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In order to adequately collect the data required to meet the aim and objectives of the study, it was required that tools for data collection be developed.

3.6.1 Development of data collection tools.

One data collection tool was required for each area of the study. These tools needed to be developed from scratch, as there was no previously existing tool which met the requirements for each area.

3.6.1.1 Clinical audit data collection form.

The data collection form used for the clinical audit was purpose designed to be as streamlined as possible for the designated task (Appendix 1).

Demographical information collected included the patient's file number, gender, the ward in which they were housed, age, weight and height as well as BMI. Admission details recorded were date of admission, diagnosis, and any co-morbid conditions present in the patient. Social demographical information was collected, specifically relating to the use or abuse of legal and illegal substances. A space was also made available for recording family history as certain mental illnesses may have a strong genetic component.

Vital sign information on the six latest readings was captured for patients, with space allowed for blood pressure, pulse, temperature, respiratory rate and blood glucose readings. A brief listing of the normal values expected to be seen with the respective vital sign was included for comparison. Past medical history of patients

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was recorded, including all medication used by a patient during their admission that was not currently being used or part of the patient's current prescription. The form differentiated between antipsychotic drugs and other drugs. Current medication, medication doses and frequency were recorded in a similar manner to past medication use.

Laboratory tests (i.e. blood tests) were recorded, including testing done immediately before (as patients will be referred to the study site from another primary health care facility) and during the admission. Space was allocated for specific tests most frequently performed in these circumstances, including the initial battery of blood tests, as well as certain specific markers for antipsychotic ADRs (e.g. Creatine Kinase). Space for four different batteries of laboratory testing was provided. Any testing which was not part of the usual routine battery of laboratory tests was also recorded. Such tests could include testing for specific markers of ADR, or for any level that was not specifically provided for, such as thyroid function tests.

Any mention of a symptom experienced by the patient that could have been linked to a possible ADR was recorded. The date upon which the symptom was documented was recorded, as well as the symptom itself, and the possible ADR it could have been related to. The documenting professional of the symptom was recorded. Finally an area for recording any ADR that was identified and documented was provided. Space was allocated for the date, the profession of the documenting person (typically doctor or nurse), the ADR that was identified, as well as whether the ADR was first noticed by the professional (observation) or the patient (report).

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The questionnaire disseminated to healthcare professionals was purpose- designed and consisted of 13 questions (Appendix 2). The aim of the questionnaire was to assess the knowledge of healthcare professionals towards ADR to antipsychotic drugs, and to determine their attitudes and opinions regarding ADR documentation.

Demographic information of the participating healthcare professional was collected, such as their profession, and their designation within that profession. Professionals could indicate the number of years they have spent working in a psychiatric setting. This information could be useful as more time spent in a psychiatric setting could translate to a greater level of understanding of the antipsychotic drugs and the ADR commonly associated with this class of drugs. Questions were included which targeted the understanding of the term 'adverse drug reaction', including one open question and two multiple choice questions wherein professionals could select multiple answers. A question was included which was designed to assess healthcare professional's knowledge regarding the ADR most commonly expected with the antipsychotic drugs and was provided in the form of a table of antipsychotic drugs often used at the study site, as well as ADR expected with the use of those antipsychotic drugs. Professionals could indicate any drug they felt would cause a given reaction. Following these questions the focus was placed on documentation of ADR. Professionals were asked the open ended questions regarding documentation of ADR and other steps in the management process of an ADR. Closed ended questions with multiple answers were asked relating to frequency of documentation, the purpose of documentation, and various tools which could be used to improve documentation

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3.6.2 Piloting of data collection tools.

For the purpose of reporting of results found during the pilot study, all times are displayed as 'x' minutes ± standard deviation.

3.6.2.1 Clinical audit data collection form pilot.

A pilot study was performed before the pre-intervention phase to assess the functionality of the data collection form as prepared by the researcher, as well as to test for reliability and reproducibility of results. The files of 10 discharged patients were screened using the original form. Each screening was timed to determine how long a screening would take on average. After the initial pilot study it was found that there were areas in which the data collection form was lacking, and areas which could be improved to streamline the data collection process overall. The data collection form was altered to reflect the recommended changes, after which a second pilot study was performed. The files of 10 different discharged patients were screened using the updated form. The screenings were again timed and any difficulties with regard to data collection were noted.

During the first pilot the mean time taken to screen patient medical files was 25.47±5.26 minutes (n=10). Problems encountered included the following: the layout of the form did not match the layout of the file; difficulties in using the form triggered rushing through the data collection. These difficulties were amended by reorganisation of the data collection form to reflect the layout of the patient medical files at the site of study.

During the second pilot study the mean time taken to screen patient medical files was 26.13±4.93 minutes (n=10).The mean time taken to screen a patient file was longer than that seen in the first pilot study, indicating less rushing through the process of data collection. Problems encountered during the second pilot study included: lack of a space for recording creatine kinase levels (a blood level taken

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to determine risk of severe ADRs to antipsychotic drugs); and frequent lack of blood test results in patient medical files. The former problem was amended by adding an area for creatine kinase level documentation in the data collection form. Given that the latter problem was based more in the patient medical files than the data collection form this could not be amended. Following the completion of the secondary pilot, the data collection form was accepted to remain in its final stage.

3.6.2.2 Healthcare professional questionnaire

pilot.

A pilot study was performed before the introduction of the questionnaire to the healthcare professionals. The purpose of the pilot was to determine the functionality and usability of the questionnaire. The questionnaire was delivered to four final year B.Pharm students at NMMU, six third year nursing students at NMMU and one staff member at NMMU who was a qualified medical doctor. Participants were timed as they filled in the questionnaire in order to determine the average time taken.

The mean time taken by B.Pharm final year students was 15.99±1.27 minutes (n=4). The only problem encountered by the B.Pharm students was that they felt the pharmacology based ADR table would be too in-depth for non-pharmacists. The mean time taken by the third year nursing students was 16.51±2.01 minutes (n=6). A similar problem to that found with the B.Pharm students was encountered in that the nursing students felt the pharmacology was at a very detailed level for nurses to deal with.

Only one medical doctor was used for the pilot study. The time taken to complete the questionnaire was 30.00 minutes. No problems were encountered.

The questionnaire was amended to reflect a less in-depth level of pharmacology. This was then finalised and used for the actual data collection. The same

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questionnaire was used for medical doctors and professional nurses, as comparing the results between the professions would be implausible if different data collection tools were used.

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