A registry for the collection of data in cochlear implant patients.

The need to optimize the use of all the information that modern technological tools have made available to the physician ENT/audiologist has increasingly emerged within the Italian scientific community. Towards this purpose, it is necessary to create a registry of the patients using cochlear implants (CIs). This registry will include a homogeneous summary of the information deriving from multiple sources related to daily clinical practice, in order to assess auditory benefits, safety and reliability in patients with cochlear implants, and organization over the national territory. The primary objectives relative to the above-mentioned analysis are to assess the impact of the use of cochlear implants on patient health, to ensure traceability of the devices currently used, monitoring their safety and reliability over time, to guarantee access of the technique in clinical and organizational conditions that can allow the best possible benefits. The aspects concerning implementation of the registry were discussed extensively during the first meetings of the Working Group (WG). In particular, owing to the complexity and high costs related mainly to the development of the technological aspects and the need to involve technological partners external to the WG, and to respect current privacy laws, the WG members decided that the project should be limited to proposal of a paper registry to be implemented at a later stage, possibly within the framework of successive research projects. During meetings, the WG members discussed various aspects of implementation of the registry, and in particular the scientific features connected to objectives, inclusion criteria, and structure of the forms needed for data collection and organizational aspects. A registry is proposed herein.

Introduction

Rationale for a Registry. The approach and management of patients who are suitable candidates for cochlear implantation varies from one centre to another. The identification of candidate subjects, their selection and preparation for the intervention, the choice of the device and surgical techniques, as well as the management of post-operative recovery, are critical elements for recovery of auditory function. All of these successive phases should be taken into account and given their correct predictive value when evaluating the outcomes of the implant. In a scenario of this type, it is essential to have as much data as possible, collected in a standard fashion, applying the same criteria, and with the same knowledge and goals.

The need to optimize the use of all the information that modern technological tools have made available to the otolaryngologist and audiologist has increasingly emerged within the Italian scientific community. Unfortunately, despite all attempts at standardization, no uniform model for outcome assessment in this therapeutic area has been reached, representing a limit to the production of high quality methodological scientific trials. On the one hand, this drawback seems to depend on objective scientific difficulties, such as the need to represent the results from the different points of view of the specialists involved (surgeon, otolaryngologist, audiologist, speech therapist, patient), and to transpose this information in a quantitative and valid manner. On the other hand, the information systems currently available in the different structures are often incompatible with one other, making it difficult to obtain information that is essential to provide safe, highquality care. Essential clinical and technical information, often missing in hospital discharge cards, can only be obtained by examining clinical records. Furthermore, a monitoring system following the implanted patient in the course of his life has not been developed. For an integrated and exhaustive study of the data, the specialists treating the candidate for cochlear implantation feel the need for an efficient clinical database assessing auditory benefits in cochlear implant patients.

Health technology assessment is becoming one of the most important institutional tasks falling within the competence of the Ministry of Health. The need to implement a registry for patients using cochlear implants reflects the interest of the Ministry of Health in assessing healthcare techniques . The Italian financial law for 2007 already planned to assign part of its funds to activities aimed at strengthening the implementation of medical devices. In particular, funds have been destined to activities of supervision of the market, control of accidents, technology assessment studies, development of registerys for diseases requiring the use of medical devices. The interest of the Health Ministry falls within the framework of cochlear implantation.

A similar national – or at least regional – initiative is designed to illustrate the state-of-the-art of the three macro areas involved in the process, namely clinical, technological and clinical governmental.

Towards this end, it is necessary to create a registry of patients using cochlear implants. This registry will include a homogeneous summary of the information deriving from multiple sources related to daily clinical practice, in order to assess the auditory benefits, safety and reliability of cochlear implants, and organization of patient travels. . The primary objectives to the abovementioned analysis are to assess the impact of the use of cochlear implants on patient health, to ensure traceability of the devices currently used, monitoring their safety and reliability over time and to guarantee access of this technique to all citizens in clinical and organisational conditions, which can allow them to achieve the best possible benefits.

Among the benefits resulting from the creation of a registry, the possibility to obtain outcomes which are statistically comparable in the different centres is particularly interesting (increasing the robustness of statistical analyses performed on a number of cases superior to those annually available for each clinic). A registry can also help to: i) develop a methodology that is able to compare and objectively assess performance of each product both from clinical and technological points of view; ii) improve clinical practice through standardized protocols; iii) improve the quality of practice, thanks to an operative monitoring system of the results; iv) assess the appropriateness of treatment, in particular for the subject categories for which application of cochlear implants must be evaluated carefully; v) increase scientific activities (e.g. clinical studies and publications), in particular by developing – if possible – independent clinical research based on a number of statistically significant cases; and vi) create a national network of centres involved in cochlear implant procedures, in order to exchange experience, clinical advice and opinions.

Methodology: project for a registry implementation

The following project for implementation of the register was defined during the phase of definition of the Aims.

Study methodology

Observational, prospective, multicentre, national or regional registries.

Recruitment of participating centres

Recruitment of structures interested in joining the registry (signing a participation form).

Inclusion criteria

Patients submitted to unilateral or bilateral cochlear implantation, using simultaneous or sequential procedures.

Exclusion criteria

The following patients will be excluded: a) all retrospective patients, as fragmentation of the information and inconsistency of the definitions with respect to the terminology requested would make it difficult to complete the different registry fields; b) all patients who refuse consent to the use of data.

Observation period

A registry of cochlear implant users implies a multiyear prospective study of the collected data in order to obtain preliminary, clinically-reliable results and implant reliability outcomes. Therefore, it is necessary to have a sufficiently large number of cases. Only long-term results are possible, because failure of devices and clinical benefits can only be assessed over the long-term. These aspects often come into conflict with the needs of institutions and projects seeking short-term results.

Data analysis

In accordance with statistical analysis planning and technological platform features, the system will include different types of reports, as well as analytical and synthetic data processing related to scientific and organizational aspects.

The information obtained from this collection of data will concern: a) clinical epidemiology of implanted deaf patients; b) epidemiology of treatment; c) epidemiology of therapeutic-diagnostic protocols; d) compliance of Centres to guidelines; e) postmarketing surveillance (study of implant survival), and analysis of risk factors that may influence outcome (e.g. different lifestyles of the patient); f) direct analysis of sanitary and social costs by assessment of economic implications determined by the use of cochlear implants and recovery of auditory abilities; g) new routes/applications; h) best practices: identification and dissemination.

Logical structure of the database

In order to obtain adhesion to the registry by as many centres as possible, it is necessary to identify a minimum set of data that is both comprehensive and functional to the aims proposed.

Identification of the two data levels can be divided into:

obligatory data, functional to the objectives of the registry, accessible to as many national centres as possible;

large amounts of non-obligatory data, alongside a minimum group of obligatory data, but only accessible to the few reference centres able to support the collection.

The data collected can be subdivided into three principal subsets.

The first subset of data allows identification of the patient and his/her clinical course within the hospital structure (identifying organization indicators, e.g. separation between place of first intervention and follow-up and/or post-intervention; waiting times between diagnosis and intervention, intervention and activation, etc.).

The second subset of data includes technical information relative to the devices used (both implantable and external), to allow traceability of the implant during the patient’s life when associated with previous data (analysis of reliability/survival curve of the implant).

The third subset of data concerns clinical data, or information related to anamnesis, surgical intervention, activation and follow-up. These elements are necessary to trace the clinical profile of the patient and to check the impact of cochlear implant usage on patient health, i.e. auditory benefit and improvement of quality of life.

e-CRF (electronic-Case Report Form) design and data management

Technical development of the project in terms of preparation of the registry will be assigned to one or more technological partners (clinical research organization (CRO ), University, research institute or other), and will concern both the practical aspects (from design and implementation of the e-CRF, with on-line control, generation of ongoing queries, to creation of the database, including dataclearing and production of tables and statistical reports in agreement with a pre-established study plan), and the maintenance aspects (hosting server, constant back-up, connections, usage licenses).

The e-CRF will include both obligatory and optional fields that will be differentiated to obtain two possible registry levels. The system will periodically check for congruence and completion, and send warning messages aimed at correcting any input mistakes made by users. All variables introduced in the registry will be codified by standard definitions and appropriate terminology to ensure a systematic approach to collection and inclusion of the data).

The server hosting the data will be protected, validated for the purpose and submitted to rigid back-up and antiintrusion protocols.

In the case of data collected on paper forms, further resources for data inclusion will be necessary to perform the above-mentioned activities.

Data flow recording

The mode of data inclusion suggested is through a webinterface, owing to the practical management that the information system offers with respect to traditional recording on paper forms. The data will be collected in a resident database stored on a centralized server owned by the registry group. The intervention of a technological provider will be necessary for implementation of the data collection cards. Transmission of the data, from local clinical to central registry sites, will essentially need to respond to the following principle: the data must be transmitted safely. This includes cryptography of the information as well as possibility of access after the authentication procedure. Furthermore, it will be possible for the person responsible for each centre, using a password, to access, consult and update at any time the data of his/her own centre. Consultation of the “national” data of the registry will also be allowed, with the following rules safeguarding privacy: this collection of data will be completely anonymous, preventing identification of patient and centre.

Privacy

All possible solutions should be taken to protect patients’ right to privacy and data security in compliance with “code 196 concerning personal data protection”, and the more recent guidelines of July 2008 “for treatment of personal data in the field of experimental clinical experimentation” 5. The patient should consent to treatment of his/ her data, signing an informed consent form.

Conclusions and implementation of the project

The aspects concerning registry implementation were discussed extensively during the first meetings of the Working Group (WG) members. In particular, owing to the complexity and high costs related mainly to the development of the technological part and the need to involve technological partners external to the WG and to respect current privacy laws, the WG members decided that the project should be limited to the proposal of a paper registry to be implemented at a later stage, possibly within the framework of successive financed research projects.

The WG members discussed various aspects of implementation of the registry, and in particular the scientific features related to objectives, inclusion criteria and structure of the forms related to data collection and organisational aspects.

The registry proposal is reported in Appendix 1.

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(R+L) CI

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