Table 5

Table 5. Fundamental requirements for implementing a post-introduction observation system.
1.Scope of the study: It is necessary to delimit the health area, geographical area, province, region or country in which it is envisaged that the post-introduction observation procedure is to be implemented. It will also be necessary to define whether the post-introduction observation will solely consider centres that form part of the public health system or will also consider private centres. In addition, the scope of study must be specified, i.e., whether it is to include primary care, specialised care or all types of centres. 2. Participant centres: Contact must be made with the centres, departments and units that are involved in the use of the new technology, in order to request their collaboration and ask them to designate a contact person. 3. Study protocol: A study protocol must be drawn up in collaboration with a multidisciplinary group made up of health professionals involved in the planning, implementation, scheduling and use of the new technology, to agree on the characteristics of the post-introduction observation system. The proposed study protocol must be reviewed at each participant centre by the various specialists involved in the health care of these patients. The study protocol must address the following points: a. Definition of the goal and purpose of the study: The study objectives and purpose must be defined a priori. The objectives will be what determine the target population, the data to be collected and the outcome variables (outcome indicators). Hence, the relevance of these being carefully considered in collaboration with the multidisciplinary group. b. Target population: It is essential to establish and clearly define the clinical indications and specific characteristics of the patients (age range, co-morbidities, severity, etc.) who are to form part of the target study population. c. Study subgroups: It is essential to establish and define whether there are subgroups of patients that must be separately evaluated (clinical indications, age, symptoms, severity, co-morbidities, pregnancy, etc.). Similarly, in cases where there are similar though not identical procedures, procedures that call for a high degree of specialisation, or procedures that are used in combination with others, it is also necessary for the technique, manner and order of administration to be registered and for the study subgroups deemed of interest for analysis purposes (country, team, technique, etc.) to be established. d. Data-collection variables: The variables to be included in the study must be stipulated, the specific criteria that define such variables must themselves be defined, and the method of coding the variables must be determined. In the case of each technology, it is important for adverse effects that are going to be classified as mild/moderate and those that are going to be classified as severe to be defined. e. Systematic data-collection: The data sources and data-collection instruments (clinical history, specific questionnaires, etc.) must be chosen, and the procedure for collecting (person responsible, method of collection, measurement scales, etc.) and distributing the data (person responsible, channel and periodicity) established. f. Outcome indicators: The outcome indicators that are deemed relevant for each technology must be chosen by consensus. Depending on the technology in question, it may be relevant for all aspects (diffusion, accessibility, effectiveness, safety, resource use and financial impact) or only some aspects of post-introduction observation to be considered. Within these, it may in turn be deemed relevant for one or more outcome indicators to be analysed. g. Patient follow-up: Patient follow-up guidelines must be agreed upon and the duration of the study established. A follow-up time of 1 year is recommended but this may be increased if the intervention is indicated in few patients or if analysis by subgroup is required. h. Acceptable or desirable standards: The standards deemed acceptable or desirable for each outcome indicator targeted for assessment (diffusion, adequacy of use, safety, effectiveness, costs, etc.) must be defined a priori. The multidisciplinary group will be responsible for establishing and agreeing upon the values deemed acceptable or desirable. For the principal variables, the values to be used to determine the success or failure of the technology must be carefully established, taking into account all the pertinent information, i.e., results reported in the scientific literature, data published in diverse data sources and personal experiences. i. Data-analysis: The data-analysis procedure (unit responsible) must be established. j. Patient information: It is recommended that the written information to be furnished to the patients at the various centres be decided upon and rendered uniform. k. Data confidentiality: The procedure for maintaining the confidentiality of the data (masking of data, encryption, etc.) must be laid down. 4. Organisation: Once the planning stage has been finalised, it will be necessary to proceed to the implementation stage. This stage can be divided into 3 parts: a. Development of data-collection instruments (specific questionnaires). b. Drafting of detailed instructions covering the data-collection and dispatch procedure. These must include the definition and coding of all variables. c. Development of a common database. 5. Data-quality control: Provided that it is feasible, consideration should be given to an external review of 5% of entries in order to assess the quality of the data registered. This activity could be undertaken by the unit responsible for data analysis. 6. Plan for dissemination of results and alert system for unforeseen problems: It is recommended that, prior to the start of the study, agreement is reached on how to proceed in the event of detection of problems and how the results of the study are to be disseminated.

Table 5. Fundamental requirements for implementing a post-introduction observation system.

1.Scope of the study: It is necessary to delimit the health area, geographical area, province, region or country in which it is envisaged that the post-introduction observation procedure is to be implemented. It will also be necessary to define whether the post-introduction observation will solely consider centres that form part of the public health system or will also consider private centres. In addition, the scope of study must be specified, i.e., whether it is to include primary care, specialised care or all types of centres.
2. Participant centres: Contact must be made with the centres, departments and units that are involved in the use of the new technology, in order to request their collaboration and ask them to designate a contact person.
3. Study protocol: A study protocol must be drawn up in collaboration with a multidisciplinary group made up of health professionals involved in the planning, implementation, scheduling and use of the new technology, to agree on the characteristics of the post-introduction observation system. The proposed study protocol must be reviewed at each participant centre by the various specialists involved in the health care of these patients. The study protocol must address the following points:
- a. Definition of the goal and purpose of the study: The study objectives and purpose must be defined a priori. The objectives will be what determine the target population, the data to be collected and the outcome variables (outcome indicators). Hence, the relevance of these being carefully considered in collaboration with the multidisciplinary group.
- b. Target population: It is essential to establish and clearly define the clinical indications and specific characteristics of the patients (age range, co-morbidities, severity, etc.) who are to form part of the target study population.
- c. Study subgroups: It is essential to establish and define whether there are subgroups of patients that must be separately evaluated (clinical indications, age, symptoms, severity, co-morbidities, pregnancy, etc.). Similarly, in cases where there are similar though not identical procedures, procedures that call for a high degree of specialisation, or procedures that are used in combination with others, it is also necessary for the technique, manner and order of administration to be registered and for the study subgroups deemed of interest for analysis purposes (country, team, technique, etc.) to be established.
- d. Data-collection variables: The variables to be included in the study must be stipulated, the specific criteria that define such variables must themselves be defined, and the method of coding the variables must be determined. In the case of each technology, it is important for adverse effects that are going to be classified as mild/moderate and those that are going to be classified as severe to be defined.
- e. Systematic data-collection: The data sources and data-collection instruments (clinical history, specific questionnaires, etc.) must be chosen, and the procedure for collecting (person responsible, method of collection, measurement scales, etc.) and distributing the data (person responsible, channel and periodicity) established.
- f. Outcome indicators: The outcome indicators that are deemed relevant for each technology must be chosen by consensus. Depending on the technology in question, it may be relevant for all aspects (diffusion, accessibility, effectiveness, safety, resource use and financial impact) or only some aspects of post-introduction observation to be considered. Within these, it may in turn be deemed relevant for one or more outcome indicators to be analysed.
- g. Patient follow-up: Patient follow-up guidelines must be agreed upon and the duration of the study established. A follow-up time of 1 year is recommended but this may be increased if the intervention is indicated in few patients or if analysis by subgroup is required.
- h. Acceptable or desirable standards: The standards deemed acceptable or desirable for each outcome indicator targeted for assessment (diffusion, adequacy of use, safety, effectiveness, costs, etc.) must be defined a priori. The multidisciplinary group will be responsible for establishing and agreeing upon the values deemed acceptable or desirable. For the principal variables, the values to be used to determine the success or failure of the technology must be carefully established, taking into account all the pertinent information, i.e., results reported in the scientific literature, data published in diverse data sources and personal experiences.
- i. Data-analysis: The data-analysis procedure (unit responsible) must be established.
- j. Patient information: It is recommended that the written information to be furnished to the patients at the various centres be decided upon and rendered uniform.
- k. Data confidentiality: The procedure for maintaining the confidentiality of the data (masking of data, encryption, etc.) must be laid down.
4. Organisation: Once the planning stage has been finalised, it will be necessary to proceed to the implementation stage. This stage can be divided into 3 parts:
- a. Development of data-collection instruments (specific questionnaires).
- b. Drafting of detailed instructions covering the data-collection and dispatch procedure. These must include the definition and coding of all variables.
- c. Development of a common database.
5. Data-quality control: Provided that it is feasible, consideration should be given to an external review of 5% of entries in order to assess the quality of the data registered. This activity could be undertaken by the unit responsible for data analysis.
6. Plan for dissemination of results and alert system for unforeseen problems: It is recommended that, prior to the start of the study, agreement is reached on how to proceed in the event of detection of problems and how the results of the study are to be disseminated.