A prospective cross-sectional descriptive observational study (AEMPS code: DAI-LOR-2020-01), without a control group, was carried out for six months (August 2020–February 2021) in a community pharmacy in Tenerife (Canary Islands, Spain). One hundred and twenty-seven patients of both genders were included in the study considering the following criteria:
Inclusion criteria: Patients starting or continuing treatment with BZD as a monodrug (lorazepam, lormetazepam, alprazolam, diazepam, bromazepam, clorazepate potassium, clonazepam, ketazolam, clobazam and flurazepam); patients aged between eighteen and ninety years of age; patients who agreed to voluntarily participate in the study and who signed the informed consent form; patients whose communication and/or decision-making abilities were not impaired; caregivers who go to the pharmacy to pick up a BZD prescribed for the patient they care for (a caregiver is defined as a person who is responsible for the acquisition and administration of medication for a dependent patient, whether or not they are a relative).
Exclusion criteria: patients who, although fulfilling the inclusion criteria, did not agree to participate in the study; patients who did not agree to sign the informed consent form; patients prescribed with combinations of BZDs or other active ingredients; patients not evaluable for a variety of reasons, at the discretion of the researcher, including incomplete records, suspicion of transcription errors in the database, unverified suspicion of exclusion criteria, among others; patients with communication, psychological or linguistic difficulties or without decision-making capacity; patients who decided to leave the study voluntarily; pregnant or breastfeeding women; patients referred from other professional pharmaceutical care services, as they may skew the results, given that patients would have received personalized information about their medication in each of these services, so their knowledge may be greater than that of patients who have not received this and the data may contain a bias.
Each patient agreed to participate voluntarily and signed an informed consent form. Data collection was performed by means of a structured clinical interview in the personalized pharmaceutical care area of the pharmacy. A questionnaire including the Eurool 5D-3L quality of life instrument and other variables such as sociodemographic variables, type of BZD, and duration of BZD treatment was used.
The sample size corresponds to an acceptable level with a confidence interval of 95% and an estimated accuracy of 5%. The statistical analysis consisted of, firstly, a description of the participants, including 95% confidence intervals (CI), and secondly, a correlation study with comparative tests of means (Pearson’s chi-square and ANOVA), considering significance p < 0.05, to study the associations between the dimensions of the EuroQol 5D-3L quality of life instrument and the rest of the variables mentioned above. Data analysis was performed using SPSS 25.0™ software from IBM Co.® (Armonk, NY, USA) on a Windows NT 365 Professional™ operating system from Microsoft Co.® (Redmond, WA, USA).
Inclusion criteria: Patients starting or continuing treatment with BZD as a monodrug (lorazepam, lormetazepam, alprazolam, diazepam, bromazepam, clorazepate potassium, clonazepam, ketazolam, clobazam and flurazepam); patients aged between eighteen and ninety years of age; patients who agreed to voluntarily participate in the study and who signed the informed consent form; patients whose communication and/or decision-making abilities were not impaired; caregivers who go to the pharmacy to pick up a BZD prescribed for the patient they care for (a caregiver is defined as a person who is responsible for the acquisition and administration of medication for a dependent patient, whether or not they are a relative).
Exclusion criteria: patients who, although fulfilling the inclusion criteria, did not agree to participate in the study; patients who did not agree to sign the informed consent form; patients prescribed with combinations of BZDs or other active ingredients; patients not evaluable for a variety of reasons, at the discretion of the researcher, including incomplete records, suspicion of transcription errors in the database, unverified suspicion of exclusion criteria, among others; patients with communication, psychological or linguistic difficulties or without decision-making capacity; patients who decided to leave the study voluntarily; pregnant or breastfeeding women; patients referred from other professional pharmaceutical care services, as they may skew the results, given that patients would have received personalized information about their medication in each of these services, so their knowledge may be greater than that of patients who have not received this and the data may contain a bias.
Each patient agreed to participate voluntarily and signed an informed consent form. Data collection was performed by means of a structured clinical interview in the personalized pharmaceutical care area of the pharmacy. A questionnaire including the Eurool 5D-3L quality of life instrument and other variables such as sociodemographic variables, type of BZD, and duration of BZD treatment was used.
The sample size corresponds to an acceptable level with a confidence interval of 95% and an estimated accuracy of 5%. The statistical analysis consisted of, firstly, a description of the participants, including 95% confidence intervals (CI), and secondly, a correlation study with comparative tests of means (Pearson’s chi-square and ANOVA), considering significance p < 0.05, to study the associations between the dimensions of the EuroQol 5D-3L quality of life instrument and the rest of the variables mentioned above. Data analysis was performed using SPSS 25.0™ software from IBM Co.® (Armonk, NY, USA) on a Windows NT 365 Professional™ operating system from Microsoft Co.® (Redmond, WA, USA).
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