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DATA-COLLECTION INSTRUMENTS

This section presents the results of the assessment of the different instruments that could be used for data-collection. The aim is to provide some key points for selecting the most ideal data-collection instrument from the existing alternatives and contexts.

On the basis of the findings of the systematic review of the literature 4 possible data-collection instruments were proposed:

  • clinical registries,
  • questionnaires/surveys,
  • medical records (paper and electronic format) and
  • available electronic databases such as Minimum Basic Set of Data(MBDS)

Table 4 presents a summary of the main conclusions of the systematic reviews specifically carried out to assess each one of these instruments, depicting the main advantages, limitations and considerations that must be taken into account when planning to use them for the post-introduction observation of new technologies.

In the complete version of the methodological guideline published on-line (http://avalia-t.sergas.es), the different instruments are briefly described and the main results of the studies included in the systematic review are shown, along with the evidence tables and search strategy.

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Table 4. Principal results of the systematic review
Data-collection instrument Advantages, limitations and important considerations
CASE REGISTRIES
  • 1) Although registries can be very useful tools for gathering comprehensive information on daily clinical practice, their usefulness in post-introduction follow-up is limited by the fact that their development is extremely complex and requires important resource use, both in terms of finance and in terms of staff and time.
  • 2) Follow-up losses and the lack of continuity in data registration are important limitations if such data are sought to be used for assessing adverse effects that appear in the medium-/long-term.
SURVEYS/QUESTIONNAIRES
  • 1) Surveys or questionnaires can be tools of great value for post-introduction observation, in view of their relatively low cost and their potential for conducting a follow-up of patients where there is no structured review process on the part of clinicians.
  • 2) The main limitations of the surveys/questionnaires concern the possibility of low response rates, incomplete or biased information or lack of representativity.
  • 3) The planning of the survey is crucial for ensuring an adequate response rate. On planning how the survey must be conducted, the following considerations should be taken into account:
    • -Response rates are highest when face-to-face interviews are conducted but these entail a higher cost than telephone interviews or postal surveys.
    • - Postal questionnaires are cheaper than other survey methods but response rates have been shown to be low in some cases. The evidence indicates however that, with adequate planning, the response rate could be similar to or even higher than that of telephone interviews, but that the proportion of unanswered questions is higher. Financial incentives are regarded as one of the best methods of improving the response rate. Previous contact and reminders are also viewed as highly effective methods of improving response rates. Other methods that increase the response rate include administration of short questionnaires, registered post, urgent post or dispatch in reply-paid envelopes.
    • - Electronic questionnaires obtain response rates much lower than those obtained via other methods. The cost of questionnaires sent by e-mail is however far lower than that of postal or telephone questionnaires.
    • - Patients and clinicians prefer postal to electronic questionnaires.
MEDICAL RECORDS
  • 1) Extracting information from medical records does not imply an extra workload for health professionals but there is evidence that frequently data is missing and retrospectively accurate information is only available for objective data.
  • 2) The available evidence is not sufficient to determine the quality of the routinely collected data.
    • - The studies identified agree on the high quality of demographic data and easily diagnosed diseases but there is discrepancy as to the quality of data regarding other diseases.
    • - There are no adequately designed studies to establish the validity of routinely recorded data for the assessment of clinical indications, side effects or affectivity problems.
  • 3) There is evidence that the degree of reporting is higher when information is obtained directly from patients than when it is extracted from their medical records, but with the available data it is not possible to establish which of the two sources furnishes better-quality data.
  • 4) There is evidence that electronic medical records could be used for post-introduction observation of new technologies if the following criteria are fulfilled:
    • - electronic health records are the only source of data for recording patient information.
    • - a system is implemented which enables close collaboration with clinicians to previously establish relevant outcome-reporting variables.
    • - a software is available to enable the collection and transfer of additional data not usually recorded on clinical histories.
MBDS In the context of observation of new technologies, the use of the MBDS is limited because, when a new technology is implemented and for a period of time thereafter, new procedures are usually grouped under general categories which do not allow for identification of cases in which the new technology is used.
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