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 operating contexts. The invention also relates to devices for implementing these methods. Prior art

[0002] The evaluation of a medical intervention requires taking into account many factors. It is not easy to compare in real life the clinical benefit of medical devices according to the different care pathways and the diversity of patient profiles. Indeed, each medical intervention depends on the practitioner who carries it out, their experience, the setting in which it is carried out, the tools at their disposal but also on the patient, their physical condition, their history, their lifestyle, their comorbidities.

[0003] Furthermore, generally speaking, performing a medical intervention systematically entails risks, even minimal ones, for the patient. However, performing a medical intervention does not always result in the expected results for the patient, even if the medical intervention is, from a medical point of view, considered successful. In particular, since each patient is different, the results of a medical or surgical intervention performed by a practitioner differ from one patient to another depending on the practices and health products used, but above all depending on the profiles of the patients themselves.

[0004] Finally, it is currently not uncommon to carry out certain medical interventions, almost systematically, generally as a precaution or for simplicity for the practitioner, without any real necessity. Indeed, the World Health Organization and the Organization for Economic Cooperation and Development indicate that approximately 30% of medical procedures are not relevant, that is to say, they do not provide any clinical benefit for the patient, in other words, they are wasted care likely to generate avoidable medical complications for the patient, and avoidable health expenses for the health care 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 many exogenous factors such as patient compliance, adherence to good practices by the practitioner, etc. It is common to observe that the results of clinical studies are not necessarily transposed into the results of real life due to its heterogeneity, for example in terms of conditions of use of health products, but also the behavior of patients and caregivers.

[0006] Consequently, there is a need to compare medical interventions with each other, in particular to compare the fitting of implants or prostheses, for example intraocular implants for cataracts, orthopedic prostheses for osteoarthritis of the hip or knee, or hearing aids for the hearing impaired or stents for patients suffering from coronary artery disease, and in particular to compare types of implants or prostheses. There is also an interest in limiting medical interventions that prove to be unnecessary for patients. Finally, there is a continuing need to help practitioners plan medical interventions. Disclosure of the invention

[0007] The invention aims to meet all or part of these needs and achieves this, according to one of its aspects, by means of a method for comparing implants or prostheses, and / or operating contexts for fitting 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 operating context for placing 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 from the population of individuals so as to obtain at least two risk profile categories indicative of a relationship between a benefit provided by a medical intervention and the risk incurred by the implementation of a medical intervention, the classification grouping the individuals according to their health gain and their clinical parameters, in particular according to the clinical parameters having a negative impact on the health gain, the classification being in particular carried out by means of a statistical regression, in particular a multivariate linear regression;

[0010] C) for each risk profile category, calculating 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 the health gains of the 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 the operating contexts according to the health gains.

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

[0013] 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 makes it possible to quickly, precisely and simply compare medical interventions with each other, that is to say to prioritize the health gain scores associated with these medical interventions and in particular with the types of implants or prostheses within a group of statistically homogeneous individuals. In particular, for a given category, it is possible to compare the implants with respect to the reference health gain, and thus determine whether the medical intervention for an individual is advantageous compared to individuals with the same profile. It is easy to determine which type of implant or prosthesis is more 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 wearing this type of implant have a health gain lower than the reference health gain of the category, then the type of implant is not suitable for individuals in said category.

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

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

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

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

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

[0022] E) for each individual of 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 types of implants or prostheses, and / or operating contexts by comparing adjusted health gains.

[0024] Thus, in a particular embodiment of the invention, the method for comparing implants or prostheses, and / or operating 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 the operating 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 provided to the individual through medical intervention;

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

[0030] C) for each risk profile category, calculating 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 the health gains of the individuals in the category, or any combination thereof;

[0031] D) for each risk profile category, determination of a weighting coefficient 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 of 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 types of implants or prostheses, and / or operating contexts by comparing adjusted health gains.

[0034] In particular, the operating context may include the name of a practitioner, the length of experience of the practitioner, his training, the operating 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 specification 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 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, independently of the category considered.

[0036] The comparison method according to the invention advantageously makes it possible, based on patient profiles, to determine the types of implants, respectively prostheses, which optimize the quality of life of patients in their daily activities.

[0037] The comparison method makes it possible, according to another of its aspects, to identify the most relevant operating contexts.

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

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

[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 implants for treating cataracts.

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

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

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

[0045] Preferably, the pre-interventional and post-interventional 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.

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

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

[0049] The answers to the questions can be analyzed by means of a psychometric analysis, in particular of the Rasch analysis type. Advantageously, the answers to the questions are thus standardized.

[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 may be a percentage, a figure or a number, for example between 0 and 100.

[0052] The health gain may be the difference between the post-intervention indicator and the pre-intervention indicator. The health gain may be a percentage, a number, or a figure, 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 a clinic.

[0055] The clinical parameters can be chosen from: age, sex, the presence of chronic diseases, diabetes, allergies, comorbidities, in particular ocular comorbidities, a 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 additionally 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, more preferably 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 a ratio between the benefit provided to the individual by a medical intervention and the clinical risk incurred by the individual. In other words, the aim of this classification is to identify profiles for which the benefit provided by the medical intervention is greater than the risk incurred by the intervention.

[0059] The algorithm can be a mobile center algorithm (or “k-means”), decision tree, principal component analysis, nearest neighbor method.

[0060] Preferably, it is carried out by means of statistical regression.

[0061] The classification can be carried out by means of a 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 so that:

[0064] [Math.l] Old AJ. VA- eU 2V], k^L cfGSréfJ = ck* GSréf,k + e <^GSajusté.i = GSajœté>k+e

[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 reference health gains, better less than 5% of the maximum reference health gains, better less than 2% of the maximum reference health gains, better less than 1% of the maximum reference health gains, even better e is zero.

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

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

[0068] The comparison may comprise an ordering of the types of implants, respectively of prostheses, and / or of the operating contexts, in particular of the types of implants, respectively of prostheses, and of the operating contexts, according to the adjusted health gain.

[0069] The comparison may 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 the characteristics specific to each individual and to each intervention, in particular to each practitioner.

[0071] Determining the adjusted health gain advantageously makes it possible to quickly, simply and precisely compare the types of implants or prostheses and / or operating 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 carrying out 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 operating context, for planning a medical intervention for a patient, the method for assisting in the selection comprising the following steps: 1) information on the results of a comparison of types of implants or prostheses for a given category of individual, and / or operating contexts for the placement of these implants, respectively prostheses, preferably the results being derived from a comparison method 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 operating context(s) for which the health gains are greater than a predetermined threshold value.

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

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

[0076] The selection assistance method may include, before step 2), the provision 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) including the following steps:

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

[0078] The selection assistance method may in particular be used to select a type of intraocular implants for a particular implantation for cataract treatment 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 implants is implemented, and in step 2) the results are thresholded so as to select the types of intraocular implants 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, then 2.2) the thresholding of the health gains by selecting from the types of intraocular implants in the category selected in step 2.1), the types of implants associated with a health gain greater than the predetermined threshold value.

[0079] A selection assistance 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 implants or prostheses so as to select at least one type of implants or prostheses, then the manufacturing of an implant or prosthesis of the same type as that which has been selected, in particular identical.

[0081] When several types of implants, respectively prostheses, are selected during the implementation of the selection assistance method, the type of implants, respectively prostheses, manufactured can be that corresponding to the type of implants, respectively prostheses, selected having the highest health gain.

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

[0083] Preferably, the results of step 1) of a selection assistance method according to the invention comprise 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 operating context(s) for which the adjusted health gains are greater than a predetermined threshold value.

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

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

[0086] The predetermined threshold value may be determined by a practitioner. It may 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 assistance method may include, before step 2), the provision 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) including the following steps:

[0090] 2.1) preselection of types of implants or prostheses, and / or operating 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 the adjusted health gains, by selecting from the types of implants or the types of prostheses, and / or the operating contexts, preselected in step 2.1), the types of implants and / or the operating contexts, respectively the types of prostheses and / or the operating contexts, associated with an adjusted health gain greater than a predetermined threshold value.

[0091] The selection assistance method can in particular be used to select a type of intraocular implants 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) possibly comprising 2.1) the preselection 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 the types of intraocular implants preselected in step 2.1), the types of implants associated with an adjusted health gain greater than the predetermined threshold value.

[0092] A selection assistance 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 implants or prostheses so as to select at least one type of implants or prostheses, then the manufacturing of an implant or prosthesis of the same type as that which has been selected, in particular identical.

[0094] When several types of implants, respectively prostheses, are selected during the implementation of the selection assistance method, the type of implants, respectively prostheses, manufactured can be that corresponding to the type of implants, respectively prostheses, selected having the highest adjusted health gain.

[0095] Alternatively, when several types of implants, respectively prostheses, are selected during the implementation of the selection assistance method, the practitioner chooses the type of implants, respectively 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 carrying an implant or prosthesis: at least one type of implant or prosthesis, and / or an operating context parameter, in particular chosen from the name of a practitioner, the length of experience of the practitioner, his training, the operating 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, cause the latter 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 comparison method according to the invention comprising:

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

[0101] - a computer program comprising instructions which, when the program is executed by a computer, lead the latter to implement steps B) and C), preferably steps B) to F), of a comparison method according to the invention.

[0102] The data processing system may comprise communication means making it possible to collect the types of implants or the types of prostheses, and / or the operating contexts, the clinical parameters and the 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 may be better understood by reading the detailed description which follows, non-limiting examples of its implementation, and by examining the attached drawing, in which:

[0105] [Fig.l] represents the steps of a method 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 method of manufacturing 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 comparison and manufacturing methods, 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 in particular hip prostheses.

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

[0116] Step A) involves acquiring 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 implants and / or a parameter of the operating context of the medical intervention, in other words the implantation, clinical parameters ({Ck,i; Ck;2;; CkjM}) and a health gain (GSk), the intervention having taken place previously.

[0118] The parameter of the operating context for placing the implant may include the name of a practitioner, the length of experience of the practitioner, his training, the operating 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 specification 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 provided.

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

[0121] Clinical parameters may include: age, sex, presence of diabetic eye diseases, presence of diabetic macular edema, presence of glaucoma, presence of macular degeneration, presence of other ocular comorbidities, degree of severity of these comorbidities, performance of previous 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 in particular determined by comparing a post-intervention indicator (indpost intjk), representative of a post-intervention state of the individual k and a pre-intervention indicator (indp,é ml.k). representative of a pre-intervention state of individual k. For example, the health gain can be calculated as GSk indpost_int>k indpré4nk k.

[0123] The post-interventional indicator and / or the pre-interventional indicator, preferably the post-interventional indicator and the pre-interventional indicator, may be determined by means of questionnaires, in particular by means of PROM and / or PREM questionnaires, preferably cataract-specific PROM and / or PREM questionnaires.

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

[0125] The 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 may 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 may 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 making it possible to define at least two risk profile categories, preferably at least three risk profile categories.

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

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

[0133] In the example of Figures 6 and 7, the risk profile categories distinguish individuals from the population into:

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

[0135] a second category whose 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 whose 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 includes 210 individuals, the second risk profile category includes 47 individuals and the third risk profile category includes 12 individuals.

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

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

[0140] [Fig.8] is a table grouping the clinical parameters identified as having a negative impact on health gain, from 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, based on clinical parameters identified as having a negative impact on health gain.

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

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

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

[0145] It is also possible to identify the most suitable types of intraocular implants, and / or operating contexts, 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 an operating context, adapted to the new individual. Calculating the baseline 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 (GSref) 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 of the 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 of the health gains of the individuals in the risk profile category and the mean of the individuals in the risk profile category. Alternatively, a quantile other than the mean and the 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 method as illustrated in [Fig.l], the types of intraocular implants and / or the operating contexts 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 operating contexts can be ordered according to an ascending, alternatively descending, order of health gains, the ordered list being for example presented to the practitioner.

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

[0153] [Fig.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] V ze [[ L AJ.vÆ e H1, k^i, ci*GSréfj, = ck'i!GSréf ic+ e •^>GSajUStij= GSajusléj( + £

[0159] GSréf 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, even better e is zero.

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

[0161] [Math.3] c*GSref_ i «c / GSref 2 « c^GSref3 1.22*20.9 « 1*25.5 « 5.54*4.6

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

[0163] Other coefficients can 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, i.e., by 1.22, for all individuals in the second category, the health gain will be multiplied by c2, i.e., 1, and for all individuals in the third category, the health gain will be multiplied by c3, i.e., 5.54. Comparison

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

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

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

[0169] [Fig.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 operating context, clinical parameters and a health gain;

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

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

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

[0174] The data processing system may comprise a screen 14 for presenting the comparison of step E). Manufacturing process

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

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

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

[0178] In the example described, the results of the implant comparison come from a method according to the invention comprising steps A) to F).

[0179] Step 2) includes 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 may be determined by a practitioner. It may 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 assistance method may include, before step 2), the provision of at least one clinical parameter of the patient, step 2) including the following steps:

[0183] 2.1) preselection of the types of intraocular implants for which the parameters clinical parameters of individuals in the population of individuals correspond to the clinical parameter reported for the patient; then,

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

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

[0186] In step 3), one type of intraocular implants is manufactured.

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

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

[0189] [Fig.5] is a block diagram of a device 2 intended to implement, among other things, a selection and manufacturing method 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 implants to an individual, the comparison being derived from a comparison method according to the invention. The comparison may further include the operating 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 by means of the clinical parameters (20) of the patient e.g.

[0195] Alternatively, the clinical parameters (20) of the patient p can be used to carry out a pre-selection, the computer processing unit firstly preselects the types of implants associated with individuals whose clinical parameters are similar to those provided for the patient p, then secondly, 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 the preselected 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] The device 2 shown diagrammatically in [Fig.5] can further implement a manufacturing method according to the invention.

[0198] When several types of implants are selected, the type of implants having the highest adjusted health gain is selected by default to be manufactured by the manufacturing means 28. Alternatively, or additionally, other criteria than the health gain can make it possible to select the type of implants to be manufactured.

[0199] When no type of intraocular implant is selected, this may be indicative of unnecessary medical intervention. For example, if too low 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 which have just been described.

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

[0203] As is now clearly apparent, the invention makes it possible to compare operating 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 having carried out the medial intervention.

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

[0205] The expression “comprising a” must be understood as “comprising at least one” in the absence of an indication to the contrary.

Claims

1. Claims Method for assisting in the selection of a type of implant or prosthesis, and / or an operating context, for planning a medical intervention for a patient, the selection assistance method comprising the following steps: 1) information on the results of a comparison of types of implants or prostheses for a given category of individual, and / or operating contexts for the placement of these implants, respectively prostheses, the results being derived from a method of comparing implants or prostheses, and / or operating contexts for the placement of the implant or prosthesis, from a population of individuals each wearing an implant or prosthesis, the comparison method comprising the following steps: 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 operating context for placing the implant or prosthesis; - acquisition of clinical parameters; and - determination of a health gain score (GS) quantifying a benefit provided to the individual by the medical intervention; (B) classification of individuals from the population of individuals so as to obtain at least two risk profile categories indicative of a relationship between a benefit provided by a medical intervention and the risk incurred by the implementation of a medical intervention, the classification grouping the individuals according to their health gain and their clinical parameters, in particular according to the 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 median, or a measure proportional to the minimal clinically important difference (“MCID”) of the health gains of individuals in the category, or any combination thereof; the method comprising, after step C), the comparison, within each category of risk profiles, of the types of implants or prostheses and / or the operating contexts according to the health gains, 2) thresholding of the results from step 1) so as to select the type(s) of implant(s), respectively prostheses, and / or the operating context(s) for which the health gains are greater than a predetermined threshold value.

2. Selection assistance method 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 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 intraocular implants, and possibly the operating contexts, by comparing the adjusted health gains.

3. Selection assistance method according to the preceding claim, in which, in step F) of the comparison method, the types of intraocular implants are compared according to the adjusted health gains and according to clinical parameters negatively impacting the health gain.

4. Selection assistance method according to the preceding claim, the clinical parameters negatively impacting the health gain being identified in step B) of the comparison method.

5. Selection assistance method according to any one of the preceding claims, in which, in step A) of the comparison method, for each individual of the population of individuals, the health gain is determined by comparison of an indicator representative of a pre-interventional state of the individual with an indicator representative of a post-interventional state of the individual, preferably the indicator(s) of pre-interventional and post-interventional states being determined by means of at least one questionnaire, in particular completed by the individual.

6. Selection assistance method 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 the clinical parameters of the population and providing as output at least two categories of risk profile, in particular the algorithm being chosen from: mobile center algorithm (or "k-means"), decision tree, principal component analysis, nearest neighbor method.

7. A selection assistance method according to any preceding claim, the comparison method being an implant comparison method, the implants being intraocular implants for treating cataracts.

8. Method for manufacturing an implant or prosthesis, comprising the implementation of a selection assistance method according to any one of the preceding claims so as to select at least one type of implant or prosthesis, then the manufacturing of an implant or prosthesis of the same type as that which has been selected, in particular identical.

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

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