Mental health, pain and likelihood of opioid misuse among adults with sickle cell disease.

Depressive symptoms are prevalent in individuals living with sickle cell disease (SCD) and may exacerbate pain. This study examines whether higher depressive symptoms are associated with pain outcomes, pain catastrophizing, interference and potential opioid misuse in a large cohort of adults with SCD. The study utilized baseline data from the 'CaRISMA' trial, which involved 357 SCD adults with chronic pain. Baseline assessments included pain intensity, daily mood, the Patient Health Questionnaire (PHQ), the Generalized Anxiety Disorders scale, PROMIS Pain Interference, Pain Catastrophizing Scale, the Adult Sickle Cell Quality of Life Measurement Information System and the Current Opioid Misuse Measure. Participants were categorized into 'high' or 'low' depression groups based on PHQ scores. Higher depressive symptoms were significantly associated with increased daily pain intensity, negative daily mood, higher pain interference and catastrophizing, poorer quality of life and a higher likelihood of opioid misuse (all p < 0.01). SCD patients with more severe depressive symptoms experienced poorer pain outcomes, lower quality of life and increased risk of opioid misuse. Longitudinal data from this trial will determine whether addressing depressive symptoms may potentially reduce pain frequency and severity in SCD.

Modernizing the Data Infrastructure for Clinical Research to Meet Evolving Demands for Evidence.

Importance: The ways in which we access, acquire, and use data in clinical trials have evolved very little over time, resulting in a fragmented and inefficient system that limits the amount and quality of evidence that can be generated. Observations: Clinical trial design has advanced steadily over several decades. Yet the infrastructure for clinical trial data collection remains expensive and labor intensive and limits the amount of evidence that can be collected to inform whether and how interventions work for different patient populations. Meanwhile, there is increasing demand for evidence from randomized clinical trials to inform regulatory decisions, payment decisions, and clinical care. Although substantial public and industry investment in advancing electronic health record interoperability, data standardization, and the technology systems used for data capture have resulted in significant progress on various aspects of data generation, there is now a need to combine the results of these efforts and apply them more directly to the clinical trial data infrastructure. Conclusions and Relevance: We describe a vision for a modernized infrastructure that is centered around 2 related concepts. First, allowing the collection and rigorous evaluation of multiple data sources and types and, second, enabling the possibility to reuse health data for multiple purposes. We address the need for multidisciplinary collaboration and suggest ways to measure progress toward this goal.

Prevalence of Substance Use Disorders in Sickle Cell Disease Compared to Other Chronic Conditions: a Population-Based Study of Black American Adults.

BACKGROUND: Sickle cell disease (SCD) is a heritable chronic health condition characterized by pain symptoms throughout the life course that are routinely treated with opioids. OBJECTIVE: This study examined differences in substance use disorders in Black American adults with SCD compared to those with other chronic conditions or with no chronic conditions. DESIGN: Data from a population-representative sample of Black Americans with SCD, other chronic conditions, and no chronic conditions were obtained from the National Survey of American Life (NSAL) database. Diagnosis of substance use disorder was determined by structured clinical interview. Hierarchical models controlling for covariates (demographics, socioeconomic status, self-rated health, and mood disorders) compared odds of diagnosis between the three groups. PARTICIPANTS: The sample included 4238 African-American and Black Caribbean participants from the NSAL study who were 18 years of age or older. MAIN MEASURES: Measures included age, sex, income, education, marital status, employment, possession of health insurance, health conditions, and substance use disorders diagnosed by structured clinical interview. KEY RESULTS: Controlling for age, sex, and socioeconomic status, there were no differences in odds of a drug use disorder when comparing individuals with SCD to Black adults with other chronic conditions (OR = 1.12; p = 0.804) or no chronic condition (OR = 2.09; p = 0.102). SCD was, however, associated with greater odds of alcohol use disorders when compared to the groups with other chronic conditions (OR = 2.15; p = 0.01) and no chronic conditions (OR = 5.11; p < 0.001). This effect was not better accounted for by socioeconomic status, marital status, self-rated physical health, or the presence of a mood disorder. CONCLUSIONS: SCD was not a risk factor for drug use disorders. Further data will be needed to understand the factors contributing to increased risk of alcohol use disorders in SCD and the role uncontrolled pain symptoms may have in driving substance use.

Differences in the prevalence of mental health disorders among Black American adults with sickle cell disease compared to those with non-heritable medical conditions or no medical conditions.

Our aim was to determine differences in the prevalence of mental health disorders between Black Americans living with sickle cell disease (SCD) and Black Americans with other, non-heritable medical conditions, or no medical conditions. We examined the prevalence of mental health disorders among a non-institutionalized, community sample of Black adults in the US from the National Survey of American Life. We compared the odds of mental health disorders between Black American adults with SCD and those with other medical conditions, or no medical condition. Among the SCD group, 38·8% reported at least one mental health disorder: 17·6% endorsed a mood disorder, 24·7% an anxiety disorder, 2·4% an eating disorder, and 11·8% a childhood disorder. Compared to those with other medical conditions, Black Americans with SCD had greater poverty, more children in the household, and were less likely to be married/cohabitating (all P < 0·05). Yet, Black Americans with SCD were not at greater odds of having a mental health disorder compared to those with other medical conditions. When compared to the group with no conditions, however, individuals with SCD had 2·57 greater odds of mood disorder (95% confidence interval: 1·43-4·65; P = 0·002). The effect remained when controlling for socioeconomic status, marital status, and perceived physical health. In this study, almost 40% of Black American adults with SCD presented with a mental health disorder. Prevalence of mental health disorders was similar among those with non-heritable medical conditions, but those without a medical condition had a lower prevalence than in SCD. Among Black Americans, there appear to be unmeasured factors, common across medical conditions, that are linked to mental health disorders.

The Relationship Between Objectively Measured Step Count, Clinical Characteristics, and Quality of Life Among Depressed Patients Recently Hospitalized With Systolic Heart Failure.

OBJECTIVE: Physical activity (PA) can improve symptoms of both depression and heart failure (HF), but objective activity data among recently hospitalized HF patients with comorbid depression are lacking. We examined PA and the relationship between daily step counts and mood, health-related quality of life (HRQoL), and heart health among patients enrolled in a clinical trial treating HF and comorbid depression. METHODS: We screened hospitalized patients with systolic HF (left ventricular ejection fraction [LVEF] ≤45%) and New York Heart Association class II-IV symptoms for depression using the two-item Patient Health Questionnaire (PHQ-2) and telephoned screen-positive patients to administer the PHQ-9 2 weeks after discharge. If the patient scored PHQ-9 ≥10 and agreed to continue in our study, we administered our baseline assessment and mailed them an armband accelerometer. We instructed patients to wear the armbands for 7 days before returning them and classified their data as "usable" if they wore it ≥10 hours per day on ≥4 separate days. RESULTS: We mailed accelerometers to 531 depressed HF patients, and 222 (42%) returned them with usable data. Their median age was 64 years, 54% were women, 23% were non-White, and they walked a median of 1170 steps daily. Higher median daily step counts were associated with lower New York Heart Association class and better physical- and HF-specific HRQoL, but not mood symptoms, mental HRQoL, or LVEF. CONCLUSIONS: Patients with HF and comorbid depression are generally sedentary after hospital discharge. Although mood symptoms and LVEF were unrelated to objective PA, patients with higher step counts self-reported better HRQoL.Trial Registration:ClinicalTrials.gov identifier NCT02044211.

Primary results of the randomized trial of metformin administration in polycystic kidney disease (TAME PKD).

Autosomal dominant polycystic kidney disease (ADPKD) is characterized by growth of kidney cysts and glomerular filtration rate (GFR) decline. Metformin was found to impact cystogenesis in preclinical models of polycystic disease, is generally considered safe and may be a promising candidate for clinical investigation in ADPKD. In this phase 2 two-year trial, we randomly assigned 97 patients, 18-60 years of age, with ADPKD and estimated GFR over 50 ml/min/1.73 m2, in a 1:1 ratio to receive metformin or placebo twice daily. Primary outcomes were medication safety and tolerability. Secondary outcomes included estimated GFR decline, and total kidney volume growth. Thirty-eight metformin and 39 placebo participants still received study product at 24-months. Twenty-one participants in the metformin arm reduced drug dose due to inability to tolerate, compared with 14 in the placebo arm (not significant). Proportions of participants experiencing serious adverse events was similar between the groups. The Gastrointestinal Symptoms Rating Scale score was low at baseline and did not significantly change over time. The annual change for estimated GFR was -1.71 with metformin and -3.07 ml/min/1.73m2 per year with placebo (mean difference 1.37 {-0.70, 3.44} ml/min/1.73m2), while mean annual percent change in height-adjusted total kidney volume was 3.87% in metformin and 2.16% per year in placebo, (mean difference 1.68% {-2.11, 5.62}). Thus, metformin in adults with ADPKD was found to be safe and tolerable while slightly reducing estimated GFR decline but not to a significant degree. Hence, evaluation of efficacy requires a larger trial, with sufficient power to detect differences in endpoints.

The Impact of Optimism and Pain Interference on Response to Online Behavioral Treatment for Mood and Anxiety Symptoms.

OBJECTIVE: This study aimed to explore a) if high pain interference has a negative effect on response to computerized cognitive behavioral therapy (cCBT) for anxiety and depression and b) whether high optimism can buffer the negative effects of pain interference on cCBT outcomes. METHODS: We performed a secondary analysis of data on 403 participants from the randomized controlled clinical trial "Online Treatment for Mood and Anxiety Disorders in Primary Care." It examined the impact of cCBT, with and without access to an Internet support group, on health-related quality of life (HRQoL), mood, and anxiety symptoms. RESULTS: High versus low pain interference had a negative effect on response to cCBT for physical HRQoL regardless of high or low optimism level (between group difference = -3.46 [-5.89 to -1.03], p = .005, or -4.06 [-6.28 to -1.85], p < .001, respectively). However, in the context of low optimism/high pain interference only negatively impacted the effect of cCBT on mental HRQoL (3.68 [0.63 to 6.73], p = .018) and anxiety symptoms (-2.61 [-4.87 to -0.35], p = .024). Although the pattern of effects was similar for depressive symptoms, the between-group differences were not significant. CONCLUSIONS: High optimism may buffer against the negative effects of pain interference on treatment response from cCBT. Primary care patients who report high pain interference yet also lack optimism may not receive as much benefit from cCBT as other groups. Furthermore, this study found an unexpected positive effect of low optimism on treatment response. For depressed and anxious patients with low pain interference, low optimism enhanced the impact of cCBT on mental HRQoL.Trial Registration:ClinicalTrials.gov Identifier: NCT01482806.

Incidence of postoperative cognitive dysfunction in older women undergoing pelvic organ prolapse surgery.

INTRODUCTION AND HYPOTHESIS: Postoperative cognitive dysfunction (POCD), a transient impairment of memory, concentration, and information processing, has been reported after 7-26% of non-cardiac surgeries with associated increase in morbidity and death. Our primary aim was to determine the incidence of POCD 2 weeks after prolapse surgery in women ≥ 60 years old. Our secondary aim was to identify risk factors for POCD. METHODS: Prospective cohort study of women ≥ 60 years old scheduled for pelvic organ prolapse surgery. Exclusion criteria included cognitive impairment history, major neurologic disorder, and abnormal cognition screen. A comprehensive neuropsychologic (NP) battery (eight tests), administered 2 weeks pre- and post-surgery, assessed premorbid IQ and domains of attention, memory, and executive function. The primary outcome was defined as decline of ≥ 1 SD on ≥ 2 NP tests or decline of ≥ 2 SD on ≥ 1 test. Raw scores were transformed to Z-scores. RESULTS: NP testing was completed by 72 women, median age 72 (IQR 69-77) years. Procedures included 16 (22.9%) laparoscopic sacrocolpopexies, 23 (32.9%) transvaginal reconstructions, and 29 (41.4%) obliterative surgeries, performed under general (63, 90%), regional (5, 7.1%), or sedation (2, 2.9%) anesthesia with a median hospital stay of 0.6 (IQR 0.6-0.75) days. POCD incidence was 33.3% (n = 24). POCD was associated with greater frailty (p = 0.006) and higher baseline depression (p = 0.05) but not with older age (p = 0.77) or inhalational gas use (p = 1.0). CONCLUSION: In this cohort, one in three women manifested POCD 2 weeks after prolapse surgery. Preoperative counseling should include discussions on POCD given its detrimental impact on postoperative recovery and independence.

Key Variables for Effective eHealth Designs for Individuals With and Without Mental Health Disorders: 212-4 Fractional Factorial Experiment.

BACKGROUND: eHealth applications not only offer the potential to increase service convenience and responsiveness but also expand the ability to tailor services to improve relevance, engagement, and use. To achieve these goals, it is critical that the designs are intuitive. Limited research exists on designs that work for those with a severe mental illness (SMI), many of whom have difficulty traveling for treatments, reject or infrequently seek treatment, and tend to discontinue treatments for significant periods. OBJECTIVE: This study aims to evaluate the influence of 12 design variables (eg, navigational depth, reading level, and use of navigational lists) on the usability of eHealth application websites for those with and without SMI. METHODS: A 212-4 fractional factorial experiment was used to specify the designs of 256 eHealth websites. This approach systematically varied the 12 design variables. The final destination contents of all websites were identical, and only the designs of the navigational pages varied. The 12 design elements were manipulated systematically to allow the assessment of combinations of design elements rather than only one element at a time. Of the 256 websites, participants (n=222) sought the same information on 8 randomly selected websites. Mixed effect regressions, which accounted for the dependency of the 8 observations within participants, were used to test for main effects and interactions on the ability and time to find information. Classification and regression tree analyses were used to identify effects among the 12 variables on participants' abilities to locate information, for the sample overall and each of the 3 diagnostic groups of participants (schizophrenia spectrum disorder [SSD], other mental illnesses, and no mental illness). RESULTS: The best and worst designs were identified for each of these 4 groups. The depth of a website's navigation, that is, the number of screens users needed to navigate to find the desired content, had the greatest influence on usability (ability to find information) and efficiency (time to find information). The worst performing designs for those with SSD had a 9% success rate, and the best had a 51% success rate: the navigational designs made a 42% difference in usability. For the group with other mental illnesses, the design made a 50% difference, and for those with no mental illness, a 55% difference was observed. The designs with the highest usability had several key design similarities, as did those with the poorest usability. CONCLUSIONS: It is possible to identify evidence-based strategies for designing eHealth applications that result in significantly better performance. These improvements in design benefit all users. For those with SSD or other SMIs, there are designs that are highly effective. Both the best and worst designs have key similarities but vary in some characteristics.

Correction: Key Variables for Effective eHealth Designs for Individuals With and Without Mental Health Disorders: 212-4 Fractional Factorial Experiment.

[This corrects the article DOI: 10.2196/23137.].