Application of an egocentric social network approach to examine changes in social connections following treatment for anxiety and depression: A novel measurement tool for clinical trials research?

The epidemic of loneliness and social isolation has been recognized as a public health crisis warranting the same prioritization as other public health issues today, such as obesity, substance use disorders, and tobacco use. Social disconnection is particularly prevalent and disabling among individuals with anxiety and depression, yet it is inadequately evaluated and addressed in most clinical psychology treatment research. Studies generally employ global measures of perceived connectedness, loneliness, or relationship satisfaction, limiting understanding about elements of one's social network that may change with treatment. This study examined changes in the degree (number of people nominated) and quality of one's social network from pre-to post-treatment using an egocentric social network approach in 59 adults (mean age = 30.8 years, range = 18 to 54) with clinically elevated anxiety or depression who were randomized to a cognitive and behavioral positive valence treatment versus waitlist. Participants (egos) named people in their lives (alters) with whom they discussed important issues or spent free time. For each alter, participants rated how close they felt, how close they thought the alter felt to them, and how frequently they communicated. Linear regressions, which included treatment group as a predictor, revealed no group differences in changes in network degree, perceived alter feelings of closeness, or communication frequency, despite prior findings from this sample indicating larger increases in perceived global connectedness in the treatment group. Unexpectedly, the control group reported a greater increase in perceived closeness to alters. Post-hoc analyses revealed this was explained by the treatment group identifying more distal social ties (e.g., extended family, colleagues, roommates) as alters following treatment - an outcome positively associated with global improvements in connectedness. This proof-of-concept study suggests egocentric social network surveys may provide unique information on treatment-related changes in social functioning. Suggestions are provided for adaptations to facilitate application of social network surveys to mental health treatment research.

"Integrated behavioral health plus": The best of the worlds of collaborative care management, primary care behavioral health, and primary care.

INTRODUCTION: Discussions comparing the components and virtues of models of integrated behavioral health (IBH), that is, collaborative care management and primary care behavioral health, have been ongoing. In this conceptual article, we recommend shifting the focus to a broader set of components we have found essential to serve the needs of our patients, and hopefully the broader aims of dissemination and implementation of IBH. METHOD: We detail our 20-year experience including the personnel, program components, challenges, successes, and plans for the future that will meet our patients' behavioral health needs and serve primary care. RESULTS: We compare our "IBH Plus" approach using the central tenets of primary care known as the "six Cs" (6Cs) to two dominant models, illustrating differences and similarities among them. The "6Cs" are first contact/accessibility, continuity, comprehensiveness, coordination, context-based, and accountability. We detail how each of these "6Cs" guides the structure and functioning of IBH Plus in the team-based patient-centered medical home setting. DISCUSSION: We believe IBH Plus more clearly relates to and supports the rest of the primary care transformation movement while integrating components of the most popular models of IBH and may support greater implementation of IBH. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Amplification of Positivity Treatment for Anxiety and Depression: A Randomized Experimental Therapeutics Trial Targeting Social Reward Sensitivity to Enhance Social Connectedness.

BACKGROUND: Social disconnection is common and causes significant impairment in anxiety and depressive disorders, and it does not respond sufficiently to available treatments. The positive valence system supports social bond formation and maintenance but is often hyporesponsive in people with anxiety or depression. We conducted an experimental therapeutics trial to test the hypothesis that targeting positive valence processes through cognitive and behavioral strategies would enhance responsivity to social rewards, a core mechanism underlying social connectedness. METHODS: Sixty-eight adults who endorsed clinically elevated anxiety and/or depression with social impairment were randomized 1:1:1 to 5 (n = 23) or 10 (n = 22) sessions of amplification of positivity (AMP) treatment or waitlist (n = 23). Pre- to posttreatment change in striatal activity (primary outcome) during social reward anticipation was measured using functional magnetic resonance imaging, and reactivity to a social affiliation task (secondary) and self-reported social connectedness (exploratory) were examined. Primary analyses compared AMP (doses combined) versus waitlist. A second aim was to compare the effects of different doses. RESULTS: AMP engaged the hypothesized treatment target, leading to greater striatal activation during anticipation of social rewards versus waitlist (d = 1.01 [95% CI = 0.42-1.61]; largest striatal volume). AMP yielded larger improvements in positive affect and approach behavior during the affiliation task (but not other outcomes) and social connectedness. Larger striatal and social connectedness increases were observed for 5-session versus 10-session AMP (d range = 0.08-1.03). CONCLUSIONS: Teaching people with anxiety or depression strategies to increase positive thoughts, behaviors, and emotions enhances activity in brain regions that govern social reward processing and promotes social connectedness. Social reward sensitivity may be a transdiagnostic target for remediating social disconnection.

A Cluster Randomized Trial of Primary Care Practice Redesign to Integrate Behavioral Health for Those Who Need It Most: Patients With Multiple Chronic Conditions.

PURPOSE: Patient outcomes can improve when primary care and behavioral health providers use a collaborative system of care, but integrating these services is difficult. We tested the effectiveness of a practice intervention for improving patient outcomes by enhancing integrated behavioral health (IBH) activities. METHODS: We conducted a pragmatic, cluster randomized controlled trial. The intervention combined practice redesign, quality improvement coaching, provider and staff education, and collaborative learning. At baseline and 2 years, staff at 42 primary care practices completed the Practice Integration Profile (PIP) as a measure of IBH. Adult patients with multiple chronic medical and behavioral conditions completed the Patient-Reported Outcomes Measurement Information System (PROMIS-29) survey. Primary outcomes were the change in 8 PROMIS-29 domain scores. Secondary outcomes included change in level of integration. RESULTS: Intervention assignment had no effect on change in outcomes reported by 2,426 patients who completed both baseline and 2-year surveys. Practices assigned to the intervention improved PIP workflow scores but not PIP total scores. Baseline PIP total score was significantly associated with patient-reported function, independent of intervention. Active practices that completed intervention workbooks (n = 13) improved patient-reported outcomes and practice integration (P ≤ .05) compared with other active practices (n = 7). CONCLUSION: Intervention assignment had no effect on change in patient outcomes; however, we did observe improved patient outcomes among practices that entered the study with greater IBH. We also observed more improvement of integration and patient outcomes among active practices that completed the intervention compared to active practices that did not. Additional research is needed to understand how implementation efforts to enhance IBH can best reach patients.

COVID-19 vaccine hesitancy: Associations with gender, race, and source of health information.

INTRODUCTION: Vaccinations for COVID-19 are being distributed, yet vaccine hesitance is placing many people at risk for infection, negative outcomes, and compromising public health. Given primary care clinics are where people most often interact with health care providers, understanding factors associated with this hesitance may help providers in integrated primary care settings best address this hesitance. METHOD: Between September and November of 2020, a survey was sent to all primary care patients within a large southern California health system, with over 10,000 responding (22% response rate). Survey items included sociodemographic variables, level of vaccine hesitance, "proximity to COVID" (e.g., direct exposure to COVID-19 and consequences), as well as a patient's primary source of health information (e.g., traditional news, social media, etc.). Responses assessed the strength of hesitance. RESULTS: Results showed that while 78% of participants "strongly" believed vaccines generally are a good way to protect from illness, only 51% reported strong willingness to get the COVID-19 vaccine. Consistent with previous surveys, younger patients were more hesitant to get vaccinated, as were people of color. Unique to this survey was the finding that those relying on social media, faith-based organizations, or family/friends for health information had the greatest vaccine hesitance. DISCUSSION: While our patient sample was less hesitant than other U.S. adult samples previously reported in the literature, our data suggest that targeting those patients who report reliance on nontraditional health information sources should be approached by primary care teams, including behavioral health providers, to address vaccine hesitancy. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Integrating behavioral health & primary care for multiple chronic diseases: Clinical trial of a practice redesign toolkit.

Context: Most patients in need of behavioral health (BH) care are seen in primary care, which often has difficulty responding. Some practices integrate behavioral health care (IBH), with medical and BH providers at the same location, working as a team. However, it is difficult to achieve high levels of integration. Objective: Test the effectiveness of a practice intervention designed to increase BH integration. Study Design: Pragmatic, cluster-randomized controlled trial. Setting: 43 primary care practices with on-site BH services in 13 states. Population: 2,460 adults with multiple chronic medical and behavioral conditions. Intervention: 24-month practice change process including an online curriculum, a practice redesign and implementation workbook, remote quality improvement coaching services, and an online learning community. Outcomes: Primary outcomes were changes in the 8 Patient-Reported Outcomes Measurement Information System (PROMIS-29) domain scores. Secondary outcomes were changes in medication adherence, self-reported healthcare utilization, time lost due to disability, cardiovascular capacity, patient centeredness, provider empathy, and several condition-specific measures. A sample of practice staff completed the Practice Integration Profile at each time point to estimate the degree of BH integration in that site. Practice-level case studies estimated the typical costs of implementing the intervention. Results: The intervention had no significant effect on any of the primary or secondary outcomes. Subgroup analyses showed no convincing patterns of effect in any populations. COVID-19 was apparently not a moderating influence of the effect of the intervention on outcomes. The intervention had a modest effect on the degree of practice integration, reaching statistical significance in the Workflow domain. The median cost of the intervention was $18,204 per practice. In post-hoc analysis, level of BH integration was associated with improved patient outcomes independent of the intervention, both at baseline and longitudinally. Conclusions: The specific intervention tested in this study was inexpensive, but had only a small impact on the degree of BH integration, and none on patient outcomes. However, practices that had more integration at baseline had better patient outcomes, independent of the intervention. Although this particular intervention was ineffective, IBH remains an attractive strategy for improving patient outcomes.

Integrating Behavioral Health and Primary Care (IBH-PC) to improve patient-centered outcomes in adults with multiple chronic medical and behavioral health conditions: study protocol for a pragmatic cluster-randomized control trial.

BACKGROUND: Chronic diseases that drive morbidity, mortality, and health care costs are largely influenced by human behavior. Behavioral health conditions such as anxiety, depression, and substance use disorders can often be effectively managed. The majority of patients in need of behavioral health care are seen in primary care, which often has difficulty responding. Some primary care practices are providing integrated behavioral health care (IBH), where primary care and behavioral health providers work together, in one location, using a team-based approach. Research suggests there may be an association between IBH and improved patient outcomes. However, it is often difficult for practices to achieve high levels of integration. The Integrating Behavioral Health and Primary Care study responds to this need by testing the effectiveness of a comprehensive practice-level intervention designed to improve outcomes in patients with multiple chronic medical and behavioral health conditions by increasing the practice's degree of behavioral health integration. METHODS: Forty-five primary care practices, with existing onsite behavioral health care, will be recruited for this study. Forty-three practices will be randomized to the intervention or usual care arm, while 2 practices will be considered "Vanguard" (pilot) practices for developing the intervention. The intervention is a 24-month supported practice change process including an online curriculum, a practice redesign and implementation workbook, remote quality improvement coaching services, and an online learning community. Each practice's degree of behavioral health integration will be measured using the Practice Integration Profile. Approximately 75 patients with both chronic medical and behavioral health conditions from each practice will be asked to complete a series of surveys to measure patient-centered outcomes. Change in practice degree of behavioral health integration and patient-centered outcomes will be compared between the two groups. Practice-level case studies will be conducted to better understand the contextual factors influencing integration. DISCUSSION: As primary care practices are encouraged to provide IBH services, evidence-based interventions to increase practice integration will be needed. This study will demonstrate the effectiveness of one such intervention in a pragmatic, real-world setting. TRIAL REGISTRATION: ClinicalTrials.gov NCT02868983 . Registered on August 16, 2016.

Outpatient clinic visits during heat waves: findings from a large family medicine clinical database.

Introduction: The purpose of this study was to determine whether heat waves are associated with increased frequency of clinic visits for ICD-9 codes of illnesses traditionally associated with heat waves. Methods: During 4 years of family medicine clinic data between 2012 and 2016, we identified six heat wave events in San Diego County. For each heat wave event, we selected a control period in the same season that was twice as long. Scheduling a visit on a heat wave day (versus a non-heat wave day) was the primary predictor, and receiving a primary ICD-9 disease code related to heat waves was the outcome. Analyses were adjusted for age, gender, race/ethnicity and marital status. Results: Of the 5448 visits across the heat wave and control periods, 6.4% of visits (n = 346) were for heat wave-related diagnoses. Scheduling a visit on heat wave day was not associated with receiving a heat wave-related ICD code as compared with the control period (adjusted odds ratio: 1.35; 95% confidence interval: 0.86-1.36; P = 0.51). Discussion: We show that in a relatively large and demographically diverse population, patients who schedule appointments during heat waves are not being more frequently seen for diagnoses typically associated with heat waves in the acute setting. Given that heat waves are increasing in frequency due to climate change, there is an opportunity to increase utilization of primary care clinics during heat waves.

Development and validation of a mental health subscale from the Quality of Well-Being Self-Administered.

PURPOSE: The purpose of this study was to create and validate a mental health subscale for the Quality of Well-Being Self-Administered (QWB-SA). METHODS: The QWB-SA and other measures such as the Profile of Mood States (POMS), Medical Outcomes Study 36 Item Short Form (SF-36), EuroQOL 5D (EQ-5D), and Health Utilities Index Mark 2 (HUI) were administered to three samples: a general population (N = 3,844), a non-psychiatric medical population (N = 535), and a psychiatric population (N = 915). Independent expert ratings of which items represented the construct of mental health were used along with psychometric methods to develop and validate a 10-item QWB-SA mental health scale. RESULTS: The mental health scale demonstrated high internal consistency (Cronbach's alpha = 0.827-0.842) and strong correlations with other measures of mental health, such as the POMS (r = -0.77), mental health scale from the SF-36 (r = 0.72), EQ-5D mood item (r = 0.61), and HUI Emotion Scale (r = 0.59). It was not highly correlated with measures of physical health. Among the psychiatric population, the new mental health scale was moderately correlated with indicators of psychiatric problem severity. CONCLUSIONS: It is now possible to report outcomes and relationships with mental health in studies that use the QWB-SA. This new mental health subscale can also be used with the large volume of previously collected data using the QWB-SA to examine the impact of illnesses and interventions on mental health-related quality of life.

Promoting self-management in diabetes: efficacy of a collaborative care approach.

Diabetes is a leading cause of death and is estimated to cost the United States 90 billion dollars annually. Increasing patient self-management skills has been shown to improve outcomes in patients with Type II diabetes. Promotion of shared decision-making between patient and provider is a core element of collaborative care and is especially well suited for increasing patient self-management. Research trials to date have been limited in demonstrating how self-management promotion can be fully integrated into primary care practices. Demonstration of the impact of this approach is needed. This study involves 22 randomly assigned physicians across three family medicine clinics to either provide usual care or work with a part-time collaborative care therapist in their clinic serving as an outreach health coach for their diabetic patients. Each outreach health coach met with each physician in the intervention group to identify patients most in need of intervention, sent identified patients a video on diabetes management, and called to encourage video viewing and discuss any patient-perceived barriers to self-management. Initial markers of patient activation in self-management, patients' video-viewing behavior, and health care encounters in the subsequent 6 months were compared between groups. Results showed that patients targeted by an outreach health coach were more likely to view the video, be seen by their primary care physician (PCP) within 6 months, and have disease-relevant laboratory tests performed than patients receiving usual care from their PCP (p < .05). This approach, linking PCPs with collaborative care staff, is viewed as expanding the engagement of PCPs with the collaborative team for superior patient health outcomes.

Establishing the Collaborative Care Research Network (CCRN): a description of initial participating sites.

Collaborative care has increased dramatically in the past decade, yet the variability in collaborative strategies and the diversity of settings in which collaboration is being implemented make it difficult to assess quality and outcomes. Therefore, three aims were addressed in the current study: (a) describe and characterize the sites in the Collaborative Care Research Network (CCRN), (b) identify factors associated with practices' self-identified collaborative care model (e.g., coordinated, integrated, care management), and (c) identify limitations of available survey data elements so as to propose additional elements for future surveys. Initial (CCRN) sites completed surveys regarding several organizational factors (e.g., setting type, size of patient population, number of behavioral health providers). Results from 39 sites showed significant heterogeneity in self-identified type of collaborative care model practiced (e.g., integrated care, coordinated care), type of practice setting (e.g., academic, federally qualified health center, military), size of clinic, and ratio of behavioral health providers to medical providers. This diversity in network site characteristics can provide a rich platform to address a number of questions regarding the current practice of collaborative care. Recommendations are made to improve future surveys to better understand elements of the patient-centered medical home and the role it may play in outcomes. (PsycINFO Database Record (c) 2012 APA, all rights reserved).

Primary care medical provider attitudes regarding mental health and behavioral medicine in integrated and non-integrated primary care practice settings.

Primary care medical providers (PCPs) have become de facto providers of services for the management of both mental and chronic illnesses. Although some reports suggest that PCPs favor having Behavioral Health colleagues provide behavioral health services in primary care, others demonstrate this view is necessarily not universal. We examined attitudes regarding behavioral health services among PCPs in practices that offer such services via onsite behavioral health providers (n = 31) and those that do not (n = 62). We compared referral rates and perceived need for and helpfulness of behavioral health colleagues in treating mental health/behavioral medicine issues. In both samples, perceived need was variable (5-100%), as were PCPs' views of their own competence in mental health/behavioral medicine diagnosis and treatment. Interestingly, neither sample rated perceived access to behavioral health providers exceptionally high. Referral rates and views about the helpfulness of behavioral health services, except in relation to depression and anxiety, were lower than expected. These results suggest a need for increased collaboration with and education of PCPs about the roles and skills of behavioral health professionals.

If you build it, will they come? A qualitative evaluation of the use of video-based decision aids in primary care.

BACKGROUND AND OBJECTIVES: Given the growing presence of Patient-centered Medical Home practices and the need for patient participation, it is concerning that tools to improve patient participation are not widely used in primary care. Despite demonstrated effect on decision quality and patient satisfaction, decision aids (DAs) are not broadly utilized. We conducted focus groups to examine the use of DAs and uncovered barriers to greater DA utilization in primary care. METHODS: The University of California, San Diego family medicine clinics use an integrated process to prescribe DA videos. We conducted provider and patient focus groups to explore use of DAs in three clinics. Using a qualitative phenomenological design, we analyzed thematic content using immersion techniques. RESULTS: Focus group discussions identified six categories: patient benefits, physician benefits, process improvements needed, reasons DAs are prescribed, barriers to watching DAs, and the role of the DA. These categories encompassed 21 themes. Four themes were salient for improving DA utilization: follow-up process needs improvement, prescribing process needs improvement, patients were unclear regarding each DA's purpose, and patient benefits. CONCLUSIONS: While previous studies have described expected barriers to hypothetical DA distribution, our analysis reveals barriers reported by physicians, staff, and patients based on actual experience in practice. Decision aids can improve patient participation in health decisions. However, physicians and patients have to recognize a need for these tools before they will be adopted in practice.

Translating patient self-management research into primary care: challenges and successes with group medical visits.

Essential to the implementation of a patient-centered medical home is use of evidence-based interventions by a well-coordinated team of providers in a cost-effective manner. Group Medical Visits (GMVs), designed to increase self-management behaviors in patients with chronic illness, have shown inconsistently to be efficacious. Despite the modest results reported thus far in the literature, GMVs have been promoted by the American Academy of Family Physicians as an important component in the patient-centered medical home. This paper describes the challenges of translating GMVs into clinical practice when research support is not available. A review of 5+ years experience in conducting GMVs in clinical practice, including the numerous barriers, is presented through a "three-world view" model utilized by collaborative care leaders. This review is followed by a comparison of variables extracted from patients' electronic health records of those who participated in GMVs to similar patients who did not participate in GMVs. Results suggest that outcomes often reported in efficacy trials are not easily obtained in real clinical practice. Overcoming the operational and financial obstacles to offering GMVs is necessary before they can be promoted as essential elements in a patient-centered medical home.

Are patients' initial experiences at the diagnosis of type 2 diabetes associated with attitudes and self-management over time?

UNLABELLED: Objective The purpose of this study was to investigate patients' experiences when diagnosed with type 2 diabetes and diabetes-related distress and self-management years later. Method One hundred seventy-nine adults with type 2 diabetes, 1 to 5 years after diagnosis, completed a questionnaire assessing what they were told and what was recommended at diagnosis as well as current diet, physical activity, and diabetes distress. RESULTS: Most patients (60%) expressed confidence in their health care provider (HCP) at diagnosis, but 30% reported that a clear action plan was not communicated. Current diabetes distress was significantly lower among those who reported being reassured at diagnosis that diabetes could be managed successfully and had developed a clearer action plan with their HCP. Patients' current dietary behaviors were significantly better among those receiving a clearer action plan at diagnosis. CONCLUSION: Patients' retrospective reports of reassuring HCP messages when diagnosed, along with the presentation of a clear action plan, are associated with less diabetes distress and better self-management at 1 to 5 years after diagnosis. Practical implications Findings suggest a long-lasting impact on patients' attitudes and behaviors when the diagnosis of type 2 diabetes is delivered clearly, a sense of hope is provided, and a specific care plan is put forward.

Laboratory evaluation to reduce respirable crystalline silica dust when cutting concrete roofing tiles using a masonry saw.

Respirable crystalline silica dust exposure in residential roofers is a recognized hazard resulting from cutting concrete roofing tiles. Roofers cutting tiles using masonry saws can be exposed to high concentrations of respirable dust. Silica exposures remain a serious threat for nearly two million U.S. construction workers. Although it is well established that respiratory diseases associated with exposure to silica dust are preventable, they continue to occur and cause disability or death. The effectiveness of both a commercially available local exhaust ventilation (LEV) system and a water suppression system in reducing silica dust was evaluated separately. The LEV system exhausted 0.24, 0.13, or 0.12 m(3)/sec of dust laden air, while the water suppression system supplied 0.13, 0.06, 0.03, or 0.02 L/sec of water to the saw blade. Using a randomized block design, implemented under laboratory conditions, the aforementioned conditions were evaluated independently on two types of concrete roofing tiles (s-shape and flat) using the same saw and blade. Each engineering control (LEV or water suppression) was replicated eight times, or four times for each type of tile. Analysis of variance was performed by comparing the mean airborne respirable dust concentrations generated during each run and engineering control treatment. The use of water controls and ventilation controls compared with the "no control" treatment resulted in a statistically significant (p < 0.05) reduction of mean respirable dust concentrations generated per tile cut. The percent reduction for respirable dust concentrations was 99% for the water control and 91% for the LEV. Results suggest that water is an effective method for reducing crystalline silica exposures. However, water damage potential, surface discolorations, cleanup, slip hazards, and other requirements may make the use of water problematic in many situations. Concerns with implementing an LEV system to control silica dust exposures include sufficient capture velocity, additional weight of the saw with the LEV system, electricity connections, and cost of air handling unit.

Assessment of family physicians' performance using patient charts: interrater reliability and concordance with chart-stimulated recall interview.

Peer-assessment processes with chart review have been used for many years to assess the clinical performance of physicians. The Quebec medical licensing authority has been required by provincial law to assess the practicing Quebec physicians on a nonvoluntary basis. During the period from January 2001 to November 2004, 25 family physicians in active practice were randomly selected from a pool of about 300. For each physician, 25 to 40 patients' medical charts were randomly selected to evaluate the interrater reliability of peer-review assessment of medical charts and to compare ratings based on chart review with a chart-stimulated recall interview to those based on chart review alone. The concordance between chart review alone and that of chart review with chart-stimulated recall interview was 75% for chart keeping, 69% for clinical investigation, 81% for diagnostic accuracy, and 74% for treatment plan. Ratings based on chart review alone achieve moderate levels of reliability (Kappa = 0.44 to 0.56). It appears that some important information about quality of care is missed when only chart review is used.

Statistics and public health at CDC.

Since CDC's inception, an important function of the agency has been the compilation, analysis, and interpretation of statistical information to guide actions and policies to improve health. Sources of data include vital statistics records, medical records, personal interviews, telephone and mail surveys, physical examinations, and laboratory testing. Public health surveillance data have been used to characterize the magnitude and distribution of illness and injury; to track health trends; and to develop standard curves, such as growth charts. Beyond the development of appropriate program study designs and analytic methodologies, statisticians have played roles in the development of public health data-collection systems and software to analyze collected data. CDC/ATSDR employs approximately 330 mathematical and health statisticians. They work in each of the four coordinating centers, two coordinating offices, and the National Institute for Occupational Safety and Health.

Management of cluster headache.

Cluster headache, an excruciating, unilateral headache usually accompanied by conjunctival injection and lacrimation, can occur episodically or chronically, and can be difficult to treat. Existing effective treatments may be underused because of underdiagnosis of the syndrome. Oxygen and sumatriptan have been demonstrated to be effective in the acute treatment of cluster headaches. Verapamil has been shown to be effective for prophylaxis. For cluster headache completely refractory to all treatments, surgical modalities and newer interventions such as the implantation of stereotactic electrodes may be useful. Patients should be encouraged to avoid possible triggers such as smoking or alcohol consumption, especially during the duster period. The intensity of duster headache pain leads to ethical concerns among researchers over the use of placebo, making randomized controlled trials difficult. As new technology and genetic studies clarify the etiology of duster headache, it is possible that more specific therapies will emerge.

Comparison of measured utility scores and imputed scores from the SF-36 in patients with rheumatoid arthritis.

PURPOSE: We sought to evaluate 3 methods for imputing utility-based outcomes from clinical trial data measured using the Medical Outcomes Study 36-Item Short Form (SF-36). SUBJECTS: Our subjects included 131 male and 505 female adults (mean age, 55.42 +/- 12.59 years) who were participating in a randomized clinical trial evaluating a new treatment of adults with rheumatoid arthritis (RA). MEASURES: Participants completed the SF-36, 2 versions of the Health Utilities Index (HUI-2 and HUI-3), the EuroQol EQ-5D, and the Health Assessment Questionnaire (HAQ). SF-36 scores were transformed to utility-based scores using 4 methods developed independently by Fryback, Nichol, and Brazier. RESULTS: All 4 imputed scores were significantly correlated with HUI-2, HUI-3, EQ-5D, and the disease-specific HAQ scores at baseline and at the end of the clinical trial period (P < 0.05). Changes in the imputed scores from baseline to end of study also were significantly correlated with corresponding changes in the measured utility scores and the HAQ score (P < 0.0001). For all imputed and measured scores, changes from baseline were associated with the clinical assessments, ACR20 and ACR50. The associations were stronger for the utility-based measures than the imputed indices. Both imputed and measured scores were sensitive to change in the clinical trial. However, mean scores for the HUI-3 and the Brazier VAS were significantly lower than for the other measures. CONCLUSION: Imputed utility-based score estimates are significantly correlated with measured utility outcomes. However, the imputed measures had more constrained variability, showed poorer correspondence to the ACR20 and ACR50 benchmarks, and predicted less than half of the variance in actual utility-based outcomes. Therefore, directly assessed, not imputed, utility-based measures should continue to be favored for cost-effectiveness analysis.