Impact Assessment of Pharmaceutical Care in the Management of Hypertension and Coronary Risk Factors after Discharge

Introduction Almost 50% of the 17.5 million deaths worldwide from cardiovascular disease have been associated with systemic arterial hypertension (SAH). Into this scenario, Pharmaceutical Care (PC) has been inserted in order to improve the management of SAH and reduce its risks. Objective To evaluate the outcomes and healthcare assistance achieved after discharge of hypertension patients from the PC program. Methods This is a quasi-experimental study with historical controls. Retrospective data collection from 2006 to 2012 was begun in 2013 and included a PC program performed over one year. PC was performed in two basic units of the public health system in Ribeirão Preto-SP, Brazil, where the pharmacist followed up 104 hypertensive patients. The clinical indicators of systolic (SBP) and diastolic blood pressure (DBP), triglycerides, total-cholesterol, high and low density lipoprotein cholesterol were collected, as well as care indicators related to the number of consultations (basic, specialized and emergency care) and antihypertensive drugs used. The coronary risk of patients by the Framingham risk score was also calculated. For the analysis, the data were divided into three periods, 2006–2008 as pre-PC, 2009 as PC and 2010–2012 as post-PC. Results In the pre-PC period, 54.4%, 79.0% and 27.3% of patients presented satisfactory levels of SBP, DBP and total-cholesterol, respectively. In the post-PC period, the percentages were 93.0% for SBP and DBP [p <0.001] and 60.6% for total-cholesterol [p <0.001]. The average number of consultations per patient/year in primary care was 1.66 ± 1.43 and 2.36 ± 1.73, [p = 0.012]; and for emergency care was 1.70 ± 1.43 and 1.06 ± 0.81, [p = 0.002] in the pre-PC and post-PC periods, respectively. The pre-PC Framingham risk in the last year was 14.3% ± 10.6 and the average post-PC was 10.9% ± 7.9. Conclusion PC was effective in the control of blood pressure and total-cholesterolafter discharge of the hypertensive patients from PC program.


Introduction
Background 2 Scientific background and explanation of rationale 2-3 -We emphasize the importance of chronic diseases in the world, the high prevalence of hypertension, ineffective results for the control of blood pressure and called it to the results that the PC has achieved, and highlight the importance of showing these results after discharge, as our study aimed.

Participants 3
Eligibility criteria for participants, including criteria at different levels in recruitment/sampling plan (e.g., cities, clinics, subjects) 3 -Individuals diagnosed with SAH and in medical care for the disease, aged over 20 years, users of the health unit within the PC program, and those who used at least one antihypertensive medication were included in the program. The program excluded patients who could not continue the planning of pharmaceutical consultations, pregnant women and those who had some kind of diagnosed cognitive impairment.
4-From August to November 2008 the patient was approached at the time of receipt of the drug in the health unit, and invited to participate in the PC program. If the patient met the inclusion criteria and did not meet any item in the exclusion criteria, they were invited to sign the Free and Informed Consent Terms, with guidance from the pharmacist of the program. o Exposure quantity and duration: how many sessions or episodes or events were intended to be delivered? How long were they intended to last?
4was scheduled to consult the pharmacist once a month during a year o Time span: how long was it intended to take to deliver the intervention to each unit?

4-one year
o Activities to increase compliance or adherence (e.g., incentives) 5-During all PC period, the pharmacist worked on health education through informative lectures, educational materials on health, and guidance during the consultations. Adherence to drug therapy was also worked on.
Objectives 5 Specific objectives and hypotheses 7-Indicators to assess the impact of Pharmaceutical Care; under hypothesis that the results are maintained even three years after discharge

Outcomes 6
Clearly defined primary and secondary outcome measures 7-The indicators were defined according to the clinical and care data, considering primary outcome, blood pressure, and secondary outcomes, plasma lipid levels, coronary risk and care.
Methods used to collect data and any methods used to enhance the quality of measurements Blinding (masking) 9 Whether or not participants, those administering the interventions, and those assessing the outcomes were blinded to study condition assignment; if so, statement regarding how the blinding was accomplished and how it was assessed.
Unit of Analysis 10 Description of the smallest unit that is being analyzed to assess No apllied 7-For the analysis of clinical indicators, the data were categorized as satisfactory; intervention effects (e.g., individual, group, or community) If the unit of analysis differs from the unit of assignment, the analytical method used to account for this (e.g., adjusting the standard error estimates by the design effect or using multilevel analysis) The inferential statistic was based on paired data, this means relating to the data of the same individuals for analysis at different time points, because of this there were no potential confounders. Thus, for the clinical indicators the Cochran Q test was performed to compare variables of categorical type. ANOVA for medication and coronary risk and Friedman for consultation.
Inclusion of aspects employed to help minimize potential bias induced due to non-randomization (e.g., matching)

Participant flow 12
Flow of participants through each stage of the study: enrollment, assignment, allocation, and intervention exposure, follow-up, analysis (a diagram is strongly recommended) o Enrollment: the numbers of participants screened for eligibility, found to be eligible or not eligible, declined to be enrolled, and enrolled in the study o Assignment: the numbers of participants assigned to a study condition o Allocation and intervention exposure: the number of participants assigned to each study condition and the number of participants who received each intervention Pg 7 -8 -The choice of the analysis methods.
We believe we represent the flow of patients in Figure 1. We put on methods due justify the stratification of the sample size for each indicator analyzed and described this methodology. This option to put the methodology is justified by this study does not refer specifically to the intervention program, but the period after discharge. However, we discussed this in the discussion of the results.
Pg 6 -The method used to select the sample was convenience sampling, whereby 191 patients were invited who were considered eligible in accordance with the inclusion criteria and 37 individuals were exclude because did not fulfill the eligibility criteria for this study; Pg 6 - Figure 1 -104 patients, after before comparasion. Baseline characteristics for each study condition relevant to specific disease prevention research pg 11-According to the sample size calculation for the dependent variable, the 57 patients who had the SBP and DBP variable analyzed in our study were representative to make inferences to the study population.
Pg 4-From this moment the patient was included in the PC program. During 2009, from January to December, one pharmacist followed up 104 patients in this PC program. In 2013, data collection for this study was performed in order to gather the clinical and health care data of individuals monitored by PC.
Baseline comparisons of those lost to follow-up and those retained, overall and by study condition Comparison between study population at baseline and target population of interest Pg 10 -11 - Table 2; table 3 and figure 2 and 3.
Pg 11 -14-We discussed the results of each indicator and compare with the literature, the limitations were explained in the last paragraph of the manuscript, and concluded by stating that there is a hypothesis generated, because this study is quasi-experimental.
Discussion of results taking into account the mechanism by which the intervention was intended to work (causal pathways) or alternative mechanisms or explanations Discussion of the success of and barriers to implementing the intervention, fidelity of implementation Discussion of research, programmatic, or policy implications Pg 13 -PC addresses the individual as a whole in their biopsychosocial characteristics, involving health-education activities. Despite using pharmacotherapy in the planning of PC actions, PC is not restricted to the pharmacological effects.
In this sense, non-pharmacological interventions and guidelines empowering the patient to their care are made, improving adherence and quality of life.
Pg 16 -. To sum up, these results showed that PC is a professional practice able to be incorporated into the health services in order to contribute to the reduction of the risk of coronary heart disease and also to morbi-mortality from hypertension, under the hypothesis generated by this work that the results are maintained even three years after discharge.
Pg 15is expected that these results help in the development of systematic reviews and methodological development of new studies evaluating this technology in health. Considering the optimization of outcomes by PC, which are also supported by other studies, it is intended that these results assist in the effective implementation of PC in the PHS, mainly in the collaboration of not only the immediate outcomes, but also for viewing the PC results after discharge of patients.