For the first, second, and third evaluation criteria 68, 70, 72, the weighting factor in this case is 1. For this reason in particular, the overall match score is calculated as an arithmetic mean. For different weighting parameters, for example, a weighted mean could be calculated. It is also conceivable for the weighting parameters to specify a hierarchical evaluation, so that, for example, certain partial match scores are disregarded for the overall evaluation if other partial match scores are within certain ranges, for example, if they fall below and / or exceed certain thresholds.Furthermore, in the present case, a weighting parameter is assigned to the fourth evaluation criterion 74 in such a way that an overall match score of 0 is enforced if the fourth evaluation criterion 74 is met, i.e., if patient 14 is already participating in another study. Accordingly, weighting parameters can, for example, in particular, contain discrete and / or continuous functions and / or calculation rules and / or numerical values ​​and / or categorizations and the like.

[0082] In the present case, a total match score of 91 for patient 14 is determined for the exemplary study, for example, as the arithmetic mean of partial match scores, provided no exclusion criteria are met. In the present case, the total match score for patient 14 is therefore determined to be 0.89, for example. The total match score of 91 and the corresponding assignment between patient 14 and the exemplary study are stored on the patient recruitment server 36.

[0083] Of course, any other evaluation lists are conceivable, including a different number of criteria and / or hierarchy levels, etc. Furthermore, instead of an arithmetic mean, it is conceivable that evaluation criteria are weighted differently.

[0084] In particular, analogous to the case of the exemplary study, the list of suitable studies and associated suitability parameters are determined and stored on the patient recruitment server 36. As mentioned above, this list can be made available to the patient 14 by means of the input and / or output unit 28, in particular by means of the first input and output device 56 assigned to the patient 14. The Figure 4shows a schematic representation of the first input and output device 56. The input and output device 56 has the display 46. In addition, the input and output device 56 has a computing unit 92 and an internal memory 93. Furthermore, the input and output device 56 has an interface 94 for connection to a network, in particular for connection to the patient recruitment server 36. Furthermore, the input and output device 56 has an input unit 96, which comprises, for example, a plurality of buttons. It is also conceivable for the input unit 96 to comprise a mouse and / or a keyboard. Furthermore, it is conceivable for the input unit 96 to be formed at least partially by the display 46, for example, if this is designed as a touch display.

[0085] In at least one operating state of the input and output device 56, the patient 14 is shown information on at least some of the studies in the list of suitable studies, for example, the studies with the highest match scores. In the illustrated case, which is of course to be understood purely as an example, for four exemplary studies 98, 100, 102, 104, for example, a study title (column 106), a match score (column 108), and contact information (column 110) are displayed. For example, by clicking or tapping a corresponding row in a displayed list, the patient 14 can retrieve further study information and / or enter an intention to participate and / or request further information, for example, from the clinical staff 30 and / or from a study coordinator. Of course, any other representations and / or types of information provision are conceivable.

[0086] In the following we will again refer to the Figures 1 and 2Reference is made here. In the present case, at least one list of evaluation criteria is created, for example in the comparison step 10 and / or in the evaluation step 18 and / or at another suitable time, which require at least one input from at least one clinical staff member 30. This list of evaluation criteria includes, in particular, evaluation criteria that cannot be evaluated automatically, for example due to the absence of corresponding patient parameters and / or due to the need to input a medical assessment or the like. Preferably, the clinical staff 30 is prompted to enter corresponding information, for example by means of the second input and output device 58.Advantageously, corresponding inputs from clinical staff 30 are used for machine processing of at least the affected evaluation criteria and / or stored on the patient data server 12 and / or the study data server 16 and / or the patient recruitment server 36.

[0087] Furthermore, in at least one input step 32, at least one further patient parameter is queried and / or entered using the input and / or output unit 28. This can be a patient parameter that is required according to the described list of evaluation criteria. The further patient parameter is advantageously queried and / or entered by the patient 14. For example, the patient 14 can be requested to complete their patient data record. In particular, in the input step, personal data and / or health data and / or preferences of the patient 14 or the like are entered by the patient 14 and advantageously used to supplement a patient data record assigned to the patient 14.

[0088] In addition, for example in the output step 26, at least one item of suitability information about the patient 14 is made available to the clinical staff 30 assigned to the patient 14 by means of the input and / or output unit 28. For example, the suitability information can be output by means of the second input and output device 58 and / or by means of the third input and output device 60. For example, the list of suitable studies can be displayed to the clinical staff 30. In particular, the clinical staff 30 is enabled to draw the patient 14's attention to their suitability for a specific study, if necessary. In principle, it is conceivable that the clinical staff 30, analogous to the patient 14, can query study data and / or enter information by means of the input and / or output unit 28.

[0089] In the present case, at least one patient parameter is also automatically recorded and processed mechanically by means of at least one sensor unit 35, for example in the input step 32. As mentioned above, any sensors are conceivable here, which are mounted, for example, in the patient room 54 and / or on a patient bed 112. In particular, these can be existing sensors from medical monitoring devices that can be integrated, for example, into a network of the patient data server 12. In the present case, the first input and output device 56 assigned to the patient 14 has the sensor unit 35. In the present case, the sensor unit 35 comprises a digital video camera. Images and videos can be recorded by means of the sensor unit 35, which can then be used, for example, for image analysis.Using the sensor unit 35, for example, images of patient 14's medication packaging can be captured. Based on an image analysis of these images, a list of patient 14's medications is then created, which the patient is then shown, for example, for checking for accuracy and / or supplementing. For example, after a specific medication has been identified, it can be queried since when and / or how often the patient 14 has been taking said medication.

[0090] In addition, at least one output parameter for outputting at least one piece of study information can be adjusted depending on the patient parameter detected by the sensor unit 35. In the present case, for example, the patient's 14 familiarity with certain clinical pictures is automatically determined based on the medication determined. Furthermore, the level of detail of study descriptions is adjusted depending on the estimated familiarity of the patient 14 with certain clinical pictures, for example, to provide the patient 14 with additional information on studies that might be of interest to them based on their personal medical history and encourage them to participate. As mentioned above, any further adjustments to output parameters are conceivable.For example, a gender and / or an age and / or a behavioral parameter and / or an attention level of the patient 14 or the like can be determined based on at least one sensor detection and an output parameter can be adjusted accordingly.

Claims

1. Method for recruiting patients for a study, in particular for at least one clinical study, wherein at least one matching step (10) involves at least one patient parameter of at least one patient (14), stored on a patient data server (12), being matched, in a computerized manner, with at least one recruitment parameter of at least one study, stored on a study data server (16), wherein at least one rating step (18) involves at least one suitability parameter, realized as a match score, of a suitability of the patient (14) for the study being determined, in a computerized manner, as a function of the patient parameter and the recruitment parameter and stored on at least one server (20), in particular a patient recruitment server (36), wherein the match score is correlated with a quality of a match between the patient (14) and the study, wherein at least one selection step (24) involves a list of studies to be matched being produced, wherein the list of studies to be matched is worked through in order to produce an ordered list of suitable studies and preferably to associate said list with the patient (14), wherein in at least one association step (22) at least an association between the patient (14) and the study is made as a function of the suitability parameter, and at least one piece of association information is stored on at least one server (20), in particular the patient recruitment server (36), wherein the association step (22) involves a plurality of suitable studies being associated with the patient (14) as a function of respectively corresponding suitability parameters, wherein the association step (22) involves an ordered list of the suitable studies being associated with the patient (14), said list being ordered with regard to the respective suitability parameters and stored on the server (20), in particular the patient recruitment server (36), wherein studies in which the match score exceeds or goes below a certain limit value are associated with the patient (14), wherein the ordered list is organized in a computerized manner according to the match score for the patient (14) that was determined in a computerized manner, wherein patient data are in principle exchanged between the patient data server (12), the study data server (16) and the patient recruitment server (36) in anonymized and / or pseudonymized form, wherein at least one output step (26) involves study information of the studies from the ordered list, for which the patient (14) is at least partially suitable, being outputted in ordered form by means of at least one input and / or output unit (28), the input and / or output unit (28) comprising a display (46) that is arranged in a patient room (54) of a healthcare institution, wherein the selection step (24), the matching step (10) and the association step (22) are performed repeatedly in automated fashion at specific time intervals and / or after additional patient parameters have been inputted, such that the list of studies to be matched is repeatedly updated in real time, and / or repeatedly worked through in real time, wherein by means of a sensor unit (35) intended for this purpose, at least one uniqueness feature of a patient is recognized and / or a feature that is not necessarily unique but is associated with the patient, such as for example a body weight, a sex, an estimated age, an eye color and / or the like, is compared with stored and / or with current detections of the sensor unit (35) in order to identify the patient, and wherein the display (46) and / or or another output means of the input and / or output unit (28) is at least temporarily deactivated and / or blocked if a different patient, other than the patient, and / or no patient is detected.

2. Method according to claim 1, characterized in that the selection step (24) involves the list of studies to be matched being produced as a function of at least one piece of location information associated with the patient (14) and / or with the study.

3. Method according to claim 1 or 2, characterized in that by means of the input and / or output unit (28) at least one participation intention parameter of the patient (14) and is inputted and is stored on at least one server (20), in particular the patient recruitment server (36).

4. Method according to one of the preceding claims, characterized in that at least one hierarchic rating list (66) containing a plurality of rating criteria is produced in a computerized manner using a plurality of recruitment parameters of the study, on the basis of which rating list (66) the suitability parameter is determined, wherein preferably respectively at least one weighting parameter is associated with each of the rating criteria.

5. Method according to one of the preceding claims, characterized in that at least one piece of contact information pertaining to the study is provided for the patient (14).

6. Method according to one of the preceding claims, characterized in that at least one input step (32) involves at least one input and / or output unit (28) being used to query and / or input at least one further patient parameter.

7. Method according to one of the preceding claims, characterized in that at least one input and / or output unit (28) is used to make available at least one piece of suitability information of the patient (14) to clinical personnel (30) that is associated with the patient (14).

8. Patient recruitment system (34) for recruiting patients (14) for clinical studies, which is specifically designed to perform a method according to claim 1, wherein the patient recruitment system (34) has a patient recruitment server (36), a patient data server (12) and a study data server (16), wherein an input and / or output unit (28) is part of the patient recruitment system (34), wherein the input and / or output unit (28) comprises at least one display (46), which is arranged in a patient room (54) of a healthcare institution (50), and wherein the patient recruitment system (34) comprises a sensor unit (35).