Helene Chokron Garneau joined the Center for Behavioral Health Services and Implementation Science in 2019 as a Senior Research Scientist. Dr. Chokron Garneau has extensive research experience in public health and substance use, with an emphasis on co-occurring psychiatric and substance use disorders. Her current efforts at the CBHSIR focus on advancing implementation science by disentangling mechanisms through which implementation strategies operate. She is particularly interested in how to optimize and tailor implementation strategies and applying this knowledge to reduce disparities pertaining to health services for addiction treatment.
Dr. Chokron Garneau obtained both her PhD and MPH in Public Health from UCLA where she concurrently worked to assist in the development, implementation, and evaluation of behavioral interventions for substance users with comorbid psychiatric diagnoses.
Current Role at Stanford
Senior Research Scientist
Sustainment of Integrated Care in Addiction Treatment Settings: Primary Outcomes From a Cluster-Randomized Controlled Trial.
Psychiatric services (Washington, D.C.)
OBJECTIVE: Integrated treatment services are the gold standard for addressing co-occurring mental and substance use disorders, yet they are not readily available. The Network for the Improvement of Addiction Treatment (NIATx) was hypothesized to be an effective strategy to implement and sustain integrated mental health and substance use care in addiction treatment programs. This study examined sustainment of integrated services for up to 2 years after the active implementation phase.METHODS: The effectiveness of NIATx strategies to implement and sustain integrated services was evaluated by using a cluster-randomized, waitlist control group design. Forty-nine addiction treatment organizations were randomly assigned to either NIATx1 (active implementation strategy) or NIATx2 (waitlist control). The Dual Diagnosis Capability in Addiction Treatment Index was used to evaluate organizations' capability to provide integrated care. The NIATx Stages of Implementation Completion scale was used to assess participation in and adherence to the NIATx implementation process. Linear mixed-effects modeling was used to evaluate changes from baseline to end of the sustainment period.RESULTS: Both cohorts sustained their capability to provide integrated treatment services. Both groups achieved successful implementation and sustained integrated services to a similar degree, regardless of sustainment year. Sustainment did not vary as a function of NIATx adherence.CONCLUSIONS: The delivery of integrated treatment services was sustained for 2 years after receipt of active implementation support. Future research should consider how contextual factors may predict, mediate, and moderate sustainment outcomes.
View details for DOI 10.1176/appi.ps.202000293
View details for PubMedID 34346729
The Integrating Medications for Addiction Treatment (IMAT) Index: A measure of capability at the organizational level.
Journal of substance abuse treatment
2021; 126: 108395
Primary care provides a treatment opportunity for many persons with opioid use disorder (OUD). The push to integrate and expand reach and adoption of medications for opioid use disorder (MOUD) within primary care has been a major focus of national, state and health systems endeavors. To guide high capability MOUD practice, we introduce the Integrating Medications for Addiction Treatment (IMAT) Index. The research team has developed IMAT along similar lines to other organizational measures of integrated services capability. We present the development and validation of the measure, and suggest its applicability for systems and organizations, as well as for process improvement and implementation research. Forty-one primary care clinics completed the IMAT at two time points: baseline and 9-month follow-up. Findings support the IMAT Index as psychometrically acceptable and pragmatically useful. It has good internal consistency, as well as concurrent and predictive validity. Changes in IMAT scores between baseline and follow-up significantly predicted increases in proportion of patients on MOUD. The IMAT has the potential to support both scientific and public health care activities.
View details for DOI 10.1016/j.jsat.2021.108395
View details for PubMedID 34116810
A mapping review of NIDA-funded implementation research studies on treatments for opioid and/or stimulant use disorders.
Drug and alcohol dependence
2021; 225: 108767
BACKGROUND: The biomedical research enterprise invests greatly in discovery-oriented science, but significantly less in how to implement the most effective of these innovations. The return on investment in public health benefit is therefore low. In the context of substance-related overdose epidemics, presently with opioids and/or stimulants, the gap in proven treatments and routine access is amplified. Implementation research is designed to deepen understanding of how best to scale-up proven treatments. This study assessed how implementation research has been deployed in the National Institute on Drug Abuse (NIDA) efforts to address the opioid and stimulant epidemics.METHODS: Adapting a procedure developed to categorize HIV-focused research, a four-stage systematic mapping review of NIDA-funded R01, R34, R61, and U studies pertaining to opioids and/or stimulants funded between 2015 and 2019 was performed. Abstracts were retrieved using NIH Research Portfolio Online Reporting Tools. Key study characteristics were abstracted and coded by two independent reviewers.RESULTS: An initial search across NIH institutes yielded 5963 relevant records. Of these, 666 (11.2 %) were NIDA funded. One-hundred-and-thirty-four (20.1 %) of the 666 studies were opioid and/or stimulant treatment related. Of these, 28 (4.2 %) were categorized as Implementation Preparation (IP), and 16 (2.4 %) were categorized as Implementation Research (IR). Over the five-year period, there was a gradual increase in both IP and IR studies.CONCLUSIONS: Implementation research is a small but slowly growing component of the federal portfolio to address substance-related public health issues. To more effectively respond to contemporary overdose epidemics, implementation research must take on an even more significant role.
View details for DOI 10.1016/j.drugalcdep.2021.108767
View details for PubMedID 34052689
COVID-19 Adaptations in the Care of Patients with Opioid Use Disorder: a Survey of California Primary Care Clinics.
Journal of general internal medicine
With the onset of the COVID-19 crisis, many federal agencies relaxed policies regulating opioid use disorder treatment. The impact of these changes has been minimally documented. The abrupt nature of these shifts provides a naturalistic opportunity to examine adaptations for opioid use disorder treatment in primary care.To examine change in medical and behavioral health appointment frequency, visit type, and management of patients with opioid use disorder in response to COVID-19.A 14-item survey queried primary care practices that were enrolled in a medications for opioid use disorder statewide expansion project. Survey content focused on changes in service delivery because of COVID-19. The survey was open for 18 days.We surveyed 338 clinicians from 57 primary care clinics located in California, including federally qualified health centers and look-alikes. A representative from all 57 clinics (100%) and 118 staff (34.8% of all staff clinicians) participated in the survey.The survey consisted of seven dimensions of practice: medical visits, behavioral health visits, medication management, urine drug screenings, workflow, perceived patient demand, and staff experience.A total of 52 of 57 (91.2%) primary care clinics reported practice adaptations in response to COVID-19 regulatory changes. Many clinics indicated that both medical (40.4%) and behavioral health visits (53.8%) were now exclusively virtual. Two-thirds (65.4%) of clinics reported increased duration of buprenorphine prescriptions and reduced urine drug screenings (67.3%). The majority (56.1%) of clinics experienced an increase in patient demand for behavioral health services. Over half (56.2%) of clinics described having an easier or unchanged experience retaining patients in care.Many adaptations in the primary care approach to patients with opioid use disorder may be temporary reactions to COVID-19. Further evaluation of the impact of these adaptations on patient outcomes is needed to determine whether changes should be maintained post-COVID-19.
View details for DOI 10.1007/s11606-020-06436-3
View details for PubMedID 33511572
What constitutes "behavioral health"? Perceptions of substance-related problems and their treatment in primary care.
Addiction science & clinical practice
2020; 15 (1): 29
BACKGROUND: Integrating behavioral health in primary care is a widespread endeavor. Yet rampant variation exists in models and approaches. One significant question is whether frontline providers perceive that behavioral health includes substance use. The current study examined front line providers': 1. definition of behavioral health, and 2. levels of comfort treating patients who use alcohol and other drugs. Frontline providers at two primary care clinics were surveyed using a 28-item instrument designed to assess their comfort and knowledge of behavioral health, including substance use. Two questions from the Integrated Behavioral Health Staff Perceptions Survey pertaining to confidence in clinics' ability to care for patients' behavioral health needs and comfort dealing with patients with behavioral health needs were used for the purposes of this report. Participants also self-reported their clinic role. Responses to these two items were assessed and then compared across roles. Chi square estimates and analysis of variance tests were used to examine relationships between clinic roles and comfort of substance use care delivery.RESULTS: Physicians, nurses/nurse practitioners, medical assistants, and other staff (N=59) participated. Forty-nine participants included substance use in their definition of behavioral health. Participants reported the least comfort caring for patients who use substances (M=3.5, SD=1.0) compared to those with mental health concerns (M=4.1, SD=0.7), chronic medical conditions (M=4.2, SD=0.7), and general health concerns (M=4.2, SD=0.7) (p<0.001). Physicians (M=3.0, SD=0.7) reported significantly lower levels of comfort than medical assistants (M=4.2, SD=0.9) (p<0.001) caring for patients who use substances.CONCLUSIONS: In a small sample of key stakeholders from two primary care clinics who participated in this survey, most considered substance use part of the broad umbrella of behavioral health. Compared to other conditions, primary care providers reported being less comfortable addressing patients' substance use. Level of comfort varied by role, where physicians were least comfortable, and medical assistants most comfortable.
View details for DOI 10.1186/s13722-020-00202-w
View details for PubMedID 32727589
INTEGRATED BEHAVIORAL HEALTH: PATIENT AND PROVIDER PERSPECTIVES FROM TWO PRIMARY CARE CLINICS
OXFORD UNIV PRESS INC. 2020: S599
View details for Web of Science ID 000546262401421
ENHANCING INTEGRATED BEHAVIORAL HEALTH PRACTICES: EVALUATION AND MEASUREMENT OF REAL-WORLD IMPLEMENTATION
OXFORD UNIV PRESS INC. 2020: S5
View details for Web of Science ID 000546262400015
Barriers to initiation of extended release naltrexone among HIV-infected adults with alcohol use disorders
JOURNAL OF SUBSTANCE ABUSE TREATMENT
2018; 85: 34–37
Alcohol consumption is a major risk factor for the acquisition of HIV/AIDS and is associated with greater disease burden and mortality among those who become HIV-infected. Of the extant pharmacological treatments for alcohol use disorders, naltrexone is recognized as one of the most efficacious, producing robust reductions in alcohol craving and use. Given that treatment with oral naltrexone has been limited by problems with adherence, which are particularly prevalent among individuals with multiple chronic, co-occurring conditions, long-acting formulations may be a promising approach for HIV-infected substance users. However, little is known about the barriers to initiation of extended-release naltrexone (XR-NTX) treatment among alcohol users living with HIV. In this report we present and discuss the content analysis of open-ended survey questions, as well as lessons learned, with regards to barriers to initiation and maintenance of XR-NTX treatment collected as part of an RCT evaluating a cognitive behavioral text messaging intervention for HIV-infected adults with alcohol use disorders. Barriers to initiation and maintenance of XR-NTX pharmacotherapy among HIV+ individuals with alcohol use disorders seem to fall in one of two categories:  barriers that are amenable to change, which include distance and transportation issues, fear of injections, and belief that alcohol use does not warrant pharmacotherapy, and  barriers that are not amenable to change, such as the potential interaction of XR-NTX with another medication regimen.
View details for DOI 10.1016/j.jsat.2017.05.004
View details for Web of Science ID 000422703500006
View details for PubMedID 28527854
View details for PubMedCentralID PMC5681892
- Glances and stares: Validating the feelings of patients with thyroid-associated orbitopathy BRITISH JOURNAL OF VISUAL IMPAIRMENT 2017; 35 (3): 211–16
DEVELOPMENT OF A COGNITIVE BEHAVIORAL THERAPY-BASED TEXT MESSAGING INTERVENTION FOR HIV-INFECTED ALCOHOL USERS
WILEY. 2017: 91A
View details for Web of Science ID 000402419600295
Mindfulness-Based Relapse Prevention for Stimulant Dependent Adults: A Pilot Randomized Clinical Trial
2017; 8 (1): 126–35
In light of the known associations between stress, negative affect, and relapse, mindfulness strategies hold promise as a means of reducing relapse susceptibility. In a pilot randomized clinical trial, we evaluated the effects of Mindfulness Based Relapse Prevention (MBRP), relative to a health education control condition (HE) among stimulant dependent adults receiving contingency management. All participants received a 12-week contingency management (CM) intervention. Following a 4-week CM-only lead in phase, participants were randomly assigned to concurrently receive MBRP (n=31) or HE (n=32). Stimulant dependent adults age 18 and over. A university based clinical research center. The primary outcomes were stimulant use, measured by urine drug screens weekly during the intervention and at 1-month post-treatment, negative affect, measured by the Beck Depression Inventory and Beck Anxiety Inventory, and psychiatric severity, measured by the Addiction Severity Index. Medium effect sizes favoring MBRP were observed for negative affect and overall psychiatric severity outcomes. Depression severity changed differentially over time as a function of group, with MBRP participants reporting greater reductions through follow-up (p=0.03; Effect Size=0.58). Likewise, the MBRP group evidenced greater declines in psychiatric severity, (p=0.01; Effect Size=0.61 at follow-up). Among those with depressive and anxiety disorders, MBRP was associated with lower odds of stimulant use relative to the control condition (Odds Ratio= 0.78, p=0.03 and OR=0.68, p=0.04). MBRP effectively reduces negative affect and psychiatric impairment, and is particularly effective in reducing stimulant use among stimulant dependent adults with mood and anxiety disorders.
View details for DOI 10.1007/s12671-016-0586-9
View details for Web of Science ID 000392485800013
View details for PubMedID 28191264
View details for PubMedCentralID PMC5300086
A Cognitive Behavioral Therapy-Based Text Messaging Intervention Versus Medical Management for HIV-Infected Substance Users: Study Protocol for a Pilot Randomized Trial
JMIR RESEARCH PROTOCOLS
2016; 5 (2): e131
Evidence-based psychosocial interventions for addictions and related conditions such as cognitive behavioral therapy (CBT) are underutilized. Obstacles to implementation of CBT in clinical settings include limited availability of quality training, supervision, and certification in CBT for clinicians; high rates of clinician turnover and high caseloads; and limited qualifications of the workforce to facilitate CBT expertise.Mobile phone-based delivery of CBT, if demonstrated to be feasible and effective, could be transformative in broadening its application and improving the quality of addiction treatment. No experimental interventions that deliver CBT targeting both drug use and medication adherence using text messaging have been previously reported; as such, the objective of this study is to develop and test an SMS-based treatment program for HIV-positive adults with comorbid substance use disorders.With user input, we developed a 12-week CBT-based text messaging intervention (TXT-CBT) targeting antiretroviral (ART) adherence, risk behaviors, and drug use in a population of HIV-infected substance users.The intervention has been developed and is presently being tested in a pilot randomized clinical trial. Results will be reported later this year.This investigation will yield valuable knowledge about the utility of a cost-effective, readily deployable text messaging behavioral intervention for HIV-infected drug users.
View details for DOI 10.2196/resprot.5407
View details for Web of Science ID 000381213600015
View details for PubMedID 27341852
View details for PubMedCentralID PMC4938885
Characterization and Outcomes of Repeat Orbital Decompression for Thyroid-Associated Orbitopathy
ORBIT-AN INTERNATIONAL JOURNAL ON ORBITAL DISORDERS AND FACIAL RECONSTRUCTIVE SURGERY
2015; 34 (2): 57–65
Orbital decompression for thyroid-associated orbitopathy (TAO) is commonly performed for disfiguring proptosis, congestion, and optic neuropathy. Although one decompression typically achieves goals, a small percentage requires repeat decompression. We performed a 10-year retrospective chart review of all orbital decompressions for TAO at a single tertiary referral institution. Four-hundred and ninety-five orbits (330 patients) were decompressed for TAO, with 45 orbits (37 patients) requiring repeat decompression. We reviewed the repeat cases for indications, clinical activity scores, approach, walls decompressed, and outcomes. Nine percent of orbits required repeat decompression for proptosis (70%), optic neuropathy (25%) or congestion (45%). Sixty-four percent were for recurrence of disease, 36% were for suboptimal decompression. Three incisional approaches were used: lateral upper eyelid crease, inferior transconjunctival, and transcaruncular, with inferior transconjunctival being most common. Of the three walls removed, deep lateral, inferior, and medial, the deep lateral wall was most common (51%). A repeat lateral decompression was the most frequent pattern. Of 37 patients requiring repeat decompression, 40% had diplopia prior to repeat, and an additional 24% developed diplopia after the repeat. Whereas previous studies published by our group cited only 2.6% of deep lateral wall orbital decompressions leading to new-onset primary gaze diplopia, repeat orbital decompressions have a much higher rate of post-operative diplopia. The new onset primary gaze diplopia after repeat decompression group had a higher average preoperative CAS (3.3 vs. 2.4, p < 0.01), higher mean blood loss (56 vs. 19 mL, p = 0.04), more frequent medial wall decompressions (47% vs. 29%, p = 0.33), and greater proptosis reduction (2.4 vs. 1.7 mm, p = 0.24).
View details for DOI 10.3109/01676830.2014.949784
View details for Web of Science ID 000418048600001
View details for PubMedID 25244551
Eyebrow Tissue Expansion An Underappreciated Entity in Thyroid-Associated Orbitopathy
ARCHIVES OF OPHTHALMOLOGY
2012; 130 (12): 1566–69
To report photographic evidence of eyebrow tissue expansion in patients with thyroid-associated orbitopathy (TAO) and to demonstrate consistency in grading through the use of standardized photographs.A retrospective cohort study of patients referred for evaluation of TAO in an orbitofacial tertiary care center between January 1, 2000, and December 31, 2010. A grading key was produced with representative views of each of 4 grades (0 [no expansion] to 3 [severe expansion]), corresponding to increasing severity of eyebrow tissue expansion. Photographs of each study patient, including both premorbid and morbid photographs, were retrieved from an electronic medical record system and graded by 6 independent, masked observers using this 4-point system.Seventy-five patients with TAO were identified for inclusion. The average grade was 0.3 for premorbid eyes and 1.1 for morbid eyes. Intraclass correlation coefficients for the premorbid photographs were 0.705 and 0.632 for the right and left eyes, respectively. Intraclass correlation coefficients for the morbid photographs were 0.921 and 0.916 for the right and left eyes, respectively.Eyebrow tissue expansion is a common manifestation in TAO. Comparison of premorbid and morbid photographs is a useful means to identify and characterize the extent of brow involvement. The use of a grading key improves the consistency of identifying and grading eyebrow tissue expansion. Recognition of the eyebrow tissue as distinct anatomically in TAO may be crucial to rehabilitation of these patients, which may entail multiple surgical procedures.
View details for DOI 10.1001/archophthalmol.2012.2543
View details for Web of Science ID 000312195300011
View details for PubMedID 23229698
Thyroid-Associated Periorbitopathy Eyebrow Fat and Soft Tissue Expansion in Patients With Thyroid-Associated Orbitopathy
ARCHIVES OF OPHTHALMOLOGY
2012; 130 (3): 319-328
To compare soft tissue and fat volumes in the supraorbital area of healthy patients and patients with thyroid-associated orbitopathy (TAO) using 3-dimensional reconstruction software.The superiolateral orbital area was delineated on a bony framework. Three-dimensional reconstruction and volumetric calculation of the retro-orbicularis oculi fat (brow fat), galeal fat (including the retro-orbicularis oculi fat), and soft-tissue muscle were performed.We analyzed 100 computed tomographic scans from 48 patients with TAO and 52 control subjects. All patients showed an age-related increase of fat volumes. The mean total eyebrow volume was greater in patients with TAO vs healthy control subjects (P < .001). Galeal fat (P = .02) and retro-orbicularis oculi fat (P = .01) volumes were significantly higher in patients with TAO vs control subjects. Soft-tissue muscle volume decreased with age in healthy females but remained constant in the aging female group with TAO. Both total volume and brow thickness did not appear to change with age in healthy patients but exhibited an increase in the female population with TAO.This study brings into focus the clinicopathologic entity of thyroid-associated periorbitopathy. Three-dimensional evaluation of computed tomographic scans can provide information on volumetric changes in the eyebrow profile of patients with TAO. Further investigation of the biologic and morphologic changes of eyebrow fat and soft tissue in patients with TAO may help better characterize, classify, and guide their treatment.
View details for Web of Science ID 000301353400006
View details for PubMedID 22411661
A Three-Dimensional Construct of the Aging Eyebrow: The Illusion of Volume Loss
AESTHETIC SURGERY JOURNAL
2012; 32 (1): 46-57
The eyebrows and eyebrow fat pads, key structures in upper facial aesthetics, are particularly vulnerable to age-related changes.In this study, the authors compare the impact of aging on the eyebrows and eyebrow fat pad volume in men and women through three-dimensional (3D) volumetric analysis.Electronic medical records of patients seen at the Jules Stein Eye Institute in the Division of Orbital and Ophthalmic Plastic Surgery between 2005 and 2010 were reviewed. Patients were included if they had undergone investigative imaging of the orbit for unilateral pathology. Computed tomography (CT) scans of patients with Graves disease diagnosis, extensive orbital trauma, and/or previous eyebrow surgery were excluded. A total of 52 CT scans (24 men and 28 women) were retained for analysis. A 3D reconstruction software was used to analyze the scans and calculate volumes of the retroorbicularis oculi fat (ROOF), galeal fat (ROOF and subcutaneous fat), and soft tissue muscles.Galeal and brow fat volumes showed a significant positive trend toward enlargement in women (P values of .01 and .05, respectively). Although men showed a tendency toward fat enlargement with age, this was not statistically significant. Soft tissue-muscle volume decreased significantly in aging women (9.32 mm(3)/y) (P = .02). Data indicated that soft tissue volume in men tended to increase with age (3.92 mm(3)/y) but not significantly (P = .36). Neither total volume nor brow thickness appeared to change significantly in women (P = .56, P = .73). In men, total volume and brow thickness showed weak evidence of increasing with age (P = .12, P = .22). Linear regressions of Hertel measurements with and without sex interaction showed no statistically significant trend between the amount of proptosis and the galeal or brow fat.Although overall eyebrow volume does not change with age, the relative contribution of fat and soft tissue to the total volume does seem to change. This pattern also differs between males and females. As women age, the fat volume increases and the soft tissue volume decreases. In men, the shift from soft tissue volume to fat volume is less pronounced. Although many clinicians have been drawn to the concept of fat volume deflation as a key element of facial aging, this study does not support this perspective in the eyebrow fat pad. An increasingly refined understanding of the dynamics of facial aging is mandatory for clinical diagnosis and will likely provide the framework from which to develop more innovative treatment options.
View details for DOI 10.1177/1090820X11430829
View details for Web of Science ID 000298960000005
View details for PubMedID 22231412
COMPARISON OF SURGICAL AND NON-SURGICAL TREATMENTS FOR CONGENITAL MICROPHTHALMIA
LIPPINCOTT WILLIAMS & WILKINS. 2012: 248
View details for Web of Science ID 000298634401436
Rituximab Treatment of Patients with Severe, Corticosteroid-Resistant Thyroid-Associated Ophthalmopathy
2010; 117 (1): 133–U167
To study the effectiveness of anti-CD20 (rituximab [RTX]; Rituxan; Genentech, Inc., South San Francisco, CA) therapy in patients with severe, corticosteroid (CS)-resistant thyroid-associated ophthalmopathy (TAO).Retrospective, interventional case series.Six consecutive subjects with severe, progressive TAO unresponsive to CS.Electronic medical record review of consecutive patients receiving RTX during the previous 18 months. Responses to therapy were graded using standard clinical assessment and flow cytometric analysis of peripheral lymphocytes.Clinical activity score (CAS), proptosis, strabismus, treatment side effects, and quantification of regulatory T cells.Six patients were studied. Systemic CS failed to alter clinical activity in all patients (mean CAS+/-standard deviation, 5.3+/-1.0 before vs. 5.5+/-0.8 during therapy for 7.5+/-6.4 months; P = 1.0). However, after RTX treatment, CAS improved from 5.5+/-0.8 to 1.3+/-0.5 at 2 months after treatment (P<0.03) and remained quiescent in all patients (CAS, 0.7+/-0.8; P<0.0001) at a mean follow-up of 6.2+/-4.5 months. Vision improved bilaterally in all 4 patients with dysthyroid optic neuropathy (DON). None of the 6 patients experienced disease relapse after RTX infusion, and proptosis remained stable (Hertel measurement, 24+/-3.7 mm before therapy and 23.6+/-3.7 mm after therapy; P = 0.17). The abundance of T regulatory cells, assessed in 1 patient, increased within 1 week of RTX and remained elevated at 18 months of follow-up.In progressive, CS-resistant TAO, rapid and sustained resolution of orbital inflammation and DON followed treatment with RTX.The author(s) have no proprietary or commercial interest in any materials discussed in this article.
View details for DOI 10.1016/j.ophtha.2009.05.029
View details for Web of Science ID 000274529700021
View details for PubMedID 19818507
View details for PubMedCentralID PMC2814962
Development of Criteria for Evaluating Clinical Response in Thyroid Eye Disease Using a Modified Delphi Technique
ARCHIVES OF OPHTHALMOLOGY
2009; 127 (9): 1155–60
To identify components of a provisional clinical response index for thyroid eye disease using a modified Delphi technique.The International Thyroid Eye Disease Society conducted a structured, 3-round Delphi exercise establishing consensus for a core set of measures for clinical trials in thyroid eye disease. The steering committee discussed the results in a face-to-face meeting (nominal group technique) and evaluated each criterion with respect to its feasibility, reliability, redundancy, and validity. Redundant measures were consolidated or excluded.Criteria were parsed into 11 domains for the Delphi surveys. Eighty-four respondents participated in the Delphi 1 survey, providing 220 unique items. Ninety-two members (100% of the respondents from Delphi 1 plus 8 new participants) responded in Delphi 2 and rated the same 220 items. Sixty-four members (76% of participants) rated 153 criteria in Delphi 3 (67 criteria were excluded because of redundancy). Criteria with a mean greater than 6 (1 = least appropriate to 9 = most appropriate) were further evaluated by the nominal group technique and provisional core measures were chosen.Using a Delphi exercise, we developed provisional core measures for assessing disease activity and severity in clinical trials of therapies for thyroid eye disease. These measures will be iteratively refined for use in multicenter clinical trials.
View details for DOI 10.1001/archophthalmol.2009.232
View details for Web of Science ID 000269765500006
View details for PubMedID 19752424
View details for PubMedCentralID PMC4005726