Providers’ Use of Pharmacogenetic Testing to Inform Antidepressant Prescribing: Results of Qualitative Interviews
Abstract
Objective:
Pharmacogenetic testing (PGx) for patients experiencing depression has been associated with modest improvements in symptoms. However, little is known about providers’ use of PGx, including how and for whom providers use the test results in clinical decision making. In this article, results from qualitative interviews on the experience of providers participating in a pragmatic trial of PGx are described; implications of the providers’ experiences are highlighted to inform future implementation of PGx.
Methods:
Interviews were conducted with providers participating in the trial (N=61) who treated veterans who had depression. Questions were informed by the Consolidated Framework for Implementation Research. A rapid analytic approach was used.
Results:
Two main themes were identified: perceptions regarding which patients would likely benefit from PGx and approaches to using the test results in prescribing. Providers generally expressed positive experiences with using PGx results. However, the providers varied in application of the test results to clinical decision making regarding medications, were uncertain about how much to rely on the results, and differed in perceptions about which patients would benefit from PGx.
Conclusions:
To support future implementation, policies and procedures are needed, as well as mechanisms to support ongoing provider education on PGx.
HIGHLIGHTS
•
Providers reported positive experiences with using pharmacogenetic testing (PGx) to inform decision making in prescribing medications for patients with depression.
•
Providers varied in the application of PGx results to clinical decision making and were uncertain about the extent to which decision making should rely on the test results.
•
Providers also varied in their perceptions of which patients were likely to benefit from PGx, as well as in their perceptions of whether the testing should be used for all patients or only for patients who had unsuccessfully tried a few medications.
Pharmacogenetic testing (PGx) is a novel practice, with a growing literature to support its use in psychiatric prescribing (1). In theory, PGx provides information on how patients’ genetic makeups may influence their responses to specific medications, enabling providers to align medication selection with individual genetic profiles and potentially avoid adverse effects of medications. Such information may be beneficial in the treatment of patients with depression, where poor medication experiences are common. Patients often try multiple antidepressants before finding an effective one, and the probability of treatment dropout increases with each failed trial (2). Furthermore, poor gene-medication matches may affect a significant proportion of patients. One study (3) reported that approximately one-quarter of patients treated by primary care providers (PCPs) were prescribed an antidepressant that may not have been a good fit for their pharmacogenomic profile. Other studies of PGx for patients with depression found significant gene-medication interactions in approximately 20% of patients (4–6). Data collected from trials (1, 4, 6) have indicated that use of PGx in the management of depression was associated with a modest increase in response and remission rates, although additional studies are needed to determine which tests perform best for which groups of patients (1).
The Precision Medicine in Mental Health Care (PRIME Care) study (7) was designed to add to the evidence base by examining the utility of PGx in the treatment of depression and to explore provider perceptions about the testing. The PRIME Care study (6, 7) was a pragmatic randomized controlled trial, assessing the effectiveness of using a commercially available pharmacogenetic test among veterans treated for major depressive disorder in the Veterans Health Administration (VHA). This 22-site study assessed whether treatment guided by the PGx results would lead to a higher rate of remission from depression and to decreased use of medications with potential gene-drug interactions. As a type-2 hybrid trial (8), the study design included implementation science methods to understand how PGx was used in clinical practice during the trial and to inform future implementation (7). This approach, guided by the Consolidated Framework for Implementation Research (9), included detailed exploration of providers’ perceptions about the intervention, their recommendations for implementation at the beginning of the trial (10, 11), and examination of providers’ experiences after using PGx in psychiatric prescribing.
As evidence for the effectiveness of PGx in depression care has accumulated, investigators have begun to study provider and patient perceptions about PGx use (12–15). Although perceptions of PGx have been mostly positive, little is known about providers’ actual experiences of using PGx results in psychiatric prescribing, including how, and for which patients, they incorporate the results into prescribing decisions. In this article, we used qualitative data to explore how providers described their use of PGx results in clinical decision making for patients with major depressive disorder during the PRIME Care study. We also highlight the implications of providers’ experiences for future implementation of PGx.
Methods
Study Context
All study procedures, including the qualitative interviews with participating providers, were approved by the U.S. Department of Veterans Affairs Central Institutional Review Board and by the regulatory bodies at each participating site. Providers gave informed consent to participate in the trial and the interviews.
The PRIME Care study used a commercially available combinatorial genetic test, GeneSight (4), which produces a report consisting of a cover page that sorts antidepressant medications into three columns on the basis of the patients’ genotype: green (use as directed), yellow (moderate gene-drug interaction), and red (significant gene-drug interaction). The table is footnoted to include the specific polymorphisms associated with higher risk for drug-gene interactions, and the direction or functional nature of the predicted interaction (i.e., resulting in slower or faster drug metabolism), to help with dosage decisions. Similar tables were provided for additional psychotropic medication classes (e.g., antipsychotics). Additional pages of the report provide detailed information on specific genes. Each individual test cost approximately $1,000 (undiscounted retail price); the testing company covered this cost for the trial.
Recruitment for Qualitative Interviews
Interview recruitment focused on VHA PCPs and mental health providers enrolled in the PRIME Care trial. Recruitment and interviews began about 2 years after enrollment of the first patient to allow sufficient time for providers to gain experience in using PGx results.
Providers who had not yet received a patient’s test result were excluded from the interviews. To ensure representation of a range of experiences, providers were categorized into primary care or mental health and then into three groups on the basis of the number of patients they had referred who were assigned to a study arm: low referring (1–2 patients), medium referring (3–7 patients), and high referring (≥8 patients). Providers from each group were then recruited via e-mail to participate in the interviews.
Over time, as interviews were completed, recruitment efforts were purposively targeted to increase provider participation from needed categories (primary care vs. mental health, low vs. high referring, and different sites). These efforts resulted in a final sample that was representative of the larger study in terms of percentage of PCPs versus mental health providers, with approximately equal numbers across referral groups and with at least one interviewee from each participating site.
Data Collection
An interview guide was developed, by using the Consolidated Framework for Implementation Research domains of individual characteristics and inner and outer settings, to inform the questions and to meet the aims of the larger study; the intervention characteristics domain had been addressed earlier in the study (11). Interview questions sought to elicit thoughts that would map back to constructs within these domains to ensure the interviews would cover an array of factors likely to be important in future implementation of PGx. The guide was adjusted iteratively, after an initial set of interviews, to eliminate identified redundancies.
All interviews were conducted via telephone and were audio recorded. Before the start of the interview, participants were informed of the purpose of the interview and were reminded of the consent procedure and voluntary nature of their participation. All participants verbally reaffirmed their consent to participate and to be recorded.
Interviews were conducted by two doctorate-level medical anthropologists, with a research assistant present to facilitate recording. All interviews were conducted between August 2019 and January 2021, with a pause from March to June 2020 during the initial phase of the COVID-19 pandemic. Interviews were 30–60 minutes long (mean=35 minutes).
Data Analysis
Interview recordings were transcribed by a professional service, and transcripts were analyzed with a rapid analytic approach (16). This approach is efficient for processing large amounts of qualitative information, with results comparable to those of more traditional line-by-line coding approaches (17, 18).
Specifically, a template matrix was designed to organize the data into primary categories that were based on the interview question guide, to summarize the content of each interview, and to capture supporting quotations. One qualitative analyst was responsible for summarizing each interview from the complete transcript. The summary and supporting details were then reviewed by a second analyst for accuracy, completeness, and consistency. The analysts then met to review the summaries and to make minor adjustments to the content on the basis of the review process.
The descriptive content of each interview was transferred to a matrix to facilitate integration and comparison of content from all the transcripts. The matrix contained rows for each category and a column for the summarized content of each interview. One analyst reviewed the content across each category, from the entire sample of interviews, and drafted a content summary for each category. This summary was reviewed by a second analyst for accuracy of interpretation and characterization of the data. The summaries included both common themes and ideas and exceptions and observations of differences among the transcripts and participants.
Results
Table 1 displays the demographic and practice characteristics of the 61 providers interviewed. Most (80%) worked in specialty mental health; the remainder were PCPs. Most (61%) had medical degrees, 31% were nurse practitioners (N=18) or physician assistants (N=1), and the remainder had doctor of pharmacy degrees.
| Characteristic | N | % |
|---|---|---|
| Gender | | |
| Male | 27 | 44 |
| Female | 34 | 56 |
| Age in years | | |
| ≤30 | 2 | 3 |
| 31–40 | 14 | 23 |
| 41–50 | 13 | 21 |
| 51–60 | 24 | 39 |
| >60 | 7 | 11 |
| Missing or unknown | 1 | 2 |
| Race-ethnicitya | | |
| White | 43 | 70 |
| Black or African American | 3 | 5 |
| Asian American | 11 | 18 |
| Prefer not to answer or missing | 5 | 8 |
| Hispanic | 6 | 10 |
| Year completed training | | |
| Before 1980 | 2 | 3 |
| 1981–1990 | 3 | 5 |
| 1991–2000 | 11 | 18 |
| After 2000 | 44 | 72 |
| Missing | 1 | 2 |
| Referral group | | |
| Low (1–2 patients) | 17 | 28 |
| Medium (3–7 patients) | 24 | 39 |
| High (≥8 patients) | 20 | 33 |
| Specialty | | |
| Primary care | 12 | 20 |
| Mental health | 49 | 80 |
| Provider type | | |
| Medical doctor | 37 | 61 |
| Nurse practitioner or physician assistant | 19 | 31 |
| Doctor of pharmacy | 5 | 8 |
a
Totals may not equal 100% because participants could choose more than one option.
Qualitative analysis identified two main themes: perceptions of patients who are most likely to benefit from PGx and approaches to using PGx results in prescribing (Box 1). The range of themes and subthemes identified were consistent regardless of provider type, setting (primary care vs. mental health), or number of patients referred to the intervention (low vs. medium vs. high) and are therefore presented in aggregate.
BOX 1. Identified themes and subthemes of provider use of pharmacogenetic testing (PGx)
Theme 1: Provider Perceptions of Patients Most Likely to Benefit From PGx
•
Patients with previously unsuccessful medication trials for depression or treatment-resistant depression
•
Patients who were resistant to or uncomfortable with the idea of taking medication to manage depression
Theme 2: Provider Approaches to Using PGx Results in Prescribing Medications for Depression
•
PGx results were thought of as influential only for certain patients.
◦
Sometimes all medications prescribed were in the green use-as-directed column.
◦
Results of the testing did not always seem to match patient experience of the medications.
◦
Results were often not specific enough (i.e., long lists of medications in each category).
•
When results were influential, the results were exciting.
•
Provider strategies for use of PGx results varied.
◦
Some relied on the cover page and tried to use medications listed in the green column.
◦
Some prescribed medications that were in the yellow or red (use-with-caution) columns but used the detailed information pages to adjust the dosage.
•
Provider comfort with test results varied, especially regarding the more detailed information provided.
Perceptions of Patients Most Likely to Benefit From PGx
Generally, providers saw PGx as most suitable for patients who had already unsuccessfully tried medications for depression. Some of these providers specifically mentioned treatment-resistant depression:
Generally, patients [who] were included were patients [who] maybe hadn’t done well on previous therapy and still needed help . . . basically, patients [who] I thought would benefit if we had some additional information in choosing which therapy to go with next. (PCP 46)
Related to this theme, providers discussed using the testing to help patients who were resistant to the idea of taking medication for depression to feel more comfortable with trying a pharmaceutical. The testing was seen as fulfilling this purpose regardless of whether the patient had previously tried medication.
A lot of times, I feel that patients have had multiple medication trials, and they’re afraid, or they’re reluctant, to try another medication. They’ve tried two or three and maybe four [medications]. Some of them have tried more than that, seven or eight, and combinations, and they’re just reluctant. They’re not doing well, . . . and so I think the study sort of gives them a little bit of hope, like, oh, maybe rather than just throwing something at the wall and seeing if it sticks, we’ll have some data. (mental health provider 30)I used it for patients [who] I knew were very depressed [and who] would not previously go on medication or had a lot of side effects with medications. It’s like the equivalent of someone saying, “I’m gonna give you the exact medication that fits you.” They were more likely to try it, so [for] my resistant patients it was very useful, because they felt more secure. (PCP 25)
Approaches to Using PGx Results in Prescribing
Providers frequently felt that PGx results did not influence the medication decision for many of their patients. However, they were excited by cases where the testing was impactful.
Well, it didn’t really change treatment decisions notably except for one person. The one time it did make a difference was when it showed that [the patient] would be a slow metabolizer, and so we would need to use a lower dose of the antidepressant than [is] typically done. (mental health provider 46)I offer it to the patient to participate. . . . When they participated, I got the results [that] indicated a certain type of medications, so I can clearly see which will be the better and which medications might not work as well, and quite often I saw medications that I offered the patient were actually in the column that were suggested to use, and sometimes they weren’t. I had one patient . . . [who] really made significant progress after I switched from one medication to another, [with] quite a remarkable . . . symptoms reduction. . . . [The] results were quite fascinating. (mental health provider 28)
Some providers expressed frustration or disappointment. They felt that the PGx results simply indicated medications to avoid, without offering more specific guidance.
I only have a few folks. But often the results were not incredibly specific, meaning that there was a long list of medications that were in each category. So [the results] didn’t narrow it down greatly that you should use this pill versus that pill. It was “use this list and stay away from that list.” (mental health provider 2)
Providers discussed primarily relying on the cover page of the results and trying to use medications in the “use as directed” (i.e., green) column first. Providers also discussed why they may not have selected a green-column medication, including patients’ comorbid conditions, associated medications, or preferences; medications not on the VHA formulary; patients doing well on a medication in the yellow or red column; and the provider’s clinical judgment. One PCP noted,
At least one time, I picked one that was in the yellow [column]. I’ve never picked one in the red column. I think there have been times when what I was using was in the yellow column. And I think at least one time maybe in the green column; it was just medications that I was not necessarily comfortable with. (PCP 16)
One mental health provider offered detailed insight into the rationale for continuing treatment with medications in the yellow or red categories:
Oftentimes, people have different responses to medications anyways. I would get the results back, . . . and then by that time, [the patient] would be like “Oh, I’m doing better” . . . the medication that I started them on . . . before I got the results [as occurred with patients in the delayed results condition], it was working. It might have been in the yellow or red category, and then the patient would get confused, and I would explain . . . a lot of [the testing] looks at your metabolism and these medications. In psychiatry, sometimes the medications are not so clear. You start somebody on a medicine, and something that you don’t think [is] going to work, based upon how you think of it, ends up working really well. Or something that you think is going to be a slam dunk doesn’t work, for a reason that you can’t explain. There’s such a subjective experience of taking psychotropic medications that sometimes the results would make you think one way, but that just wasn’t the way the patient was experiencing it. And then they would ask me, “What would you do? It’s yellow. Should we change?” And I’m like, “Well, you’ve been on this medication for a few months now and you’re doing well. I don’t think we should change it.” (mental health provider 50)
Some providers said that they used PGx to inform dosage considerations, rather than to completely switch medications. They used the medication they already had in mind for a patient regardless of which column it fell in but adjusted the dosage to be either higher or lower than usual, in accordance with the genetic results. This approach was particularly common among mental health providers, some of whom saw the dosage adjustments as a particularly valuable aspect of the testing.
Dosing. That is one of the things I appreciate for the medications that do have gene-drug interactions, like the recommendations for dosing, whether to dose higher or lower. But, yeah, I think that’s the biggest benefit I’ve had from that so far when there [are not] too many options that are “use as directed.” That has been the most useful aspect of the results of testing. (mental health provider 44)
Some providers discussed their experiences with explaining the PGx results to patients in situations where the test results did not match the patient’s past medication experiences:
I would say about maybe 75% [of the time results matched patients’ experiences], but there were definitely a couple of cases [where] it [did] not. I can think of at least two or three [who] swore that they could not take certain medicines and [that] they made them really sick, and [the medications] were in the use-as-directed column, or that [patients] felt [a medication] was really, really helpful and they tolerated it well, and they’re doing excellent on it, but [the medication] was in that moderate [column], where it says that they may be more likely to have side effects. Again, I just had that conversation with [patients] that this isn’t an exact science yet, but it just helps to guide the providers, and [the patients] were usually fine with it. (mental health provider 12)
Providers generally felt comfortable using the test results and reported that their confidence grew with PGx use. However, some felt less confident and expressed a desire for more training and education on PGx, especially regarding additional details beyond the first page. For example, one provider said,
I remember asking the study people to just make sure I was understanding the study correctly with one of the patients, because interestingly, he was on a medication that he found helpful. And the study said just to be cautious because there . . . were enough interactions that it’s just [a] “use with caution” [medication]. . . . And then I think I read the bottom part, the little . . . subscript of notes, and it kind of made sense to me. I'll say, when it got to the nitty-gritty of the pharmacogenetic stuff, it sort of made sense, but it was a little bit more above my head than I would’ve liked. (mental health provider 48)
A few providers felt comfortable with these more detailed results and found them to be valuable. One provider, referring to the longer report, commented,
I basically got all the information from . . . all those annotations in the pages. The information that I had in front of me . . . was sufficient to make a decision and learn. (mental health provider 28)
Discussion
This article presents the results of qualitative interviews with PCPs and mental health providers participating in the PRIME Care trial of PGx among veterans receiving treatment for depression. We found considerable variation in how the providers described their use of the PGx results in their clinical decision making and in the degree of uncertainty about the extent to which the results should be relied on for medication decisions. These findings are consistent with those of previous studies (13–15, 19) of provider perceptions and experiences of PGx. Our findings extend the extant literature by providing detailed descriptions of providers’ experiences with using PGx results in prescribing medications for depression. Similar to findings by Frigon et al. (19), in our study most providers had limited awareness of PGx before participating in the study, and some expressed a need for clearer guidelines on the use of the PGx results. After using PGx during the study, providers in our sample described instances where they felt the testing had made a meaningful difference in a patient’s treatment. Others remained somewhat skeptical, unsure whether the testing had benefited most of their patients.
These results have several implications for future clinical implementation and research. First, most of the study providers felt that PGx was best suited to patients with a history of unsuccessful medication use. This approach may be warranted, because patients who have already tried several medications without success may have an increased likelihood of having actionable PGx results. However, treatment-resistant depression may also result from complicating factors (i.e., substance use or medical or psychiatric comorbid conditions) that could limit the utility of the test results (20).
Alternatively, the full impact of PGx results on treatment outcomes may be more evident for patients seeking depression treatment for the first time (20). PGx could lead to earlier identification of patients who are likely to experience adverse reactions to antidepressants. Finding an effective and well-tolerated medication sooner may help patients avoid adverse effects and ineffective medications, thereby reducing the likelihood that patients will drop out of treatment (2). Waiting until a patient has already tried a few medications before ordering PGx may limit the impact of the test results (20) and may result in missed opportunities for reducing patients’ depression symptoms.
Second, although providers’ experiences of using PGx varied, many discussed having one or two patients for whom the testing had a marked effect on treatment decisions and outcomes. These positive experiences may make providers more likely to use PGx; however, with only approximately 20% of patients having actionable test results, providers may need to use PGx multiple times before reaping that benefit. Our findings highlight provider concerns regarding patient-level criteria for PGx (i.e., whether PGx should be used for all patients or only those with certain characteristics) and about the optimal timing of testing (at the initial prescription or after a few medication trials). More research is needed to understand these issues and to identify criteria that maximize the cost-effectiveness of treatment incorporating PGx relative to treatment as usual.
Third, the providers discussed using the PGx results in various ways and using more or less of the information provided. Some providers used only the cover page with the three columns, whereas others felt more comfortable using the footnotes and more detailed information to make dosage and other adjustments. This variation indicates that some providers may not have used all the information available to inform their decisions, whereas others may have overinterpreted the details in the footnotes. Ongoing provider education is needed to ensure PGx is used appropriately and to the greatest benefit.
Finally, the providers’ comments on how they used PGx in their clinical decision making may have implications for future research. In particular, some providers adjusted medication dosages by using the guidance provided by the moderate and significant gene-drug interaction (i.e., the yellow and red) columns, as well as by using more specific genetic information, whereas others reported relying primarily on medications in the no-gene-drug interaction column (i.e., the green column). These different approaches to incorporating the test results have implications, in terms of assessing and understanding the use of PGx and of what constitutes adherence to the testing, for future clinical trials. Additionally, some providers commented that a placebo effect possibly increased patient confidence in the medications, whereas others worried that patients who saw that their medication was in the yellow or red column may have been negatively disposed toward it, even if there were valid reasons for the use of the medication. Empirically exploring these impressions, the extent to which a placebo effect influences the effectiveness of pharmacogenetically guided treatment, and patient perceptions of PGx may be important next steps for research.
This work had some limitations. Because the study was conducted in the VHA, unique patient populations and site-specific structural factors may have contributed to providers’ experiences and perceptions, and the results may not be applicable to PGx in mental health care in community settings. We also could not determine how site-specific variation within the VHA may have influenced providers’ perceptions, because the study methods did not allow for that level of analysis. Additionally, interview participants were from a convenience sample of providers who volunteered to participate in the PRIME Care trial; as such, their views about PGx may differ from those of the general population of providers. However, the wide range of PGx uptake and perceptions in our sample was likely comparable to that of the broader population. Furthermore, provider experiences during a research study may differ from those of regular clinical practice (i.e., imposed limitations on patients’ eligibility and presence of supportive research coordinators and local site investigators encouraging PGx use). However, because this was a pragmatic trial, providers had a lot of autonomy in how they used the test results in their clinical decision making. Finally, the scope of the study did not allow us to explore how patients experienced PGx. Understanding the patient experience, and its contribution to shared decision making around prescribing of antidepressants, may further understanding of the use of PGx (21) and could be examined in future studies.
Conclusions
Providers in our study generally expressed positive experiences with using PGx to inform prescribing of medications for depression. However, their experiences highlighted variations in perceptions about which patients were likely to benefit from this type of testing and in the application of the testing results to prescribing decisions. Future implementation and adoption of PGx should consider establishing policies and procedures for use of the testing, as well as mechanisms to support ongoing provider education.
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Information & Authors
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History
Received: 17 October 2022
Revision received: 23 March 2023
Accepted: 26 April 2023
Published online: 2 August 2023
Published in print: December 01, 2023
Keywords
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Competing Interests
Dr. Wray has received support from the VA Center for Integrated Healthcare and the VA Western New York Healthcare System, Buffalo. Dr. Thase has served as an adviser or consultant for Acadia, Akili, Alkermes, Allergan (Forest, Naurex), Axsome, Boehringer-Ingelheim, Clexio Biosciences, GH Therapeutics, H. Lundbeck A/S, Janssen Pharmaceuticals (Johnson and Johnson), Jazz Pharmaceuticals, Otsuka Pharmaceuticals, Perception Neuroscience, Pfizer, Sage Therapeutics, Seelos Pharmaceuticals, Sunovion, and Takeda; he has received grant support from AbbVie, Acadia, Allergan (Forest, Naurex), Alkermes, Assurex Health (now Myriad), Axsome Therapeutics, Clexio, Intracellular, Janssen Pharmaceuticals (Johnson and Johnson), NIMH, Otsuka, the Patient-Centered Outcomes Research Institute, and Takeda; and he receives royalties from the American Psychiatric Association, Guilford Press, Herald House, and W.W. Norton. His spouse is employed by Peloton Advantage and is a senior vice president of Open Health; both of these companies conduct business with pharmaceutical companies. Dr. Oslin has received research support from Johnson and Johnson and Myriad Genetics. The other authors report no financial relationships with commercial interests.
Funding Information
This work was supported by the VA (Health Services Research and Development SDR-16-348). Additional support was received from Myriad Genetics (in-kind testing support) and from Johnson and Johnson (grant support for a substudy).These views represent the opinions of the authors and not necessarily those of the VA or the U.S. government.
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