Evidence based practice

Protocol

The multiple lifestyle modification for patients with prehypertension and hypertension patients: a systematic review protocol

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  1. Juan Liane,
  2. Hui Zheng1,
  3. Huai-bin Dutwo,
  4. Xiao-ping Tian2,
  5. Yi-jing Jiang3,
  6. Shao-lan Zhangiv,
  7. Yu Kangv,
  8. Xiang Li2,
  9. Jie Chenone,
  10. Chao Lu1,
  11. Zhen-hong Lai1,
  12. Fan-rong Liang1
  1. 1 Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, People's Republic of Red china
  2. 2 Third Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, People's Republic of Communist china
  3. 3 Fujian Academy of Traditional Chinese Medicine, Fuzhou, Fujian, People's Democracy of People's republic of china
  4. 4 Chengdu Medical College, Chengdu, Sichuan, People'south Commonwealth of China
  5. 5 First Affiliated Hospital of Chengdu Academy of Traditional Chinese Medicine, Chengdu, Sichuan, People'south Republic of Communist china
  1. Correspondence to Fan-rong Liang; acuresearch{at}126.com

Abstruse

Introduction The objective of this systematic review is to investigate the effectiveness, efficacy and safety of multiple concomitant lifestyle modification therapies for patients with hypertension or prehypertension.

Methods and analysis Electronic searches volition be performed in the Cochrane Library, OVID, EMBASE, etc, along with manual searches in the reference lists of relevant papers found during electronic search. We will place eligible randomised controlled trials utilising multiple lifestyle modifications to lower claret force per unit area. The command could exist drug therapy, single lifestyle change or no intervention. Changes in systolic blood pressure and diastolic blood pressure constitute primary end points, and secondary stop points include the number of patients meeting the role target blood pressure, the number of patients reporting microvascular or macrovascular complications, etc. We volition extract descriptive, methodological and efficacy data from identified randomised controlled trials (RCTs). We will calculate the relative risk for proportion of patients with a normal blood pressure level in the experimental group. Dichotomous data will be analysed using risk difference and continuous information using weighted mean differences, both with 95% CI. We will use the χ2 test and the I2 statistic to assess heterogeneity. We will utilize the fixed effects model to compute the efficacy unless there is evidence of heterogeneity. If heterogeneity of consequence size persists with respect to claret force per unit area modify, farther metaregression will be performed inside groups. We will examine the potential for publication bias by using a funnel plot.

Broadcasting Nosotros volition synthesise results from RCTs which provide more precise and accurate information on the event of multiple lifestyle changes on blood pressure level. The results of this review will increase the understanding of multiple lifestyle modifications for patients with hypertension or prehypertension.

This is an Open Admission article distributed in accordance with the Creative Commons Attribution Non Commercial (CC By-NC iii.0) license, which permits others to distribute, remix, adapt, build upon this work not-commercially, and license their derivative works on different terms, provided the original piece of work is properly cited and the utilize is non-commercial. See: http://creativecommons.org/licenses/past-nc/iii.0/

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Strengths and limitations of this study

  • To the best of our knowledge, this is the outset systematic review to investigate the effectiveness, efficacy and prophylactic of multiple lifestyle changes for patients with hypertension.

  • The results of this systematic review can provide clinicians with useful clinical information to guide their patient intendance and increase the understanding of lifestyle modifications, too equally motivate patients with hypertension to adopt and maintain multiple lifestyle changes.

  • The limitation of this systematic review is that it may be difficult to retrieve all the multiple lifestyle modifications for patients with hypertension. We volition cooperate with the experienced medical librarian to design an appropriate search strategy, in order to ensure a broad search.

Background

Essential hypertension continues to be an important public health challenge worldwide.1 Hypertension (7%) is the leading cause of death followed past stroke (16.6%) and heart failure (7.3%).2 It is an contained gamble gene affecting the development of cardiovascular illness (myocardial infarction, middle failure and stroke), chronic kidney affliction and peripheral vascular disease.two Hypertension affects 29.3% of the adult population in the Usa.3 Information technology affects almost 18.8% of the Chinese population according to the fourth National Nutrition and Wellness Survey in 2002.four The Joint National Committee (JNC)-7 created a new category of hypertension, 'prehypertension',v which is divers every bit systolic claret pressure (SBP) of 120–139 mm Hg or diastolic blood pressure (DBP) of fourscore–89 mm Hg. Patients in this category are at increased risk for progression to hypertension. Numerous studies emerged later to investigate the chance of prehypertension for various types of agin outcomes, including stroke, coronary heart affliction and cardiovascular affliction (CVD), and all-cause mortality.6–nine From 2005 to 2006, approximately three of viii adults in the United states had blood pressure level in the prehypertensive range of 120–139/eighty–89 mm Hg and roughly one in viii adults had blood pressure in the range of 130–139/85–89 mm Hg.10 Furthermore, the number of patients with hypertension and prehypertension patients is nevertheless increasing. Although hypertension and prehypertension affects a big portion of the population, recognition and adequate treatment are less than platonic.11 Despite the availability of multiple effective antihypertensive drugs, hypertension control rates remain poor. Hypertension expenditures represent a significant amount of healthcare resource use.12 The full annual medical expenditures attributed to hypertension including comorbidities are estimated to range from US$108 to United states of america$110 billion.13 As we all known, some antihypertensive drugs may cause side furnishings such every bit dizziness, headache, fatigue, chest discomfort, cough and sexual dysfunction, prompting some patients to discontinue therapy.

Therefore, there is an urgent need to develop and implement non-pharmacological methods (such equally common salt reduction, weight loss and exercise) to ameliorate prevention and treatment of this major cause of death. Every bit a modifiable chance factor, treatment of prehypertension and hypertension through lifestyle changes is a vital approach.fourteen Lifestyle interventions accept a profound impact on the national economical impact of hypertension.12 The JNC-815 and 2013 ESH/ESC16 guidelines and the results of trials17–20 on lifestyle modification for hypertension recommended that lifestyle modification is capable of lowering the blood pressure. Withal, piffling is known about the efficacy of programmes that arbitrate on multiple lifestyle factors to maximise the blood force per unit area lowering event. Testify regarding the magnitude of multiple lifestyle modification-related reductions in blood pressure is inconsistent. As well, the benefits of multiple lifestyle changes have not been carefully examined. We raised the post-obit questions: (1) Is a multiple concomitant lifestyle modification therapy effective for patients with hypertension or prehypertension? (two) If so, what is the magnitude of multiple lifestyle modification-related reductions on claret pressure? We will pool results from randomised control trials to provide more than precise and accurate information on the effect of multiple lifestyle changes on blood pressure.

Method and pattern

Criteria for considering studies for this review

Blazon of studies

The review will include randomised controlled trials published in the English language only. Completed or ongoing trials will be included in this review, likewise as trials using only the parallel design.

Participant characteristics

Participants to be included are adult participants (≥18 years of age) presenting with prehypertension (SBP: 120–139 mm Hg; DBP 80–89 mm Hg) or essential hypertension (SBP ≥140 mm Hg; DBP ≥90 mm Hg), according to the JNC guideline.5 Restrictions will not exist placed on the gender or indigenous groundwork of participants.

Intervention characteristics

Studies utilising multiple lifestyle modifications (a combination of at least two of the following methods: weight loss,21 Nuance diet,22–25 dietary sodium reduction,26 concrete action,27 moderation of alcohol consumption) will be reviewed. We include multiple lifestyle modifications consisting of at least dietary pattern changes (including sodium reduction) and physical activity. We also allow cointerventions if they are practical in all arms (including antihypertensive drugs, self-monitoring). The lifestyle modification should last for at least 4 weeks, and the follow-up stage should be at least 4 weeks. And how did the patients implement the lifestyle changing must be specified in the original article. However, studies using nurse, doc or pharmacologist counselling (face-to-face, grouping counselling, etc), and computer or telephone monitoring volition exist excluded.

Command arm characteristics

Studies utilising any type of non-pharmacological handling, single lifestyle change, waiting list, no intervention or any type of antihypertensive drugs as a command arm volition be included.

We volition include the following controls:

  1. Multiple lifestyle modifications+antihypertensive drugs versus antihypertensive drugs;

  2. Multiple lifestyle modifications versus waiting list control or no intervention;

  3. Multiple lifestyle modifications versus sham command (irrelevant lifestyle modification for hypertension);

  4. Multiple lifestyle modifications versus single lifestyle modification.

Outcome measures

The primary outcomes of this systematic review are the changes of SBP and DBP betwixt baseline and after treatment. The secondary outcomes including (1) the number of patients meeting the role target claret force per unit area; (2) the number of patients reporting microvascular complications (retinopathy, neuropathy, nephropathy); (3) the number of patients with macrovascular complications (cardiovascular affliction, stroke/transient ischaemic attack, myocardial infarction, peripheral vascular affliction); (4) All cause mortality, cardiovascular bloodshed, cerebrovascular mortality.

The whole process of this systematic review is presented in figure 1.

Database and search

We will identify relevant randomised controlled trials, only in the English language, by a systematic search of EMBASE, MEDLINE, AMED, the Cochrane library, CINAHL, ISI Web of Noesis and the Cochrane Key Registry of Controlled Trials. An experienced medical librarian designed terms (encounter table 1) to retrieve trials enrolling participants with prehypertension or hypertension managed with multiple lifestyle modifications. Reviewers will scan all the retrieved trials and other relevant manufactures. We will review the reference list of previously published articles for possible candidates. Nosotros also searched for ongoing trials from mainstream registries, such as the metaRegister of Controlled Trials, ClinicalTrials.gov trials registry, the Australian New Zealand Clinical Trials Registry, etc.

View this table:

  • View inline

Tabular array 1

Search strategy used in the OVID MEDLINE database

Studies selection

Two experienced reviewers (JL and JC) volition independently screen the titles and abstracts of identified citations for potential eligible trials and exclude the duplicates. Then they will apply eligibility criteria to the full text of potentially eligible trials. If the reviewers (HZ and JL) cannot clearly screen the trials according to the titles and abstracts, the other two reviewers (JC and CL) will screen the full copies of these studies. Conflicts will be resolved by team discussion. If disagreements persist, a third reviewer (F-RL) will be consulted.

Data extraction

Data concerning patient characteristics (age, gender, BMI, etc), report characteristics (interventions, control arms, length of intervention, length of follow-upwards and and then on), blazon of blood pressure monitoring (office, domicile, ambulatory), co-intervention and outcome (SBP, DBP, cardiovascular events, etc) were extracted independently by two reviewers (HZ and JL) using a standardised extraction course. If data are missing from published reports, we volition contact the authors of the included trials for further information. Disagreements will be resolved by team discussion. FRL volition review the data to ensure no input data errors.

Risk of bias cess

Two reviewers will assess the risk of bias independently using the Cochrane take a chance of bias tool. The post-obit items will be assessed (http://www.cochrane-handbook.org): random sequence generation (selection bias); allocation concealment (selection bias); blinding (functioning bias and detection bias); incomplete consequence information (attrition bias); selective upshot reporting (reporting bias). The run a risk of bias is categorised as a depression/unclear/high risk of bias. Trials which run into all criteria will be judged equally having a low take chances of bias, whereas trials which meet none of the criteria will be judged every bit having a high risk of bias and trials with insufficient information to judge volition exist classified equally an unclear risk of bias. Disagreement between the reviewers over the hazard of bias in specific studies will be resolved by word and consensus, with the involvement of a third review writer (FRL) where necessary.

Strategy for information synthesis

Weight mean differences will exist calculated for the overall mean change from baseline of SBP and DBP (using function, coincidental or ambulatory blood pressure measurements) for experimental and control groups. When the proportion of responders (participants who report a BP lower than 140/ninety mm Hg after treatment) is reported, we will calculate the relative run a risk using the control group as a reference.

We will assess heterogeneity using the Higgins I2 statistics; an I2>50% will be considered as heterogeneity existing among studies. In that example, we volition first utilise metaregression to discover out the source of heterogeneity (historic period, gender, interventions, outcome measurements, etc) and then use subgroup analysis. If the problem remains, we will utilize the random effect model and explain the results with circumspection. A fixed effect model will be used when there is no evidence of heterogeneity.

We will examine the potential for publication bias by using a funnel plot.

If the data are not advisable to perform a meta-assay, we will but do a narrative synthesis.

Analyses will be performed with R project 3.02 (http://www.r-projection.org). If the required information are not reported, nosotros will request data from the corresponding writer. However, if the missing information are out of reach, nosotros volition exclude such studies and synthesise the data from the residual of the included studies.

Assay of subgroups or subset

To investigate the potential heterogeneity beyond studies, we will conduct subgroup assay based on the different combinations of lifestyles, classification of blood force per unit area (prehypertension, balmy hypertension, moderate hypertension, astringent hypertension) and quality of bear witness. Random effects metaregression models will be used to quantify the divergence between subgroups and to test for statistical significant interactions amid subgroups.

Sensitivity analysis

We will conduct sensitivity assay to assess the effects of individual studies on the combined estimates and determine whether certain studies boss the pooled event (particularly if these studies were at a loftier risk of bias). If certain studies have borderline eligibility status for any reason, analysis will be conducted with and without such studies.

Discussion

Many existing systematic reviews26 ,27 focus on the upshot of a single lifestyle modification on claret pressure. Although the unmarried lifestyle modification has been shown to lower elevated blood pressure level, it is currently not known whether their combined utilise produces an condiment antihypertensive event. Of the diverse lifestyle interventions, physical activity and dietary intervention have been shown to diminish the claret pressure and reduce CVD events, which have emerged as the two most effective and physiologically desirable approaches. That is why we divers that the multiple lifestyle changes should at least include physical activity and dietary intervention.

This is outset systematic review that attempts to investigate the effectiveness of multiple lifestyle changes simultaneously. The aim of this systematic review is to synthesise the available prove of effectiveness of multiple lifestyle interventions in the handling of prehypertension and hypertension. The systematic review also intends to help clinicians to make decisions on the clinical applicability of multiple lifestyle modifications; at the same fourth dimension, the results of this review will increase the agreement of multiple lifestyle changes for patients with prehypertension and hypertension; encourage and motivate patients with prehypertension or hypertension to adopt and maintain mulitple lifestyle changes in their daily home life so as to better hypertension outcomes.

Withal, nosotros will select the trials which implemented the multiple lifestyle interventions for at least 4 weeks. The multiple lifestyle interventions have to be sustained for a time to achieve the effect of lowering the claret pressure. Trials employing lifestyle modification therapies usually intervene for more than 4 weeks.17 ,20 ,28

The reason why nosotros excluded trials utilising counselling or monitoring was that both of them had been reported to achieve antihypertensive effects.29–31 No matter counselling or monitoring, lots of manpower, material resources and fiscal resource accept to be invested. Moreover, we excluded such trials so as to investigate the genuine effects of multiple lifestyle modifications.

This systematic review volition provide a general view and evidence of the effects of multiple lifestyle changes on blood pressure. The results of this systematic review will likewise provide clinicians with useful information to guide their patient care. The finding of the systematic review will be disseminated through publication in a peer-reviewed journal; reporting of the systematic review volition follow recommendations described in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and the Cochrane Handbook for Intervention Reviews, and will exist formatted co-ordinate to the specific periodical publication guideline.

Acknowledgments

The author would like to thank Wen-xiang Zeng for his aid in the development of the search strategies for this protocol.

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Published by the BMJ Publishing Group Express. For permission to utilize (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions This is an Open up Access article distributed in accordance with the Creative Commons Attribution Not Commercial (CC Past-NC 3.0) license, which permits others to distribute, remix, conform, build upon this piece of work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the apply is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/