Method for comparing implants or prostheses

Abstract

Method for comparing implants or prostheses. Method for comparing implants or prostheses, and / or surgical contexts, from a population of individuals each carrying an implant or prosthesis, the method comprising: A) for each individual: - information on the type of implants or prostheses, and / or at least one parameter of the surgical context of placement of the implant or prosthesis; - acquisition of clinical parameters; and - determination of a score (GS) quantifying a benefit provided to the individual by the intervention; B) classification of individuals so as to obtain at least two risk profile categories indicative of a ratio between a benefit provided and the risk incurred; C) for each category, calculation of a reference GS, the reference GS being a quantile of the GSs of the individuals in the category; after step C), comparison, within each category, of the types of implants or prostheses and / or surgical contexts according to the GS.Figure for the abridged version: Fig. 1.

Description

Title of the invention: Method for comparing implants or prostheses technical field

[0001] The present invention relates to methods for comparing the benefit provided by a medical device such as an implant, for example an intraocular implant in ophthalmology, a hip prosthesis in orthopedics, a hearing aid in audiology, a dental prosthesis in dentistry, or a stent in cardiology, to an individual, and more generally for comparing surgical contexts. The invention also relates to devices for implementing these methods. Previous technique

[0002] Evaluating a medical intervention requires taking into account numerous factors. It is not easy to compare the real-world clinical benefits of medical devices across different care pathways and patient profiles. Indeed, each medical intervention depends on the practitioner performing it, their experience, the setting in which it is carried out, the tools at their disposal, but also on the patient, their physical condition, medical history, lifestyle, and comorbidities.

[0003] Moreover, in general, any medical procedure systematically entails risks, however minimal, for the patient. However, a medical procedure does not always produce the expected results for the patient, even if the procedure is considered successful from a medical standpoint. In particular, since each patient is different, the results of a medical or surgical procedure performed by a practitioner vary from one patient to another depending on the practices and health products used, but above all, depending on the patient's individual profile.

[0004] Finally, it is currently not uncommon to perform certain medical interventions almost systematically, generally as a precaution or for the practitioner's convenience, without any real necessity. Indeed, the World Health Organization and the Organisation for Economic Co-operation and Development indicate that approximately 30% of medical procedures are not appropriate, meaning they provide no clinical benefit to the patient; in other words, they represent wasted care that can generate avoidable medical complications for the patient and avoidable healthcare costs for healthcare systems.

[0005] Furthermore, the comparison of real-life results differs significantly from the results of randomized controlled clinical trials published in the literature scientific, because real life involves contingencies that clinical trial protocols control, with the interaction of numerous exogenous factors such as patient compliance, adherence to best practices by the practitioner, etc. It is commonly observed that the results of clinical studies are not necessarily transposed to real-life outcomes due to its heterogeneity, for example in terms of the conditions of use of health products, but also in the behaviors of patients and caregivers.

[0006] Consequently, there is a need to compare medical interventions, particularly for comparing the implantation of implants or prostheses, for example, intraocular implants for cataracts, orthopedic prostheses for hip or knee osteoarthritis, hearing aids for the hearing impaired, or stents for patients with coronary artery disease, and especially for comparing different types of implants or prostheses. There is also an interest in limiting medical interventions that prove unnecessary for patients. Finally, there is an ongoing need to assist practitioners in planning medical interventions. Description of the invention

[0007] The invention aims to meet all or part of these needs and achieves this, according to one of its aspects, through a method of comparing implants or prostheses, and / or operative contexts for placing the implant or prosthesis, from a population of individuals each wearing an implant, for example an intraocular implant, an orthopedic prosthesis, a hearing aid, or a stent, the comparison method comprising the following steps:

[0008] A) for each individual in the population of individuals: - information on the type of implants or prostheses, and / or at least one parameter of the operative context for the placement of the implant or prosthesis; - acquisition of clinical parameters; and - determination of a "health gain" (GS) score quantifying a benefit provided to the individual by the medical intervention;

[0009] B) classification of individuals in the population of individuals so as to obtain at least two risk profile categories indicative of a ratio between a benefit provided by a medical intervention and the risk incurred by the implementation of a medical intervention, the classification grouping individuals according to their health gain and their clinical parameters, in particular according to clinical parameters having a negative impact on the health gain, the classification being carried out in particular by means of a statistical regression, in particular a multivariate linear regression;

[0010] C) for each risk profile category, calculation of a reference health gain, the reference health gain being a quantile, in particular the mean or the median, or a measure proportional to the minimum clinically important difference (“MCID”) of health gains of individuals in the category, or any combination thereof;

[0011] the method comprising, after step C), the comparison, preferably within each category of risk profiles, of the types of implants or prostheses and / or operative contexts according to the health gains.

[0012] By medical intervention, we must understand the surgical administration of the implant when considering an implant or the placement of a prosthesis when considering a prosthesis.

[0013] The health gain can be used to quantify the improvement in the patient's quality of life generated by the medical intervention.

[0014] Alternatively or additionally, the comparison can be made by considering the population of individuals as a whole.

[0015] A method according to the invention advantageously allows for the rapid, precise, and simple comparison of medical interventions, that is, for ranking the health gain scores associated with these medical interventions, and in particular with the types of implants or prostheses, within a statistically homogeneous group of individuals. Specifically, for a given category, it is possible to compare implants against the reference health gain, and thus determine whether the medical intervention is advantageous for an individual compared to individuals with the same profile. It is easy to determine which type of implant or prosthesis is most effective for a given category.

[0016] It is also possible to determine, based on a calculated health gain, whether an implant is relevant for individuals in a category. For example, if, for a given type of implant, all patients in the category with that type of implant have a health gain lower than the reference health gain for the category, then the type of implant is not suitable for individuals in that category.

[0017] The comparison after step C) may include an ordering of implant types, respectively of prostheses, and / or operative settings, in particular of implant types, respectively of prostheses, and operative settings, according to the health gain, for each of the categories considered separately.

[0018] The comparison can be presented by being displayed on a screen or printed on a medium.

[0019] A comparison method according to the invention may include the following steps, after step C):

[0020] D) for each risk profile category, determination of a weighting coefficient and then calculation of an adjusted reference health gain equal to the product of the weighting coefficient and the reference health gain,

[0021] the weighting coefficients being chosen so as to obtain a set of adjusted reference health gains that are substantially equal to each other;

[0022] E) for each individual in the population of individuals, adjustment of the health gain, determined in step A), by multiplying the health gain by the weighting coefficient determined for the category to which the individual belongs, so as to obtain a set of weighted health gains;

[0023] F) comparison of implant or prosthesis types, and / or operative contexts by comparing adjusted health gains.

[0024] Thus, in a particular embodiment of the invention, the method for comparing implants or prostheses, and / or surgical contexts for placing the implant or prosthesis, comprises the following steps:

[0025] A) for each individual in the population of individuals:

[0026] - information on the type of implants or prostheses, and / or at least one parameter of the operative context of the placement of the implant or prosthesis;

[0027] - acquisition of clinical parameters; and

[0028] - determination of a health gain score quantifying a benefit brought to the individual through medical intervention;

[0029] B) classification of individuals in the population of individuals so as to obtain at least two risk profile categories indicative of a ratio between a benefit provided by a medical intervention and the risk incurred by the implementation of a medical intervention, the classification grouping individuals according to their health gain and their clinical parameters, in particular according to clinical parameters having a negative impact on the health gain, the classification being carried out in particular by means of a statistical regression, in particular a multivariate linear regression;

[0030] C) for each risk profile category, calculation of a reference health gain, the reference health gain being a quantile, in particular the mean or the median, or a measure proportional to the minimum clinically important difference (“MCID”) of health gains of individuals in the category, or any combination thereof;

[0031] D) for each risk profile category, determination of a weighting coefficient and then calculation of an adjusted reference health gain equal to the product of the weighting coefficient by the reference health gain, the weighting coefficients being chosen so as to obtain a set of adjusted reference health gains substantially equal to each other;

[0032] E) for each individual in the population of individuals, adjustment of the health gain, determined in step A), by multiplying the health gain by the weighting coefficient determined for the category to which the individual belongs, so as to obtain a set of weighted health gains;

[0033] F) comparison of implant or prosthesis types, and / or operative contexts by comparing adjusted health gains.

[0034] In particular, the operative context may include the name of a practitioner, the length of the practitioner's experience, their training, the operative technique, the hospital or clinic where the medical intervention takes place or the department or municipality where the medical intervention takes place, in particular specifying whether the medical intervention takes place in a medical desert or not, one or more medical devices used during the intervention (other than the implant itself or the prosthesis itself).

[0035] The method of comparing implants or prostheses makes it possible in particular to compare the benefits provided by different types of implants or prostheses respectively, regardless of the category considered.

[0036] The comparison method according to the invention advantageously allows, depending on patient profiles, the determination of the types of implants, or prostheses, which optimize the quality of life of patients in their daily activities.

[0037] The comparison process allows, according to another of its aspects, the identification of the most relevant operational contexts.

[0038] Two implants of the same type are identical implants or possibly differ in size, being adapted for example to people with larger or smaller eyes.

[0039] Two prostheses of the same type are identical prostheses or possibly differ in size, being adapted for example to people of greater or lesser heights.

[0040] The type of implant, or prosthesis, can be characterized by its shape, its properties, the materials used, its mode of action or administration.

[0041] Preferably, the implants are cataract treatment implants.

[0042] The prostheses may be hearing aids, orthopedic prostheses, breast prostheses, or dental prostheses. Preferably, the prostheses are hip and knee prostheses.

[0043] In step A), for each individual in the population of individuals, the health gain can be determined by comparing an indicator representative of a pre-intervention state of the individual with an indicator representative of a post-intervention state of the individual.

[0044] Pre-intervention and / or post-intervention indicators, preferably pre-intervention and post-intervention indicators, may be measures of the outcome of the intervention reported by the patient expressed in terms of quality of life or functional score, known as "PROM" indicators ("Patient-reported outcomes measures") or measures of the patient's experience of the intervention expressed for example in terms of relational quality with the caregiver (or PREM, "Patient-reported experience measures").

[0045] Preferably, the pre-intervention and post-intervention indicator(s) are determined by means of at least one questionnaire, in particular completed by the individual.

[0046] The questionnaire may be a generic questionnaire. It may include questions relating to: the individual's quality of life, the impact of a pathology on the individual's life, a part of the body, pain, a state of health, the family context, satisfaction with care received, satisfaction with information received, and / or the surgical experience experienced.

[0047] The questionnaire can advantageously be completed remotely by each individual, for example via a digital interface, and then stored in a database.

[0048] From the questionnaire containing several questions, a single pre-intervention, or post-intervention, indicator can be calculated.

[0049] The answers to the questions can be analyzed using psychometric analysis, in particular Rasch analysis. Advantageously, the answers to the questions are thus normalized.

[0050] In a particular embodiment, the answers to the questions can be validated, for example by a medical assistant or a practitioner.

[0051] The pre-intervention indicator and the post-intervention indicator can be a percentage, a figure or a number, for example between 0 and 100.

[0052] The health gain can be the difference between the post-intervention indicator and the pre-intervention indicator. The health gain can be a percentage, a figure, or a number, for example, between -100 and 100.

[0053] The health gain of each individual can be stored in a database, preferably after anonymization.

[0054] The acquisition of clinical parameters can be carried out by a medical assistant, a practitioner, by the individual or by searching in a medical record, for example stored in a general database of a hospital or clinic.

[0055] Clinical parameters may be chosen from: age, sex, presence of chronic diseases, diabetes, allergies, comorbidities, in particular ocular comorbidities, the degree of severity of these comorbidities, the number of previous medical interventions, the nature of previous medical interventions, For example, previous ophthalmic interventions. Clinical parameters may also include socio-demographic parameters.

[0056] In step B), the classification can be implemented by any known classification algorithm. The algorithm takes as input at least the health gains and the clinical parameters, and provides as output at least two risk profile categories, or better yet, at least three risk profile categories.

[0057] In a particular case, the algorithm provides exactly three risk profile categories as output: a first category comprising individuals with a severe risk profile, a second category comprising individuals with an intermediate risk profile and a third category comprising individuals with a low risk profile.

[0058] The objective of this classification is to determine categories distinguishing individuals based on the ratio between the benefit conferred on the individual by a medical intervention and the clinical risk incurred. In other words, the purpose of this classification is to identify the profiles for which the benefit conferred by the medical intervention is greater than the risk incurred by the intervention.

[0059] The algorithm may be a moving center (or "k-means") algorithm, decision tree, principal component analysis, nearest neighbors method.

[0060] Preferably, it is carried out using statistical regression.

[0061] The classification can be carried out using multivariate linear regression, the explanatory variables of the regression being all or part of the clinical parameters.

[0062] In parallel with the classification, in step B) a feature selection algorithm can be implemented, identifying clinical parameters having a negative impact on health gain and / or clinical parameters having a positive impact on health gain.

[0063] In step D), the weighting coefficients are chosen such that:

[0064] [Math.l] Old 1. -NI, V k ejl, Nli, k^i, cfGS^fj= ck* GSref,k+ £ GSajust^ GSajust^ k + £

[0065] GSæfj, being the reference health gain of category i, GSajUSté>i being the adjusted health gain of category i, N being the number of categories determined in step B), Ci being the weighting coefficient of category i, e being less than 10% of the maximum of the reference health gains, better less than 5% of the maximum of the reference health gains, better less than 2% of the maximum of the reference health gains, better less than 1% of the maximum of the reference health gains, better still better e is zero.

[0066] In step F), the comparison can be made by comparing the health gains adjusted according to clinical parameters having a negative impact on the health gain.

[0067] Alternatively or additionally, the comparison can be made by comparing health gains adjusted for clinical parameters having a positive impact on health gain.

[0068] The comparison may include an ordering of implant types, respectively of prostheses, and / or operative settings, in particular of implant types, respectively of prostheses, and operative settings, according to the adjusted health gain.

[0069] The comparison can be presented by being displayed on a screen or printed on a medium.

[0070] The invention makes it possible to compare medical interventions carried out independently of individuals and of the characteristics specific to each individual and to each intervention, in particular to each practitioner.

[0071] Determining the adjusted health gain makes it advantageous to compare quickly, simply and precisely the types of implants or prostheses and / or surgical contexts using a single criterion.

[0072] The invention makes it possible to revalue complex but necessary interventions, compared to unnecessary routine interventions which would initially present a health gain similar to the health gain resulting from the complex medical intervention, and thus avoid the performance of irrelevant interventions.

[0073] The invention also relates to a method for assisting in the selection of a type of implant or prosthesis, and / or an operative context, for planning a medical intervention for a patient, the selection assistance method comprising the following steps: 1) providing results of a comparison of types of implants or prostheses for a given category of individual, and / or of operative contexts for the placement of these implants, respectively prostheses, preferably the results being obtained from a comparison process according to the invention; 2) thresholding of the results from step 1) so as to select the type(s) of implant(s), respectively prosthesis(es), and / or the surgical context(s) for which the health gains are greater than a predetermined threshold value.

[0074] In step 2), several types of implants, or prostheses, can be selected. It is also possible that no type of implant, or prosthesis, is selected. When no type of implant, or prosthesis, is selected, the appropriateness of the medical intervention may be called into question.

[0075] Similarly, when the method relates to an aid in the selection of operating contexts, in step 2), several operating contexts can be selected or no operating context can be selected.

[0076] The selection aid method may include, before step 2), the entry of at least one clinical parameter of the patient, step 1) resulting from the implementation of a comparison method according to the invention, step 2) comprising the following steps:

[0077] 2.1) selection of the risk profile category based on at least one patient clinical parameter; then, 2.2) thresholding of health gains of the category selected in step 2.1), by selecting from the types of implants or types of prostheses, and / or operative settings, the types of implants and / or operative settings, respectively the types of prostheses and / or operative settings, associated with a health gain greater than a predetermined threshold value.

[0078] The selection aid method can in particular be used to select a type of intraocular lens implant for a particular cataract treatment implantation for a patient. In this particular case, in step 1), a method for comparing the benefit conferred to an individual by a type of intraocular lens implant is implemented, and in step 2) the results are thresholded so as to select the types of intraocular lenses for which the health gains are greater than the predetermined threshold value, step 2) possibly comprising 2.1) the selection of a risk profile category for which the clinical parameters of the individuals correspond to a clinical parameter entered for the patient, and then 2.2) the thresholding of the health gains by selecting from among the types of intraocular lenses in the category selected in step 2.1), the types of lenses associated with a health gain greater than the predetermined threshold value.

[0079] A selection aid method can also be used to select a type of prosthesis, for example for a hip prosthesis.

[0080] The invention further relates to a method for manufacturing an implant or a prosthesis, comprising the implementation of a method for assisting in the selection of a type of implant or prosthesis so as to select at least one type of implant or prosthesis, and then the manufacture of an implant or prosthesis of the same type as the one which has been selected, in particular identical.

[0081] When several types of implants, or prostheses, are selected during the implementation of the selection aid process, the type of implant, or prosthesis, manufactured may be that corresponding to the type of implant, or prosthesis, selected having the highest health gain.

[0082] Alternatively, when several types of implants, or prostheses, are selected during the implementation of the selection aid process, the practitioner chooses the type of implants, or prostheses, to be manufactured for the intervention.

[0083] Preferably, the results of step 1) of a selection aid method according to the invention include the implementation of a comparison method according to the invention comprising steps A) to F), step 2) comprising: 2) thresholding of the results from step 1) so as to select the type(s) of implant(s), respectively prosthesis(es), and / or the surgical context(s) for which the adjusted health gains are greater than a predetermined threshold value.

[0084] In step 2), several types of implants, or prostheses, can be selected. It is also possible that no type of implant, or prosthesis, is selected. When no type of implant, or prosthesis, is selected, the appropriateness of the medical intervention may be called into question.

[0085] Similarly, when the method relates to an aid in the selection of operating contexts, in step 2), several operating contexts can be selected or no operating context can be selected.

[0086] The predetermined threshold value can be determined by a practitioner. It can be chosen in agreement with the patient. A minimum threshold value may be imposed by the practitioner's hospital or clinic.

[0087] In step 2), the threshold value can be defined so that the thresholding will select the health gains for which the post-intervention indicator is at least 10% greater than the pre-intervention indicator, better at least 20% greater than the pre-intervention indicator, even better at least 30% greater than the pre-intervention indicator.

[0088] In a particular embodiment, the threshold value is calculated based on parameters of the patient for whom an intervention is planned.

[0089] The selection aid method may include, before step 2), the entry of at least one clinical parameter of the patient, step 1) resulting from the implementation of a comparison method according to the invention, step 2) comprising the following steps:

[0090] 2.1) pre-selection of implant or prosthesis types, and / or surgical contexts, for which the clinical parameters of the individuals in the population of individuals correspond to the clinical parameter entered for the patient; then, 2.2) thresholding of adjusted health gains, by selecting from the types of implants or prosthetic types, and / or operative settings, pre-selected in step 2.1), the types of implants and / or operative settings, respectively the types of prostheses and / or operative settings, associated with an adjusted health gain greater than a predetermined threshold value.

[0091] The selection aid method can in particular be used to select a type of intraocular implant for a particular treatment implantation of cataract for a patient. In this particular case, in step 1), a method for comparing the benefit provided to an individual by a type of intraocular implant is implemented, and in step 2) the results are thresholded so as to select the types of intraocular implants for which the adjusted health gains are greater than the predetermined threshold value, step 2) may include 2.1) the pre-selection of intraocular implants for which the clinical parameters of the individuals correspond to a clinical parameter entered for the patient, then 2.2) the thresholding of the adjusted health gains by selecting from among the types of intraocular implants pre-selected in step 2.1), the types of implants associated with an adjusted health gain greater than the predetermined threshold value.

[0092] A selection aid method can also be used to select a type of prosthesis, for example for a hip prosthesis.

[0093] The invention further relates to a method for manufacturing an implant or a prosthesis, comprising the implementation of a method for assisting in the selection of a type of implant or prosthesis so as to select at least one type of implant or prosthesis, and then the manufacture of an implant or prosthesis of the same type as the one that has been selected, in particular identical.

[0094] When several types of implants, or prostheses, are selected during the implementation of the selection aid process, the type of implant, or prosthesis, manufactured may be that corresponding to the type of implant, or prosthesis, selected having the highest adjusted health gain.

[0095] Alternatively, when several types of implants, or prostheses, are selected during the implementation of the selection aid process, the practitioner chooses the type of implants, or prostheses, to be manufactured for the intervention.

[0096] The invention also relates to a data processing system comprising:

[0097] a database storing, for a population of individuals, each an implant or prosthesis: at least one type of implant or prosthesis, and / or an operative context parameter, in particular chosen from the name of a practitioner, the length of experience of the practitioner, their training, the operative technique, the hospital or clinic where the intervention takes place, one or more medical devices used during the intervention (other than the implant itself or the prosthesis itself);

[0098] a computer program comprising instructions which, when the program is executed by a computer, lead the computer to implement steps B) and C), preferably steps B) to F), of a comparison method according to the invention, and / or steps 1) and 2) of a method for assisting in the selection, in particular of a type of implant or a type of prosthesis.

[0099] The invention also relates to a data processing system for implementing a selection aid comparison method according to the invention, comprising:

[0100] - a database storing for a population of individuals each an implant or prosthesis: at least one type of implant or prosthesis, and possibly a parameter of the operative context, clinical parameters and a health gain;

[0101] - a computer program comprising instructions which, when the program is executed by a computer, leading the latter to implement steps 1) and 2) of a selection aid method according to the invention, in particular of a type of implant or a type of prosthesis.

[0102] The data processing system may include communication means for collecting implant types or prosthesis types, and / or operative contexts, clinical parameters and health gains for the implementation of step A) of a comparison method according to the invention.

[0103] The means of communication may be digital means of communication enriching the database from information provided via a digital interface. Brief description of the drawings

[0104] The invention will be better understood upon reading the detailed description that follows, the non-limiting examples of its implementation, and upon examination of the accompanying drawing, in which:

[0105] [Fig-1] represents the steps of a procedure for comparing implants and / or operating contexts according to the invention;

[0106] [Fig.2] represents the steps of a method for comparing implants and / or operating contexts according to the invention;

[0107] [Fig.3] represents the steps of a manufacturing process for an implant according to the invention;

[0108] [Fig.4] is a block diagram of a data processing system according to the invention;

[0109] [Fig.5] is a block diagram of a device for implementing a method of manufacturing an implant;

[0110] [Fig.6] is a table illustrating a classification resulting from the implementation of a step B);

[0111] [Fig.7] represents box plots of the categories resulting from the classification illustrated in [Fig.6]; and

[0112] [Fig.8] is a table illustrating a selection of clinical parameters having a negative impact on health gain. Detailed description

[0113] The figures relate to methods of comparison and manufacturing, and systems for implementing these methods for implants, in particular intraocular implants.

[0114] The invention is not limited to this particular case. In particular, a similar development can be carried out for prostheses and especially hip prostheses.

[0115] Fig. 1 illustrates the different stages of a method for comparing implants and / or operating contexts according to the invention. Data acquisition

[0116] Step A) relates to the acquisition of data relating to a population of individuals, comprising N individuals.

[0117] For each individual k, k belonging to N, the parameters include at least one type of implant and / or one parameter of the operative context of the medical intervention, in other words the implantation, clinical parameters ({Ck X ; Ck ;2 ;; CkjM}) and a health gain (GSk), the intervention having taken place previously.

[0118] The parameter of the operative context of the placement of the implant may include the name of a practitioner, the length of experience of the practitioner, his training, the operative technique, the hospital or clinic where the medical intervention takes place or the department or municipality where the medical intervention takes place, in particular the precision of whether the medical intervention takes place in a medical desert or not, one or more medical devices used during the intervention (other than the implant itself).

[0119] In a particular embodiment, several parameters of the operating context are specified.

[0120] In the particular case of a method for comparing the benefit of an intraocular implant to an individual, the parameters include at least one type of intraocular implant (Ik), preferably a type of intraocular implant for treating cataracts, clinical parameters ({Ck X ; Ck ;2 ;; CkjM}) and a health gain (GSk).

[0121] Clinical parameters may include: age, sex, presence of diabetic eye disease, presence of diabetic macular edema, presence of glaucoma, presence of macular degeneration, presence of other ocular comorbidities, degree of severity of these comorbidities, prior operations, in particular operation of one or both eyes, presence of hereditary pathologies, presence of family history.

[0122] The health gain for an individual k (GSk) is determined in particular by comparison of a post-intervention indicator (indpost_intjk), representative of a state post-intervention of individual k and a pre-intervention indicator (indpre_int>k), representative of a pre-intervention state of individual k. For example, the health gain can be calculated as follows: — indp,,,, ml k indpre-int , k*

[0123] The post-intervention indicator and / or the pre-intervention indicator, preferably the post-intervention indicator and the pre-intervention indicator, can be determined by means of questionnaires, in particular by means of PROM and / or PREM questionnaires, preferably PROM and / or PREM questionnaires specific to cataracts.

[0124] The questionnaires can be completed by the individual, without intervention from a practitioner.

[0125] Questionnaires can be completed via a digital interface, for example a questionnaire via the Internet, a mobile phone, a tablet, a computer, the results of the questionnaires then being transmitted via digital communications to a database storing the results.

[0126] The health gain can be a number or a figure, for example between -100 and 100, a negative health gain corresponding to a state of an individual degraded by the medical intervention.

[0127] The parameters can be acquired independently of each other, in particular they can be entered at different times and by different operators.

[0128] The parameters can be stored in a database 10. Classification

[0129] In step B), a classification is carried out from the parameters of step A).

[0130] Preferably, a statistical regression is carried out allowing the definition of at least two risk profile categories, preferably at least three risk profile categories.

[0131] Risk profile categories are indicative of a ratio between a benefit provided by a medical intervention and the risk incurred by the implementation of a medical intervention, the classification grouping individuals according to their health gain and their clinical parameters.

[0132] An example of a classification providing three risk profile categories is summarized in the table in [Fig.6] and the graph in [Fig.7].

[0133] In the example in Figures 6 and 7, the risk profile categories distinguish individuals in the population by:

[0134] a first category whose clinical parameters do not a priori indicate any difficulty in recovery or for medical intervention;

[0135] a second category in which the health gain is relatively high and the clinical parameters include at least one parameter indicating potential difficulties in recovery and / or for medical intervention;

[0136] a third category in which the health gain is relatively low and the clinical parameters include at least one parameter indicating potential difficulties in recovery and / or for medical intervention.

[0137] In the example of Figures 6 and 7, N (number of individuals in the population) is equal to 269, the first risk profile category comprises 210 individuals, the second risk profile category comprises 47 individuals and the third risk profile category comprises 12 individuals.

[0138] Figure 7 represents the distribution of individuals within each of the three categories based on their health gain. In particular, [Fig.7] highlights the average health gain, minimum health gain, maximum health gain, 1st quartile and 3rd quartile of health gains, for each category.

[0139] The classification can make it possible to identify, by means of a feature selection algorithm, the clinical parameters that have a negative impact on health gain. In particular, the main difference between the second risk profile category and the third risk profile category in the example illustrated in Figures 6 and 7 is the presence of clinical parameters that negatively impact health gain in individuals in the third risk profile category.

[0140] Figure 8 is a table grouping the clinical parameters identified as having a negative impact on health gain, based on the population of individuals in the example illustrated in Figures 6 and 7. Thus, the presence of macular degeneration was identified as having a statistically significant negative impact on health gain (p-value <0.05). Similarly, the presence of glaucoma was identified as having a statistically significant negative impact on health gain (p-value <0.05). Risk index

[0141] A risk index can be determined from clinical parameters identified as having a negative impact on health gain.

[0142] The risk index can be a weighted sum, with negative impact coefficients on health gain being determined. The negative impact coefficients can be chosen so that the more a clinical parameter has a statistically significant negative impact on health gain, the larger the negative impact coefficient on health gain will be.

[0143] The risk index can be calculated using multivariate linear regression. Other statistical calculation methods may be used.

[0144] This risk index makes it possible, in particular, to identify, for a new individual, the risk profile category to which they belong. The population can be enriched.

[0145] It is also possible to identify the most suitable types of intraocular implants and / or surgical settings based on the risk profile category. Thus, by determining which category a new individual belongs to, it is possible to propose an intraocular implant and / or surgical setting adapted to the new individual. Calculation of the reference health gain

[0146] In step C), for each risk profile category determined in the classification step, a reference health gain is calculated.

[0147] In particular, this reference health gain (RSG) is equal to the median of the health gains of individuals in the risk profile category.

[0148] The reference health gain may alternatively be equal to the average health gains of individuals in the risk profile category.

[0149] The reference health gain may be a combination, possibly a linear combination, of the median health gains of individuals in the risk profile category and the mean health gains of individuals in the risk profile category. Alternatively, a quantile other than the mean and median may be used to determine the health gain. A combination of quantiles may be used.

[0150] At the end of step C) of a comparison procedure as illustrated in [Fig.1], the types of intraocular implants and / or the operative settings are compared by comparing the health gains, for each risk profile category considered separately.

[0151] In particular, the types of intraocular implants and / or the operative settings can be ordered in ascending, or alternatively descending, order of health gains, the ordered list being presented for example to the practitioner.

[0152] The comparison can be displayed on a screen 14.

[0153] Figure 2 illustrates different steps of a method for comparing implants and / or operating contexts according to the invention, further comprising steps D) to F).

[0154] The comparison method according to the invention is advantageously implemented by computer.

[0155] Steps A) to C) are described above. Weighting coefficients

[0156] In step D), for each risk profile category, a weighting coefficient is determined.

[0157] The weighting coefficients are chosen such that:

[0158] [Math.2] Visu NJ,Vk €U NI, k*i, ¢ / 65,.^, = ^ / 05^.+ £ ^GSadjustedJ = GSadjusted,k + £

[0159] GSref j, being the reference health gain of category i, GSajUSté ,i being the adjusted health gain of category i, N being the number of categories determined in step B), Ci being the weighting coefficient of category i, e being less than 10% of the maximum reference health gains, better less than 5% of the maximum reference health gains, better less than 2% of the maximum reference health gains, better still e is zero.

[0160] In the example of Figures 6 and 7, the following coefficients can be chosen: Ci = 1.22; c2 = 1; c3 = 5.54. We then obtain:

[0161] [Math.3] c^GS^f ^ GSref>2~ c3*GSref3 <=> 1.22*20.9= 1*25.5 = 5.54*4.6

[0162] the reference health gain (GSref) being equal to the median of the category.

[0163] Other coefficients may be chosen. Adjusting health gains

[0164] In step E), for each individual in the population, the health gain is multiplied by the weighting coefficient determined for the category to which the individual belongs, so as to obtain a set of adjusted health gains.

[0165] For example, for all individuals in the first category, the health gain will be multiplied by cb, that is, by 1.22; for all individuals in the second category, the health gain will be multiplied by c2, that is, by 1; and for all individuals in the third category, the health gain will be multiplied by c3, that is, by 5.54. Comparison

[0166] In step F), the types of intraocular implants and / or operative settings are compared by comparing the adjusted health gains.

[0167] In particular, the types of intraocular implants and / or the operative settings can be ordered in ascending, or alternatively descending, order of adjusted health gains, the ordered list being presented, for example, to the practitioner.

[0168] The comparison can be displayed on a screen 14. Data processing system

[0169] Figure 4 is a block diagram of a data processing system 1 for implementing a comparison method according to the invention, comprising:

[0170] a database 10 storing for a population of individuals each wearing an intraocular implant: at least one type of intraocular implant and / or a parameter of the operative context, clinical parameters and a health gain;

[0171] a computer program 12 comprising instructions which, when the program is executed by a computer, lead the computer to implement steps B) to E) of a comparison method according to the invention.

[0172] The data processing system 1 may include communication means 16 for collecting the type of implants and / or the parameter of the operative context, clinical parameters and health gains for the implementation of step A) of a comparison method according to the invention.

[0173] The means of communication 16 may be digital means of communication enriching the database from information provided via a digital interface 18.

[0174] The data processing system may include a screen 14 to present the comparison of step E). Manufacturing process

[0175] Fig. 3 represents the steps of a manufacturing process for an intraocular implant.

[0176] The manufacturing process comprises steps 1) and 2) of a process to aid in the selection of a type of intraocular implant, followed by a manufacturing step of an implant chosen from among the selected types of implants. Selection process

[0177] Step 1) consists of providing results of an implant comparison, resulting from the implementation of a comparison method as described above to compare the benefit provided by a type of intraocular implant to an individual.

[0178] In the example described, the results of the comparison of implants are obtained from a process according to the invention comprising steps A) to F).

[0179] Step 2) involves thresholding the results provided in step 1), so as to select the types of intraocular implants for which the adjusted health gains are greater than a predetermined threshold value.

[0180] The predetermined threshold value can be determined by a practitioner. It can be chosen in agreement with the patient. A minimum threshold value may be imposed by the practitioner's hospital or clinic.

[0181] In a particular embodiment, the threshold value is calculated based on clinical parameters of the patient for whom a medical intervention is planned, in particular clinical parameters identified as having a negative impact on health gain.

[0182] The selection aid process may include, before step 2), the entry of at least one clinical parameter of the patient, step 2) comprising the following steps:

[0183] 2.1) pre-selection of the types of intraocular implants for which the parameters clinical presentations of individuals in the population correspond to the clinical parameter entered for the patient; then,

[0184] 2.2) Thresholding of adjusted health gains, by selecting from implant types intraoculars preselected in step 2.1), the types of intraocular implants associated with an adjusted health gain greater than a predetermined threshold value.

[0185] The pre-selection in step 2.1) can be carried out by calculating a risk index. Implant manufacturing

[0186] In step 3), a type of intraocular implant is manufactured.

[0187] In particular, when several types of implants are selected in step 2), the type of implant with the highest adjusted health gain can be manufactured in step 3).

[0188] Alternatively, when several types of implants are selected, the type of implants to be manufactured can be chosen according to other criteria. Device

[0189] The [Fig.5] is a block diagram of a device 2 intended to implement, among other things, a selection and manufacturing process according to the invention.

[0190] The device comprises a computer processing unit 22, a display module 24 and manufacturing means 28.

[0191] The computer processing unit 22 receives a comparison 14 of the benefit provided by a type of intraocular implant to an individual, the comparison being derived from a comparison method according to the invention. The comparison may further include the surgical contexts.

[0192] The computer processing unit then filters the comparison 14 by thresholding so as to select only the types of implants having an adjusted health gain greater than a predetermined threshold value.

[0193] In particular, clinical parameters 20 of a patient p are entered and transmitted to the computer processing unit.

[0194] The threshold value can be determined using the patient's clinical parameters (20) p.

[0195] Alternatively, the clinical parameters (20) of patient p can be used to perform a pre-selection, the computer processing unit first pre-selects the types of implants associated with individuals whose clinical parameters are similar to those entered for patient p, then in a second step, the processing unit selects the types of implants having an adjusted health gain greater than the predetermined threshold value, the types of implants being selected from among the pre-selected types of implants.

[0196] The selected implant types are presented to an operator 26 by means of a display module 24, preferably to the practitioner, for example on a screen.

[0197] Device 2 shown schematically in [Fig.5] can further implement a manufacturing process according to the invention.

[0198] When multiple implant types are selected, the implant type with the highest adjusted health gain is selected by default to be manufactured by manufacturing means 28. Alternatively, or additionally, criteria other than health gain may be used to select the implant type to be manufactured.

[0199] When no type of intraocular implant is selected, this may indicate an unnecessary medical intervention. For example, if too small a health gain is selected, the benefit of the intraocular implant will likely be negligible, or even detrimental in the case of a negative health gain.

[0200] Preferably the manufacture of the implant depends on the clinical parameters 20 of the patient p.

[0201] Of course, the invention is not limited to the examples just described.

[0202] As previously stated, the examples are detailed for the specific case of an intraocular implant. The examples are applicable to an implant intended for any other medical procedure. The examples are also applicable to any type of prosthesis, and in particular to the case of a hip prosthesis.

[0203] As is now clear, the invention makes it possible to compare operative contexts and in particular types of implants or types of prostheses, regardless of the individual wearing the implant, respectively the prosthesis, and regardless of the practitioner who performed the medial intervention.

[0204] The invention also makes it possible to take into account the actual contribution of the medical intervention and thus limit irrelevant interventions.

[0205] The expression "comprising one" should be understood as "comprising at least one" unless otherwise indicated.

Claims

Demands

1. A method to assist in the selection of a type of prosthesis, and / or an operative setting, for planning a medical intervention for a patient, the method of assistance in selection comprising the following steps: 1) input of results of a comparison of prostheses for a given category of individual, and / or of operative settings for the placement of these prostheses, the results being derived from a method of comparing prostheses, and / or of operative settings for the placement of the prosthesis, from a population of individuals each wearing a prosthesis, the comparison method comprising the following steps: A) for each individual in the population of individuals: - input of the type of prosthesis, and / or of at least one parameter of the operative setting for the placement of the prosthesis; - acquisition of clinical parameters; and - determination of a health gain score (HS) quantifying a benefit provided to the individual by the medical intervention;B) classification of individuals in the population of individuals so as to obtain at least two risk profile categories indicative of a ratio between a benefit provided by a medical intervention and the risk incurred by the implementation of a medical intervention, the classification grouping individuals according to their health gain and their clinical parameters, including clinical parameters having a negative impact on the health gain, the classification being carried out in particular by means of a statistical regression, in particular a multivariate linear regression; C) for each risk profile category, calculation of a reference health gain, the reference health gain being a quantile, in particular the mean or the median, or a measure proportional to the minimum clinically significant difference (MCID) of the health gains of the individuals in the category, or any combination thereof;the process including, after step C), the comparison, within each category of risk profiles, of the types of prostheses and / or operative contexts according to the health gains,; 2) thresholding of the results from step 1) so as to select the type(s) of prosthesis, and / or the operative context(s) for which the health gains are greater than a predetermined threshold value, the prostheses being hearing aids, orthopedic prostheses, breast prostheses or dental prostheses.

2. A method for assisting selection according to the preceding claim, the comparison method comprising, after step C) the following steps: D) for each risk profile category, determining a weighting coefficient and then calculating an adjusted reference health gain equal to the product of the weighting coefficient by the reference health gain, the weighting coefficients being chosen so as to obtain a set of adjusted reference health gains substantially equal to each other; E) for each individual in the population of individuals, adjusting the health gain, determined in step A), by multiplying the health gain by the weighting coefficient determined for the category to which the individual belongs, so as to obtain a set of weighted health gains; F) comparing the types of prostheses, and possibly the operative settings, by comparing the adjusted health gains.

3. A method for assisting selection according to the preceding claim, wherein, in step F) of the comparison method, the types of prostheses are compared according to adjusted health gains and according to clinical parameters that negatively impact health gain.

4. A method for assisting selection according to the preceding claim, the clinical parameters negatively impacting the health gain being identified in step B) of the comparison method.

5. A method for assisting in selection according to any one of the preceding claims, the prostheses being hip and knee prostheses, preferably being a hip prosthesis.

6. A selection aid method according to any one of the preceding claims, wherein, in step A) of the comparison method, for each individual in the population of individuals, the health gain is determined by comparing a representative indicator of a pre-intervention state of the individual with a indicator representative of an individual's post-intervention state, preferably the indicator(s) of pre-intervention and post-intervention states being determined by means of at least one questionnaire, in particular completed by the individual.

7. A method for assisting selection according to any one of the preceding claims, wherein, in step B) of the comparison method, the classification is carried out by implementing a classification algorithm taking as inputs the health gains and clinical parameters of the population and providing as output at least two risk profile categories, in particular the algorithm being chosen from: moving centers (or "k-means") algorithm, decision tree, principal component analysis, nearest neighbors method.

8. A method for manufacturing a prosthesis, comprising implementing a method for assisting selection according to any one of the preceding claims so as to select at least one type of prosthesis, and then manufacturing a prosthesis of the same type as the one that has been selected, in particular identical.

9. Data processing system for implementing a method for assisting selection according to any one of claims 1 to 7, comprising: - a database storing for a population of individuals each wearing a prosthesis: at least one type of prosthesis, and optionally a parameter of the operative context, clinical parameters and a health gain; - a computer program comprising instructions which, when the program is executed by a computer, lead the computer to implement steps 1) and 2) of a method for assisting selection according to any one of claims 1 to 7, in particular of a type of prosthesis.

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