Systematic review protocol: following PRISMA guide from Cochrane to generate evidence as treatment effect of pharmaceutical care for hypertension in primary care

Cazarim, Maurílio de Souza; Reis, Tiago Marques dos; Cruz-Cazarim, Estael Luzia Coelho da; Pereira, Leonardo Régis Leira

doi:10.1590/s2175-979020200001181028

Maurílio de Souza Cazarim ^**Correspondence: M. S. Cazarim. Centro de Pesquisa em Assistência Farmacêutica e Farmácia Clínica (CPAFF). Faculdade de Ciências Farmacêuticas de Ribeirão Preto. Universidade de São Paulo. Sala 23, bloco S. Av. Café, s/nº 14040-903, Ribeirão Preto - SP, Brasil. Phone: +55 16 3315-4236. E-mail: maurilio.jf@gmail.com

PhD. Pharmaceutical Sciences department, Pharmaceutical Services and Clinical Pharmacy Research Center (CPAFF), School of Pharmaceutical Sciences of Ribeirão Preto, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.

Professor of Faculty of Farmacy of Federal University of Juiz de Fora, Juiz de Fora, Minas Gerais, Brazil

https://orcid.org/0000-0002-2826-5903

Tiago Marques dos Reis

PhD. Professor of Faculty of Pharmaceutical Sciences, Federal University of Alfenas, Alfenas, Minas Gerais, Brazil.

Estael Luzia Coelho da Cruz-Cazarim

MSc. Pharmacist of Pharmaceutical Service of School of Pharmaceutical Sciences of Ribeirão Preto, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.

Leonardo Régis Leira Pereira

Professor of Department of Pharmaceutical Sciences department, Pharmaceutical Services and Clinical Pharmacy Research Center (CPAFF), School of Pharmaceutical Sciences of Ribeirão Preto, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.

*Correspondence: M. S. Cazarim. Centro de Pesquisa em Assistência Farmacêutica e Farmácia Clínica (CPAFF). Faculdade de Ciências Farmacêuticas de Ribeirão Preto. Universidade de São Paulo. Sala 23, bloco S. Av. Café, s/nº 14040-903, Ribeirão Preto - SP, Brasil. Phone: +55 16 3315-4236. E-mail: maurilio.jf@gmail.com

CONFLICT OF INTEREST

The authors confirm that the content of this paper has no conflict of interest.

PICO PECO
Population: patients with systemic arterial hypertension	Population: patients with systemic arterial hypertension
Intervention: pharmaceutical care	Exposure: non-exposed individuals are those who were assisted by pharmaceutical care, and exposed are those who received only conventional care from the health care system.
Comparator: conventional care of the hypertensive patient in the health system basic care service (all the service offered by the health system in this area without pharmaceutical care)	Comparator: conventional care of the hypertensive patient in the health system basic care service.
Outcomes: are not indicated by Cochrane in the strategy because they limit the search too much and lose the search sensitivity.	Outcomes: are not indicated by Cochrane in the strategy because they limit the search too much and lose the search sensitivity.

MeSH	Emtree thesaurus	DeCS
Population: “hypertension”[MeSH Terms] OR “Blood Pressure”[MeSH Terms] OR “Arterial Pressure”[MeSH Terms]	Population: "hypertension”/exp OR "blood pressure”/exp OR “arterial pressure”/exp OR “pulse pressure”/exp OR “diastolic blood pressure”/exp OR “systolic blood pressure”/exp	Population: (Hypertension) OR (Prehypertension) OR (Blood Pressure) OR (Arterial Pressure) OR (Pulse) OR (Blood Pressure High) OR (Diastolic Pressure) OR (Pressure Systolic)
Intervention: “Pharmacy”[MeSH Terms] OR “Pharmacists”[MeSH Terms] OR “Pharmaceutical Services”[MeSH Terms]	Intervention: “pharmaceutical care”/exp OR “clinical pharmacy”/exp OR “pharmacist”/exp	Intervention: (Pharmaceutical Care) OR (Community Pharmacy Services) OR (Pharmaceutical Services) OR (Pharmacists) OR (Pharmacy) OR (Pharmacy Residence) OR (Medication Therapy Management) OR (Drug Therapy Management) OR (Pharmacist Intervention)
Comparator: “Primary Health Care”[MeSH Terms] OR “Community Health Services”[MeSH Terms] OR “Preventive Medicine”[MeSH Terms] OR “Secondary Care"[MeSH Terms]	Comparator: “Primary Health Care”/exp OR “Community Care”/exp OR “Preventive Medicine”/exp OR “Secondary Health Care"/exp	Comparator: (Primary Health Care) OR (Primary Care) OR (Community Health Services) OR (Community Health Care) OR (Preventive Medicine) OR (Comprehensive Health Care) OR (Secondary Care) OR (Secondary Health Care)

Population	Intervention	Comparator
(hypertension) OR (“Blood Pressure High”) OR (“Blood Pressures High”) OR (“High Blood Pressure”) OR (“High Blood Pressures”) OR (“Pressure Blood”) OR (“Blood Pressure”) OR (“Pressures Blood”) OR (“Blood Pressures”) OR (“Diastolic Pressure”) OR (“Pressure Diastolic”) OR (“Diastolic Pressures”) OR (“Pressures Diastolic”) OR (“Pulse Pressure”) OR (“Pressure Pulse”) OR (“Systolic Pressure”) OR (“Pulse Pressures”) OR (“Pressures Pulse”) OR (“Systolic Pressures”) OR (“Pressure Systolic”) OR (“Pressures Systolic”) OR (“Arterial Pressure”) OR (“Arterial Pressures”) OR (“Pressure Arterial”) OR (“Pressures Arterial”) OR (“Arterial Tension”) OR (“Arterial Tensions”) OR (“Tension Arterial”) OR (“Tensions Arterial”) OR (“Blood Pressure Arterial”) OR (“Arterial Blood Pressure”) OR (“Arterial Blood Pressures”) OR (“Blood Pressures Arterial”) OR (“Pressure Arterial Blood”) OR (“Pressures Arterial Blood”) OR (“Aortic Pulse Pressure”) OR (“Aortic Pulse Pressures”) OR (“Pressure Aortic Pulse”) OR (“Pressures Aortic Pulse”) OR (“Pulse Pressure Aortic”) OR (“Pulse Pressures Aortic”) OR (“Mean Arterial Pressure”) OR (“Arterial Pressure Mean”) OR (“Arterial Pressures Mean”) OR (“Mean Arterial Pressures”) OR (“Pressure Mean Arterial”) OR (“Pressures Mean Arterial”) OR (“Aortic Pressure”) OR (“Aortic Pressures”) OR (“Pressure Aortic”) OR (“Pressures Aortic”) OR (“Aortic Tension”) OR (“Aortic Tensions”) OR (“Tension Aortic”) OR (“Tensions Aortic”) OR (“Blood Pressure Aortic”) OR (“Aortic Blood Pressure”) OR (“Aortic Blood Pressures”) OR (“Blood Pressures Aortic”) OR (“Pressure Aortic Blood”) OR (“Pressures Aortic Blood”) OR (“Mean Aortic Pressure”) OR (“Aortic Pressure Mean”) OR (“Aortic Pressures Mean”) OR (“Mean Aortic Pressures”) OR (“Pressure Mean Aortic”) OR (“Pressures Mean Aortic”) OR (hypertensive) OR (“hypertensive patients”) OR (“hypertensive patient”) OR (“mean artery pressure”) OR (“mean blood pressure”) OR (“mean arterial blood pressure”) OR (“mean artery pressure”) OR (“preexistent hypertension”) OR (“hypertensive effect”) OR (“hypertensive response”) OR (“cardiovascular hypertension”) OR (“blood tension”) OR (“blood tensions”) OR (“vascular pressure”) OR (“vascular pressures”) OR (“arterial pulse pressure”) OR (“arterial pulse pressures”) OR (“artery pulse pressure”) OR (“artery pulse pressures”) OR (“pulse tension”) OR (“pulse tensions”) OR (“artery blood pressure”) OR (“artery blood pressures”) OR (“artery pressure”) OR (“artery pressures”) OR (“aorta blood pressure”) OR (“blood pressure aorta”) OR (“pressure aorta”) OR (“aorta blood pressures”) OR (“blood pressures aorta”) OR (“systemic arterial pressure”) OR (“systemic artery pressure”) OR ("diastolic blood pressure") OR ("Systolic blood pressure") OR (“blood pressure systolic”) OR (“blood systolic pressure”) OR (“blood diastolic pressure”) OR (“blood pressure diastolic”) OR (“systemic arterial pressures”) OR (“systemic artery pressures”) OR ("diastolic blood pressures") OR ("Systolic blood pressures") OR (“blood pressures systolic”) OR (“blood systolic pressures”) OR (“blood diastolic pressures”) OR (“blood pressures diastolic”)	(“Medication Therapy Management”) OR (“Management Medication Therapy”) OR (“Therapy Management Medication”) OR (“Drug Therapy Management”) OR (“Management Drug Therapy”) OR (“Therapy Management Drug”) OR (“Pharmaceutical Care”) OR (“Care Pharmaceutical”) OR (“Pharmacist Interventions”) OR (“Pharmacist Intervention”) OR (“Pharmacists Interventions”) OR (“Pharmacists Intervention”) OR (“medication management”) OR (“medication reconciliation”) OR (“Pharmaceutic Intervention”) OR (“Pharmaceutic Interventions”) OR (“Pharmaceutical Interventions”) OR (“Pharmaceutical Intervention”) OR (“Pharmaceuticals Intervention”) OR (“Pharmaceuticals Interventions”) OR (“Clinical Pharmacists”) OR (“Clinical Pharmacist”) OR (“Pharmacist Clinical”) OR (“Pharmacists Clinical”) OR (“Pharmaceutical Service Community”) OR (“Pharmaceutical Services Community”) OR (“Service Community Pharmaceutical”) OR (“Services Community Pharmaceutical”) OR (“Pharmacy Services Community”) OR (“Community Pharmacy Service”) OR (“Pharmacy Service Community”) OR (“Services Community Pharmaceutic”) OR (“Services Community Pharmacy”) OR (“Community Pharmaceutic Services”) OR (“Community Pharmaceutic Service”) OR (“Pharmaceutic Service Community”) OR (“Pharmaceutic Services Community”) OR (“Service Community Pharmaceutic”) OR (“Community Pharmaceutical Services”) OR (“Community Pharmaceutical Service”) OR (“Service Community Pharmacy”) OR (“Pharmacy Service Clinical”) OR (“Service Clinical Pharmacy”) OR (“Clinical Pharmacy Services”) OR (“Pharmacy Services Clinical”) OR (“Services Clinical Pharmacy”) OR (“Clinical Pharmacy Service”) OR (“Pharmacy Residencies”) OR (“Pharmacy Residency”) OR (“Medication Management”) OR (“medication reconciliation”)	(“Care Primary Health”) OR (“Primary Care”) OR (“Care Primary”) OR (“Primary Healthcare”) OR (“Healthcare Primary”) OR (“Health Services Community”) OR (“Community Health Service”) OR (“Health Service Community”) OR (“Service Community Health”) OR (“Services Community Health”) OR (“Community Health Care”) OR (“Care Community Health”) OR (“Health Care Community”) OR (“Community Healthcare”) OR (“Community Healthcares”) OR (“Healthcare Community”) OR (“Healthcares Community”) OR (“Community Health Services”) OR (“Preventative Medicine”) OR (“Medicine Preventative”) OR (“Preventive Medicine”) OR (“Preventive Care”) OR (“Care Preventive”) OR (“Preventative Care”) OR (“Care Preventative”) OR (“Health Care Comprehensive”) OR (“Comprehensive Healthcare”) OR (“Healthcare Comprehensive”) OR (“First Line Care”) OR (“Health Care Primary”) OR (“Community Care Service”) OR (“Community Care Services”) OR (“Preventive Health Care”) OR (“Secondary Health Care”) OR (“Secondary Healthcare”) OR (“Care Secondary”) OR (“Secondary Care”) OR (“Secondary Cares”)

Name of reviewer	Identification of the study	Eligibility criteria	Confirmation of eligibility
• Who is making the search and assessing the studies	• Author • Title • Reference.	• Meeting all the items described in the inclusion criteria; • Absence of biases that strongly compromise the credibility of the study; • Availability of data to be included in the systematic review.	• Considering the study design, the intervention, and the population involved, does the study have potential to be included? (Yes or No or Not clear)

Items	Description
Basic data	Year Reference Country Author Planned sample number
Method details	1. Study Design 2. Number of pharmaceutical consultations 3. Follow-up time 4. Number of pharmacists (for follow-up) 5. Randomization (“adequate”, “inadequate” or “not reported” by the study) 6. Allocation concealment (reported or unreported) 7. Blinding scheme: • Researchers – “yes”, “no” or “not reported” • Participants – “yes”, “no” or “not reported” • Outcome assessors – “yes”, “no” or “not reported”
Participants	Number of patients randomized by treatment branch or divided between comparison groups (exposed and not exposed) Number of follow-up losses per group
Clinical scenario	Primary/preventive care unit (regarding the basic health unit, there should also be other professionals, if not it can be considered as a community pharmacy) Outpatient Community pharmacy (regarding the drugstore or basic pharmacy, with only the pharmacist as a health professional) Others
Intervention (Characteristics of monitoring)	1. Educational / Empowerment 2. Multi-professional support 3. Patient compliance was worked on 4. Pharmacotherapy management model (SOAP, PW, DADER, Proper or unspecified)
Instruments and equipment used to measure outcomes	Take note of the brand label and company that made it
Outcomes	• Definition of each outcome investigated with its respective diagnostic criteria. • Unit of measurement (if applicable) used as the gold standard (yes or no) • For scales: • report the upper and lower limits; • report whether the score was high or low and whether it represented clinical improvement Main outcomes 1. Blood pressure 2. Cardiovascular risk 3. Total Cholesterol 4. Fractions (LDL, VLDL, HDL) 5. Consumption of antihypertensive drugs (mg/day or month or year) 6. Number of consultations (Basic, Cardiologist and Urgent/Emergency) 7. Number of examinations related to the follow-up of Systemic Arterial Hypertension 8. Percentage of patients with blood pressure at satisfactory levels (if this information is direct in the article, add which guideline was used as reference, if it is possible to calculate the percentage, the American guideline ACC / AHA should be used as reference)
Results	• For each outcome, report categorical and/or continuous and/or discrete variables. • Subgroups to be analyzed: calculate the number of events to the total number of patients in each group
Sociodemographic descriptive data	• Average age • Gender percentage • Average income • Schooling Ethnicity • Previous history of diseases • Comorbidities • History of health events associated with systemic arterial hypertension
Clinical parameters of interest for systemic arterial hypertension	• Hypertension and cardiovascular risk staging • Body Mass Index • Obesity • Abdominal circumference • Smoker • Drinker • Others

[1] *Correspondence: M. S. Cazarim. Centro de Pesquisa em Assistência Farmacêutica e Farmácia Clínica (CPAFF). Faculdade de Ciências Farmacêuticas de Ribeirão Preto. Universidade de São Paulo. Sala 23, bloco S. Av. Café, s/nº 14040-903, Ribeirão Preto - SP, Brasil. Phone: +55 16 3315-4236. E-mail: maurilio.jf@gmail.com