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. 2020 Nov 11;15(11):e0241193. doi: 10.1371/journal.pone.0241193

Motivational interviewing to support modifiable risk factor change in individuals at increased risk of cardiovascular disease: A systematic review and meta-analysis

Justin Lee Mifsud 1,2,*, Joseph Galea 2, Joanne Garside 3, John Stephenson 4, Felicity Astin 3
Editor: Maggie Lawrence5
PMCID: PMC7657493  PMID: 33175849

Abstract

Background

Programmes using motivational interviewing show potential in facilitating lifestyle change, however this has not been well established and explored in individuals at risk of, yet without symptomatic pre-existent cardiovascular disease. The objective of this systematic review and meta-analysis was to determine the effectiveness of motivational interviewing in supporting modifiable risk factor change in individuals at an increased risk of cardiovascular disease.

Methods

Systematic review and meta-analysis with results were reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Health-related databases were searched for randomised controlled trials from 1980 to March 2020. Criteria for inclusion included; preventive programmes, motivational interviewing principles, modification of cardiovascular risk factors in adults of both genders, different ethnicities and employment status, and having at least 1 or more modifiable cardiovascular risk factor/s. Two reviewers independently extracted data and conducted a quality appraisal of eligible studies using an adapted Cochrane framework. The Cochrane framework supports to systematically identify, appraise and synthesize all the empirical evidence that meets the pre-specified eligibility criteria to answer a specific question.

Findings

A total of 12 studies met the inclusion criteria. While completeness of intervention reporting was found to be adequate, the application of motivational interviewing was found to be insufficiently reported across all studies (mean overall reporting rate; 68%, 26% respectively). No statistical difference between groups in smoking status and physical activity was reported. A random effects analysis from 4 studies was conducted, this determined a synthesized estimate for standardised mean difference in weight of -2.00kg (95% CI -3.31 to -0.69 kg; p = 0.003), with high statistical heterogeneity. Pooled results from 4 studies determined a mean difference in LDL-c of -0.14mmol/l (5.414mg/dl), which was non-significant. The characteristics of interventions more likely to be effective were identified as: use of a blended approach delivered by a nurse expert in motivational interviewing from an outpatient-clinic. The application of affirmation, compassion and evocation, use of open questions, summarising, listening, supporting and raising ambivalence, combining education and barrier change identification with goal setting are also important intervention characteristics.

Conclusions

While motivational interviewing may support individuals to modify their cardiovascular risk through lifestyle change, the effectiveness of this approach remains uncertain. The strengths and limitations of motivational interviewing need to be further explored through robust studies.

Introduction

The European guidelines on cardiovascular disease (CVD) prevention in clinical practice have focused on behaviour change by highlighting and promoting lifestyle therapies, namely; smoking cessation, physical activity as per Joint European Societies’ (JES) 5 guidelines [1] and a cardio-protective diet, such as the Mediterranean diet. Adherence to these lifestyle changes is known to reduce CVD risk [2]. Central to these preventive guidelines is the delivery of a person-centred approach. Motivational Interviewing (MI) has been recommended as an intervention to promote lifestyle change in clinical guidelines and is graded as class 1 level A of evidence [2].

The collaborative counselling style contrasts MI to the more directive, expert-driven form of counselling [3]. MI may be adapted to accommodate different culture groups, however the counselling style should hold the core principles and spirit of MI [4]. MI involves reflective listening and understanding the person’s views in a non-judgmental, non-biased way without the clinician superimposing their own notions. There are four key principles that form the foundation of MI. First, that the clinician can express empathy. Second that they can promote the client’s self-efficacy. Third, that they can recognise resistance or ambivalence expressed by a client about a suggested lifestyle change and ‘roll with it rather than wrestle’ with it. Fourth, that they can work with their client to help them to notice potential discrepancies between their current circumstances and desired future goals [5, 6]. The principles of MI underpin the development of a therapeutic alliance between the clinician and patient. The ‘spirit’ of MI is underpinned by partnership, acceptance, compassion and evocation [6] using four overarching processes; engaging, focusing, evoking and planning [6, 7]. The practice of MI involves micro-counselling skills which go by the mnemonic acronym OARS [8]. These include the use of open-ended questions, affirmation, reflective listening, summarizing, informing and advising. By asking open-ended questions, the clinician invites the client to reflect and elaborate further. Affirmation allows the clinician to identify the client’s strengths and reflect them back to them to increase their confidence in their own ability to make change (self-efficacy). Reflective listening involves the clinician showing that they fully understand the ideas expressed by a client by reflecting them back to them through paraphrasing the content of the discussion. At the end of the session, the key points of the discussion are summarized by the clinician in an attempt to provide an overall brief understanding of what has been said. The ability to successfully summarise the key aspects of the discussion also demonstrate active listening and understanding on the part of the clinician. Lastly, the important skill of informing and advising comes into play after having gained the client’s consent or if the client asks for further information or advice [7, 8]. Application of these key skills may address ambivalence to change risky behaviour.

Existing studies report MI as an effective intervention used in primary care settings with as few as one MI session of 15–20 minutes reported as being effective in changing behavioural outcomes, including an improvement in modifiable CVD risk factors [911]. Moreover, MI has been reported to outperform traditional advice-giving approaches [12]. Consequently, researchers have suggested that clinicians should be trained in using MI skills [11].

There is one systematic review with meta-analysis that provides important information about the effectiveness of MI on primary and secondary prevention of CVD risk factors [13]. The authors concluded that MI could have a favourable effect on efforts to change tobacco smoking habits and improving psychological parameters such as depression and quality of life, compared to usual care. Results for other outcomes were inconclusive and the authors suggested that additional research was required to better understand the optimal format and delivery for MI interventions [13]. Other researchers suggested that primary research should be conducted to determine whether MI can be used with specific groups of individuals ‘at increased risk’ which could maximise the application and potential impact of this intervention [11]. To date the impact of a MI approach used with individuals at increased risk for CVD, but without established disease, is uncertain as there is limited research on this topic [11, 13]. There does not appear to be a published systematic review that has focused specifically on the effectiveness of MI as an intervention to promote risk factor modification in primary prevention. As previously published systematic reviews [11, 13] have included studies that have recruited both individuals at increased risk of CVD, or diagnosed with CVD. The proposed review specifically focuses on the effectiveness of MI as an intervention to promote risk factor modification in primary prevention and also addresses a gap in the current research by evaluating the characteristics of MI interventions used in clinical trials, including what content is delivered, how and where it is delivered and by whom. In this way the ‘active’ elements in MI interventions can be considered.

Review questions

Our review sought to determine the effectiveness of MI intervention in supporting primary prevention through changing modifiable cardiovascular risk factors. Additionally, the review provides an account of the characteristics of MI interventions reported in trials that supported risk factor modification.

The primary and secondary review questions are as follows:

  1. Is MI effective in supporting adults at increased risk of cardiovascular disease to make healthy lifestyle changes to reduce cardiovascular risk?

  2. What are the characteristics of MI interventions that support risk factor modification?

Methods

This review is reported using items described in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement [14] (see S1 Table in S1 Appendix). A review protocol can be found in the supplementary information (see S2 Table in S1 Appendix).

Search strategy

The search strategy was formulated and applied to identify published primary research literature from databases (CINAHL Complete, APA PsycINFO, Academic Search Ultimate, Cochrane Central Register of Controlled Trials, MEDLINE, PubMed,) and electronic journals within health-related resources (E-Journals, Wiley Online Library, PLOS, DynaMed Plus). As Motivational Interviewing was developed in the early 1980s [6], searches were conducted to retrieve peer reviewed articles, published in English, from 1980 to March 2020. Search terms were combined using the Boolean operator OR. Then search terms for each PICO element was combined using the Boolean operator AND. This has ensured that all search terms appear in the record to make the search more focused. Truncations and wildcard symbols were used to broaden the search results. This gave us a comprehensive search strategy to support the identification of relevant studies. For the smaller database (DynaMed) and electronic journals (PLOS) a broad strategy was used, by only using the main search term “motivational interviewing”, this was done to ensure completeness of the search. The search strategy is included as supplementary information (see S3 Table in S1 Appendix).

Study selection

Studies fulfilling the eligibility criteria listed in Table 1 were included. These were studies recruiting adult participants over the age of eighteen, of both genders, representing multiple ethnicities and employment statuses and having at least 1 or more modifiable cardiovascular risk factor/s. The interventions for inclusion consisted of primary prevention interventions, which used MI with the aim to support changes in modifiable cardiovascular risk factors. The comparisons consisted of any other approach used that aimed to support participants to change modifiable cardiovascular risk factors, and did not include MI as part of the intervention. Studies for inclusion were those published between 1980 and March 2020, and limited to randomised controlled trials as reliable sources of evidence [15, 16]. After applying filters (date limiter, peer reviewed, excluding children and adolescents) all article titles and abstracts were screened and duplicates identified and excluded. Studies were assessed for eligibility against the criteria (Table 1). Full text versions of studies meeting the criteria were managed using EndNote software. Reference lists of identified studies were manually searched to identify further potentially eligible publications. Full texts of each eligible study were independently read by two researchers and any disagreements resolved through discussion and where necessary, consultation with a third researcher.

Table 1. Eligibility criteria as per (PICOs) criteria.

Elements Inclusion Exclusion
Population (P) Adult, aged 18 and over, with at least 1, or more, CVD modifiable risk factor/s Studies of adults with established CVD
Intervention (I) MI identified as part of a primary preventative intervention programme to enhance modifiable risk factor modification Studies using any other form of counselling
Comparative intervention (C) Usual care in general practice/other interventions not including MI Studies in which their comparative intervention includes MI
Outcomes (O) Measurements of modifiable CVD risk factors such as smoking cessation, engagement in physical activities, changes in dietary habits, changes in serum cholesterol and blood pressure status, changes in anthropometric measurements (BMI, weight, waist circumference) All other form of outcomes and not including measurements of modifiable risk factors such as smoking cessation, engagement in physical activities, changes in dietary habits, changes in serum cholesterol and blood pressure status, changes in anthropometric measurements (BMI, weight, waist circumference)
Studies (S) Randomised controlled studies published between 1980—March 2020 All other methodological studies

Data extraction for study methodology, settings and findings

Data extraction was carried out independently by two researchers using a standardized form which was review specific (see S4 Table in S1 Appendix) [17]. Data was extracted from each study for methodological quality, participant characteristics, total number of participants randomised, setting, country, nature of intervention (MI content, type, frequency, duration), characteristics of the deliverer (professional discipline, training and experience), type of outcomes measured, and relevant findings/results.

Study outcomes

Effectiveness of the intervention using MI was determined by change in modifiable cardiovascular risk factors (smoking status, dietary eating patterns, physical activity levels, lipid profile levels, blood pressure levels, weight, waist circumference, body mass index).

Data on the characteristics of the MI interventions designed to support CVD risk factor modification were assessed using TIDieR checklist (S5 Table in S1 Appendix) and an MI checklist (S6 Table in S1 Appendix).

Risk of bias assessment and quality of evidence

Critical appraisal of included studies was undertaken to evaluate the quality of the evidence. An assessment of risk of bias domains was carried out for each individual study [17]. The body of evidence was rated in quality depending on the risk of bias and inconsistency, imprecision, indirectness and publication bias [15, 18]. The GRADE rating was used [15] to determine the fulfilment of key criteria to help to judge the level of confidence that could be placed in the conclusions that were drawn.

Data synthesis

A statistically significant increase in mean smoking quit attempts, physical activity levels and cardio-protective diet adherence in the intervention group was considered to indicate improvement in CV risk factors. Similarly, a statistically significant decrease in mean blood pressure level, serum cholesterol, weight, waist circumference or body mass index were considered to mark improvements in CV risk factors. Any trends identified across results were also explored. Findings for each outcome were described in a narrative format. Percentage scoring was used for intervention reporting (TIDieR) and reporting of MI elements, as we believe that this would be helpful in synthesizing the overall result of the intervention reporting. To complement the narrative summary the level of heterogeneity across included studies was evaluated to assess the indication for meta-analyses. Should outcomes be sufficiently consistent across studies, unstandardized measures to construct meta-analyses were to be applied. Reflecting the clinical and methodological diversity between the studies a conservative approach to the statistical analysis was planned with a random effect meta-analysis. This was considered as more appropriate than a fixed effects model. The statistical heterogeneity established in the meta analyses is likely to reflect this observed clinical and methodological diversity and suggests that the utilisation of random effect models was appropriate. Stata statistical software (Version 14) was used for the data analysis [19].

Heterogeneity

Quantitative measures were applied to measure variability between results and determine the level of statistical heterogeneity as measured by values of the I2 statistic in excess of 80%. This is illustrated in forest plots (Figs 2 and 3).

Fig 2. Forest plot for meta-analysis of LDL-c.

Fig 2

Fig 3. Forest plot for meta-analysis of weight.

Fig 3

Results

The systematic search identified a total of 1,968 records. Following the removal of duplicates, 1,668 records remained. A total of 1,592 records were excluded based on a review of the titles and abstracts. Seventy-six full text records were assessed using the parameters of the eligibility criteria. After assessment 64 were excluded. In total 12 studies met the eligibility criteria and were included. The PRISMA flow for study selection and exclusion is illustrated in Fig 1.

Fig 1. Prisma flow chart of the study selection and inclusion.

Fig 1

Study characteristics

The randomised controlled trials were conducted in 6 countries: Eight were in Europe: Spain [20], Netherlands [2124], Denmark [25] and United Kingdom [26, 27]; 2 were in Asia: Taiwan [28] and Malaysia [29]; and 1 in the United States of America [30]. Studies were designed in different ways and MI was used as part of a broader intervention. MI was combined with an individualized healthy lifestyle educative session [28], an educational workbook about hypertension [30], and dietary education and a weight management dietary menu [29]. Other studies combined MI with an online health risk assessment and tailored feedback [21], risk communication and action planning [31], identification of barriers to change and goal setting [23, 24], behaviour theoretical frameworks [22, 2527], and clinical dyslipidaemia protocol recommendations [20]. Sample size ranged from 88 [29] to 1742 participants [26]. The number of MI sessions offered, ranged from 1 to 12 sessions and the length of the sessions ranged from 15 to 140 minutes. Seven studies consisted of in-person combined with telephone-based MI [2124, 28, 30, 31] and 4 studies consisted of face-to-face MI only [20, 2527, 29]. In 7 studies, sessions took place in community clinics [20, 2527, 2931]; other studies used an outpatient clinic [28], an occupational health centre [21], and a diabetes research centre [22]. Two studies did not report the setting [23, 24]. An expert nurse in MI [28], other nurses [22, 25, 31], general practitioners [20], occupational health physicians/nurses [21, 23, 24], licensed dieticians [27, 29] or a physical activity specialist [27], research assistants [30] or health trainers [20] delivered the sessions in all the studies. Training received ranged from 0 to 36 hours of MI training, and only one study had an expert in MI to deliver the session [28]. Five of the RCTs were multicentre trials [2022, 24, 27, 31]. Ten studies used a 2-group design [2024, 26, 27, 31] and 2 studies used a 3-group design [24, 25]. A summary of the study characteristics is presented in Table 2.

Table 2. Characteristics of included studies.

Author and year Country Participants Participants randomized Intervention Control Follow-up Outcomes Study Design
Hardcastle (2008), [27] United Kingdom Age: 18–65, mean (SD): 51 (1) years. N = 552 MI-based approach. Use of health promotion leaflet. 6 months Physical activity, weight, BMI, low- density lipoprotein cholesterol, systolic Bp, diastolic Bp, fruit and vegetable intake Individual randomisation using blocks, to 1 of the 2 groups
Theory-based (principles & strategies from models of psychotherapy and behaviour change theory).
Gender: 67% females.
Ethnicity: White.
Use of open-ended questions and reflective listening.
Risk profile: At least with 1 CHD risk factor.
Different strategies were used depending on an individual’s needs and readiness to change.
Koelewijn-van Loon, 2009, [31] Netherlands Age: …, mean (SD): 57 (7) years. N = 615 MI-based approach. Use of risk assessment only & usual nurse led care. 3 months Physical activity, smoking cessation, fruit intake. Multicentre, randomised controlled, using blocks to 1 of the 2 groups
Emphasising reflection on the information received.
Gender: 55% females.
Ethnicity: White.
Risk assessment & communication, Use of a Decision support tool (DST).
Risk profile: one or more CVD risk factors.
Groenewald (2010), [23] Netherlands Age:18–65, mean (SD): 46.9 (9.1) years. N = 816 MI-based approach. Use of verbal and written information about their CVD risk profile. 12 months Weight, BMI, systolic and diastolic Bp. Individual randomization, to 1 of the 2 groups
Focus on modification of diet, physical activity and smoking
Use of open questions, summarizing, listening, supporting, and raising ambivalence.
Gender: 100% males.
Ethnicity: White.
Risk profile: CVD 10-year risk score ≥ moderate calculated using Framingham risk score.
CVD risk communication, action planning using pros and cons of changing the behaviour.
Lakerveld, (2013) [22] Netherland Age: mean (SD) 43.6 (5.1) years N = 622 MI-based approach Received existing health brochures. 12months Developing T2DM and estimation of CVD risk mortality, self-reported physical activity, fruit and vegetable intake, smoking behaviour. Multicentre, Randomised, controlled, 2-group
Theory-based (theory of planned behaviour).
Gender: 58.4% females.
Ethnicity: White Caucasian.
Problem-solving treatment.
Risk profile: with ≥10% estimated risk of T2DM and/or CVD mortality.
Aadahl, (2014) [25] Denmark Age: 18–69 years; mean (SD) 52.2 (13.8); N = 166 MI-based approach; Instructed to maintain usual lifestyle. 6 months Daily sitting. Single centre, open-ended, controlled, randomised, 2-group.
Theory-based (behavioural choice theory);
Gender: 57% females;
Individual behaviour goal-setting, self-efficacy.
Ethnicity: White Caucasians;
Risk factor: self-reported 3.5 hours of daily leisure-time sedentary behaviours.
Bóveda-Fontán, 2015 [20] Spain Age: 40–75 years, mean (SD): 52 (8.59); N = 227 MI-based approach; Consultation delivered by general practitioners who did not receive MI training. 12 months Serum cholesterol. Multicentre, open, controlled, randomised, cluster, 2-group.
Gender: 62% females; Use of a dyslipidaemia protocol.
Ethnicity: White Caucasians;
Risk factor: with dyslipidaemia.
Boutin-Foster, (2016) [30] United States Age: Mean (SD) 56 (11) years; N = 238 MI-based approach; Received a workbook of strategies on blood pressure control. 12 months Blood pressure. Multicentre, randomised, controlled, in a 1:1 ratio to 1 of the 2 groups.
Gender: 70% females;
Positive thinking to enhance core values on a daily basis.
Ethnicity: African Americans;
Risk factor: uncontrolled hypertension.
Lin, (2016), [28] Taiwan Age: 40+, mean (SD): 63.1 (8.5); N = 115 MI-based approach; Received a single brief lifestyle modification counselling session with a brochure on lifestyle modification; usual care. 3 months Physical activity, metabolic syndrome risks. Single centre, randomised, controlled, with 3-parallel groups.
Gender: 100% females;
lifestyle modification program using MI.
Ethnicity: White Asian;
Risk profile: Metabolic syndrome.
Kong, (2017), [29] Malaysia Age:18–59 years, mean (SD): 34(9) years; N = 88 MI-based approach; Received traditional counselling and weekly aerobic exercise from a medical officer and a Physiotherapist. 3 months Weight and waist circumference. Single-centre, randomised controlled 2 group.
Focus on modification of diet and increase in high intensity interval training.
Gender: 72% females;
Ethnicity: White Asian;
Risk factor: BMI of at least 18.5 kg/m2 or above.
Kouwenhoven-Pasmooij, 2018 [21] Netherlands Age: 40+, mean (SD): 51(6) years; N = 491 MI-based approach; Web-based Health Risk Assessment; 12 months Body weight, physical activity, health behaviours, daily intake of vegetables. Multicentre, randomised, controlled, cluster, 2-group.
Web-based Health Risk Assessment; an additional motivational paragraph in the electronic newsletter;
Personalized suggestions for health promotion;
Gender: 15% females;
Ethnicity: White Caucasian;
Risk factor; having at least 1 risk factor (+ve CVD family history, not meeting physical activity target, smoking, self-reported diabetes mellitus or random glucose of ≥ 11.1 mmol/l, obesity, hypertension or the use of antihypertensive drugs; and dyslipidaemia.
Electronic newsletter with general information on a healthy lifestyle.
Personalized suggestions for health promotion.
Ismail, (2020), [26] United Kingdom Age: 40–74, mean (SD): 69 (4) years; N = 1742 MI-based approach; Use of community- based weight loss, smoking cessation and/or exercise programmes. 24 months Physical activity, weight, low- density lipoprotein cholesterol. Multicentre, randomised controlled, in a 4:3:3 ratio, to 1 of the 3 groups
Theory-based (social cognitive theory, & theory of planned behaviour);
Focus on modification of diet and physical activity
Use of behaviour change techniques;
Gender: 14.5% females;
Ethnicity: White (89.4%);
workbook, action planning worksheets, case studies, self- monitoring diaries and a pedometer.
Risk profile: CVD 10-year risk score ≥20.0% calculated using QRisk2.
Groeneveld, 2011, [24] Netherlands Age:18–65, mean (SD): 46.9 (9.1) years; N = 816 MI-based approach; Use of verbal and written information. 12 months Physical activity, fruit intake. Individual randomization, to 1 of the 2 groups
Focus on modification of diet, physical activity and smoking
Use of open questions, summarizing, listening, supporting, and raising ambivalence;
Gender: 100% males;
Ethnicity: White;
CVD risk communication, action planning using pros and cons of changing the behaviour.
Risk profile: CVD 10-year risk score ≥ moderate calculated using Framingham risk score.

Standard deviation (SD), Type 2 diabetes mellitus (T2DM), body mass index (BMI)

Quality appraisal and risk of bias

A computer method to generate the allocation sequence was used by 8 studies [2128]. Only 6 of the studies prevented risk of selection bias by allocation concealment [2225, 28, 31]. Lack of blinding of participants and investigators to group allocation was noted in 6 studies [20, 21, 23, 24, 28, 30]. Six studies blinded the assessment of the outcomes to prevent the risk of detection bias [2328]. Attrition bias was minimalised throughout most studies [2024, 2628, 30, 31]. There was no selective reporting in 6 of the 12 studies [20, 23, 24, 26, 28, 31]. The remaining 6, did not provide sufficient detail about the reporting of study outcomes as no protocol was available and a judgement regarding the risk of reporting bias could not be made [22, 25, 27, 29, 30]. For 1 study in particular [21], although a study protocol was made available, it was noted that not all pre-specified outcomes that are of interest in the review were reported in a pre-specified way. Therefore, this study can be indicative of selective reporting, as it allows for reporting bias [21]. Although all authors claimed to use randomization to assign participants to groups, the process may not have been optimal by introducing potential risk of selection bias. The studies have also shown several further weaknesses hindering credibility. For example, the sample size of some studies may have been too small to detect a statistically significant change. Table 3 illustrates a summary of risk of bias across domains.

Table 3. Risk of bias summary.

Authors Random sequence generation Allocation concealment Blinding of participants and personnel Blinding of outcome assessment Incomplete outcome data Selective reporting
Selection Performance Detection Attrition Reporting
Hardcastle, 2007 [27] + ? + + + ?
Koelewijn-van Loon, 2009 [31] + ? + ? + +
Groeneveld, 2010 [23] + + - + + +
Groeneveld, 2011[24] + + - + + +
Lakervald, 2013 [22] + + + ? + ?
Aadahl, 2014 [25] + + + + - ?
Boveda-Fonatan, 2015 [20] ? - - - + +
Boutin-Foster, 2016 [30] ? - - - + ?
Lin, 2016 [28] + + - + + +
Kong, 2017 [29] - ? + ? ? ?
Kowenhaven-Poamooin, 2018 [21] + - - - + -
Ismail, 2020 [20] + ? ? + + +
Action +/-/? + = action performed to reduce risk - = action not performed ? = insufficient information given

Primary outcome -modifiable cardiovascular risk factor change

Heterogeneity between the reviewed studies made it difficult to pool results and arrive at an overall conclusion. This was due to: substantive differences in how the outcomes were measured across the studies; substantive differences in study parameters outwith reasonable limits of heterogeneity, or unavailable statistical information. As such, the majority of the results had to be interpreted narratively [32]. Where possible, certain parameters, which were not provided, were calculated from others that were given.

Smoking outcome measurements

Smoking outcome was measured by 4 studies [20, 22, 24, 31]. Three studies revealed no statistically significant differences between the intervention groups and the control groups [20, 22, 31]. One study found a statistically significant effect at 6 months (OR smoking 0.3, 95%CI 0.1;0.7) but this was not sustained until 12 months follow-up (OR 0.8, 95%CI 0.4; 1.6) [24]. Following MI the number of cigarettes smoked per day reduced significantly across both groups (95% CI: -3.32 to -7.94: mean difference = -5.66: p <0.001), but the difference between groups was non-significant (p = -0.749) [20]. Trend towards smoking cessation in both groups at 6-month and 12-month follow-up was present. However, this change was statistically non-significant [22].

Dietary outcome measurements

Dietary outcomes were measured in 6 studies. Mediterranean diet score increased from 8.30 (SD = 2.43) at baseline to 9.41 (SD = 2.47) (MD = 1.11: 95% CI: 1.42 to 7.29: p< 0.001), at 12-month follow-up. However, the difference between intervention and control group was non-significant [20]. In the study by Lakervald,[22], the only group difference was for daily fruit consumption of 0.2 pieces of fruit (95% CI: -0.3 to 0.0, p = 0.05) in favour of the control group, but this was only evident at 6-month follow-up. In the study by Groeneveld, [24] a statistically significant beneficial intervention effect was found for snack and fruit intake, and the effect was sustained at 12 month follow-up. In other studies there was no difference between intervention group and control in dietary changes [21, 27]. On the other hand, between-group significant differences were noted by Kong, Jok [29], in total calorie intake (MD = -553.02, SD = 339.18, CI = -448.64 to -657.41, p = 0.01), dietary fibre intake (MD = 5.11, SD = 0.93, CI = 3.26 to 6.95, p = 0.01), carbohydrate intake (MD = -33.23, SD = 10.72, CI = -54.54 to 11.91, p = 0.03), fat intake (MD = -23.29, SD = 4.42, CI = -32.07 to -14.51, p = 0.01) and protein intake (MD = -12.45, SD = 3.41, CI = -19.23 to -5.68, p = 0.365).

Physical activity outcome measurements

Physical activity levels were measured in 9 studies. No statistically significant difference between groups were recorded at 3 months [28, 31], at 6 months [24, 25], at 12 months [2022, 24], and at 24 month follow-up [26]. In the study by Lin [28], when a generalised estimating equation was used, it showed that participants in the MI group had a greater increase in the physical activity levels than the non-MI intervention at 3-month follow-up (MET-min/week = 337, p = 0.02), but no differences were noted when compared to those participants who received the brief intervention [28]. In the study by Hardcastle [27], the MI group were more active, particularly with respect to walking (t = -2.72, P = 0.01). In the study by Bóveda-Fontán [20] and Kouwenhoven-Pasmooij [21] an improvement in both groups was evident, where lack of physical activity was reduced by 96.6% [20], and 50% [21] at the 12-month time point.

Serum cholesterol outcome measurements

Serum cholesterol was measured in 5 studies. Significant reductions in total cholesterol levels (MD = -1.3 mmol/l, SD = 0.3, CI = -0.9 to -0.7, p = 0.01), low density lipoprotein cholesterol (MD = -0.8 mmol/l, SD = 0.3, CI = -1.3 to 0.3, p = 0.01) and triglyceride cholesterol (MD = -2.2 mmol/l, SD = 0.2, CI = -2.7 to -1.7, p = 0.01) favoured the motivational intervention group [29]. Significant reductions were also evident in the study by Aadahl [25] for total cholesterol (intervention = -22.7%, control = -1%, p = <0.05) and low density lipoprotein cholesterol (intervention -30.5%, control -11%, p = <0.05). On the other hand, in three studies, participants in the MI group exhibited no significantly greater reduction in total cholesterol, low density lipoprotein cholesterol or triglycerides cholesterol, than the control group at 6 months [27], 12 months [20, 26], and at 24 months [26]. In the study by Boveda, [20], it is interesting to note that when researchers assessed the degree of lipid control by combining those participants who achieved the target total cholesterol and target LDL-c (Tot-c <5.172 mmol/l, LDL-c <3.362 mmol/l) a higher number of patients achieved target figures in the experimental group versus comparator group (13.1% vs 5.0%: adjusted OR = 5.77, 95% CI: 1.67 to 19.91) [20]. Moreover, an overall improvement was observed, with both groups achieving better results in total cholesterol levels (Total sample; MD = -0.51: 95% CI: -0.39 to -0.62 mmol/l: p = 0.001), in low density lipoprotein cholesterol (Total sample MD = -0.36: 95% CI: -0.25 to -0.46 mmol/l: p< 0.001) and triglycerides (Total sample MD = -0.5: 95% CI: -0.3 to -0.7 mmol/l: p< 0.001), but no differences were observed in the high density lipoprotein cholesterol levels (Total sample MD = 0.007: 95% CI: -0.06 to 0.0437 mmol/l: p = 0.309) [20].

Meta-analysis for LDL-c

A random effects analysis determined that a synthesized estimate for the unstandardized mean difference in total LDL-c reduction (no intervention vs intervention) was -0.14 mmol/l (95% CI -0.032 to 0.04). A Z-test for overall effect revealed no evidence that the value was non-zero (Z = 1.54, p = 0.124). Individual estimates for the unstandardized mean difference ranged from -0.81 [29] to 0.08 [25]. Cochran's Q test revealed evidence for statistical heterogeneity at the 0.1 significance level (Heterogeneity x2(3) = 24.5; p< 0.001). The I2 statistic was 87.8%, indicating high statistical heterogeneity. The T2 statistic (extent of between-study variance) was calculated to be 0.0237. The data is summarised in a forest plot showing that overall results favour the intervention in reducing LDL-c (Fig 2).

Blood pressure outcome measurements

Four studies measured blood pressure outcomes. Significant group differences favouring the motivational intervention group, in systolic blood pressure (-5.14 mmHg, SD = 2.02, CI = -9.15 to 1.14, p = 0.01) were evident in the study by Kong, [29], and the study by Groenevald, [23] (-0.3 mmHg, CI = -2.8 to 2.2). In the study by Hardcastle, [27], although there was a trend towards improvement, this was nonsignificant.

In contrast, Boutin-Foster [30], found no statistically significant difference in the proportion of participants who had achieved blood pressure control between intervention and control group. Furthermore, the intervention did not prove to be effective in maintaining blood pressure in target range (OR = 1.33, CI: 0.57 to 3.10, p = 0.50), that is <140/90 mmHg, at the 12-month follow-up mark.

Anthropometric outcome measurements

Anthropometric outcomes were measured in 8 studies, of which 6 studies exhibited statistical differences between groups [21, 23, 25, 2729]. Waist circumference decreased amongst participants in the MI group, from 84.2% to 63.2% (p = 0.03) [28]. This resulted in a decrease in the proportion of participants with metabolic syndrome by 18.4% (p = 0.01) at 3 months [28]. The waist circumference of participants also improved in the study by Aadahl, [25] at 6 months, in favour of the MI group (MD = -1.42 cm, 95% CI = -2.54 to -0.29, p = 0.01). This is in line with the study by Kong, [29], where in the MI group (n = 43), waist circumference and body weight decreased by -6.92 cm (SD = 0.87, 95% CI = -8.65 to 5.18, p = 0.01) and -3.35 kg (SD = 0.65, CI = -5.17 to 2.59, p = 0.01) respectively. Percentage reductions for waist circumference and body weight were 8.4% and 6.8% for the MI group (n = 43), versus 1.1% and 0.8% for the control group (n = 45) (p<0.05) [29]. Improved BMI was also evident in the study by Kouwenhoven-Pasmooij, [21], where at 12-month follow-up, there was a statistically significant difference in BMI favouring the intervention group (n = 271); BMI was reduced by 0.69 kg/m2 whilst no reduction was observed in the control group (n = 213).

Conversely, 2 studies found no significant difference between groups in anthropometric outcome measures [20, 26]. However, in the study by Bóveda-Fontán, [20], sub-group analysis showed a significant reduction in the waist circumference and weight of obese and overweight patients from baseline to post intervention (MD = -0.79 cm: 95% CI: -0.287 to -1.746 cm: p = < 0.001; MD = -1.77kg: 95% CI: -0.91 to -2.64 kg p = <0.001) at 12-months [20]. In the intervention group (n = 98), the proportion of obese patients decreased by 8.4% versus 6.7% in the control group (n = 98), indicating a 1.7% difference between groups (McNemar χ2 = 13.899, p = 0.001). Although there was no difference in BMI between the intervention and control groups (p = 0.452), when researchers analysed the total sample (N = 198), it was noted that a BMI difference between groups becomes statistically significant (MD = -0.61 kg/m2: 95% CI: -0.34 to -0.88 kg/m2 p = <0.001) [20].

Meta-analysis for weight

In view of the variations in clinical and methodological heterogeneity a random effects analysis was conducted on this outcome. The analysis determined that a synthesized estimate for unstandardized mean difference in total weight reduction (no intervention vs intervention) was -2.00 kg (95% CI -3.31 to -0.69). A Z-test for overall effect revealed strong evidence that the value was non-zero (Z = 2.99, p = 0.003). Individual estimates for the unstandardized mean difference ranged from -0.82 kg [25] to -3.88 kg [29]. Cochran's Q test revealed evidence for statistical heterogeneity at 0.1 significance level (Heterogeneity x2(3) = 27.4; p< 0.001). The I2 statistic was 89.1%, indicating high statistical heterogeneity, thus implying generalizability. The T2 statistic was calculated to be 1.44. The data is summarised in a forest plot showing that overall results favour the intervention in reducing weight (Fig 3).

Secondary outcomes- reported intervention elements

The intervention content reported in the studies was assessed against the template for intervention description and replication (TIDieR) (see S5 Table in S1 Appendix) [33] and an MI checklist (see S6 Table in S1 Appendix). The average of total percentage reporting to at least one of the 12 items across all 12 studies amounted to 68%, highlighting that the overall intervention descriptions were adequately reported (Table 4) and the majority of the included studies may support replicability of the intervention. Reporting for the description of ‘what procedures’ (item 4), was incomplete in 4 studies [20, 22, 25, 26]. We could not identify any MI elements applied in the intervention arm. In 2 of the studies [23, 24], we could not identify the schedule of intervention delivery (item 8). There was no reporting about tailoring (item 9) in 8 studies [20, 2226, 30, 31], and modifications (item 10) in 11 studies [2026, 2831]. Only 2 of the studies reported testing for fidelity (item 12) [21, 26] (Table 4).

Table 4. Summary of reported intervention elements.
Intervention elements reported in the study 1. Brief name 2. Why 3. What materials 4. What procedures 5. Who provided 6. How 7. Where 8. When and how much 9. Tailoring 10. Modifications 11. Planned strategies to maintain fidelity 12. Extent to which intervention was delivered as planned 1. Evocation 2. Developing a change plan 3. compassion 4. affirmation 5. profound acceptance 6. Open-ended questions 7. reflection 8. Rolling with resistance 9. Eliciting and strengthening change talk 10. Summarization 11. Recognizing and reinforcing change talk 12. Consolidating a client's commitment
Hardcastle, 2007 - + + + + + + + + + + - - + - + - + + + + - + +
Koelewijn-van Loon, 2009 + + + + + + + + - - - - - + - - + - + - - - - -
Gronevald, 2010 - + + + + + + - - - + - - - - - - + + + - + - +
Groeneveld, 2011 - + + + + + + - - - + - - - - - - + + + - + - +
Lakervald, 2013 - + + - + + + + - - + - + - - - - - - - - - - -
Aadahl, 2014 - + + - + + + + - - - - - + - - - - - - - - - -
Boveda-Fonatan, 2015 - + + - + + + + - - + - - - - - - - - - - - - -
Boutin-Foster, 2016 + + + + + + + + - - - - + + - + - - - + - - - -
Lin, 2016 - + + + + + + + + - + - + - + + - - - - - - - -
Kong, 2017 + + + + + + + + + - - - + + - - - - - - + - - -
Kowenhaven-Poamooin, 2018 + + + + + + + + + - + + + + + - + + + - - - - -
Ismail, 2020 + + + - + + + + - - + + - - - - - - - - - - - -
Intervention elements reported, presented as percentages across all 8 studies (%) 42 100 100 67 100 100 100 83 33 8 67 16 42 50 16 25 17 33 42 33 8 17 8 25
Mean overall (%) reporting rate 68% 26%

+ reported,—not reported

The MI content reported was assessed against a checklist that was developed by the authors and drew upon literature from Miller and Rollnick (see S6 Table in S1 Appendix) [7]. None of the included studies reported all of the 12 expected components of MI [7], and only 1 study used the validated Motivational Interviewing Treatment Integrity code (MITI) [21]. The reported MI components in the studies ranged from 0/12 [20, 26] to 8/12 [27], as shown in Table 4. Developing a change plan appeared to be the most commonly used strategy, evident in 6 studies (50%). Evocation (Drawing out rather than imposing ideas) and reflection appeared to be the second commonly used strategies (42%). These were followed by use of open ended questions (33%), affirmation (25%) and consolidating a client’s change talk (25%). Compassion, profound acceptance, rolling with resistance, eliciting, and strengthening change talk, summarization, recognizing and reinforcing change talk, appeared to be rarely evident in the included studies. The average of total percentage reporting to at least one of the 12 MI elements across all 12 studies amounted to only 26% (Table 4).

Indicators in supporting risk factor modification

Compassion was reported as being used in 2 of the studies; of which programmes showed significant difference effect between groups [21, 28]. Furthermore, evocation which was reported as being performed in 5 of the reviewed studies, 3 studies showed significant differences in effect between groups [21, 28, 29]. Two studies which used open questions, summarising, listening, supporting and raising ambivalence, also showed significant intervention beneficial effects [23, 24]. Being trained in MI techniques or being an expert, also seemed to be one of the components contributing towards a significant group difference effect. Programmes that reported using MI in conjunction with theoretical frameworks such as the behavioural choice theory or theory of planned behaviour, social cognitive theory and theory of self-regulation appeared to be ineffective [22, 25, 26]. Programmes which used MI combined with education [28], or combined with education and Zumba classes [29], or combined with online health screening with tailored feedback [21], or combined with lifestyle clinical guidelines [20], all had a significant group difference effect. The identified and selected components were categorised according to the study methodological qualities based on our evaluation by using the risk of bias assessment tool [34]. Only those components from moderate to high quality studies are illustrated in Table 5.

Table 5. Characteristics of the intervention to support risk factor modification.

Intervention characteristics High quality study (Low risk of bias) showing positive impact/s Moderate to high quality studies (Low risk of bias) showing no impact/s
Nature of the program MI combined with education using a brochure to promote physical activity [28]. MI programme based on behavioural choice theory [25].
MI programme based on theory of planned behaviour and theory of self-regulation [22].
MI combined with identification of barriers to change & goal setting [23, 24] MI programme based on social cognitive theory and theory of planned behaviour, using behaviour change techniques, a workbook, action planning worksheets, case studies, self-monitoring diaries and a pedometer [26]
Type, frequency, duration, interval Type- Blended Type- Blended
Frequency- 13 (1 face to face, 12 telephone-based) Frequency- 4 (2 face to face and 2 telephone-based)
Time- 15–30 mins each [28] Time- 30–45 minutes
Interval- every 6-weeks [25].
Type- Blended
Interval- weekly
Frequency- 9 (6 face-to-face, 3 telephone-based)
Type- Blended Time- 30 min
Interval- monthly [22].
Frequency- 7 (3 face to face, 4 telephone-based)
Type- face to face
Frequency- 10
Time- 15–60 mins each
Time- 40–120 min
Interval- 1 session/week for the 1st 3 months, followed by 4 sessions delivered at 3, 6, 9 and 12 months [26]
Interval- Not reported [23, 24]
MI content MI consisting of affirmation, compassion, evocation and engagement [28]. MI consisting of individual behaviour goal settings, self-efficacy enhancement [25].
MI consisting of open questions, summarising, listening, supporting & raising ambivalence [23, 24]
Characteristics of the deliverer (professional discipline, training and experience) Professional discipline—Nurse with expertise in MI, Experience- Not reported [28]. Professional discipline–Nurses, Training and experience–Not reported [25].
Professional discipline–Health trainers,
Training and experience–Not reported [26]
Professional discipline–Occupational physician/nurse
Experience- Not reported [23, 24]
Setting Setting—Outpatient clinic [28]. Setting—Community clinic [25].
Setting–Not reported [23, 24] Setting–Community centres [26]

Summary of outcome findings

Findings show that when results were pooled from 4 studies, meta-analyses for LDL-c did not show a statistically significant group difference. From 4 studies, 2 studies exhibited statistically significant group differences in reducing blood pressure [23, 29]. From 8 studies, 5 studies exhibited statistical differences between groups in improving anthropometric outcomes [21, 23, 25, 28, 29]. A meta-analysis from 4 studies demonstrated statistically significant weight reduction favouring the MI intervention group. Findings for the four meta-synthesized outcomes using the GRADE rating [15, 3538], show that these may not be reliable due to the low quality of evidence (Table 6). The quality level was graded using the GRADE’s approach [15].

Table 6. Programme consisting of MI compared to non-MI programme for individuals at increased risk of CVD.

Outcome MI group vs non-MI group 95% CI No of participants Quality Comments Grading the quality across domains
Improved LDL-c Weighted mean difference of -0.14 CI = -0.32 to 0.04 N = 2603 (4RCTs) [2527, 29] ⨁◯◯◯ Very low Pooled results favour the intervention but not statistically significant. Risk of Bias- serious
Inconsistency- not serious
Indirectness- not serious
Imprecision- serious
Publication bias- likely
Decreased weight Weighted mean difference of -2.0 CI = -3.31 to -0.69 N = 2542 (4RCTs) [21, 25, 29, 39] ⨁◯◯◯ Very low Pooled results favour the intervention in reducing weight Risk of Bias- very serious
Inconsistency- not serious
Indirectness- not serious
Imprecision- not serious
Publication bias- likely

CI: Confidence interval

Quality level and current definitions [15];

High quality ⨁⨁⨁⨁- We are very confident that the true effect lies close to that of the estimate of the effect

Moderate ⨁⨁⨁◯- We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.

Low ⨁⨁◯◯- Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect

Very low ⨁◯◯◯- We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.

Discussion

In our review, group differences in the studies have indicated that programmes using MI as part of their intervention in primary care settings for patients at increased risk of cardiovascular disease may lower serum cholesterol [20, 27, 29], systolic blood pressure [27, 29], metabolic risk [28], and decrease anthropometric measurements [20, 21, 23, 2729]. These interventions showed significant and clinically effective results within MI intervention groups (participants with dyslipidaemia, having at least 1 risk factor, BMI ≥18.5k/m2) in modifying behaviour [20, 21, 23, 29] as well as an equal effect on those with physiological, metabolic and anthropometric conditions [20, 21, 23, 2729].

Our meta-analysis showed a trend towards LDL-c reduction but this did not reach statistical significance. This is consistent with the work by Lee, [13]. On the contrary to the finding of the study by Lee, [13] our meta-analyses from 4 studies shows evidence, but with limited quality (⨁◯◯◯), for weight reduction favouring the MI intervention group. Our review highlights the notion that application of elements such as compassion, affirmation, evocation, use of open questions, summarising, listening, supporting & raising ambivalence and having the intervention delivered by a nurse expert in MI, or having MI combined with educative resources might yield better results. Barrier change identification and goal setting also seem important elements. Other evidence, however, with quality limitations are: using MI elements with health screening resources and tailored feedback, or having MI applied in conjunction with a set of clinical guidelines. It is also evident that Lin [28] and Groeneveld [23, 24] delivered a programme through a sound study methodology, which consisted of a blended delivery (face to face; telephone). The programme by Groenevald [23, 24] consisted of 3 face to face, and 4 telephone-based sessions lasting between 15 to 60 minutes each. Lin, [28], delivered a one face to face session followed by weekly telephone-based MI calls lasting between 15 to 20 minutes each. In the study by Lin, the number of metabolic risks in the MI group was reduced significantly when compared with both brief intervention group and usual care group.

Study limitations, strengths and generalisability

Although this systematic review attempts to reduce bias by being transparent, rigorous and replicable, there are several limitations at study and outcome level. The first issue is, that this review included English language articles only. Other issues are that the summary of this review is only as reliable as the methods used to test for effectiveness in the included studies. Thus, where the quality of the research is possibly contaminated with risk of bias due to inherent problems in the design and its methodology, the results presented in this systematic review need to be interpreted with caution. Heterogeneity between the reviewed studies made it difficult to pool results and arrive at an overall conclusion. This was due to: a wide variation in the context and programme designs as well as differences in how the data outcomes were measured. As such, the majority of the results had to be interpreted narratively [32]. Data such as the application of MI elements was found to be insufficient across the 12 studies and, therefore, it was difficult to detect potential meaningful interactions (mean overall reporting rate 26% to at least one element). Unlike Lee, Choi [13], our review has focused on primary prevention studies only. Our review has not only focused on the effectiveness of MI, but has elaborated on intervention items, such as the characteristics of the intervention delivery. These included the type, frequency, duration, interval from 1 session to the other and setting of sessions, characteristics of the deliverer (professional discipline, training and experience), and the possible mechanisms by which the intervention could have supported risk factor modification. Our review adds to the current MI and lifestyle behavioral change literature, and highlights the likely program intervention components which could work better than other components, acknowledging that, if MI is combined with an educative tool, this might work better. In addition, an intervention which consists of a blended approach (face-to-face, telephone-based sessions), using short intervals (once weekly call) for 3 months, of about 15–30 minutes each, seems to be the ideal format and dosage of the intervention. Having the intervention delivered by a nurse with expertise in MI, adjusting the focus on affirmation, compassion, evocation, and engagement, are other characteristics and mechanisms by which the intervention could have supported change. As our review has identified these components, there is added value into how new study interventions could be developed and delivered. Our review also highlights the importance of fully reporting comprehensive information about MI intervention components. In addition to Lee, Choi [13], we suggest that if an intervention is not MI compliant; i.e. uses a counselling style approach adapted from MI, then this should be reported. This might encourage researchers to use the available MI compliance assessment tools to establish whether an intervention is MI or a counselling style approach that draws upon some, but not all MI principles and practices [40]. Although, all the included studies evaluated programs using MI to support risk modification in adult individuals at increased CVD risk and of all ethnic origins, application of the evidence must be considered carefully given the methodological heterogeneity of the studies and the outlined review limitations.

Implications for research

Identifying and understanding the key parameters of interventions is paramount to delivering a preventive program including MI intervention. This systematic review aimed to provide valuable knowledge, which may have useful significance for researchers and clinicians [41, 42]. Firstly, future primary studies should aim to evaluate interventions using standardised measuring tools, with comparable data outcomes. Thus, enabling for pooling of standard results to quantitively synthesize in the case of a systematic review. This will support a conclusive reliable assessment of the intervention effectiveness.

Additionally, the practicality of MI interventions being used in day-to-day clinical practice as well as the cost for its application requires future evaluation. We suggest that MI communication skills (OARS) could be combined with existing resources such as CVD risk calculators. This might act as a triple effect resource: an evaluative, educative and communicative tool, which may further support the modification of cardiovascular risk. MI may be an ideal approach for supporting a specific group of individuals who are at an increased risk of CVD and may likely respond to MI by modifying lifestyle risk factors. Using this approach may be ideal amongst first-degree relatives of CVD patients as they are more likely to have a higher incidence of central obesity, smoking, hypertension and hypercholesterolemia than populations who do not have a biological relative with CVD [4346]. Therefore, as first-degree relatives of CVD patients generally have multiple risk factors it may be more appropriate to implement MI amongst this group rather than amongst other lower risk populations.

In conclusion, while we adopt a motivational style of counselling for individuals who are at increased risk of developing CVD, the effectiveness of this intervention method remains uncertain as its strengths and limitations require further exploration. As such, programmes using MI may be effective and some intervention components might be more powerful than others in affecting specific cardiovascular risk factor change. Elements such as compassion, affirmation and evocation, if adhered to, could be important mechanisms to establish successful cardiovascular risk factor change in patients at high risk of CVD.

Supporting information

S1 Appendix

(DOCX)

Data Availability

Data is available in S1 Appendix Table S4.

Funding Statement

This study was part of a funded PhD programme by the University of Malta. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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Decision Letter 0

Maggie Lawrence

19 Mar 2020

PONE-D-19-35907

Motivational interviewing to support modifiable risk factor change in individuals at increased risk of cardiovascular disease: a systematic review and meta-analysis.

PLOS ONE

Dear Mr Mifsud

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Reviewer #1: Thank you for the opportunity to review this manuscript (PONE-D-19-35907). The manuscript is a systematic review and meta-analysis to determine the effectiveness of motivational interviewing (MI) for supporting modifiable risk factor change in people at increased risk of cardiovascular disease (CVD).

The abstract is structured using appropriate sub-headings and is concisely written. The initial background section states MI has not been well established and explored (line 56), which is a little misleading because there is a wealth of research investigating the use of MI with various health settings and the paper later refers to a recent systematic review on a similar topic. It might be worth adding some additional context to this statement e.g. what areas are poorly established and have not been explored?

The introduction sets the scene for the review and outlines the role of lifestyle therapies in the prevention of CVD. The introduction also introduces MI and outlines some of the core features of the approach. Understandably this is a fairly concise overview of MI, but I wonder whether it would be worth adding something about how these features are used when working with ambivalence and supporting behaviour change.

The introduction continues by highlighting a gap in the literature and stating how this review compliments other literature. The paper then provides a separate rationale section, which is a little unusual. I wonder whether this rationale content might be better embedded within the introduction section?

The review question is appropriate, but could be a little concise (e.g. Our review sought Line 141). There is also a little blurring between effectiveness, strategies, and mechanisms. I wonder whether it might be clearer to present the aims as three bullet points: 1) effectiveness 2) characteristics 3) mechanisms?

The methods section begins by stating the review aligns with PRISMA, which is good. Although, I could see the attached table in the supporting information section to check completeness. A search strategy section is provided, but this could be more transparent and possibly more accurate. The search strategy is rather difficult to read because of the way the information is presented. The use of brackets to group the databases accessed via EBSCO is useful, but this is not used for databases accessed via ProQuest. I could be wrong, but I also think there is some confusion between databases (e.g. MEDLINE) and database providers (e.g. EBSCO and ProQuest) because there is not a consistent approach to how these are presented. It might be useful to list the databases and put the provider in brackets (e.g. MEDLINE (ProQuest)).

The use of key words/subject headings could also be more explicit and it is unclear whether Boolean operators and/or delimiters were used. I understand an example of the search strategy is provided in the supplementary information, but I was unable to access this. I would also suggest changing the term “concepts” (line 164) to “search terms” or similar. The study selection section refers to RCTs “a high body of evidence”, which is rather unusual language (line 185) and might benefit from re-wording. It also refers to filters being applied when using endnote (line 187), but it is unclear what these filters are and whether they are referring to the delimiters applied during the initial database search.

The data extraction section makes reference to critical appraisal (lines 205-208), but this is rather confusing and might be better re-worded and placed within the risk of bias section further down the paper.

The paper includes a study outcomes sub-heading, which might be unnecessary given the other text provided. This section also does not mention effectiveness, which is one of the main aims of the review.

The results section outlines the search and screening results and provides a PRISMA flowchart. The PRISMA flowchart is a little unusual, but provides the necessary information. The results section then provides a summary of the study characteristics. It would be good to explain the differences in the RCTs (line 265), so readers learn a little more about the studies instead of having to refer to the table. Table two shows the study characteristics, but could be enhanced by providing details of the actual participants (e.g. gender, mean age) instead of reporting the inclusion/exclusion criteria used in the original studies.

The effectiveness of MI in supporting modifiable risk factor change is reported comprehensively. A summary of MI component is also provided, but I am a little unsure how the 12 items were selected and wonder whether a more comprehensive reporting method might be better (e.g. TIDieR DOI: 10.1136/bmj.g1687). It might also be worth considering whether the studies being reviewed used any competence measures (e.g. MITI DOI: 10.1016/j.jsat.2004.11.001).

The discussion and limitation section are clear and make relevant points. The conclusion is brief and accurate. Check wording (line 606) and consider amending “possess”.

Overall, this is a really interesting topic and thorough systematic review. It will be of interest to a wide number of people and help inform practice/research. It does needs some minor revision before publication and could be written more concisely in places.

Reviewer #2: Many thanks for inviting to review this manuscript. Overall,the topic is interesting but there are numerous weaknesses, lack of clarity, poorsynthesis of results and general inconsistencies throughout the manuscript thatmade it difficult to review it to the end. I have picked at sections and willgo ahead to provide some comments. I am happy to re-review the whole manuscriptwhen the authors have attended to the preliminary comments.The manuscript will immensely benefit from professional editingservice prior to resubmission.  

Abstract

Pg 3 line 63-64: It is not clear why only manuscriptsfrom 2013 to August 2018 were explored. What about earlier studies or studiesdone since after August 2018.

Introduction:

The rationale for this review was not effectivelyestablished. Given that a previous review suggested primary research (page 5lines 116 – 118) why implement a review instead of a primary research.

Rationale

Page 6 line 125 – 127 (The impact of MI… has remainedsuboptimal) – provide citation

Search strategy- page 7

It is not clear if the search strategy is adequate. Thereaders will benefit from search strategy/ies implemented in individual database/sand journal/s. EbSCO host a number of databases so a generic strategy cannotapply to all the databases in EBSCO. I wonder what informed the decision to doa separate search in BMJ and Plos Journals and not the numerous psychology andallied health journals. It is also strange that BMJ and Plos journals willreturn lots of articles whereas search in databases returned just a few numbers. It wasnot clear where the conference proceedings were searched (169)

Study Selection –

pg 8Line 183 – what does the authors mean by internationalstudies? Line 185… Not clear what high body of evidence means. Lines 190 – 191… Reference lists of identified studies weremanually search to identify further eligible publication - at what point wasthis done? Was this done only for the 7 included papers?How was disagreement between reviewers regarding studieseligibility dealt with?What was done where it was not declared in a study whetheror not people with established CVD were included?

Dataextraction – pg 9

Lines 205- 207 … Could this be stated as one of thelimitations? Only 3/7 satisfied the items on the risk of bias tables. Again,consideration should be given to the relevance of each of the items to theoverall risk of bias outcomes. E.g. Is it possible to blind a personnel deliveryMI to group allocation?Risk of bias assessment and quality of evidence – pg 10It is great that assessment of risk of bias was done at theoutcome level but were there considerations to the relevance of each domain toindividual outcomes? Could GRADE rating be objectively executed when there notformal meta-analysis in majority of the outcomes? How was inconsistency,imprecision, indirectness and publication bias assessed?

Datasynthesis – pg 10

There are three aspects of heterogeneity – conceptual/clinical,statistical, and methodological. Some aspect of methodological heterogeneity mayhave been dealt with by including only RCT. However, MI in this review werepart of broader interventions in different contexts. Therefore, transparent reporting and justification of how data are grouped for synthesis is essential tocompletely deal with the methodological and conceptual heterogeneity.

Synthesis of results

Apart from the implemented meta-analysis, there were no realattempt at synthesis of results but a mere corroboration of the results fromprimary studies, making this section bulky and cumbersome to understand. Inaddition, implementing alternative metric synthesis means alternative questionswere answered. Although, this was mentioned in passing in the data synthesis section, the authors did not reflect this in reporting result synthesis. Indeed,meta-analysis asks the question of what is the size of the average effect. Onthe other hand, methods like summarising effect estimates only answer thequestion of the range and distribution of the effect. Combining p-values willshow if there is evidence that there is an effect in at least in one study.Lastly, vote counting based on direction(trends) of an effect teases out if thereis evidence of an effect? Therefore, the manuscript will benefit from a real synthesisand reporting that recognises these differences.

Summary of outcome findings

Similar to synthesis of results, the summary of outcomesfindings lumps everything together. For instance, it is not clear what wasbeing compared against MI for each of the outcomes – MI vs other behaviouralchange techniques, or MI vs usual care. In addition, the interpretation of the qualityof evidence did not reflect that each of the synthesis were not from ameta-analysis (as per the diver synthesis methods).

Fig 1 - PRISMA flow diagram

It is strange to see 2724 record excluded only by title reading leaving on 39 for abstract reading. It is typical to do title and abstract screening simultaneously because it may not be clear to remove many studies at the level of the title reading.

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Reviewer #1: No

Reviewer #2: Yes: Dr Ukachukwu Abaraogu Physiotherapy and Paramedicine School of Health and Life Sciences Glasgow Caledonian University Scotland United Kingdom

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PLoS One. 2020 Nov 11;15(11):e0241193. doi: 10.1371/journal.pone.0241193.r002

Author response to Decision Letter 0


19 May 2020

Reviewer’s feedback (reviewer 1)

4. The abstract is structured using appropriate sub-headings and is concisely written. The initial background section states MI has not been well established and explored (line 56), which is a little misleading because there is a wealth of research investigating the use of MI with various health settings and the paper later refers to a recent systematic review on a similar topic. It might be worth adding some additional context to this statement e.g. what areas are poorly established and have not been explored?

Reply: Thank you for pointing this out. Now I have clarified that this statement is specifically referring to primary prevention. This review, gives focus on individuals without pre-existent cardiovascular disease.

5. The introduction sets the scene for the review and outlines the role of lifestyle therapies in the prevention of CVD. The introduction also introduces MI and outlines some of the core features of the approach. Understandably this is a fairly concise overview of MI, but I wonder whether it would be worth adding something about how these features are used when working with ambivalence and supporting behaviour change?

Reply: Thank you for asking this question. I have elaborated on the application of open questions, affirmation, reflective listening, summarizing, informing and advising. This now shows how these features are applied to address ambivalence and support behavior change.

6. The introduction continues by highlighting a gap in the literature and stating how this review compliments other literature. The paper then provides a separate rationale section, which is a little unusual. I wonder whether this rationale content might be better embedded within the introduction section?

Reply: Thank you for the comment. The rational content is now embedded within the introductory section.

7. The review question is appropriate, but could be a little concise (e.g. Our review sought Line 141). There is also a little blurring between effectiveness, strategies, and mechanisms. I wonder whether it might be clearer to present the aims as three bullet points: 1) effectiveness 2) characteristics 3) mechanisms?

Reply: Thank you for this point. Amendments were done as follows:

‘Our review sought to determine the effectiveness of MI intervention in supporting primary prevention through changing modifiable cardiovascular risk factors. Additionally, the review provides an account of the characteristics of MI interventions reported in trials that supported risk factor modification.

The primary and secondary review questions are as follows:

1) Is MI effective in supporting adults at increased risk of cardiovascular disease to make healthy lifestyle changes to reduce cardiovascular risk?

2) What are the characteristics of MI interventions that support risk factor modification?

8. The methods section begins by stating the review aligns with PRISMA, which is good. Although, I could see the attached table in the supporting information section to check completeness. A search strategy section is provided, but this could be more transparent and possibly more accurate. The search strategy is rather difficult to read because of the way the information is presented. The use of brackets to group the databases accessed via EBSCO is useful, but this is not used for databases accessed via ProQuest. I could be wrong, but I also think there is some confusion between databases (e.g. MEDLINE) and database providers (e.g. EBSCO and ProQuest) because there is not a consistent approach to how these are presented. It might be useful to list the databases and put the provider in brackets (e.g. MEDLINE (ProQuest)).

The use of key words/subject headings could also be more explicit and it is unclear whether Boolean operators and/or delimiters were used. I understand an example of the search strategy is provided in the supplementary information, but I was unable to access this. I would also suggest changing the term “concepts” (line 164) to “search terms” or similar.

Reply: The search was retaken. Table showing details (results for each systematic step, use of Boolean operators, truncations and wildcard symbols, application of filters) is now available for each database. The term “concepts” was used when referring to the main term (Coronary heart disease, Motivational interviewing, Adult, Prevention, Risk modification, and Clinical trial). For each concept then there are a number of search terms. For example for Coronary heart disease; "coronary disease*" OR "cerebrovascular disorder*" OR "cardiovascular disease*" OR "cardiovascular disorder*" OR "cerebrovascular disease*" OR "heart disease*" OR "myocardial infarction" OR "heart disease*" OR "coronary*disease" OR "ischemic*disease" OR "athero*" OR "myocardial"….these all fall under this concept. Search strategy is now included in Table S3 of S1 appendix

9. The study selection section refers to RCTs “a high body of evidence”, which is rather unusual language (line 185) and might benefit from re-wording.

Reply: We thank the reviewer for pointing this out. The sentence now reads as follows:

Studies for inclusion were those published between February 2013 and March 2020, but limited to randomised controlled trials as reliable sources of evidence.

10. The data extraction section makes reference to critical appraisal (lines 205-208), but this is rather confusing and might be better re-worded and placed within the risk of bias section further down the paper. (Page 6)

Reply: We thank the reviewer for the suggestion. This was now amended and moved under the risk of bias section.

11. The paper includes a study outcomes sub-heading, which might be unnecessary given the other text provided. This section also does not mention effectiveness, which is one of the main aims of the review.

Reply: We thank the reviewer for the suggestion. We feel that this section now shows the specifics and it was amended as follows 235-250:

Effectiveness of the intervention using MI was determined by change in modifiable cardiovascular risk factors (smoking status, dietary eating patterns, physical activity levels, lipid profile levels, blood pressure levels, weight, waist circumference, body mass index).

Data on the characteristics of the MI interventions designed to support CVD risk factor modification were identified;

1) Reported intervention characteristics:

• Nature of the intervention

• Type, frequency, duration, interval

• Characteristics of the deliverer (professional discipline, training and experience)

• Setting

2) Reported MI elements:

• Motivational interviewing content of the intervention

12. The results section then provides a summary of the study characteristics. It would be good to explain the differences in the RCTs (line 265), so readers learn a little more about the studies instead of having to refer to the table. Table two shows the study characteristics, but could be enhanced by providing details of the actual participants (e.g. gender, mean age) instead of reporting the inclusion/exclusion criteria used in the original studies.

Reply: I thank the reviewer for this suggestion. Table 2 was made more explicit. Exclusion criteria was removed and replaced by details such as gender and mean age. More details were included about the RCT design. Line 292-295.

13. The effectiveness of MI in supporting modifiable risk factor change is reported comprehensively. A summary of MI component is also provided, but I am a little unsure how the 12 items were selected and wonder whether a more comprehensive reporting method might be better (e.g. TIDieR DOI: 10.1136/bmj.g1687). It might also be worth considering whether the studies being reviewed used any competence measures (e.g. MITI DOI: 10.1016/j.jsat.2004.11.001)..

Reply: We thank the reviewer for this comment. Now the TIDieR checklist is referred to under the subheading ‘Reported intervention elements’ and table 4. line 451-454.

We do not feel that the TIDieR should replace our previous work, but added to it. Table 5. also reflects to items covered by the TIDieR checklist. These then were categorized according to the study methodological qualities. This will support clinicians/researchers to select intervention components which look promising and likely to succeed. The motivational interviewing content reported was assessed against a checklist that was developed by the authors and drew upon literature from Miller and Rollnick (see Table S6 in S1 appendix). We believe that this highlights the lack of intervention elements reported and the importance of using an MI competence measure.

14. The discussion and limitation section are clear and make relevant points. The conclusion is brief and accurate. Check wording (line 606) and consider amending “possess”.

Reply: I thank the reviewer for their comment. This was now changed to ‘adapted’.

Reviewer2:

15. Pg 3 line 63-64: It is not clear why only manuscripts from 2013 to August 2018 were explored. What about earlier studies or studies done since after August 2018?

Reply: I thank the reviewer for the comment. Two similar systematic reviews were taken previously. These included searches from January 1999 to December 2009, and from 1980 to February 2013. The difference is that our review has specifically focused on individuals without pre-existent CVD. Now we have updated the search up to March2020.

16. Introduction: The rationale for this review was not effectively established. Given that a previous review suggested primary research (page 5lines 116 – 118) why implement a review instead of a primary research.

Reply: We thank the reviewer for the comment. The previous review included RCTs up to February 2013, and did not specifically focus on individuals without pre-existent disease. It was decided that firstly a systematic literature review should be conducted. Our review identified 8 RCTs, which were critically appraised using the Cochrane risk of bias tool. Suggestions for a primary study have been put forward throughout this review. A protocol for a primary study is being developed and a primary research study will be tested in the future.

17. Rationale Page 6 line 125 – 127 (The impact of MI… has remained suboptimal) – provide citation

Reply: I thank the reviewer for the comment. Now citations are provided.

18. Search strategy- page 7 It is not clear if the search strategy is adequate. The readers will benefit from search strategy/ies implemented in individual database/s and journal/s. EbSCO host a number of databases so a generic strategy cannot apply to all the databases in EBSCO. I wonder what informed the decision to do a separate search in BMJ and Plos Journals and not the numerous psychology and allied health journals. It is also strange that BMJ and Plos journals will return lots of articles whereas search in databases returned just a few numbers. It was not clear where the conference proceedings were searched (169)

Reply: I thank the reviewer for pointing this out. Search was retaken. Searches were done individually. We have included a Table (see Table S3 in S1 appendix) showing details of the filters applied and the search results. The search strategy section in the manuscript was amended accordingly.

19. Study Selection –pg 8Line 183 – what does the authors mean by international studies? Line 185… Not clear what high body of evidence means. Lines 190 – 191… Reference lists of identified studies were manually search to identify further eligible publication - at what point was this done? Was this done only for the 7 included papers? How was disagreement between reviewers regarding studies eligibility dealt with? What was done where it was not declared in a study whether or not people with established CVD were included?

Reply: We thank the reviewer for the comments. What we meant by ‘international studies’ is, all studies across the globe. However, since this might not have been interpreted clearly, we decided to remove the term ‘international’.

By having a high body of evidence, we were referring to RCT design. This was amended and now reads line 204-206;

‘but limited to randomised controlled trials as these are initially considered as the gold standard of evidence (11, 12)’.

Manual searching of reference lists was done for the 8 identified RCTs.

Any disagreements between the two researchers, were solved through discussion and if necessary, the third researcher was consulted. All studies declared clear inclusion criteria. Only one study was excluded after consulting with the third researcher. This study included participants who underwent coronary angiography. Such a procedure will only be done in symptomatic individuals (positive Exercise tolerance stress test, stable angina, unstable angina, ECG changes). For the latter reason, it was decided to exclude the study and list under ‘secondary prevention’.

20. Data extraction – pg 9 Lines 205- 207 … Could this be stated as one of the limitations? Only 3/7 satisfied the items on the risk of bias tables. Again, consideration should be given to the relevance of each of the items to the overall risk of bias outcomes. E.g. Is it possible to blind a personnel delivery MI to group allocation?

Reply: We thank the reviewer for the comments. The following sentence; ‘In our review, critical appraisal for methodological quality was not done to ascertain eligibility status of the studies to be included, but to identify intervention effectiveness of those studies who have used a high-quality methodology’, was now moved under the subheading ‘Risk of bias assessment and quality of evidence’.

We do understand that it is not always possible to blind personal. Such interventions are considered as ‘complex interventions’, hence a double blinded procedure is not always possible. However, we feel that the risk of bias outcome, does reflect the features of the design and conduct of the included studies.

21. Risk of bias assessment and quality of evidence – pg 10 It is great that assessment of risk of bias was done at the outcome level but were there considerations to the relevance of each domain to individual outcomes? Could GRADE rating be objectively executed when there not formal meta-analysis in majority of the outcomes? How was inconsistency, imprecision, indirectness and publication bias assessed?

Reply: We thank the reviewer for the comments.

We have reconsidered how to go about the individual outcomes. Now the GRADE’s approach was used for meta-analysis (LDL-c, weight) only. We started with a high default rating, since the included studies are RCTs.

For these 2 outcomes (LDL-c, weight) a decision was made whether to downgrade or upgrade the certainty of the evidence by one or two levels for each factor, leading to a final rating.

The level of certainty was downgraded by one level for serious concerns about risk of bias or two levels for very serious concerns. The I2 statistic, was used for the meta-analysis, and indicated high statistical heterogeneity for the two outcomes (LDL-c, weight). The results for these outcomes across the studies were consistent and directing towards effectiveness. Therefore, the high statistical heterogeneity could be explained by the variations between the interventions used. This could be seen as a clear reason for heterogeneity. Therefore, it was decided not to downgrade, hence reason why ‘inconsistency’ for ‘Improved LDL-c’ and ‘Decreased weight’ were marked as ‘not serious’. For ‘decreased weight’, as the confidence interval excluded the possibility of no effect, we are confident that an effect is present, so we decided that imprecision was not serious. On the other hand, for ‘Improved LDL-c’, the result was considered imprecise as the confidence interval includes both a meaningful result in one direction and crosses the line of no effect. Also, the confidence interval resulted wide, therefore cannot exclude any meaningful effect in either direction. Hence, the ‘Improved LDL-c’ outcome was downgraded by one level for serious concerns about imprecision. We decided not to downgrade for indirectness, however we made it clear that the results only refer to the population reflected in the systematic review (individuals at an increased risk of CVD).

Publication bias was addressed with the Cochrane RoB (risk of bias) tool. This was considered under the risk of bias/study limitations factor for GRADE.

22. Data synthesis – pg 10

There are three aspects of heterogeneity – conceptual/clinical, statistical, and methodological. Some aspect of methodological heterogeneity may have been dealt with by including only RCT. However, MI in this review were part of broader interventions in different contexts. Therefore, transparent reporting and justification of how data are grouped for synthesis is essential to completely deal with the methodological and conceptual heterogeneity. Synthesis of results- Apart from the implemented meta-analysis, there were no real attempt at synthesis of results but a mere corroboration of the results from primary studies, making this section bulky and cumbersome to understand. In addition, implementing alternative metric synthesis means alternative questions were answered. Although, this was mentioned in passing in the data synthesis section, the authors did not reflect this in reporting result synthesis. Indeed, meta-analysis asks the question of what is the size of the average effect. On the other hand, methods like summarising effect estimates only answer the question of the range and distribution of the effect. Combining p-values will show if there is evidence that there is an effect in at least in one study. Lastly, vote counting based on direction (trends) of an effect teases out if there is evidence of an effect? Therefore, the manuscript will benefit from a real synthesis and reporting that recognises these differences.

Reply: We thank the reviewer for the comments.

For each outcome (numerical), we planned to extract:

Number in control group

Mean value of outcome measure in control group

SD of outcome measure in control group

Number in treatment group

Mean value of outcome measure in treatment group

SD of outcome measure in treatment group

A number of outcomes common to 2 or more studies (weight, LDL cholesterol) were observed. Meta analyses were conducted with respect to both of these outcomes. Although the pre-specified outcomes are all measurable outcomes, it was not possible to quantitively synthesize most of the outcomes from the different studies. This is due to either existent and substantive differences in how the outcomes were measured across the studies; substantive differences in study parameters outwit reasonable limits of heterogeneity, or unavailable statistical information. Where possible, certain parameters, which were not provided, were calculated from others that were given: e.g. SD was calculated from mean, confidence interval and number of cases. However, for most of the variables we did not have the means of generating the statistics needed for a particular study for both study groups being compared Therefore we could not include the study in an MA.

All outcomes that could not be quantitatively synthesized were interpreted narratively.

We conducted meta analyses using the more conservative random effects models (rather than fixed effects models), reflecting the clinical and methodological diversity between the studies considered, which is identified and acknowledged elsewhere in our paper. The statistical heterogeneity established in the meta analyses is likely to reflect this observed clinical and methodological diversity and suggests that the utilisation of random effect models was appropriate

23. Summary of outcome findings

Similar to synthesis of results, the summary of outcomes findings lumps everything together. For instance, it is not clear what was being compared against MI for each of the outcomes – MI vs other behavioural change techniques, or MI vs usual care. In addition, the interpretation of the quality of evidence did not reflect that each of the synthesis were not from a meta-analysis (as per the diver synthesis methods).

Reply: We thank the reviewer for the comments. We have amended this section. Now references are made available for each of the outcomes. The quality of evidence now reflects the outcomes from the meta-analysis.

24. Reviewer 1: Overall, this is a really interesting topic and thorough systematic review. It will be of interest to a wide number of people and help inform practice/research. It does need some minor revision before publication and could be written more concisely in places.

25. Reviewer 2: Many thanks for inviting to review this manuscript. Overall, the topic is interesting but there are numerous weaknesses, lack of clarity, poor synthesis of results and general inconsistencies throughout the manuscript that made it difficult to review it to the end. I have picked at sections and will go ahead to provide some comments. I am happy to re-review the whole manuscript when the authors have attended to the preliminary comments. The manuscript will immensely benefit from professional editing service prior to resubmission.

Reply: We thank the reviewers for finding the topic and the results interesting to a wide number of health professionals to support better practice and research in preventive cardiology.

I would be glad to answer any further questions or comments that you may have.

I look forward to hearing from you,

Thank you for your time,

Justin Lee Mifsud

Attachment

Submitted filename: Response to reviewers.docx

Decision Letter 1

Maggie Lawrence

4 Sep 2020

PONE-D-19-35907R1

Motivational interviewing to support modifiable risk factor change in individuals at increased risk of cardiovascular disease: a systematic review and meta-analysis.

PLOS ONE

Dear Mr Misfud

Thank you for submitting your manuscript to PLOS ONE.

I am extremely sorry that it has taken me so long to get back to you. Busy workloads (mine and the reviewers’) following COVID 19 restrictions are in part to blame for this. Now that I have had time to consider the review comments of both the original reviewers and the statistical reviewer, I have revisited your paper with these comments in mind. 

I believe this is a good review which has merit, however after revisiting your paper, I find that does not fully meet PLOS ONE’s publication criteria as it currently stands and major revision is required before it meets publication standards. Some revisions are minor, others are major. I have listed these below. 

We invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

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We look forward to receiving your revised manuscript.

Kind regards,

Maggie Lawrence

Academic Editor

PLOS ONE

Additional Editor Comments (if provided):

Dear Mr Misfud

I am extremely sorry that it has taken me so long to get back to you. Busy workloads (mine and the reviewers’) following COVID 19 restrictions are in part to blame for this. Now that I have had time to consider the review comments of both the original reviewers and the statistical reviewer, I have revisited your paper with these comments in mind.

I believe this is a good review and worthy of publication in PLOS One however after revisiting your paper, I find that major revision is required before it meets publication standards. Many are minor, some are more major. I have listed these below.

Abstract

In the Conclusion section that is a result - please remove that.

Main body of the manuscript

line 113 you refer to one systematic review and meta-analysis - please be clear about your meaning here. One review is about primary and secondary prevention, the other is not.

Line 130 you refer to updating previous reviews - this is not accurate - the focus of your current review is narrower, please clarify.

Line 161 after ‘electronic journals’ is everything in brackets an electronic journal or did you look at electronic journals within these resources? Please clarify.

Line 164 I agree with the reviewers, the use of the word ‘concept’ is not useful here. It would be clearer to explain the PICOs elements (to use the term you use in Table 1) and then describe your search in terms of the PICOs elements.

Line 180 are these ‘preventive interventions’ primary prevention interventions? Please clarify.

Line 185 remove the word ‘but’ and replace it with ‘and’.

Line 191 is it possible to conduct searches using Endnote? If not, remove the words ‘retrieved and’.

Line 192 insert the word ‘potentially’ between the 'further’ and ‘eligible’.

Table 1 insert ‘primary’ in your description of the Inclusion criteria for the Intervention element.

line 212 I am aware that the reviewers suggested that you use the TIDieR checklist. The review would be more robust, I think, if you did used TIDieR to report the data extracted. You can add supplementary items, if you felt this was necessary but I haven't identified any items in sections 1) or 2) that would be supplementary. All would fit with TIDieR, item four, in particular. Also, I note you have used TIDieR in the Results section therefore it would make sense to also use it here.

Lines 226 and 228 - swap the order of these two sentences.

Line 223 do you mean ‘data extraction’ rather than ‘data abstraction’? Move the sentence to the data extraction section above and state that it was review specific or ‘adapted from...’

line 250 the heterogeneity paragraph in this location should be about methods only. The results element of this paragraph belongs in the Results section.

Results

Line 256 you report 1114 hits which after duplicates were removed reduced to 860. 792 records were then excluded – leaving a total of 68 - NOT 69 as stated. This mistake is replicated in the PRISMA flow diagram. Please check the numbers and amend both the text and the flow diagram accordingly.

Table 2

Aadahl (2014) record complete the comment in the ‘control’ section

Remove ‘both’ from after ‘gender’ in the Boutin-Foster, (2016) record.

Insert 100% after ‘females’ in the Lin (2016) record

Insert key to acronyms used in the table

Line 303 the meaning here is unclear – either there was or wasn’t selective reporting.

Line 306 surely there was reporting bias in what was reported (Tabel 3 indicates that this is the issue) and, if that is the case, it is not clear why you have singled out one study for comment.

Line 312 replace ‘into’ with ‘to; ‘by’ is not the right word to use in this sentence.

Line 314 – provide an example

Line 322 remove ‘existent and’

Line 324 ‘outwith’ not ‘outwit’

Line 330 here and for all outcomes headings remove the information in brackets from the heading

Line 368 – consider reporting this is such a way as to demonstrate that it is a positive finding.

Line 414 why was a meta-analysis not doe for BP? After a bit of digging, I find it was because the results were reported in different was – it may be worth explaining that here – but also please note, the references are numbered incorrectly. Please check all reference numbering.

Line 459 - what papers are being referred to in this section?

Lines 479 – 481 How do you justify your interpretation of this finding? Is 73% ‘adequate’?

Table 4 The meaning of the second row from the bottom is unclear I.e. Mean overall (%) reporting rate to at least one element

Line 505 I think there is typo - ‘elements’ is used twice, and the meaning is unclear.

Indicators paragraph

This paragraph needs work the English could be improved and the paragraph would perhaps benefit from an explanatory opening sentence. For example, my understanding is that frequency of use of MI elements is mapped against intervention effectiveness. Is that right? This should be described in the methods section and not be making a first appearance here.

Table 5 Presenting this aspect of your findings in this way is a good idea but I would be tempted to reduce this to include only the high-quality study columns - as these will be the results most likely to influence future practice, surely?

The limitations section needs to include the issue of using English language papers only as this is not considered good practice.

Reviewer 2

I note that reviewer 2 continues to argue that since the two previous reviews did not specifically focus on people without pre-existing CVD, findings from them should not represent results specific to people without pre-existing condition. I therefore suggest extending the search to older literature which focused on people without pre-existing CVD. I agree with reviewer 2 and think you either need to follow his suggestion or be clearer about this issue in the body of the text.

Reviewer 3

Please address the issues raised by reviewer 3.

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

Reviewer #2: (No Response)

Reviewer #3: (No Response)

**********

2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: I Don't Know

Reviewer #2: Yes

Reviewer #3: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: (No Response)

Reviewer #2: Authors have done well to address almost all my queries. However, I continue to argue that given the two previous reviews did not specifically focus on people without pre-existing CVD, findings from them should not represent results specific to people without pre-existing condition. I therefore suggest extending the search to older literature which focused on people without pre-existing CVD.

Reviewer #3: interestimg paper.

Abstract

Definition of cochrane framework should be added

Why from 8 studies for pnly 3 was analusis performed?

Authors say that some features may be more likely like ...: how were these variables defined?

Introduction is too long and should be shortened

Methods: did authors performed sub analysis according to grading of paper

Methods: did authors performed sub anakysis for grading of the paper

Methods:authors spoke about conservative effect for random. This should be better specified

Results: plots should be modified and made more consistent

Discussion: high risk patients like hiv may be also interested by this procedure (quote on PMID: 26851703)

**********

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Reviewer #1: No

Reviewer #2: Yes: Dr Ukachukwu Abaraogu School of Health and Life Sciences Glasgow Caledonian University

Reviewer #3: Yes: Fabrizio D'Ascenzo

[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

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PLoS One. 2020 Nov 11;15(11):e0241193. doi: 10.1371/journal.pone.0241193.r004

Author response to Decision Letter 1


3 Oct 2020

Revision 2.

Author response

Justin L. Mifsud – Department of Nursing, University of Malta

Email address: justin-lee.mifsud@um.edu.mt

ORCID iD: https://orcid.org/0000-0001-5380-9418

Re: Motivational interviewing to support modifiable risk factor change in individuals at increased risk of cardiovascular disease: a systematic review and meta-analysis. (Reference number PONE-D-19-35907)

Dear Editor,

I would like to thank you and the reviewers for their helpful comments. I have taken their suggestions on board and did all the possible changes as discussed below. Please find enclosed the edited manuscript in word format. We believe that now the manuscript fully meets PLOS ONE’s publication criteria.

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

Reply: Thank you. We have now addressed all the points highlighted by reviewer 2 and reviewer 3.

2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

Reply: Thank you

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: I Don't Know

Reviewer #2: Yes

Reviewer #3: Yes

Reply: Thank you

4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

Reply: Thank you

5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

Reply: Thank you

Reviewer #2: Authors have done well to address almost all my queries. However, I continue to argue that given the two previous reviews did not specifically focus on people without pre-existing CVD, findings from them should not represent results specific to people without pre-existing condition. I therefore suggest extending the search to older literature which focused on people without pre-existing CVD.

Reply: Thank you, we have now extended the search and included older studies which fit the inclusion and exclusion criteria of our review.

Reviewer #3: interesting paper.

Reply: Thank you

1. Abstract

Definition of Cochrane framework should be added

Reply: Thank you, we have now included the principles of the Cochrane framework.

2. Why from 8 studies for only 3 was analysis performed?

Reply: Thank you for your comment. In view of variations between studies in measuring the variables, meta-analysis was not always possible.

3. Authors say that some features may be more likely like ...: how were these variables defined?

Reply: Thank you for your comment. We have deemed these particular intervention characteristics as potential intervention items, after carrying out a careful evaluation of risk of bias and intervention effectives of each study. Studies which had minimal risk and showed significant intervention benefits, their intervention characteristics were identified and selected as more likely to be effective than other characteristics. The selected characteristics will then be used in primary research.

4. Introduction is too long and should be shortened

Thank you for your comment, we have now deleted some of the word count in the introduction section.

5. Methods: did authors performed sub analysis according to grading of paper

Reply: By “sub analysis” we assume the reviewers are referring to subgroup analyses as part of the meta analyses. These were not conducted as there were no appropriate strata in the included studies over which results could be presented. We chose to assess statistical heterogeneity with random effects meta analyses.

6. Methods: authors spoke about conservative effect for random. This should be better specified

Reply: Thank you for your comment. More detail is now included in the manuscript. We conducted meta analyses using the more conservative random effects models (rather than fixed effects models), reflecting the clinical and methodological diversity between the studies considered, which is identified and acknowledged elsewhere in our paper. The statistical heterogeneity established in the meta analyses is likely to reflect this observed clinical and methodological diversity and suggests that the utilisation of random effect models was appropriate.

7. Results: plots should be modified and made more consistent

Reply: Thank you for your comment. We have now modified the plots to include data from the new studies. The plots have been, and remain consistently presented, and they and the accompanying summary text follow a standard format for the presentation of meta analyses results.

Editorial comments

1. Abstract: In the Conclusion section that is a result - please remove that.

Reply: Thank you for pointing this out. We have edited the conclusion section and moved part of it under the result section.

2. Main body of the manuscript: line 113 you refer to one systematic review and meta-analysis - please be clear about your meaning here.

Reply: Thank you for pointing this out. We were referring to the same study which is a systematic review with meta-analysis. Now this has been clarified in the manuscript.

3. One review is about primary and secondary prevention, the other is not. Line 130 you refer to updating previous reviews - this is not accurate - the focus of your current review is narrower, please clarify.

Reply: Thank you for pointing this out. Now we have made it explicitly clear that our review specifically focuses on primary prevention. Our review, gives focus on individuals without pre-existent cardiovascular disease. For this reason, we agreed to update the search and included older studies which were eligible as per inclusion/exclusion criteria.

4. Line 161 after ‘electronic journals’ is everything in brackets an electronic journal or did you look at electronic journals within these resources? Please clarify.

Reply: Thank you for pointing this out. Now we have clarified this sentence in the manuscript. This now reads- The search strategy was formulated and applied to identify published primary research literature from databases (CINAHL Complete, APA PsycINFO, Academic Search Ultimate, Cochrane Central Register of Controlled Trials, MEDLINE, PubMed,) and electronic journals within health-related resources (E-Journals, Wiley Online Library, PLOS, DynaMed Plus).

5. Line 164 I agree with the reviewers, the use of the word ‘concept’ is not useful here. It would be clearer to explain the PICOs elements (to use the term you use in Table 1) and then describe your search in terms of the PICOs elements.

Reply: Thank you for pointing this out. Now we have replaced the term concept by the term ‘search terms’ which links to the PICO elements.

6. Line 180 are these ‘preventive interventions’ primary prevention interventions? Please clarify.

Reply: Thank you for your comment. We are referring to primary prevention interventions, therefore we now have included the term ‘primary’.

7. Line 185 remove the word ‘but’ and replace it with ‘and’.

8. Line 191 is it possible to conduct searches using Endnote? If not, remove the words ‘retrieved and’.

9. Line 192 insert the word ‘potentially’ between the 'further’ and ‘eligible’.…..

Reply: Thank you for the suggestions. We now have amended the manuscript accordingly.

10. Table 1 insert ‘primary’ in your description of the Inclusion criteria for the Intervention element.

line 212 I am aware that the reviewers suggested that you use the TIDieR checklist. The review would be more robust, I think, if you did used TIDieR to report the data extracted. You can add supplementary items, if you felt this was necessary but I haven't identified any items in sections 1) or 2) that would be supplementary. All would fit with TIDieR, item four, in particular. Also, I note you have used TIDieR in the Results section therefore it would make sense to also use it here.

Reply: We have now referred to the TIDieR under the heading ‘methods’. S1 appendix now shows items checked for each individual study. This is then presented in Table 4. ‘Summary of reported intervention elements’. We used percentage scoring for each item and calculated the overall mean, as we believe that this will make it more interesting for PLOS readers.

Now we have used TIDieR to report intervention items as shown under the subheading ‘Secondary outcomes- Reported intervention elements.

Then we moved on to report The MI intervention element. The item checklist to check for MI elements is review specific and draws upon literature from Miller WR, Rollnick S, (Motivational interviewing: Helping people change: Guilford press; 201 2). The results of the checklist used is now available for each study as part of the S1 appendix. Table S5 is the template of the MI checklist. We believe that this checklist highlights the lack of intervention elements reported and the importance of using an MI competence measure.

11. Lines 226 and 228 - swap the order of these two sentences. Line 223 do you mean ‘data extraction’ rather than ‘data abstraction’? Move the sentence to the data extraction section above and state that it was review specific or ‘adapted from...’

line 250 the heterogeneity paragraph in this location should be about methods only. The results element of this paragraph belongs in the Results section.

Reply: Thank you for the suggestions. We have now amended the manuscript accordingly.

12. Results: Line 256 you report 1114 hits which after duplicates were removed reduced to 860. 792 records were then excluded – leaving a total of 68 - NOT 69 as stated. This mistake is replicated in the PRISMA flow diagram. Please check the numbers and amend both the text and the flow diagram accordingly.

Reply: Thank you, we have now re-taken the search to extend to older studies. We have changed numerical records accordingly.

13. Table 2-Aadahl (2014) record complete the comment in the ‘control’ section. Remove ‘both’ from after ‘gender’ in the Boutin-Foster, (2016) record. Insert 100% after ‘females’ in the Lin (2016) record. Insert key to acronyms used in the table

Reply: Thank you for the suggestions. We have now amended the table accordingly.

14. Line 303 the meaning here is unclear – either there was or wasn’t selective reporting.

Reply: Thank you for pointing this out. We have clarified this statement and it now reads: There was no selective reporting in 6 of the 12 studies

15. Line 306 surely there was reporting bias in what was reported (Tabel 3 indicates that this is the issue) and, if that is the case, it is not clear why you have singled out one study for comment.

Reply: Thank you for your comment. We have commented on 1 particular study, as this study had a protocol available, however it was noted that not all pre-specified outcomes were reported in a pre-specified way. Therefore, this study can be indicative of selective reporting. The remaining 6 studies did not provide sufficient detail about the reporting of study outcomes as no protocol was available. Therefore, judgement with respect to reporting bias could not be carried out.

16. Line 312 replace ‘into’ with ‘to; ‘by’ is not the right word to use in this sentence. Line 314 – provide an example. Line 322 remove ‘existent and’ Line 324 ‘outwith’ not ‘outwit’ Line 330 here and for all outcomes headings remove the information in brackets from the heading. Line 368 – consider reporting this is such a way as to demonstrate that it is a positive finding.

Reply: Thank you for the suggestions. We have now amended the manuscript accordingly.

17. Line 414 why was a meta-analysis not doe for BP? After a bit of digging, I find it was because the results were reported in different was – it may be worth explaining that here – but also please note, the references are numbered incorrectly. Please check all reference numbering.

Reply: Thank you for the suggestions. We have now amended the manuscript accordingly. Meta-analysis was not always possible due to variations between studies in the measurements used to calculate same variable/s. Also, we were not able to use the Groeneveld study in the revised meta analysis of weight. This was because although Groeneveld measured weight in both groups at baseline and at 12 months, no stats were provided for the change in weight. Of course, mean weight change can easily be calculated from baseline and follow-up data, but the SD of weight change cannot. We were able to add the other studies and create new plots accordingly.

18. Line 459 - what papers are being referred to in this section?

Reply: Thank you for pointing this out. We are referring to the studies by Kouwenhaven 2018, Aadahl, 2014 and Kong, 2017. Reference is being made in a forest plot (fig. 3), showing that the synthesized data from the three studies, overall result favour the intervention in reducing weight.

19. Lines 479 – 481 How do you justify your interpretation of this finding? Is 73% ‘adequate’?

Reply: Thank you for pointing this out. This has now changed since we have included older studies. Now the percentage is 68%. This now reads:

The average of total percentage reporting to at least one of the 12 items across all 12 studies amounted to 68%, highlighting that the overall intervention descriptions were adequately reported (Table 4) and may, support replicability of the intervention.

20. Table 4 The meaning of the second row from the bottom is unclear I.e. Mean overall (%) reporting rate to at least one element

Reply: Thank you for pointing this out. We have now amended this in the manuscript. This now reads: Mean overall (%) reporting

Line 505 I think there is typo - ‘elements’ is used twice, and the meaning is unclear.

Reply: Thank you, this is now corrected.

21. Indicators paragraph

This paragraph needs work the English could be improved and the paragraph would perhaps benefit from an explanatory opening sentence. For example, my understanding is that frequency of use of MI elements is mapped against intervention effectiveness. Is that right? This should be described in the methods section and not be making a first appearance here.

Reply: Thank you for your comment. Our intension was to identify and select intervention program elements from those studies which showed a significant beneficial between group difference effect. Only elements from high quality studies were selected. The use of these intervention elements was then put forward to be used in primary research. A protocol for a primary study has been drafted and is proposed to be tested.

22. Table 5 Presenting this aspect of your findings in this way is a good idea but I would be tempted to reduce this to include only the high-quality study columns - as these will be the results most likely to influence future practice, surely?

Reply: Thank you for your suggestion. We have now included only the elements from high quality studies.

23. The limitations section needs to include the issue of using English language papers only as this is not considered good practice.

Reply: Thank you for your comment. This is now included in the limitations section.

Reply: We thank the reviewers for finding the topic and the results interesting to a wide number of health professionals to support better practice and research in preventive cardiology.

I would be glad to answer any further questions or comments that you may have.

I look forward to hearing from you,

Thank you for your time,

Justin Lee Mifsud

Attachment

Submitted filename: Response to reviewers.docx

Decision Letter 2

Maggie Lawrence

12 Oct 2020

Motivational interviewing to support modifiable risk factor change in individuals at increased risk of cardiovascular disease: a systematic review and meta-analysis.

PONE-D-19-35907R2

Dear Mr Mifsud

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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Kind regards,

Maggie Lawrence

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Dear Mr Mifsud

It was pleasure to read your paper this afternoon. I apologise again for it being such unextended process - but I believe your efforts and perseverance have resulted in an excellent, interesting paper of relevance to clinicians and researchers. This is robust work with which to underpin your empirical study.

Reviewers' comments:

Acceptance letter

Maggie Lawrence

15 Oct 2020

PONE-D-19-35907R2

Motivational interviewing to support modifiable risk factor change in individuals at increased risk of cardiovascular disease: a systematic review and meta-analysis.

Dear Dr. mifsud:

I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department.

If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org.

If we can help with anything else, please email us at plosone@plos.org.

Thank you for submitting your work to PLOS ONE and supporting open access.

Kind regards,

PLOS ONE Editorial Office Staff

on behalf of

Dr. Maggie Lawrence

Academic Editor

PLOS ONE

Associated Data

    This section collects any data citations, data availability statements, or supplementary materials included in this article.

    Supplementary Materials

    S1 Appendix

    (DOCX)

    Attachment

    Submitted filename: Response to reviewers.docx

    Attachment

    Submitted filename: Response to reviewers.docx

    Data Availability Statement

    Data is available in S1 Appendix Table S4.


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