Bioethics Paper

4/22/2021 A Rapid Systematic Review of Outcomes Studies in Genetic Counseling – Madlensky – 2017 – Journal of Genetic Counseling – Wiley Online Library

https://onlinelibrary.wiley.com/doi/full/10.1007/s10897-017-0067-x 1/20

Journal of Genetic Counseling / Volume 26, Issue 3 / p. 361-378

Review Paper Free Access

A Rapid Systematic Review of Outcomes Studies in Genetic Counseling

Lisa Madlensky , Angela M. Trepanier , Deborah Cragun , Barbara Lerner , Kristen M. Shannon ,
Heather Zierhut

First published: 06 February 2017
https://doi.org/10.1007/s10897-017-0067-x
Citations: 35

Abstract

As healthcare reimbursement is increasingly tied to value‐of‐service, it is critical for the
genetic counselor (GC) profession to demonstrate the value added by GCs through
outcomes research. We conducted a rapid systematic literature review to identify outcomes
of genetic counseling. Web of Science (including PubMed) and CINAHL databases were
systematically searched to identify articles meeting the following criteria: 1) measures were
assessed before and after genetic counseling (pre‐post design) or comparisons were made
between a GC group vs. a non‐GC group (comparative cohort design); 2) genetic counseling
outcomes could be assessed independently of genetic testing outcomes, and 3) genetic
counseling was conducted by masters‐level genetic counselors, or non‐physician providers.
Twenty‐three papers met the inclusion criteria. The majority of studies were in the cancer
genetic setting and the most commonly measured outcomes included knowledge, anxiety or
distress, satisfaction, perceived risk, genetic testing (intentions or receipt), health behaviors,
and decisional con�ict. Results suggest that genetic counseling can lead to increased
knowledge, perceived personal control, positive health behaviors, and improved risk
perception accuracy as well as decreases in anxiety, cancer‐related worry, and decisional
con�ict. However, further studies are needed to evaluate a wider array of outcomes in more
diverse genetic counseling settings.

Introduction
Genetic counselors are health care providers who have completed specialized graduate training
to function as professionals in this discipline. While the term “genetic counseling” can be used

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https://doi.org/10.1007/s10897-017-0067-x

4/22/2021 A Rapid Systematic Review of Outcomes Studies in Genetic Counseling – Madlensky – 2017 – Journal of Genetic Counseling – Wiley Online Library

https://onlinelibrary.wiley.com/doi/full/10.1007/s10897-017-0067-x 2/20

somewhat generically to describe the activity of genetic counseling, regardless of the type of
health care provider involved, we use the term genetic counseling in this paper to mean an
intervention delivered by individuals trained as genetic counselors speci�cally.

The practice of genetic counseling has been de�ned as, “…the process of helping people
understand and adapt to the medical, psychological and familial implications of genetic
contributions to disease”. The de�nition states that the process includes three components‐
risk assessment, education, and counseling (NSGCDTF 2006). Outcomes that are stated or can
be implied from this de�nition include: improved patient knowledge through e�ective
education and attention to the impact of genetic information; accurate identi�cation and
communication of risk on the part of the genetic counselor; and informed patient decision‐
making. The adaptation component of the de�nition alludes to multiple potential outcomes
including improving patient adherence to available medical management recommendations,
enhancing quality of life, reducing morbidity and mortality, and promoting patient sharing of
information with at‐risk relatives. In addition, genetic testing is increasingly a component of risk
assessment. Appropriate genetic testing, which encompasses identifying the right genetic
test(s) and o�ering it to appropriate patients, might also be a potential genetic counseling
outcome.

Rising health care costs in the absence of concomitant improvements in the public’s health are
driving health care professionals, including genetic counselors, to identify and implement
evidence‐based strategies that improve patient outcomes. Prior work to generate a
comprehensive list of genetic counseling outcomes includes work by The Western States
Genetics Services Collaborative. This group developed an outcomes menu for public health and
clinical genetics services based on a review of the literature, two existing documents describing
genetics outcomes, and an iterative review process (Silvey et al. 2009). The group identi�ed 12
major outcomes with 42 sub‐outcomes falling into �ve impact areas: knowledge and
information; �nancing; screening and identi�cation; diagnosis, treatment and management;
and population health. Outcomes speci�c to genetic counseling included making informed
health and life decisions based on a genetic diagnosis, participating in treatment “at optimal
levels” after genetic counseling, and feeling supported in managing their emotional reactions to
the genetic information (Silvey et al. 2009).

Establishing a set of meaningful genetic counseling outcomes, although not without its
challenges, is critical to supporting evidence‐based practice in genetic counseling. The goals of
this rapid systematic literature review are 1) to catalogue and summarize the outcomes that
have been previously measured in the setting of genetic counseling provided by genetic
counselors; 2) to identify potential gaps in the literature; 3) to discuss some of the challenges in
outcomes research; and 4) make recommendations about future outcomes research in genetic
counseling.

4/22/2021 A Rapid Systematic Review of Outcomes Studies in Genetic Counseling – Madlensky – 2017 – Journal of Genetic Counseling – Wiley Online Library

https://onlinelibrary.wiley.com/doi/full/10.1007/s10897-017-0067-x 3/20

Methods
We conducted a literature review using a “systematic rapid‐review” approach (Ganann et al.
2010). The Web of Science (including Pub Med) and CINAHL databases were searched using the
terms “genetic* counsel*” and “genetic consul*” to capture all papers with a title, abstract, or
topic that included the phrase “genetic counselor”, “genetic counseling”, “genetic consult” and
variant spellings. Searches were performed on July 18, 2013, no date limits were applied.
Searches were re�ned to exclude case reports and non‐peer reviewed journal articles (such as
commentaries), non‐English papers, and animal studies. Our primary goal was to simply
catalogue the outcomes that had been used in previous research, not to apply any quality
metrics or meta‐ analyses as might be done in a more traditional systematic review of an
intervention.

The inclusion criteria were:

1. Genetic counseling was provided by non‐physician genetics specialists. (Masters‐level
genetic counselor, advanced practice genetics nurse, or other graduate‐level genetics
specialist trained in accordance with the standards and accreditations appropriate to that
country). In the case of multiple types of providers performing genetic counseling within a
study, the study was included if the majority of providers were non‐physician genetic
counselors. We excluded studies that measured the outcomes of genetic testing. Receiving
a genetic test result as part of a genetic counseling session is an event that may
profoundly alter medical management or reproductive decision‐making in and of itself. As
such, genetic testing is likely to have outcomes that are distinct from genetic counseling
outcomes.

2. Measures occurred before and after genetic counseling (pre‐post design) OR measures
were compared between a genetic counseling arm vs some other intervention or a control
arm that did not include genetic counseling (comparative cohort design).

One author reviewed the initial list of references and papers that clearly did not meet eligibility
criteria were excluded. The remaining abstracts were each reviewed by two authors
independently to determine inclusion. When the two authors did not agree on eligibility,
discussion between the two authors resulted in resolution in all cases. In cases where eligibility
could not be determined from the publication (e.g., in cases where the paper did not indicate
who provided the genetic counseling), the corresponding author of the respective paper was
contacted for clari�cation. Once the list of eligible studies was �nalized, key data elements were
extracted from the published papers and summarized. Variables extracted included sample
size, clinical setting, geographic location, study design, patient/family characteristics, outcome
measures reported, and results.

4/22/2021 A Rapid Systematic Review of Outcomes Studies in Genetic Counseling – Madlensky – 2017 – Journal of Genetic Counseling – Wiley Online Library

https://onlinelibrary.wiley.com/doi/full/10.1007/s10897-017-0067-x 4/20

Results
The Web of Science/PubMed search identi�ed a total of 13,329 papers; CINAHL identi�ed 1038.
An initial review of all abstracts resulted in retention of 1063 references for further review. A
total of 23 papers met our inclusion criteria. The clinical setting, geographic location, study
design, and outcomes measured are reported in Table 1.

Table 1. Characteristics of studies that reported outcomes of genetic counseling (n = 23)

Total >100% since some studies measured >1 outcome

Eleven studies compared patients receiving genetic counseling to a control or comparison
group (Table 2), and twelve studies used a pre‐ post‐ design (Table 3). There were six

Setting

Cancer 13 57

General 6 26

Prenatal 2 9

Pediatric 1 4

Psychiatric 1 4

Country

United States 16 70

Canada 2 9

Australia 2 9

Israel 1 4

Netherlands 1 4

Spain 1 4

Study design and comparison

Observational, comparative, GC vs. no GC (Table 2) 5

a

N %

4/22/2021 A Rapid Systematic Review of Outcomes Studies in Genetic Counseling – Madlensky – 2017 – Journal of Genetic Counseling – Wiley Online Library

https://onlinelibrary.wiley.com/doi/full/10.1007/s10897-017-0067-x 5/20

randomized trials that directly examined genetic counseling versus some other intervention.
Most studies were conducted in the United States with Masters‐level genetic counselors
providing the genetic counseling.

Table 2. Comparative studies‐ randomized or observational

Intention, attitude, receipt, desire, interest, or completion of Genetic Testing MS‐ GC (Masters‐level genetic counselor)

CF (cystic �brosis) Follow‐up to Ciske et al. 2001

Table 3. Observational, single‐arm studies with pre‐post design

Bowen et al.

2002

(Randomized)

Cancer

(USA)

357 MS‐ GC Female

relatives of

breast

cancer

patients

GC vs group

session with

health

counselor vs

control (no

GC or group)

Burke et al.

2000

(Randomized)

Cancer

(USA)

243 MS‐ GC Female

relatives of

breast

cancer

patients

GC vs control

group (no

GC)

Ciske et al.

2001

General

genetics

(USA)

138 MS‐ GC Parents of

children

with CF

GC vs no GC

(per self‐

report)

X

Cavanagh et

al 2010

General

genetics

37 MS‐ GC Parents of

children

GC vs no GC

(per self‐

X

b

c

d

a b

c d

Study Setting

(Location)

Sample

size

Genetic

Counselor

Study

population

Comparison

groups

Outcomes

Knowledge Anxiety,

Depression,

or Distress

Study Setting

(Location)

Sample

size

Genetic

Counselor

Study

population

Timing of

Measures

Outcomes

4/22/2021 A Rapid Systematic Review of Outcomes Studies in Genetic Counseling – Madlensky – 2017 – Journal of Genetic Counseling – Wiley Online Library

https://onlinelibrary.wiley.com/doi/full/10.1007/s10897-017-0067-x 6/20

Satisfaction with genetic counseling and/or genetic testing or perceived usefulness of genetic counseling Health

behavior constructs (e.g. cancer screening in Meiser et al. 2001; BMI in Taylor and Wu 2009) Communication with family

members and family relationships Perceived personal control Quality of Life Masters‐level trained genetic counselors

(MS‐GC)

Table 4 summarizes the measures used and the results of the included studies, organized by
outcome domains. The most frequently measured outcomes were knowledge, satisfaction,
anxiety and distress (including disease‐speci�c distress and general distress), perceived risk,
genetic testing (intent or receipt), decisional con�ict, and health behaviors (including
adherence). Measures used were a mix of previously validated measures and study‐speci�c
measures.

Table 4. Results of studies by outcome type

Austin and

Honer 2008

Psychiatric

(Canada)

13 MS‐GC Parents of

children with

psychiatric

disorder

Baseline,

Immediately

post‐GC, 1‐

month post‐

GC

X

Baldwin et

al. 2012

General

genetics

(USA)

244 MS‐GC Deaf/hard of

hearing adults

Baseline,

immediately

post‐GC

X

Berkenstadt

et al. 1999

Prenatal

(Israel)

256 MS‐GC, few

with MD

geneticist

Patients

referred for

age‐related

prenatal

diagnosis with

Baseline,

immediately

post‐GC

f

a b

c

d e f

Study Setting

(Location)

Sample

size

Genetic

Counselor

Study

population

Timing of

Measures

OutcomesKnow‐
ledge

Know‐
ledge

Anxiety,

Distress,

Concern,

or

Depression

Anxiety,

Distress,

Concern,

or

Depression

Study Study population Measures Main results

4/22/2021 A Rapid Systematic Review of Outcomes Studies in Genetic Counseling – Madlensky – 2017 – Journal of Genetic Counseling – Wiley Online Library

https://onlinelibrary.wiley.com/doi/full/10.1007/s10897-017-0067-x 7/20

BRCA breast cancer, HBOC hereditary breast and ovarian cancer, CF cystic �brosis, NHGRI National Human Genome

Research Institute, AMA advanced maternal age

Knowledge
The outcome studied most extensively in this review is knowledge. This is not unexpected given
that education is one of the primary components of the genetic counseling process, and
knowledge can be measured in a variety of settings. The majority of studies that used a pre‐
post design showed an increase in knowledge across several di�erent practice settings.
However, the majority of studies were in the hereditary breast cancer setting. All studies
measured knowledge within 6 months of genetic counseling. The few studies that compared
genetic counseling to a di�erent educational intervention (e.g., pamphlet, computer‐based
modules) found that genetic counseling and the other interventions all increased knowledge.

Anxiety, Depression, Distress

Knowledge

Baldwin

et al. 2012

Deaf or hard of

hearing individuals

10 true/false knowledge

questions on genetics given at

baseline and pre‐ and post

genetic counseling

Statistically signi�cant increase in

knowledge following pre‐test genetic

counseling (paired t(239) = 3.45, p = .0007).

Cabrera

et al. 2010

Patients without a

cancer diagnosis

presenting for BRCA

genetic

counseling/with a

family history of

breast cancer

13 question knowledge

questionnaire developed by the

study investigators to evaluate

prevention, diagnosis, and

treatment of breast cancer, risk

of breast cancer and HBOC risk.

Score 0–31 with higher = more

knowledge. Administered at

baseline, immediately post

genetic counseling (P1) and 6

months later (P2)

A signi�cant increase in knowledge was

detected from baseline (mean knowledge

score of 16.37, S.D. 4.1) to Post 1 (mean

score of 19.6, S.D. 4.3, p < 0.001) and from baseline to Post 2 (mean score of 19.6, S.D. 4.2, p = 0.005. Changes in knowledge were less signi�cant for participants who were older, lower levels of education, and having 4 or more children. Cavanagh et al. 2010 Parents of children with CF 18‐item knowledge questionnaire (multiple choice and yes/no/unsure) regarding the genetics of CF and their Parents who received genetic counseling had signi�cantly higher knowledge scores than those who did not receive genetic counseling (r = 0 53 95% CI = 0 73 to Study Study population Measures Main results 4/22/2021 A Rapid Systematic Review of Outcomes Studies in Genetic Counseling - Madlensky - 2017 - Journal of Genetic Counseling - Wiley Online Library https://onlinelibrary.wiley.com/doi/full/10.1007/s10897-017-0067-x 8/20 Five studies measured anxiety. Four of these studies used the State Trait Anxiety Inventory (STAI) and all studies showed either decreases or no change in anxiety levels. No studies found an increase in anxiety. Four of the �ve studies were conducted in the hereditary breast cancer setting. Several studies evaluated depression, concern, negative a�ect, and/or distress. Notably, several studies in the cancer setting speci�cally used the Impact of Events Scale, where genetic counseling was the “event”. The majority of studies demonstrated no change in distress, with a few showing reduced distress. Perceived Risk All but one study of perceived risk were in the breast cancer setting where a variety of study‐ speci�c measures were used. Most studies showed a decrease in perceived risk. This result was interpreted as a bene�cial outcome as many study participants were overestimating their cancer risk at baseline. Satisfaction/Perceived Usefulness Five studies examined satisfaction with the genetic counseling process, or satisfaction with decision‐making. A study by Hunter et al. (2005) is notable as it was a randomized trial of various genetic counseling approaches in the prenatal setting. The study found that women having individual genetic counseling were more satis�ed than women receiving group genetic counseling or who were given a decision aid. Genetic Testing Intent or Receipt All except one of the �ve studies looking at intention to undergo genetic testing or receipt of genetic testing were in the breast cancer genetics setting; in some cases the goal was to decrease inappropriate testing intentions in low‐risk women. Health Behaviors Including Adherence Five studies measured aspects of health behavior. One study, conducted in the diabetes setting, measured weight loss and attendance at a 12‐week lifestyle balance course. Another study, conducted in the cancer setting, measured breast cancer screening practices. A third study investigated lifestyle and health changes (weight, blood pressure, sodium intake and physical activity) in a hypertensive population. The fourth investigated adherence to medical management recommendations (various) in a pediatric genetics patient population. The �fth investigated adherence to medical recommendations made in a pediatric genetics clinic. Decisional Con�ict 4/22/2021 A Rapid Systematic Review of Outcomes Studies in Genetic Counseling - Madlensky - 2017 - Journal of Genetic Counseling - Wiley Online Library https://onlinelibrary.wiley.com/doi/full/10.1007/s10897-017-0067-x 9/20 Three studies measured decisional con�ict; all used the Decisional Con�ict scale and all showed decreases in decisional con�ict. Two studies were in the cancer setting and one was in the prenatal setting. Other Outcomes The review identi�ed several outcomes that were measured in only one or two studies, including: self‐esteem, quality of life, family outcomes (communication and relationships), and perceived personal control. Discussion Although our �ndings are based on the relatively small number of studies meeting our inclusion criteria, the studies to date show that a wide variety of outcomes can be considered in genetic counseling research. Results of these studies demonstrate that genetic counseling can lead to increases in knowledge, perceived personal control, positive health behaviors, and increased accuracy of perceived risk. Anxiety, cancer‐related worry, and decisional con�ict often decrease following genetic counseling, and patient satisfaction is typically high. The studies we identi�ed used a variety of di�erent measures which limits the ability to make speci�c cross study comparisons. Furthermore, the majority of studies we reviewed occurred within the oncology/cancer risk setting which limits applicability to the other practice settings such as reproductive or pediatric genetics. The focus on outcomes in the cancer setting may be due to the availability of evidence‐based guidelines for cancer genetic risk assessment and widespread interest and availability of genetic counseling and testing for familial breast and ovarian cancer risk. An important strength of the current review stems from the broad search terms and methods we used to increase our ability to capture relevant papers meeting our inclusion criteria. Despite our e�orts, additional studies meeting our criteria may not have been captured. Furthermore, this review must be interpreted in light of our strict criteria which deliberately focused on genetic counseling as provided by predominantly masters‐level genetic counselors. We identi�ed some additional studies that included advanced practice genetics nurses, and other types of genetic counselors as de�ned by their jurisdiction at the time of the study (for example, the Australian graduate diploma in genetic counseling). A recent review by McAllister and Dearing (2015) used a broader de�nition of “genetic services” which included genetic counseling by physicians, non‐physicians, and genetic testing. In contrast, our review excluded studies that combined the outcomes of genetic counseling and testing, as our focus was to look at what outcomes had been measured in the context of the genetic counseling process, rather than as the result of a genetic test. Finally, several cross‐sectional studies that showed patient satisfaction with genetic counseling or other post‐genetic counseling only measures were also 4/22/2021 A Rapid Systematic Review of Outcomes Studies in Genetic Counseling - Madlensky - 2017 - Journal of Genetic Counseling - Wiley Online Library https://onlinelibrary.wiley.com/doi/full/10.1007/s10897-017-0067-x 10/20 excluded from this review as there was no baseline comparison measure. It should also be noted that we identi�ed two additional studies that were published following our cut‐o� date for the review that meet our inclusion criteria; Hippman et al. (2016) measured knowledge, risk perception, internalized stigma, and perceived control over illness in a pilot randomized trial of genetic counseling vs. an educational booklet; results indicated that genetic counseling improved risk perception and both interventions improved knowledge. Palmer et al. (2014) found that understanding of genetic test results improved after genetic counseling, and deaf identity remained stable in a sample of individuals undergoing genetic testing for mutations in genes related to deafness. An important limitation of this study is that we did not attempt to evaluate the quality of the individual studies or identify biases that might be present in the study designs. Although randomized controlled trials are considered the gold standard, the quality can vary widely. We also chose to include pre‐post study designs, even though they are typically less scienti�cally rigorous, because we were primarily interested in capturing a broad spectrum of the types of outcomes that have been studied. Future work is needed to incorporate scales and checklists (such as CONSORT) that have been developed to rate the quality of studies. Despite study limitations, critical gaps that this review highlights include the relatively small number of genetic counseling outcomes studied to date and lack of studies that focus on morbidity, mortality or other long‐term health outcomes. However, several outcomes may have direct or indirect in�uences on morbidity and mortality. For instance, genetic counseling may in�uence self‐e�cacy to follow treatment or surveillance recommendations as well as adherence to these recommendations in cases where such recommendations have been shown or are expected to result in decreased morbidity and mortality. Self‐e�cacy was not an outcome evaluated in any of the studies we identi�ed. However, after the date of our literature search, a randomized controlled trial of individuals with a �rst degree relative of colon cancer was published in which genetic counselors delivered a motivational interviewing risk communication intervention designed to increase perceptions of colorectal cancer risk and disease severity as well as self‐e�cacy and response‐e�cacy. That study found that rates of colonoscopy were substantially higher in the intervention group (35.4%) as compared to the comparison group who received mailed informational materials only (15.7%) (Kinney et al. 2014). Nevertheless, unlike colorectal cancer, not all genetic or familial conditions have clear treatment or prevention guidelines that reduce morbidity and mortality and therefore the e�ect of genetic counseling on other measures such as self‐reported quality of life may be areas to explore. Likewise, in prenatal genetic counseling, where the primary goal is autonomous, informed decision making, measures such as decisional con�ict and perceived personal control may be more appropriate. 4/22/2021 A Rapid Systematic Review of Outcomes Studies in Genetic Counseling - Madlensky - 2017 - Journal of Genetic Counseling - Wiley Online Library https://onlinelibrary.wiley.com/doi/full/10.1007/s10897-017-0067-x 11/20 Additional focus on patient‐reported genetic counseling outcomes is critical as healthcare shifts to a more patient‐centered focus that emphasizes value and outcomes. All potential outcomes of interest, particularly those that have not been evaluated or that were included in only a single study in our review, will require additional veri�cation in a wider variety of settings. Identi�cation or development of standardized measures would also be useful for assisting in the ability to make comparisons across settings and across studies. Some outcomes scales speci�c to the genetic counseling setting have already been developed (McAllister et al. 2011), but our search did not identify any studies meeting our inclusion criteria that used this instrument within our search dates. A Satisfaction with Genetic Counseling scale has also been published (Shiloh et al. 1990) and was used in one study in our review. Several general measures that have been validated in multiple populations were used repeatedly (e.g. STAI, Impact of Events), but these were primarily in the cancer setting and were focused on cancer‐ related distress or distress related to cancer genetic counseling. At the present time, there is a limited, but growing body of literature on genetic counseling outcomes to guide evidence‐based practice. However, there are a number of challenges to measuring these outcomes. One challenge is that there are a variety of health care professionals who provide genetic counseling services. Some, such as Master's trained genetic counselors, advanced practice genetics nurses, physician medical geneticists, and PhD medical geneticists have specialized training and certi�cation in genetics whereas others may have no or minimal training in genetics. These di�erences may translate into variations in how genetic counseling is provided by genetics professionals versus other health professionals who o�er genetic services, which limits the validity of comparing genetic counseling outcomes across professions and also highlights the need to identify which genetic counseling processes or strategies contribute most to patient outcomes. Even amongst genetic specialists, clinical training, practice‐based competencies and scopes of practice vary (ACGC 2013; ACMG 2011). For instance, in the United States and Canada, genetic counselor training is focused on four competency domains‐ genetics expertise and analysis, interpersonal communication, psychosocial and counseling skills, education, and professional development and practice (ACGC 2013). Competencies for the physician medical geneticists overlap with many aspects of the genetic counselor competencies in areas such as genetics knowledge, family …

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