Relationship between trust and patient involvement in medical decision-making: A cross-sectional study.

INTRODUCTION: Patients vary in their preferences regarding involvement in medical decision-making. Current research does not provide complete explanation for this observed variation. Patient involvement in medical decision-making has been found to be influenced by various mechanisms, one of which could be patients' trust in physicians. The aim of this study was to examine whether trust in physicians fosters or impairs patient involvement in medical decision-making. This study also aimed to determine to what extent the relationship between trust and preferences regarding decision-making roles was influenced by the sociodemographic characteristics of the patients. We hypothesised that trust can both foster and impair patient involvement in medical decision-making.
MATERIALS AND METHODS: A survey was sent out to members of the Nivel Dutch Health Care Consumer Panel in February 2016 (response rate = 47%, N = 703). The Wake Forest Physician Trust Scale was used to measure trust. Patient involvement was measured using two items based on the study published by Flynn and colleagues in 2006. Multiple regression analysis was used to analyse the relationship between trust and patient involvement.
RESULTS: We found a negative relationship between trust and patient involvement in medical decision-making in men. Women with high trust reported to be more involved in medical decision-making compared to men with high trust.
CONCLUSION: The results suggest that trust impairs involvement in medical decision-making for men but not for women. Further research could provide a more comprehensive explanation of the variation in patient preferences regarding involvement in medical decision-making to further elucidate which underlying mechanisms could enhance patient participation.

Introduction

The last few decades have witnessed a major shift from paternalism to shared decision-making (SDM) in the patient-physician relationship [1], which led to an increasing emphasis on patients’ active participation in medical decision-making (MDM). SDM represents one of the approaches to MDM [2]. In contrast to the paternalistic model, where physicians impose their decisions on the patients, SDM is “the process through which clinicians and patients share information with each other and work toward decisions about treatment chosen from medically reasonable options that are aligned with the patients’ values, goals, and preferences” [3]. The idea of SDM has emerged from the principles of patient-centred care, which is defined as “care that is respectful of and responsive to individual patient preferences, needs, and values” and that ensures “that patient values guide all clinical decisions” [4]. Therefore, SDM is an essential attribute of patient centred care and good quality of care as it implies that patient preferences are taken into account [5].

Previous studies indicate that most patients, especially younger, higher educated, and female patients prefer a shared approach to MDM [6-9]. Additionally, patients’ experience of illness and medical care, their diagnosis and health status, the type of decision that needs to be made, the amount of knowledge patients have acquired about their condition, their attitude towards SDM, and the patient-physician relationship play a role in forming patient preferences about involvement in MDM [6]. It can be concluded that patients vary in their preferences for involvement in MDM and that these preferences are developed as a consequence of a highly complex process under the influence of multiple factors mentioned above [6]. A number of mechanisms including critical high health literacy, availability of medical informational support, and non-conservative social norms were found to positively influence patient involvement in MDM [10-12]. However, the studied mechanisms account for only a part of the observed variation in patient preferences for involvement in MDM [10-12]. To provide a more comprehensive explanation, other mechanisms that might influence patient involvement need to be studied as well. One of such mechanisms might be trust.

This study examines trust in physicians as a mechanism that might further explain the variation in patient preferences regarding participation in MDM. In this study, we focus on the interpersonal trust of patients in their physician, which can be defined as “the optimistic acceptance of a vulnerable situation in which the patient believes that the physician will care for the patients’ interests” [13]. On the one hand, trust in physicians is considered to be an important aspect of a therapeutic relationship, a key predictor of patient involvement in MDM [7], and an important source of support, especially for critically ill patients, helping them deal with uncertainty and fear [14]. On the other hand, trust can also prevent patients from being truly autonomous and taking the responsibility for their own health, thereby hindering an optimal patient-physician relationship [15]. Therefore, patients’ trust in physicians can act both as a barrier and a facilitator of patient involvement in MDM [16-21].

Relationship between trust and patient involvement in medical decision-making

Although earlier studies found that higher trust in physicians can both foster and impair involvement in MDM [16,20,22], more insight into the mechanisms of this relationship is needed. Since trust in physicians is influenced by patients’ sociodemographic characteristics [21,23,24], investigating how sociodemographic characteristics affect the relationship between trust and patient involvement in MDM might provide an explanation of why for some patients high trust acts as a facilitator of their involvement in MDM, while for others it can be a barrier. Furthermore, previous studies have been performed either among specific patient groups including patients of breast cancer, prostate cancer and fracture outpatient clinics [21], African-American patients with diabetes [16,17], patients with cardiovascular disease [20] or among a group of breast cancer specialists [25]. Trachtenberg and colleagues (2005) examined a random national sample in the US; however, the sample was not fully representative of the general American population [7]. Since the samples of earlier studies examine various specific groups, generalizability of the findings is in question. Therefore, this study was performed among a representative sample of the general population in the Netherlands, which is likely to increase the generalizability of the findings.

Relationship between trust and sociodemographic characteristics

Several studies also examined the relationship between sociodemographic characteristics and trust. These studies established some correlation between the level of trust and age [23,24], gender [21,23], and educational level [21,23]. Nevertheless, according to Hall and colleagues (2001), among others, demographic characteristics, with the exception of age, are not strong predictors of trust [13]. Because previous studies produced conflicting results, this study examined the relationship between the level of trust and age, gender, and educational level in the sample of a general population in the attempt to explain the bidirectionality of the relationship between trust and patient involvement in MDM.

Aims of the study

The aims of this study were to examine the relationship between patients’ trust in their physician and their involvement in MDM and to determine the extent to which this relationship was influenced by sociodemographic characteristics of the patients. This study was performed among a sample of the general population aged 18 years and older in the Netherlands and focussed on the self-reported patient involvement in MDM.

Hypothesis and conceptual model of the study

Based on the aims of the study and the reviewed literature concerning the relationship between trust and patient involvement as well as predictors of trust, several hypotheses were developed.

It is hypothesized that higher level of trust can both foster and impair patient involvement in MDM [16,20,21]. A trusting patient-physician relationship motivates patients to engage in MDM, because they feel comfortable to speak up and ask questions [17]. On the other hand, high level of trust might also encourage passivity [7,21]. Patients with high level of trust are more likely to assume a passive role [21]; they believe that their physician acts in their best interest and, thus, do not deem their involvement necessary [22]. Therefore, the first hypothesis is:

H1: High trust can both foster and impair patient involvement in medical decision-making.

Older patients tend to have higher levels of trust in their physician in comparison to younger patients [23,24]. This is likely due to the generational effect, which means that the elderly have more respect towards physicians compared to younger generations [13]. The association between older age and higher trust might also be related to the fact that older patients are more likely to have more contacts and a generally longer relationship with their physician and, therefore, develop higher level of trust [13]. On the other hand, younger people use less healthcare [26] and are less likely to develop trust in their physician during infrequent visits. Older patients also tend to have a lower level of health literacy [27,28], which makes it more difficult for them to obtain, process and understand basic health information and services needed to make appropriate health decisions [29]. Additionally, elderly find SDM less important [30] and prefer a more passive role in MDM [6]. It can be assumed that low health literacy prevents older people from engaging in MDM and higher trust in their physician might help them cope with vulnerability. Based on this, we hypothesize that:

H2: Older people with higher trust in their physician are less involved in medical decision-making, while younger people with higher trust are more involved in medical decision-making.

Women are presumed to have more trust in their physician compared to men [31,32]. Patients who have a longer relationship with their physicians are more likely to trust their physicians [33]. Women are found to use more healthcare services compared to men [34-36], and are, therefore, more likely to develop a longer relationship with their physician, which might explain why women tend to exhibit higher levels of trust compared to men. Besides, women generally prefer a shared approach to MDM [6-9,37]. In addition, women are generally more risk averse than men in the context of physical health and safety [38-41]. It can be hypothesized that women attempt to control the risk by actively participating in MDM. Based on this, it is hypothesized that:

H3: Women with higher trust in their physician are more involved in medical decision-making, while men with higher trust are less involved in medical-decision making.

Less educated people are presumed to have higher trust in their physician as opposed to highly educated people [7,21,23,42], which might be attributed to differences in health literacy [27,28]. In addition, less educated people find SDM less important [30] and prefer a more passive role in MDM [6]. It can be assumed that, similarly to the elderly, lower health literacy prevents less educated people from engaging in MDM and that trust helps them cope with vulnerability. Therefore, we hypothesize that:

H4: Lower educated people with higher trust in their physician are less involved in medical decision-making, while higher educated people with higher trust are more involved in medical decision-making.

Methods

Setting

The data for this study were collected in the Dutch Health Care Consumer Panel, which gathers information about opinions and experiences of the general population in relation to healthcare. Themes of the questionnaires include, among other, trust, solidarity, health insurance, opinions on healthcare insurers and care providers, and eHealth. The Dutch Health Care Consumer Panel is an access panel, which consists of a large number of members that agreed to respond to questionnaires on a regular basis. Certain background characteristics such as age, gender, and self-reported health status of the panel members are known. The panel allows to draw samples for individual studies that are representative with respect to gender and age of the general Dutch population age 18 years and older. The members are recruited in two manners. First, addresses of potential participants are bought from an address supplier. Second, new members are recruited through general practitioner practices that participate in the Primary Care Database programme. People cannot sign up to become a member of the panel on their own initiative. Surveys and questionnaires are being distributed approximately eight times per year. Every member receives a questionnaire about three times a year and is free to quit the panel at any time. Members are able to choose whether they prefer to fill out paper-based or online questionnaires. There are no costs associated with the membership. At the moment of data collection (February 2016), the Dutch Health Care Consumer Panel consisted of approximately 12,000 members of 18 years or older [43]. As of 2021, the number of panel members is approximately 11,500. According to the Dutch legislation, neither obtaining informed consent nor approval by a medical ethics committee is obligatory for conducting research through the panel [44]. Data are analysed anonymously, and processed according to the privacy policy of the Dutch Healthcare Consumer Panel, which complies with the General Data Protection Regulation (GDPR). A privacy regulation is available for the Consumer Panel [45]. The questionnaires used in this study were anonymous in nature. Besides, the researchers who analysed the data did not have access to any identifiable information of the participants (e.g. name and address).

For this study, a questionnaire was sent to a sample of 1,500 panel members in February 2016. The sample was randomly selected and was representative of the Dutch adult population for age and sex. The survey inquired about various topics. For this study, only two sections of the survey related to patient involvement in MDM and trust in their physician were assessed. Two electronic reminders (after one and two weeks) and one postal reminder (after two weeks) were sent out to the panel members who did not return the questionnaires. The closing date for the questionnaire was four weeks after the initial distribution. The respondents were not obliged to answer the questionnaire. 703 panel members returned the questionnaire (response rate of 47%).

Measurements

Trust

Trust was measured using the Dutch version of the “Wake Forest Physician Trust Scale” (WF-D) [46], which consists of one question subdivided in ten items (Table 1). The respondents were asked to indicate to what extent they trust their physician on a 5-point Likert scale (“completely disagree” = score 1; “completely agree” = score 5). Items b, c, and h contained negative statements and were, therefore, reverse coded. Only respondents that filled out all questions were included; based on this 70 participants were excluded. The internal consistency of the scale is high as indicated by the Chronbach’s alpha (0.9). The total score for each participant was calculated by averaging the responses. The scores ranged from 1 to 5 with higher scores indicating higher trust.

Table 1

Measurement of trust: Wake Forest Physician Trust Scale.

Questions	Answer categories
Indicate the extent to which you agree with the following statements:	Completely disagree (score 1), disagree (score 2), neither agree or disagree (score 3), agree (score 4), completely agree (score 5)
a. Your physician will make every effort to ensure that you receive the care you need.
b. Sometimes your physician sets his/her own interests above your medical interest (reverse coded)
c. Your physician’s medical skills are not as good as they should be (reverse coded)
d. Your physician is extremely careful and accurate.
e. You have every confidence in your physician’s decision about which medical treatments are best for you.
f. You physician informs you in all fairness about the different treatments available for your condition.
g. Your physician thinks only about what is best for you.
h. Sometimes your physician does not pay full attention to what you are trying to tell him/her (reverse coded)
i. You do not worry about putting your life in the hands of your physician.
j. All in all, you trust your physician completely.

Patient involvement in medical decision-making

Two questions based on the items developed by Flynn et al [9] were used to measure patient involvement in MDM (Table 2). The respondents were asked to indicate to what extent they were involved in MDM. Both questions contained negative statements and were, therefore, reverse coded. For each respondent that filled out all questions (n = 40 excluded), the mean score was calculated. The internal consistency given by Cronbach’s alpha is 0.68, which is considered acceptable [47]. The scores ranged from 1 to 4; the higher the score, the more actively the respondent stated to be involved in MDM.

Table 2

Measurement of patient involvement in medical decision-making (based on Flynn et al. 2006 [9]).

Questions	Answer categories
1. How often do you think that:	Never (score 1), sometimes (score 2), often (score 3), always (score 4)
a. You let your physician decide what is the best for your health? (reverse coded)
b. The most important medical decisions will be taken by your physician and not by yourself? (reverse coded)

Sociodemographic characteristics

The following sociodemographic characteristics of the respondents were assessed: age (1 = young, below 40; 2 = middle, between 40 and 64; 3 = elderly, 65 and above); gender (1 = male, 2 = female); educational level (1 = low, 2 = middle, 3 = high). Low educational level referred to none, primary school or prevocational education. Middle educational level referred to secondary or vocational education. High educational level referred to professional higher education or university.

Statistical analysis

First, descriptive statistics were populated to describe the characteristics of the sample. Second, the relationship between trust and sociodemographic characteristics was tested in a multiple regression model with trust as a dependent variable and the sociodemographic characteristics as independent variables. To analyse the relationship between trust and patient involvement a Pearson correlation was calculated. To examine whether the relationship between trust and patient involvement differs between groups of respondents, a second multiple regression analysis was performed. In the second analysis, patient involvement was included as the dependent variable, trust and sociodemographic characteristic were included as the independent variables. The interactions between trust and sociodemographic characteristics were also included in the second analysis. To carry out statistical analyses, STATA, version 14.0, was used. P<0,05 was considered to be statistically significant.

Results

Descriptive statistics

Table 3 describes the characteristics of the respondents. Half (50%) of the respondents were female; the mean age of the respondents was 56 years (range 21 to 91). The majority of the respondents had a middle (54%) or high (31%) level of education. The mean score for patient involvement was 2.43 (SD = 0.71) on a scale from 1 (no involvement) to 4 (active involvement). Most respondents had a score around 2.5, which means that on average the respondents tended to take medical decisions together with their physician. The mean score for trust was 4.03 (SD = 0.71) on a scale from 1 (low trust) to 5 (high trust). Most respondents (93%) had a score of 3 or higher. The mean score of 4.03 among the respondents indicates relatively high level of trust in their physician.

Table 3

Descriptive statistics of the respondents.

Characteristic	N	Category	N	%/mean (SD)*
Gender	703	Male	351	49.9
		Female	352	50.1
Age	703			56 (15.7)*
		Male	351	56.4 (15.4)*
		Female	352	55.7 (15.9)*
Educational level	685	Low (non, primary school or pre-vocational education)	103	15
		Middle (secondary or vocational education)	368	53.7
		High (professional higher education or university)	214	31.2
Questionnaire	703	Post	354	50.4
		Internet	349	49.6
Trust	633			4.03 (.71)*
Involvement in medical decision-making	663			2.43 (.71)*

Test of the hypotheses

First, the general relationship between trust and patient involvement in MDM was analysed. The analysis indicated that the relationship between trust and patient involvement without controlling for sociodemographic characteristics was negative (Pearson correlation -0.204; p<0.001), which means that higher level of trust was associated with lower patient involvement in MDM. Second, we looked at the relationship between trust and sociodemographic characteristics (Table 4). We found that middle aged (coef. = 0.223; p = 0.003) and elderly people (coef. = 0.357; p = 0.000) had significantly higher trust in their physician compared to younger people. No relationship between trust and gender and trust and educational level was found.

Table 4

Relationship between trust and sociodemographic characteristics, results from the regression analysis.

Trust
	Category	Coefficient	P value
Gender	Male	Reference category
	Female	-0.033	0.565
Age	Young	Reference category
	Middle aged	0.223	0.003
	Elderly	0.357	0.000
Educational level	Low	Reference category
	Middle	0.090	0.280
	High	0.062	0.501
Constant	3.774

Third, we tested the relationship between trust and patient involvement controlled for the sociodemographic characteristics (Table 5). Interactions between age and trust, educational level and trust, and gender and trust were also included in the model. The relationship between trust and patient involvement in MDM in this model was negative (Pearson correlation -0.315, p = 0.031). In this model, no significant associations between the sociodemographic characteristics and patient involvement in MDM were found. We found a positive interaction between trust and gender among women compared to men (Table 5, coef. = 0.191; p = 0.015). Fig 1 illustrates the relationship between trust and patient involvement in men and women. Women with higher trust were found to be more involved in MDM compared to men with higher trust. Furthermore, the line that illustrates the relationship between trust and patient involvement in MDM in women is significantly flatter compared to the line illustrating the same relationship in men. Among men higher trust was associated with less involvement in MDM, while the relationship between trust and involvement in MDM among women was not significant. There were no significant interactions between age and trust and educational level and trust.

Table 5

Relationship between patient involvement in MDM and trust, including interactions with sociodemographic characteristics, results from regression analysis.

Patient involvement in MDM
	Category	Coefficient	P value
Trust		-0.315	0.031
Age	Young	Reference category
	Middle	-0.002	0.996
	Elderly	-0.221	0.679
Educational level	Low	Reference category
	Middle	0.027	0.953
	High	0.542	0.280
Gender	Male	Reference category
	Female	-0.612	0.057
Interaction between age and trust	Young	Reference category
	Middle	0.010	0.928
	Elderly	0.027	0.835
Interaction between educational level and trust	Low	Reference category
	Middle	0.055	0.618
	High	-0.046	0.706
Interaction between gender and trust	Male	Reference category
	Female	0.191	0.015
Constant	3.393

Fig 1

Relationship between trust and involvement in medical decision-making in men and women.

Based on our findings, we could analyze the hypotheses of the study.

H1: High trust can both foster and impair patient involvement in medical decision-making.

The relationship between trust and patient involvement in MDM was shown to be significantly negative for men, while for women there was only a weak negative, non-significant, correlation (Fig 1). This means that trust impairs patient involvement in MDM among men, but not among women. Therefore, the first hypothesis was partially confirmed.

H2: Older people with higher trust in their physician are less involved in medical decision-making, while younger people with higher trust are more involved in medical decision-making.

No effect of age on the relationship between trust and patient involvement in MDM was observed. Therefore, the second hypothesis was not accepted.

H3: Women with higher trust in their physician are more involved in medical decision-making, while men with higher trust are less involved in medical-decision making.

Gender was found to have an effect on the relationship between trust and patient involvement in MDM. This relationship was significantly less negative among women compared to men. Fig 1 shows that women with higher trust were found to be more involved in MDM compared to men with higher trust. Therefore, the third hypothesis was confirmed.

H4: Lower educated people with higher trust in their physician are less involved in medical decision-making, while higher educated people with higher trust are more involved in medical decision-making.

Educational level was found to have no effect on the relationship between trust and patient involvement in MDM. Therefore, the fourth hypothesis was not accepted.

Discussion

The aims of this study were to examine the relationship between trust in physicians and patient involvement in MDM and to determine how this relationship is influenced by sociodemographic characteristics of the patients. The relationship between trust and patient involvement in MDM was found to be generally negative. This means that people with higher trust in physicians prefer to be less involved in MDM and people with lower trust prefer to be more involved in MDM. However, we found that for women this relationship was different than for men. Women with higher trust preferred to be more involved in medical decision-making compared to men with higher trust.

Although higher trust was associated with less involvement in MDM among men, it is crucial to interpret the results with the consideration of the respondents’ characteristics. The level of trust among the respondents in our study was generally high (Table 3), which means that in the group of people with lower trust the actual level of trust was still relatively high based on the scale. This could be attributed to the generally high level of trust in physicians among the Dutch population [48]. Additionally, on average the respondents preferred a shared approach to MDM (Table 3). Based on this, we expect that the differences between the different subgroups were not large enough to capture significant relationships between the variables. This has to be taken into account in terms of transferability of the findings, as the results of this study might not be applicable to other settings where the differences between the subgroups are larger.

The relationship between trust and involvement in MDM among women was significantly more positive compared to men, meaning that women with higher trust were more involved in MDM compared to men with higher trust. Furthermore, we found that the relationship between trust and involvement in MDM was weaker for women than for men. This might indicate that other mechanisms explaining the variability of patient preferences regarding their involvement in MDM such as health literacy, availability of medical informational support, or social norms are more important for women. Additionally, we found a strong positive relationship between age and trust; older respondents reported to have more trust in physicians compared to younger respondents. However, no direct association between age and patient involvement in MDM was found in a model including trust. Based on the established relationship between trust and involvement in MDM and the relationship between age and trust, we can conclude that age might have an indirect effect on patient involvement in MDM through trust. The educational level of the respondents was not associated with trust, with patient involvement in MDM, and with the relationship between trust and patient involvement in MDM. The fact that we did not find a relationship between educational level and involvement in MDM among the respondents is not in line with the literature [8,9]. This could, however, potentially be attributed to the overrepresentation of the respondents with middle and high educational level in this study and could be explored further in a more representative sample.

Our findings contribute to the understanding of the relationship between trust and patient involvement in MDM in the general population in particular by providing a deeper insight into how this relationship is influenced by sociodemographic characteristics of the respondents. In this study the survey was sent out to a large sample size (N = 1,500) that was representative of the general Dutch population. Although the response rate of 47% was relatively low, the number of respondents (n = 703) was large enough to ensure the generalizability of the results to the larger population in the Netherlands. However, it is important to note that the respondents of this study were not entirely representative of the Dutch general population. Younger and less educated people were underrepresented, while middle aged, elderly and higher educated were overrepresented in the group compared to the general Dutch population [43].

We used a validated instrument (WF-D) to measure the level of interpersonal trust of the respondents in their physician. It is important to note that WF-D was not fully balanced in terms of the nature of the statements. It contained seven positive statements and three negative statements, which might have led to acquiescence bias. However, WF-D has been validated [46] and frequently used for trust research [49,50]. Furthermore, this study focussed on the interpersonal trust of patients in their physician. Although Trachtenberg and colleagues (2005) found that general trust in the medical profession is significantly stronger associated with patient involvement compared to the interpersonal trust in a specific physician [7], it was not specified how trust was measured in that study. Additionally, scales to assess trust in a specific physician are more advanced compared to the scales assessing trust in medical institutions or in the medical profession in general [13]. To assess patient involvement in MDM, adapted questions by Flynn et al. were used. Although these questions have not been validated, they were used previously in multiple studies [10-12]. Additionally, patient involvement was measured through patients’ self-assessment instead of observing actual behaviour and it is not clear whether the respondents reported their actual or perceived participation in MDM, which could have affected the validity of our results. Both instruments used in this study did not refer to a particular physician (e.g. respondent’s general practitioner). This might have affected the accuracy of the responses in case some of the respondents had more than one treating physician. Finally, to collect the data for this study a cross-sectional survey was conducted. A limitation of the study design is that it only allowed us to test associations, and not causal relationships between the variables. Therefore, we cannot conclude whether higher trust leads to more or less active patient involvement or vice versa.

Our hypotheses were based on the existing literature. For further research, it would be interesting to test the generalizability of our hypotheses in a general population sample with a larger range of trust. An example of such a setting is the US, where the average level of trust in healthcare providers is significantly lower compared to the Netherlands [51]. The hypotheses of this study could also be tested using a mixed methods approach, which would entail observing actual involvement in MDM among the participants in addition to the measurement of the perceived involvement. This would allow the researchers to gain insight into the differences between perceived and actual involvement in MDM and improve the validity of the results. Employing a qualitative study design could also be interesting for investigating the reasons for why women with high trust in their physician are more involved in MDM compared to men with high trust. This could help design strategies for facilitating the involvement of men with high trust in MDM. Furthermore, trust is only one of the mechanisms that explains the variability in patients’ preferences for involvement in MDM and we found it to be less important for women. Other mechanisms including high critical health literacy, availability of medical informational support, and non-conservative social norms [10-12] were found to positively influence participation in MDM. To provide a more comprehensive explanation of variability in patient preferences regarding involvement in MDM, future research could focus on exploring the relationship between these mechanisms and patient involvement in one sample. Finally, further research could use longitudinal data to gain insight into causal relationships between the variables.

Optimal patient-physician relationship requires trust as well as patient’s active participation in decision-making. Therefore, clinical practice requires an approach that can foster both trust and patient involvement in MDM. In our study, we observed that women with higher trust are more actively involved in MDM. This poses a question whether there is a possibility to design strategies that could potentially reverse the negative association between trust and participation in MDM among men. The knowledge developed by this study could help develop such strategies and interventions. This would also lead to multiple health benefits for the patients, since SDM is generally associated with greater adherence to treatment, patient satisfaction and superior health outcomes [52,53].

Conclusion

The results of this study suggest that trust is negatively associated with patient involvement in MDM among men. Women with high trust were more involved in MDM compared to men with high trust. Further research is recommended to provide a more comprehensive explanation of the variability in patient preferences regarding involvement in MDM by simultaneously looking at various mechanisms that were previously found to affect patient involvement in MDM. This knowledge would be important for developing strategies to enhance involvement in MDM among various patient groups.

30 May 2021

PONE-D-21-10608

Relationship between Trust and Patient Involvement in Medical Decision-Making: A Cross-Sectional Study

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• Abstract-Line 33: Mention ‘’Flynn et al. (2006).’’ as a part of a complete sentence (avoid the bracket and accordingly edit the sentence.

• Introduction-Line 69: The first sentence of the new paragraph should be included as the last sentence of the previous paragraph. Begin the new paragraph with the sentence ‘’This study examines ………………. ‘’

• Line 89-‘’along with other groups’’: Mention the other groups.

• Line 147: Replace ‘’Based on the aforementioned,’’ with ‘’Therefore,’’.

• Methods-Line 162: Who exactly is a provider here?

• Line 168: Replace ‘’12.000’’ with ‘’12,000’’ if you are referring to twelve thousand.

• Lines 168-170: In addition, would you prefer to mention the related number at the end of 2020?

• Line 175: On what basis 1,500 panel members were selected/considered out of the total pool of 12,000 participants (panel members)?

• Lines 177-179: Weren’t the completed questionnaires anonymous in nature?

• Line 187: Three items were negative statements and seven items were positive statements. In other words, most of the statements were positive statements. What impact does that have on your findings? It can affect what is termed 'acquiescence bias'. Such surveys/questionnaires have a more balanced number of negative and positive statements.

• Line 195: Use the journal style while citing a reference.

• Results-Line 223: In addition, provide the mean(SD) age separately for male and female.

• Table 3: The last column consists of % and mean(SD). Indicate ‘’mean(SD)” with * both in the heading of the column and for the related values.

• Table 3: With reference to the rows, provide the row related to ‘’trust’’ before ‘’involvement in medical-decision making’’.

• Table 4: Replace ‘’Men’’ with ‘’Male’’ for uniformity’s sake when compared to Table 3 and other Tables.

• Besides, address the reviewers’ comments.

• In addition, let us know the etiology for the delay in submission of this manuscript (data collection: beginning of 2016; manuscript submission: beginning of 2021).

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

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. 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

**********

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

Reviewer #1: Yes

Reviewer #2: I Don't Know

**********

3. 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: No

Reviewer #2: Yes

**********

4. 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

**********

5. 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: Overall, this is a well-written manuscript that confirms earlier findings on the relationship between trust and shared-decision making. The findings, such as the relationship between trust, SDM, and gender, are important contributions towards understanding the factors/determinants of SDM. I have no further comments on the content and recommend this manuscript for publication.

With regard to the availability of data, the authors should provide an ethical/legal justification for not making it accessible.

Reviewer #2: Overall, this is a very interesting study and will be a valuable addition to the literature on SDM and MDM. I congratulate the authors.

I have one query:

Were the survey participants asked to respond about a particular physician, e.g. their General Practitioner? If no, would the survey participants likely have multiple physicians? (In some countries patients have a General Practitioner and specialist physicians treating them at the same time).

And one comment:

It would be interesting to conduct a qualitative study to understand why women with high trust are more involved in MDM compared to men with high trust – this may help with strategies to reverse men’s less than optimal involvement in MDM that you mention in the last paragraph of page 16 of the PDF.

**********

6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

Reviewer #2: No

[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.]

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.

10 Aug 2021

Dear Dr. Chenette,

We would like to re-submit the revised manuscript entitled “Relationship between Trust and Patient Involvement in Medical Decision-Making: A Cross-Sectional Study” drafted by I. Pokhilenko, Dr. T.E.M. van Esch, Dr. A.E.M. Brabers, and Prof. J.D. de Jong for publication as a research article in PLOS ONE. We are happy to have received the positive feedback and the suggestions for further improvements. All comments were used to revise the paper. In the response letter below, we provided a response to each comment and described how we revised the paper accordingly. In the main file, the revised sections are marked in track changes.

Some comments referred to the availability of the data used in this study. The data for this study was collected in the Dutch Heath Care Consumer Panel of the Netherlands Institute for Health Services Research (Nivel). We will upload the minimal anonymized data set to replicate our study findings to the DANS EASY repository in the upcoming weeks. This dataset will be made available upon request. Additionally, the same minimal anonymized data set is directly available upon request from prof. Judith D. de Jong (j.dejong@nivel.nl), project leader of the Dutch Health Care Consumer Panel, or the secretary of this panel (conusmentenpanel@nivel.nl). The Dutch Health Care Panel had a program committee, which supervises processing the data of the Dutch Health Care Consumer Panel and decides about the use of the data. This program committee consists of representatives of the Dutch Ministry of Health, Welfare and Sport, the Health Care Inspectorate, Zorgverzekeraars Nederland (Association of Health Care Insurers in the Netherlands), the National Health Care Institute, the Federation of Patients and Consumer Organisations in the Netherlands, the Dutch Healthcare Authority and the Dutch Consumers Association. All research conducted within the Consumer Panel has to be approved by this program committee. The committee assesses whether a specific research fits within the aim of the Consumer Panel, which is to strengthen the position of the health care user.

We also revised the reference list. Reference #44 has been updated from “CCMO. Your research: does it fall under the WMO? [cited 2018 May 8]. Available from: http://www.ccmo.nl/en/your-research-does-it-fall-under-the-wmo” to “CCMO. Your research: Is it subject to the WMO or not? [cited 2021 July 6]. Available from: https://english.ccmo.nl/investigators/legal-framework-for-medical-scientific-research/your-research-is-it-subject-to-the-wmo-or-not” as the original link was no longer available. Furthermore, we believe to have followed the PLOS ONE’s style requirements.

With the aim of reaching the broad multidisciplinary audience of your journal, we would be grateful if you would consider this submission for publication in PLOS ONE. Hereby, we confirm that each author contributed to the conception, design, analysis and interpretation of data and the writing of the paper. All authors have approved the submitted version of the manuscript. The manuscript is an original contribution and is not being considered for publication elsewhere.

I look forward to hearing from you, on behalf of the co-authors,

Yours sincerely,

Irina Pokhilenko

Journal Requirements:

When submitting your revision, we need you to address these additional requirements.

1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at

https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and

https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf

2. Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

3. We note that you have indicated that data from this study are available upon request. PLOS only allows data to be available upon request if there are legal or ethical restrictions on sharing data publicly. For information on unacceptable data access restrictions, please see http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions.

In your revised cover letter, please address the following prompts:

a) If there are ethical or legal restrictions on sharing a de-identified data set, please explain them in detail (e.g., data contain potentially identifying or sensitive patient information) and who has imposed them (e.g., an ethics committee). Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent.

b) If there are no restrictions, please upload the minimal anonymized data set necessary to replicate your study findings as either Supporting Information files or to a stable, public repository and provide us with the relevant URLs, DOIs, or accession numbers. Please see http://www.bmj.com/content/340/bmj.c181.long for guidelines on how to de-identify and prepare clinical data for publication. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories.

We will update your Data Availability statement on your behalf to reflect the information you provide.

Additional Academic Editor Comments:

• Abstract-Line 33: Mention ‘’Flynn et al. (2006).’’ as a part of a complete sentence (avoid the bracket and accordingly edit the sentence.

Author response: We thank the editor for this and other comments. The sentence was revised.

“Patient involvement was measured using two items based on the study published by Flynn and colleagues in 2006.” (lines 33-34)

• Introduction-Line 69: The first sentence of the new paragraph should be included as the last sentence of the previous paragraph. Begin the new paragraph with the sentence ‘’This study examines ………………. ‘’

Author response: We revised the paragraphs accordingly.

• Line 89-‘’along with other groups’’: Mention the other groups.

Author response: The sentence was revised accordingly.

“Furthermore, previous studies have been performed either among specific patient groups including patients of breast cancer, prostate cancer and fracture outpatient clinics, African-American patients with diabetes along with other groups, patients with cardiovascular disease or among a group of breast cancer specialists.” (lines 88-91)

• Line 147: Replace ‘’Based on the aforementioned,’’ with ‘’Therefore,’’.

Author response: The sentence was revised accordingly.

“Therefore, we hypothesize that: …” (line 150)

• Methods-Line 162: Who exactly is a provider here?

Author response: The correct term would be “address supplier”. We revised the sentence accordingly.

“First, addresses of potential participants are bought from an address supplier.” (lines 164-165)

• Line 168: Replace ‘’12.000’’ with ‘’12,000’’ if you are referring to twelve thousand.

Author response: The sentence was revised accordingly.

“At the moment of data collection (February 2016), the Dutch Health Care Consumer Panel consisted of approximately 12,000 members of 18 years or older.” (lines 170-172)

• Lines 168-170: In addition, would you prefer to mention the related number at the end of 2020?

Author response: The number of participants as of 2021 is approximately 11,500. We mentioned this in the text.

“As of 2021, the number of panel members is 12,000.” (line 172)

• Line 175: On what basis 1,500 panel members were selected/considered out of the total pool of 12,000 participants (panel members)?

Author response: The sample was selected randomly. The only criteria was to ensure that the group was representative of the Dutch adult population. We added a sentence to clarify this.

“The sample was randomly selected and was representative of the Dutch adult population for age and sex.” (lines 180-181)

• Lines 177-179: Weren’t the completed questionnaires anonymous in nature?

Author response: The questionnaires were anonymous. Besides, the researchers who analysed the data did not have access to the identifiable data of the respondents.

“The questionnaires used in this study were anonymous in nature. Besides, the researchers who analyse the data do not have access to any identifiable information of the participants (e.g. name and address).” (lines 177-179)

• Line 187: Three items were negative statements and seven items were positive statements. In other words, most of the statements were positive statements. What impact does that have on your findings? It can affect what is termed 'acquiescence bias'. Such surveys/questionnaires have a more balanced number of negative and positive statements.

Author response: We reflected on this aspect in the discussion section.

“It is important to note that WF-D was not fully balanced in terms of the nature of the statements. It contained seven positive statements and three negative statements, which might have led to acquiescence bias. However, WF-D has been validated [46] and frequently used for trust research [49, 50].” (lines 334-337)

• Line 195: Use the journal style while citing a reference.

Author response: The reference was revised.

“Two questions based on the items developed by Flynn et al [9] were used to measure patient involvement in MDM (Table 2).” (line 201)

• Results-Line 223: In addition, provide the mean(SD) age separately for male and female.

Author response: We added two rows in Table 3 with the mean age and SD separately for male and female respondents.

• Table 3: The last column consists of % and mean(SD). Indicate ‘’mean(SD)” with * both in the heading of the column and for the related values.

Author response: Table 3 was revised accordingly.

• Table 3: With reference to the rows, provide the row related to ‘’trust’’ before ‘’involvement in medical-decision making’’.

Author response: Table 3 was revised accordingly.

• Table 4: Replace ‘’Men’’ with ‘’Male’’ for uniformity’s sake when compared to Table 3 and other Tables.

Author response: Table 4 was revised accordingly.

• Besides, address the reviewers’ comments.

Author response: We believe to have addressed all reviewers’ comments and explained how we addressed them in the note below.

• In addition, let us know the etiology for the delay in submission of this manuscript (data collection: beginning of 2016; manuscript submission: beginning of 2021).

Author response: The data used in this study was originally collected in 2016. The current study was conducted based on secondary data analysis in 2018. The delay in manuscript submission occurred due to the delays in the internal review process. However, we believe that this delay does not have impact on the relevance of the results.

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. 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

________________________________________

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

Reviewer #1: Yes

Reviewer #2: I Don't Know

________________________________________

3. 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: No

Reviewer #2: Yes

________________________________________

4. 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

________________________________________

5. 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: Overall, this is a well-written manuscript that confirms earlier findings on the relationship between trust and shared-decision making. The findings, such as the relationship between trust, SDM, and gender, are important contributions towards understanding the factors/determinants of SDM. I have no further comments on the content and recommend this manuscript for publication.

With regard to the availability of data, the authors should provide an ethical/legal justification for not making it accessible.

Author response: The authors thank the reviewer for taking time to review the manuscript and for recommending it for publication.

With regard to the availability of data, we will upload the minimal anonymized data set to replicate our study findings to the DANS EASY repository. This dataset will be made available upon request. Additionally, the same minimal anonymized data set is directly available upon request from prof. Judith D. de Jong (j.dejong@nivel.nl), project leader of the Dutch Health Care Consumer Panel, or the secretary of this panel (conusmentenpanel@nivel.nl). The Dutch Health Care Panel had a program committee, which supervises processing the data of the Dutch Health Care Consumer Panel and decides about the use of the data. This program committee consists of representatives of the Dutch Ministry of Health, Welfare and Sport, the Health Care Inspectorate, Zorgverzekeraars Nederland (Association of Health Care Insurers in the Netherlands), the National Health Care Institute, the Federation of Patients and Consumer Organisations in the Netherlands, the Dutch Healthcare Authority and the Dutch Consumers Association. All research conducted within the Consumer Panel has to be approved by this program committee. The committee assesses whether a specific research fits within the aim of the Consumer Panel, which is to strengthen the position of the health care user.

Reviewer #2: Overall, this is a very interesting study and will be a valuable addition to the literature on SDM and MDM. I congratulate the authors.

I have one query:

Were the survey participants asked to respond about a particular physician, e.g. their General Practitioner? If no, would the survey participants likely have multiple physicians? (In some countries patients have a General Practitioner and specialist physicians treating them at the same time).

Author response: The authors thank the reviewer for taking time to review the manuscript and for recommending it for publication. This study was conducted among the general Dutch population. The questionnaire in Dutch did not refer to any particular physician. In the Dutch healthcare system, every person is only able to be assigned to one general practitioner at a time. Therefore, we assume that the respondents provided responses regarding their general practitioner. However, we agree that in case one is treated by multiple physicians, there might be some confusion. We reflected on this point in the discussion.

“Both instruments used in this study did not refer to a particular physician (e.g. respondent’s general practitioner). This might have affected the accuracy of the responses in case some of the respondents had more than one treating physician.” (lines 347-349)

And one comment:

It would be interesting to conduct a qualitative study to understand why women with high trust are more involved in MDM compared to men with high trust – this may help with strategies to reverse men’s less than optimal involvement in MDM that you mention in the last paragraph of page 16 of the PDF.

Author response: We thank reviewer for this comment. We agree that such study could be very interesting. We added this point in the discussion.

“Employing a qualitative study design could also be interesting for investigating the reasons for why women with high trust in their physician are more involved in MDM compared to men with high trust. This could help design strategies for facilitating the involvement of men with high trust in MDM.” (lines 360-363)

________________________________________

6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

Reviewer #2: No

Submitted filename: response_plosone_ipokhilenko.docx

Click here for additional data file.

13 Aug 2021

Relationship between Trust and Patient Involvement in Medical Decision-Making: A Cross-Sectional Study

PONE-D-21-10608R1

Dear Dr. Pokhilenko,

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,

Prof. Ritesh G. Menezes, M.B.B.S., M.D., Diplomate N.B.

Academic Editor

PLOS ONE

17 Aug 2021

PONE-D-21-10608R1

Relationship between trust and patient involvement in medical decision-making: A cross-sectional study

Dear Dr. Pokhilenko:

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

Prof. Dr. Ritesh G. Menezes

Academic Editor

PLOS ONE