Journal of Psychosomatic Research 132 (2020) 109989

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Journal of Psychosomatic Research

journal homepage: www.elsevier.com/locate/jpsychores

Beliefs about immunosuppressant medication and correlates in a German T

kidney transplant population
Maybrit Bünemanna,g, Maximilian Bauer-Hohmanna,g, Felix Klewitza,g,
Eva-Marie Kyaw Tha Tuna,b,g, Uwe Tegtburc,g, Lars Paped,g, Lena Schifferd,g, Mario Schiffere,f,g,
⁎
Martina de Zwaana,g, Mariel Nöhrea,g,
a
Department of Psychosomatic Medicine and Psychotherapy, Hannover Medical School, Hannover, Germany
b
Department of Psychosomatic Medicine and Psychotherapy, University of Göttingen Medical Centre, Germany
c
Department of Sports Medicine, Hannover Medical School, Hannover, Germany
d
Department of Pediatric Kidney, Liver and Metabolic Diseases, Hannover Medical School, Hannover, Germany
e
Department of Nephrology and Hypertension, University Hospital Erlangen, Erlangen, Germany
f
Department of Nephrology and Hypertension, Hannover Medical School, Hannover, Germany
g
Project Kidney Transplantation 360° (NTX360°), Hannover Medical School, Hannover, Germany

A R T I C LE I N FO A B S T R A C T

Keywords: Objective: A common reason for organ rejection after transplantation is the lack of adherence regarding im-
Adherence munosuppressive medication (ISM). A variety of different aspects can promote non-adherent behavior, including
Beliefs about medicines the relationship between perceived benefits and concerns regarding ISM (“necessity-concerns-framework”).
Immunosuppressive medication Little is known about the variables associated with this framework.
Kidney transplantation
Methods: As part of this cross-sectional study, 570 patients after kidney transplantation who participated in a
Renal transplantation
structured multimodal follow-up program (KTx360°) were examined in two transplant centers in Lower Saxony.
We used the Beliefs about Medicines Questionnaire (BMQ) to evaluate the patients' believes and concerns re-
garding their ISM.
Results: The mean age of the participants was 51.9 (SD 14.17) years, 58.4% were men, and 25.8% had
≥12 years of school attendance. The mean time since transplantation was 65.9 months. In patients undergoing
kidney transplantation, the perceived benefit of ISM mostly exceeded the concerns. We found an association
between lower perceived benefits and greater concerns and lower adherence. Also, a higher perceived necessity
was significantly associated with higher age and lower levels of depression and anxiety. Greater concerns were
significantly associated with more symptoms of depression and anxiety, lower perceived social support, and
lower kidney functioning (eGFR).
Conclusion: Even though patients after kidney transplantation usually acknowledge the importance of their ISM,
they still have considerable concerns that are associated with less adherence and various psychosocial risk
factors. Further longitudinal studies are needed to assess the extent to which beliefs about medication are
variable and can be individually addressed to improve adherence.

1. Introduction
Kidney transplantation (KTx) is the preferred treatment for patients
suffering from end-stage renal disease (ESRD). Compared to dialysis
treatment, KTx is associated with an improved quality of life as well as
lower morbidity and mortality [1]. With increasing numbers of ESRD
patients and persistently small numbers of deceased organ donors, in
Germany, the mean waiting time for KTx candidates is about 6 to
7 years [2,3]. After KTx, it is an important aim to secure long transplant
survival. A crucial factor in preventing transplant rejection is the ad-
herence to the immunosuppressive medication (ISM). Non-adherence is
common and affects between 28% and 52% of the KTx patients [4–6].
Therefore, measuring adherence, recognizing non-adherence, and im-
plementing interventions to improve adherence, if needed, is decisive in
this patient group. However, to be able to intervene successfully, it is
essential to understand non-adherent behavior. With adherence being a

⁎
Corresponding author at: Department of Psychosomatic Medicine and Psychotherapy, Hannover Medical School, Carl-Neuberg-Strasse 1, 30625 Hannover,
Germany.
E-mail address: noehre.mariel@mh-hannover.de (M. Nöhre).

https://doi.org/10.1016/j.jpsychores.2020.109989
Received 22 September 2019; Received in revised form 29 February 2020; Accepted 29 February 2020
0022-3999/ © 2020 Elsevier Inc. All rights reserved.
M. Bünemann, et al.
complex construct, there is a multitude of influencing aspects, including
patient-, health system-, condition-, social-, and therapy-related factors
[7]. In 2017, a review focusing on aspects associated with non-ad-
herence in KTx patients was published [6]. The authors named younger
age, male gender, low social support, unemployment, low educational
level, and having received an organ from a living donor as variables
correlating with higher rates of non-adherence. Additionally, they
found negative beliefs associated with non-adherence and came to the
conclusion that negative beliefs and other patient-related factors in-
fluence the patient's attitude. Above that, however, no further in-
formation regarding patients' beliefs and adherence can be gathered
from this review.
There are different ways to evaluate patients' beliefs about medi-
cines. One frequently used model is the necessity-concerns framework.
The necessity-concerns framework is deduced from the Health Belief
Model [8–10] and focuses primarily on perceived benefits and per-
ceived barriers. Horne and Weinman [8] suggested that the patients
perform a cost-benefit assessment based on their views regarding their
prescribed medication. On the one hand, there is the expected benefit
(“necessity”), e.g., maintaining good transplant functioning, preventing
organ rejection. On the other hand, there are “concerns” regarding
potential adverse effects or drug dependency. “Necessity” and “con-
cerns” are weighted against each other, leading to a necessity-concerns
differential. The authors suggest that adherent behavior is promoted
when the perceived necessities predominate the concerns [8,9].
In the last years, there has been further research in the field of
health belief models. Especially the Capability, Opportunity, and
Motivation Model of Behavior (COM-B model) grew in popularity [11].
In contrast to binary models like the necessity-concerns-framework, the
COM-B model allows a more in-depth exploration of non-adherent be-
havior [11,12]. However, since the necessity-concerns-framework has
already been broadly used to evaluate medication adherence in several
different medical conditions, we decided to focus on this framework.
Additionally, a short and internationally well-validated instrument, the
Beliefs about Medicines Questionnaire (BMQ), is available to assess this
framework. The BMQ was developed in 1999 [9]. The instrument
consists of four subscales: two specific ones with five items each (“ne-
cessity” and “concerns”) and two general ones with four items for each
scale (“harm” and “overuse”). We decided to focus on the specific
subscales “necessity” and “concerns”, which allow us to specifically
evaluate the patients' beliefs regarding their ISM. Since 2010, a German
version of the BMQ is available, which provided good psychometric
properties in the validation study with chronically ill primary care
patients [13].
Three recent meta-analyses have examined the association between
patients' beliefs about medicines using the BMQ and adherence
[10,14,15]. Patients with different chronic medical conditions were
evaluated, including patients after organ transplantation. Overall, there
was a small but significant correlation between beliefs about medicines
and adherence taking all medical conditions together.
There are already a few studies in which the BMQ was used in pa-
tients after organ transplantation (Table 1). Except for Drangsholt et al.
[16], all studies focused on the association between adherence and
beliefs about medicines evaluated with the BMQ. Adherence was
measured differently in the studies. However, regardless of the ad-
herence measurement applied, an association between BMQ scores and
adherence could be found in most but not all studies [16–23]. There are
contradicting statements if necessity or concerns have a higher impact
on adherence. While some suggest that adherence seems to be driven by
perceived necessity [17,20], Foot et al. [10] suggest that it is more
important to address the concerns to improve adherence behavior.
When considering the BMQ “necessity” and “concerns” scores as
well as the differential, organ transplant patients often report higher
necessity and lower concerns compared to other chronic medical con-
ditions, including patients undergoing dialysis treatment [8,16,24].
Consequently, this usually leads to a positive BMQ differential in
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Journal of Psychosomatic Research 132 (2020) 109989
transplant patients, indicating that the perceived necessities outweigh
the concerns.
However, it is essential to note that so far, there is only little in-
formation available regarding factors associated with the necessity-
concerns-framework. Horne et al. [25] found that more concerns in
patients with rheumatoid arthritis were related to a higher degree of
disease severity. Associations described in KTx patients are scarce.
Vankova et al. [22] described a correlation between higher necessity
and higher age at the time of transplantation in patients after KTx.
Additionally, they found higher levels of concern with increasing time
after transplantation. Drangsholt et al. [16] reported an association
between higher necessity and lower concerns with a higher educational
level in patients after KTx. Additionally, they noted more concerns to be
associated with higher levels of depression. Above that, there is no
information available regarding factors associated with the necessity-
concerns-framework in KTx patients.
Our study aimed at evaluating the necessity-concerns framework in
a large sample of German KTx patients. Additionally, we wanted to
confirm the association already described between necessities and
concerns and self-reported adherence to the ISM. Above that, we aimed
to investigate correlates of necessities and concerns. Based on previous
studies, we expected to find associations with sociodemographic vari-
ables such as age and educational level, with psychosocial variables
such as level of depression, and disease-specific variables such as time
since KTx and disease severity. Further, we were interested in exploring
additional potential associations with sociodemographic, medical,
psychological, and donation-specific variables.
2. Methods
2.1. Sample selection
Participants were recruited within the structured post-transplant
care program KTx360° [26]. The project is conducted in the transplant
centers of Hannover Medical School and Hannoversch Münden in
Lower Saxony, Germany. Within this ongoing study, participants in-
cluded between May 2017 and December 2018 were evaluated in this
sub-study.
A mental health professional (physician or psychologist) performed
a psychosocial assessment in all participating patients. All patients were
asked to fill out several questionnaires. Patients with an inability to
speak, read, or understand German, with visual impairment or a known
history of severe developmental delay, hindering them from filling out
the questionnaires were excluded from the study. The Institutional
Ethics Review Board of Hannover Medical School approved the study
(Number 3464–2017), and all participants gave written informed con-
sent.
2.2. Instruments
2.2.1. Beliefs about Medicines Questionnaire (BMQ)
We used the German version of the BMQ to measure patients' beliefs
about their medication, which has been used in patients with different
chronic illnesses before and has even been used in patients with ESRD
and after KTx [8,9,13,16]. The instrument consists of 18 items. The
scale comprises four subscales: two specific ones with five items each
(“necessity“ and “concerns”) and two general ones with four items for
each scale (“harm” and “overuse”). In our study, we concentrated on
the specific scales, which we adapted in agreement with the original
authors to focus on the ISM explicitly. The items can be found in Fig. 2.
Each item is rated on a 5-point Likert scale ranging from 1 =
“strongly disagree“ to 5 = “strongly agree,“ leading to total scores for
the “necessity” and “concerns” scales ranging from 5 to 25. To evaluate
the balance between the perceived advantages and disadvantages of the
ISM, the necessity–concerns differential was calculated. For this pur-
pose, the score of the subscale “concerns“ is subtracted from the total
 M. Bünemann, et al.

Table 1
Summary of Beliefs about Medicines questionnaire results in kidney transplant patient samples.
Sample size BMQ “necessity” mean (SD) BMQ “concerns” mean (SD) BMQ differential mean (SD) Association with The instrument to measure adherence
median (IQR) median (IQR) median (IQR) adherence

Butler et al., 2004 [17] N = 58 Non-adherent patients: 19 (IQR 3), na na Yes Electronic monitoring, individuals missing more than 20%
adherent patients: 21 (IQR 4) of the doses were defined as non-adherent
Chisholm-Burns et al., N = 512 22.1 (SD 3.2) 12.5 (SD 4.1) 9.6 (SD 5.7) Yes The Immunosuppressant Therapy Adherence Scale (ITAS), a
2012 [18] score < 12 indicating non-adherence
Lennerling & Forsberg, N = 250 median = 23 median = 11 na No The Basel Assessment of Adherence to Immunosuppressive
2012 [19] Medication Scale (BAASIS), scores ≥1 indicating non-
adherence
Griva et al., 2012 [20] N = 218 na na na Yes Medication Adherence Report Scale (MARS), scores ≤23
indicating non-adherence

3
Massey et al., 2013 [21] N = 113 T1: 22.8 (SD 2.5) T1: 10.5 (SD 4.1) T1: 12.3 (SD 4.9) No The Basel Assessment of Adherence to Immunosuppressive
(T2: T2: 22.0 (SD 3.0) T2: 11.1 (SD 3.8) T2: 10.9 (SD 5.0) Medication Scale (BAASIS), scores ≥1 indicating non-
N = 106) adherence
Vankova et al., 2018 [22] N = 211 23.5⁎ 11.5⁎ na Yes Medication Adherence Report Scale (MARS), scores ≤23
[reported mean value per item: 4.7 [reported mean value per item: 2.3 indicating non-adherence, ISM serum levels
(SD 0.5)] (SD 1.0)]
Cossart et al., 2019 [23] N = 156 Non-adherent patients: 22.6 (SD Non-adherent patients: 12.4 (SD Non-adherent patients: 10.3 (SD No The Basel Assessment of Adherence to Immunosuppressive
2.8), adherent patients: 22.6 (SD 4.0), adherent patients: 11.8 (SD 5.1), adherent patients: 10.8 (SD Medication Scale (BAASIS), scores ≥1 indicating non-
3.1) 4.1) 5.0) adherence
Drangsholt et al., 2019 N = 96 median = 25 median = 12 11.5 (SD 5.6) na na
[16]

T1: six weeks after transplantation; T2: six months after transplantation,na: not assessed.
⁎
estimated subscale score based on the reported item mean values.
Journal of Psychosomatic Research 132 (2020) 109989
M. Bünemann, et al. Journal of Psychosomatic Research 132 (2020) 109989

Table 2 comprising seven items each. The items are rated between 0 and 3,
Patients characteristics. leading to a sum score between 0 and 21. Higher scores indicate higher
Patient characteristics N=570 (100%) levels of depression or anxiety. Cronbach's α was 0.868 for depression
and 0.818 for anxiety.
Age in years
Mean (SD) 51.9 (0.59)
2.2.4. Perceived social support (F-SozU K7)
Median (IQR) 55.0 (19.0)
Female sex, n (%) 237 (41.6%)
The German F-SozU K7 assesses aspects of practical support, emo-
≥ 12 years school attendance, n (%) 146 (25.8%) tional support, and social integration to give information on general
Living in a partnership (n=555), n (%) 381 (68.6%) perceived social support [32,33]. The questionnaire consists of seven
Living donation, n (%) 173 (30.4%) items rated on a 5-point Likert scale, ranging from 1 (“does not apply”)
Time since transplantation in months
to 5 (“exactly applicable”). A total score between 7 and 35 can be
Mean (SD) 65.9 (2.83)
Median (IQR) 53.0 (76.0) reached, with higher scores indicating higher perceived social support.
eGFR (ml/min/1.73 m2) at time of assessment Cronbach's α in our sample was 0.897.
Mean (SD) 46.0 (0.59)
Median (IQR) 43.4 (23.85)
2.2.5. Medical, sociodemographic and donation-specific variables
Diabetes mellitus, n (%) 98 (17.2%)
Hypertension, n (%) 490 (86.0%)
The estimated glomerular filtration rate (eGFR) at the time of the
Coronary heart disease, n (%) 63 (11.1%) psychosocial assessment, as well as information on the presence of
HADS-D Anxiety score (n=561) hypertension, coronary heart disease, and diabetes mellitus were taken
Mean (SD) 5.2 (0.17) from the medical records.
Median (IQR) 4.0 (6.0)
Additionally, sociodemographic and donation-specific variables in-
HADS-D Depression score (n=562)
Mean (SD) 4.4 (0.17) cluding sex, age, partnership status, level of education (≥12 years/
Median (IQR) 3.0 (5.3) < 12 years), donation type (living/deceased donor), time since KTx
F-SozU K7 score (n=562) were collected using a self-report questionnaire. We added missing data
Mean (SD) 4.3 (0.04) from the medical records.
Median (IQR) 4.6 (1.14)
MARS-D score (n=564)
Mean (SD) 24.4 (0.05) 2.3. Statistical analyses
Median (IQR) 25.0 (1.0)
BMQ necessity (specific) score For each variable descriptive statistics (percentages, means, and
Mean (SD) 22.2 (0.15)
standard deviations) were calculated. Spearman's correlations were
Median (IQR) 24.0 (5.0)
BMQ concerns (specific) score performed for BMQ subscales “necessity” and “concerns,” the BMQ
Mean (SD) 10.8 (0.17) differential and self-reported adherence (MARS-D) as well as age, time
Median (IQR) 10.5 (5.2) since KTx, eGFR, symptoms of anxiety and depression (HADS-D) and
BMQ differential: necessity minus concern perceived social support (F-SozU K7). Furthermore, Mann-Whitney-U
Mean (SD) 11.4 (0.23)
Median (IQR) 12.0 (9.0)
tests were utilized to calculate differences in BMQ subscale scores be-
tween two groups (sex, level of education, partnership status, and type
BMQ = Beliefs about Medicines Questionnaire; eGFR = estimated glomerular of donation). Multiple linear regression analyses were performed with
filtration rate; F-Sozu K7 = Questionnaire for Perceived Social Support; HADS- the BMQ subscales “necessity” and “concerns” and the BMQ differential
D = Hospital Anxiety and Depression Scale; IQR = interquartile range; MARS- as the dependent variable and sex, age, and variables with an associa-
D = Medication Adherence Report Scale; SD = standard deviation. tion p < .1 in the univariate statistics as independent variables.
Statistical significance was set at p < .05. In addition to the sta-
score of the subscale “necessity.“ This leads to a range between −20 tistical significance value, the corresponding effect size was calculated
and 20, with higher scores indicating a higher perceived benefit and (Spearman's r and eta squared (η2)): For η2, a value of 0.01 indicates a
scores above 0 defining patients in which the “necessity“ outnumbers small effect, 0.06 a medium, and 0.14 a large effect. All statistical
the “concerns “[8]. Cronbach's α in our sample was 0.785 for “ne- analyses were performed using IBM® Statistical Software Package of
cessity“ and 0.785 for “concerns”. Social Science (SPSS®, Chicago, IL, USA) version 25.

2.2.2. Medication Adherence Report Scale (German version, MARS-D) 3. Results

The German version of the Medication Adherence Report Scale
(MARS-D) was used to assess adherence to the ISM [8,27]. The five-
item self-report instrument is rated on a 5-point Likert scale leading to a
total score between 5 and 25. Higher ratings indicate better adherence.
Patients were defined as non-adherent if they scored below 25, as
suggested by others [28,29].
As we were focusing primarily on the adherence to the ISM, patients
were asked only to consider these medicines when answering the
questions. We adapted the MARS-D for this purpose with the approval
of the original authors. The MARS-D consists of two subscales, one to
evaluate unintentional non-adherence (item 1) and the other to mea-
sure intentional non-adherence (items 2 to 5). Cronbach's α for the total
score was 0.584.
2.2.3. Hospital Anxiety and Depression Scale (HADS-D)
We used the German version of the Hospital Anxiety and Depression
Scale (HADS-D), a self-report instrument, which is specifically designed
to evaluate levels of anxiety and depression in physically ill patients
[30,31]. It consists of two subscales “depression” and “anxiety,”
3.1. Sample characteristics
Of the first 619 consecutive KTx patients included in KTx360°, a
total of 570 (92.1%) fit the inclusion criteria and completed the BMQ.
Comparing participants and non-participants we found no difference
regarding age, sex, time since transplantation and educational level
(data not shown). Table 2 summarizes the demographic and clinical
details of the sample. The mean age was 51.9 years; more men (58.4%)
participated than women. Most participants had received less than
12 years of formal education (73.8%). The mean eGFR was 46.0 ml/
min/1.73 m2. Time passed since KTx measured up to a mean of
65.9 months. The majority of KT patients had received a donor kidney
from a deceased donor (69.6%). Overall, 66.7% of the participants re-
ported being in a partnership.
3.2. BMQ descriptives
In the BMQ subscale “necessity” the participants reached a mean

4
M. Bünemann, et al.
Fig. 1. Distribution of the BMQ subscale scores. a) BMQ “Necessity”. b) BMQ “Concerns”.
score of 22.2 (SD 0.2) (Fig. 1). In the subscale “concerns” a mean value
of 10.8 (SD 0.2) could be found. Regarding the BMQ differential, the
mean score was 11.4 (SD 0.4). Most patients reported higher necessity
than concerns; only 1.4% of the participants perceived greater concerns
than necessity.
Fig. 2 illustrates the distribution of answers for the BMQ subscales
“necessity” and “concerns.” Overall, acceptance in the “necessity”
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Journal of Psychosomatic Research 132 (2020) 109989
subscale was high with 80.8% to 89.8% of the patients indicating that
they “totally agree” or “agree” with the statements.
At the same time, 41.4% reported that they worry about the po-
tential long-term effects of the ISM. Regarding the other items of the
“concerns” subscale however, the percentage of patients reporting
concerns was low ranging from 18.7 to 7.4%.
M. Bünemann, et al. Journal of Psychosomatic Research 132 (2020) 109989

Fig. 2. Patient responses to the BMQ items. a) BMQ “Necessity”. b) BMQ "Concerns".

3.3. Association between BMQ and self-reported adherence adherence were significantly associated with more perceived social
support. There was an inverse correlation between adherence and
Overall, 40.2% (n = 229) of the participants had MARS-D scores higher age as well as higher levels of depression and anxiety. Overall,
below the maximum score of 25 and, thus, had less than ideal ad- even though the correlations were statistically significant, the small
herence, including unintentional as well as intentional non-adherence; correlation coefficients indicated only a weak association.
36.3% of the participants reported unintentional non-adherent beha-
vior.
3.4. Correlates of the BMQ
Evaluating the correlation between the BMQ and the self-reported
adherence measured with the MARS-D, we found statistically sig-
Spearman's correlations between the BMQ subscales “necessity” and
nificant but small correlations for the BMQ subscales “necessity”
“concerns” as well as the BMQ differential and continuous variables can
(r = 0.088, p = .04), “concerns” (r = −0.133, p = .002) and the BMQ
be found in Table 3. Associations with dichotomous variables are pre-
differential (r = 0.132, p = .002).
sented in Table 4.
Additionally, 9.7% reported intentional non-adherence, which cor-
Higher BMQ “necessity” subscale scores were significantly asso-
related significantly with the BMQ subscales “necessity” (r = 0.089,
ciated with higher age, being in a partnership, lower levels of anxiety
p = .03), “concerns” (r = −0.133, p = .001) and the BMQ differential
and depression, and higher perceived social support. Overall, the effect
(r = 0.144, p = .001). Unintentional non-adherent behavior correlated
sizes were small. No association could be found between the BMQ
with the BMQ subscale “concerns” (r = −0.098, p = .02) and the BMQ
“necessity” subscale and time since transplantation, sex, educational
differential (r = 0.093, p = .03).
level, type of donation, kidney function (eGFR), and somatic co-
Correlations between the MARS-D and clinical as well as socio-
morbidities (diabetes mellitus, hypertension, coronary heart disease).
demographic variables can be found in Table 3. Higher levels of
Higher BMQ “concerns” subscale scores were significantly

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M. Bünemann, et al. Journal of Psychosomatic Research 132 (2020) 109989

Table 3
Correlational analyses of the BMQ scales and the MARS sum score using Spearman's correlations.
BMQ “necessity” (specific) BMQ “concerns” (specific) BMQ differential MARS-D

Age (years) r = 0.188, p < .001 r = 0.004, p = .92 r = 0.090, p = .03 r = 0.060,
p = .16
Time since transplantation (months) r = 0.023, r = 0.004, p = .92 r = 0.030, p = .48 r = −0.270, p < .001
p = .58
eGFR (ml/min/1.73 m2) r = 0.044, r = −0.107, p = .01 r = 0.112, p = .007 r = 0.077,
p = .29 p = .07
HADS-D anxiety score (n = 561) r = −0.096, r = 0.393,p < .001 r = −0.331, p < .001 r = −0.190, p < .001
p = .02
HADS-D depression score (n = 562) r = −0.091, r = 0.366,p < .001 r = −0.306, p < .001 r = −0.154, p < .001
p = .03
F-SozU K7 score (n = 562) r = 0.114, p = .007 r = −0.310,p < .001 r = 0.272, p < .001 r = 0.150,p < .001

BMQ = Beliefs about Medicines Questionnaire; eGFR = estimated glomerular filtration rate; F-SozU K7 = Questionnaire for Perceived Social Support; HADS-
D = Hospital Anxiety and Depression Scale, MARS-D= Medication Adherence Report Scale.

associated with lower kidney function (eGFR), higher levels of anxiety
and depression, and lower perceived social support. The effect sizes
were moderate. No associations were found for the other variables. A
similar pattern evolved for the BMQ differential.
Multiple linear regression analyses were conducted to identify in-
dependent predictors of the BMQ subscales and the BMQ differential
(Table 5). The independent variables explained only 5.7% of the total
variance in the BMQ subscale “necessity.” However, 19.6% of the BMQ
subscale “concerns” and 15.4% of the total variance of the BMQ dif-
ferential were explained. Age, educational level, and perceived social
support were significantly associated with the BMQ subscale “ne-
cessity.” Perceived social support and anxiety were significantly cor-
related with the BMQ subscale “concerns.” Age, level of anxiety, per-
ceived social support, as well as kidney functioning were significantly
linked to the BMQ differential. The Variance Inflation Factors in all
three linear regression analyses were below 1.1 indicating that there is
no relevant collinearity between the independent variables.
4. Discussion
Overall, compared to other medical conditions and other
medications, patients after KTx report high necessity and moderate
concerns regarding their ISM [10,14,16]. Almost all patients in our
study had a positive differential score indicating that they perceive
greater benefits than costs regarding their ISM. This is in line with the
few other studies in transplant patients (Table 1). In addition, we could
confirm the results of other studies concerning the association between
the necessity-concerns framework and self-reported adherence. We
found a significant positive association between adherence and the
necessity subscale of the BMQ and a significant negative association
between adherence and the concerns subscale. However, the effects
sizes (r) indicate a small effect as has been described in many other
studies [10,14,16,20,22]. Nevertheless, given the importance of ad-
herence behavior, the findings provide support for the role of patients'
beliefs. Overall, the frequency of self-reported adherence was compar-
able to other studies evaluating patients after KTx, with 40% reporting
less than ideal adherence (< 25 MARS-Total). Lower adherence scores
were associated with longer time since KTx, more symptoms of anxiety
and depression and lower levels of perceived social support. These re-
sults are in line with previous studies [6,21,34]. Unintentional non-
adherence was significantly more common (36.3%) than intentional
non-adherence (9.7%). While intentional non-adherence was correlated

Table 4
Comparison of BMQ scale scores between dichotomous variables.
BMQ “necessity“ BMQ “concerns“ BMQ differential

N Median (IQR) Statistics U tests Median (IQR) Statistics U tests Median (IQR) Statistics U tests

Sex
Female 237 23.0 (4.0) Z = -0.286, p = .77 11.0 (5.0) Z = -0.325, p = .75 12.0 (7.5) Z = -0.301, p = .76
Male 333 24.0 (5.0) 10.0 (7.0) 12.0 (9.0)

Partnership status
In a partnership 381 24.0 (4.0) Z = -2.466, p = .01, η2 = 0.645 10.0 (5.0) Z = -0.246, p = .81 12.0 (8.0) Z = -1.239, p = .22
No partnership 174 23.0 (5.0) 11.0 (7.0) 11.0 (8.0)

Educational level
≥12 years 146 24.0 (4.0) Z = -0.747, p = .46 10.5 (6.0) Z = -0.519, p = .60 12.0 (8.0) Z = -0.575, p = .57
< 12 years 420 23.37 (5.0) 10.5 (5.0) 12.0 (9.0)

Type of donation
Living donor 173 23.0 (5.0) Z = -0.442, p = .66 11.0 (6.0) Z = -0.637, p = .52 12.0 (8.0) Z = -0.294, p = .76
Deceased donor 397 24.0 (5.0) 10.0 (5.5) 12.0 (9.0)

Diabetes mellitus
Yes 98 23.0 (5.0) Z = -1.392, p = .16 10.0 (6.0) Z = -0.522, p = .60 11.0 (9.0) Z = -0.464, p = .64
No 471 24.0 (5.0) 11.0 (5.75) 12.0 (8.0)

Hypertension
Yes 490 24.0 (5.0) Z = -0.947, p = .34 10.0 (5.19) Z = -0.872, p = .38 12.0 (8.0) Z = -1.036, p = .30
No 80 23.0 (5.0) 11.0 (5.75) 11.5 (8.0)

Coronary heart disease

Yes 63 24.0 (4.0) Z = -0.986, p = .32 11.0 (6.0) Z = -0.547, p = .58 12.0 (9.0) Z = -0.037, p = .97
No 507 24.0 (5.0) 10.0 (5.0) 12.0 (9.0)

IQR = interquartile range.

7
M. Bünemann, et al. Journal of Psychosomatic Research 132 (2020) 109989

Table 5
Linear regression analyses for variables associated with the BMQ subscales and differential.
Variables N β T p-value CI Adjusted R2

BMQ“Necessity” 538 0.057

Age 0.187 3.996 p < .001 0.024, 0.070
Sex 0.011 0.264 p = .79 −0.525, 0.688
Partnership status 0.012 0.262 p = .79 −0.610, 0.797
Educational level 0.085 1.973 p = .049 0.003, 1.368
Depression (HADS-D) 0.006 0.088 p = .93 −0.109, 0.119
Anxiety (HADS-D) 0.045 0.743 p = .46 −0.067, 0.149
Perceived social support (F-SozU-K7) 0.154 3.107 p = .002 0.232, 1.029
BMQ„Concerns“ 549 0.196
Age 0.018 0.433 p = .67 −0.018, 0.028
Sex 0.024 0.610 p = .54 −0.443, 0.842
Educational level 0.022 0.547 p = .59 −0.524, 0.929
Depression (HADS-D) 0.096 1.659 p = .10 −0.018, 0.214
Anxiety (HADS-D) 0.309 5.646 p < .001 0.212, 0.439
Perceived social support (F-SozU-K7) −0.097 −2.173 p = .03 −0.876,
−0.044
eGFR −0.071 −1.752 p = .08 −0.034, 0.002
BMQ differential 549 0.154
Age 0.122 2.935 p = .003 0.016, 0.079
Sex −0.013 −0.336 p = .74 −1.035, 0.732
Educational level 0.038 0.934 p = .35 −0.524, 1.474
Depression (HADS-D) −0.087 −1.471 p = .14 −0.280, 0.040
Anxiety (HADS-D) −0.194 −3.446 p < .001 −0.429,
−0.117
Perceived social support (F-SozU-K7) 0.154 3.359 p = .001 0.406, 1.549
eGFR 0.098 2.371 p = .02 0.005, 0.054

BMQ = Beliefs about Medicines Questionnaire; eGFR = estimated glomerular filtration rate; F-SozU K7 = Questionnaire for Perceived Social Support; HADS-
D = Hospital Anxiety and Depression Scale.

with lower necessity beliefs and higher concerns, unintentional non-
adherence was associated only with greater concerns but not with ne-
cessity beliefs. It is in line with previous findings that patients with low
perceived necessity are more endangered to be willingly non-adherent
[20,35]. Necessity beliefs appear to be more salient in driving inten-
tional adherence behavior.
The main aim of our study was to identify variables associated with
the patient's beliefs about ISM since this has been neglected in the lit-
erature so far. As far as we know we are the first to focus on this par-
ticular aspect in a large sample of KTx patients. In this group of patients
adherence is a topic of utmost importance. Knowledge about variables
associated with the necessity-concerns-framework is relevant to iden-
tify patients at risk to have an unfavorable necessity-concerns ratio and
to design suitable interventions, e.g. to improve adherence or influence
patients' beliefs about necessities and concerns regarding their ISM in
this specific group of patients. Therefore we want to discuss the cor-
relates which we were able to identify:
4.2. Perceived social support
Perceived social support was strongly correlated with higher ne-
cessity, lower concerns, and consequently, a higher BMQ differential.
Also in all regression analyses perceived social support remained a
significant and independent predictor of the BMQ subscales. As far as
we know, there are no studies available focussing on the relationship
between perceived social support and the necessity-concerns frame-
work. However, Bennett et al. [40] investigated women with breast
cancer and found that patients with high levels of social support worry
less about their illness. Consequently, we hypothesize that the same
mechanisms might help to lessen concerns regarding the ISM. Ad-
ditionally, it is well known that social support is associated with the
occurrence of health-promoting behaviors [41,42]. Therefore, it seems
logical that not only the health behavior itself but also the attitude
toward health behavior, e.g., necessities and concerns can be positively
influenced.

4.1. Sociodemographic variables 4.3. Levels of anxiety and depression (HADS-D)

We found a higher age to be associated with higher perceived ne-
cessity. Looking at the preexisting literature, there are conflicting re-
sults regarding age and the BMQ “necessity” scale. Some studies,
however, came to the same conclusion as we did [22,36,37]. One ex-
planation is that older patients often report trusting their practitioners
more than younger patients [38]. As practitioners generally emphasize
the necessity of ISM, we can speculate that older patients adopt these
beliefs more readily than younger patients.
When looking at the partnership status, patients living in a part-
nership reported significantly higher BMQ “necessity” scores. It has
been described before that patients living in a partnership are often
reminded by their partner to take their medication and about the im-
portance of adherence in general [39]. It seems logical that these as-
pects might increase the perceived necessity of ISM.
More pronounced symptoms of anxiety and depression were asso-
ciated with higher concerns and lower perceived necessity as well as
lower values in the BMQ differential. According to the results of the
regression analyses, anxiety seems to have a stronger association spe-
cifically with concerns regarding ISM compared to depression. One
explanation might be that patients suffering from depressive and/or
anxiety symptoms tend to worry more and are suffering from feelings of
insecurity, which may lead to more concerns about the ISM. This result
is in accordance with the finding of Drangsholt et al. [16] who de-
scribed higher concerns in patients with more depressive symptoms. In
a recent review, Goodwin et al. [43] found that patients with gen-
eralized anxiety disorder tend to be biased toward threatening stimuli,
and at the same time worry more. From this viewpoint, it seems only
logical that patients with more symptoms of anxiety report higher
concerns about the ISM.

8
M. Bünemann, et al.
4.4. Medical conditions
Patients with reduced kidney functioning measured by the eGFR
reported more concerns about the ISM. This is in accordance with the
findings of Horne et al. [25] who examined patients with rheumatoid
arthritis. Patients in poor clinical status reported more concerns. Re-
garding ISM, it is well known that especially calcineurin inhibitors can
lead to reduced kidney functioning [44]. Keeping that in mind, it ap-
pears to be intelligible that especially patients with reduced kidney
functioning might have more concerns. However, it might also be that
more concerns might lead to less adherence which might lead to re-
duced kidney functioning. However, in our study, there was no direct
association between adherence and eGFR. No difference could be found
in patients with and without diabetes, hypertension, or coronary heart
disease. This is not surprising, as the BMQ in our study focused pri-
marily on the ISM and not on medicines used to treat other conditions.
However, somatic comorbidity as a potential marker of the overall se-
verity of the disease was not associated with the necessity-concerns-
framework.
4.5. Model fit
Linear regression analyses revealed that only 5.7% of the variance
of the necessity score was explained by the independent variables,
while the independent variables explained 19.6% of the variance of the
concerns score and 15.4% of the variance of the BMQ differential. The
necessity score was mainly explained by age and educational level,
while the concerns score was primarily associated with the level of
anxiety. Perceived social support played an important role in predicting
both necessities and concerns. The BMQ differential was explained by
age, the level of anxiety, perceived social support and – interestingly –
kidney functioning. These results help us to define patients with a risk
profile for an unfavorable necessity-concerns ratio. Due to the possible
adverse effects of an unfavorable necessity-concerns ratio on ad-
herence, from a clinical perspective is seems inevitable to evaluate
possibilities to intervene at these targets with the aim to improve ad-
herence behavior. Therefore we searched the literature to identify in-
terventions targeting the necessity and concerns beliefs. So far, studies
focusing on this aspect are limited:
Karamanidou et al. [45] designed a psychoeducational intervention
to improve the understanding of the necessity of phosphate-binding
medication in patients with ESRD. Directly after the four-month inter-
vention patients in the intervention group reported significantly higher
necessity compared to the control group. However, this effect could not
be found in the one- and four-month follow-up. The authors did not
evaluate the concerns in this study. Magadza et al. [46] used a six-
month educational intervention in patients with hypertension. While
necessity scores were already high before the intervention started and
did not improve significantly, the authors were able to reduce concerns
through their intervention. These findings suggest that beliefs about
medicines are modifiable; however, information on how modification
of beliefs might affect adherence is still missing. Therefore conducting
further studies on this topic seems to be of high importance.
4.6. Limitations
There are some limitations to keep in mind. The cross-sectional
design limits the inferences of causality. We cannot differentiate whe-
ther medication beliefs influence adherence behavior or whether non-
adherence causes patients to adjust their beliefs to justify their beha-
vior. Another limitation is the use of a self-report instrument to measure
adherence. It is well known that adherence is difficult to measure, and it
is important to keep the limitations of the used method in mind, e.g.
socially desirable response behavior [47]. As we were only able to ex-
plain between 5.7% and 19.6% of the variance using linear regression
analyses, it becomes obvious that there are other variables important to
9
Journal of Psychosomatic Research 132 (2020) 109989
explain beliefs about medicines. Further research is required to gain
further insight into this topic.
Above that we want to point out that the Cronbach's alpha for the
MARS-D was quite low. One possible explanation for the low
Cronbach's alpha is the fact that the MARS-D consists only of five
questions. It has been described before that a small number of items
often results in low Cronbach’ alphas whereas in questionnaires with
higher numbers of items the alphas are often higher [48]. In the
German validation study of the MARS-D comparable results (Cronbach's
alpha 0.60–0.69) have been found [13].
The present study also has several strengths, such as the inclusion of
a large well-defined sample and comprehensive data collection to en-
able the analysis of variables associated with medication beliefs.
5. Conclusion
As far as we know, we were the first to evaluate the necessities-
concerns-framework using the BMQ in a large consecutive sample of
German KTx patients. In line with others, we detected high necessity in
nearly all patients, but varying concerns with necessity outweighing
concerns in almost all patients [10]. As described before, we also found
a significant association between the necessity-concerns framework and
adherence. Concerns were foremost associated with high levels of an-
xiety. Therefore, it is important to take the patients' fears and worries
seriously, and the level of anxiety has to be taken into consideration and
addressed when working with patients on their concerns with ISM and
their adherence. Even though some people tend to worry more than
others, it seems important to identify irrational fears and to help pa-
tients to overcome them. Overall, these results demonstrate that psy-
chosocial variables are in fact associated with the patients' beliefs about
medicines and consequently with the adherence to ISM.
Funding sources
The study is supported by a grant the Federal Joint Committee of
the Federal Republic of Germany under the number 01NVF16009.
Declaration of Competing Interest
None.
Acknowledgments
We thank Melanie Hartleib-Otto and Raoul Gertges for their man-
agement support. Additionally, we thank the Department of General
Practice and Health Services Research and Department of Internal
Medicine VI, Clinical Pharmacology and Pharmacoepidemiology,
University Hospital Heidelberg, Heidelberg, Germany” for providing
the translation of the MARS-D and the BMQ.
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