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Introduction: In a randomized controlled trial, we previously investigated if melanoma patients receiving checkpoint inhibitors had fewer severe immune-related adverse events (irAEs) when they reported symptoms using electronic patient-reported outcomes (ePRO) with triggered alerts as an add-on to standard care, compared to standard care alone. The aim of this study is to examine between-group differences in health-related quality of life (HRQoL) and associations between irAEs severity and HRQoL. Methods: The study population of 138 patients completed the EuroQol EQ-5D-5L Index and FACT-M questionnaires at baseline and weeks 24 and 48. We analyzed HRQoL from all patients who completed at least one questionnaire. Missing FACT-M items were imputed following existing guidelines. Results: There was no difference in HRQoL at baseline as measured EQ-5D-5L between the intervention and the control group. Between baseline and 48 weeks, mean EQ-5D-5L scores were unchanged among patients in the intervention group (p = 0.81) but decreased significantly among patients in the control group (p = 0.03). Consequently, patients in the intervention group had higher mean scores than those in the control group (p = 0.05) at 48 weeks. Mean FACT-M scores did not differ significantly between the two groups at any of the time points. There were observed no between-group differences in mean EQ-5D-5 and mean FACT-M scores between patients with severe irAEs and patients who had none. Conclusion: Melanoma patients receiving CPIs who self-reported irAEs using ePRO with triggered alerts as a supplement to standard care maintained their HRQoL compared to patients who received standard care alone. Patients in the intervention group had a significantly better HRQoL measured by EQ-5D-5L than controls 48 weeks after baseline. The results suggest that including ePRO in standard care increases melanoma patients´ well-being. Further and larger studies are needed to confirm this finding and examine the impact of severe irAEs on cancer patients' HRQoL. Trial registration: Clinicaltrials.gov NCT03073031 Registered 8 March 2017, Retrospectively registeredhttps://clinicaltrials.gov/. [ABSTRACT FROM AUTHOR]

Background: Emergency department (ED)-initiated buprenorphine/naloxone with continuation in primary care was found to increase engagement in addiction treatment and reduce illicit opioid use at 30 days compared to referral only or a brief intervention with referral.Objective: To evaluate the long-term outcomes at 2, 6 and 12 months following ED interventions.Design: Evaluation of treatment engagement, drug use, and HIV risk among a cohort of patients from a randomized trial who completed at least one long-term follow-up assessment.Participants: A total of 290/329 patients (88% of the randomized sample) were included. The followed cohort did not differ significantly from the randomized sample.Interventions: ED-initiated buprenorphine with 10-week continuation in primary care, referral, or brief intervention were provided in the ED at study entry.Main Measures: Self-reported engagement in formal addiction treatment, days of illicit opioid use, and HIV risk (2, 6, 12 months); urine toxicology (2, 6 months).Key Results: A greater number of patients in the buprenorphine group were engaged in addiction treatment at 2 months [68/92 (74%), 95% CI 65-83] compared with referral [42/79 (53%), 95% CI 42-64] and brief intervention [39/83 (47%), 95% CI 37-58; p < 0.001]. The differences were not significant at 6 months [51/92 (55%), 95% CI 45-65; 46/70 (66%) 95% CI 54-76; 43/76 (57%) 95% CI 45-67; p = 0.37] or 12 months [42/86 (49%) 95% CI 39-59; 37/73 (51%) 95% CI 39-62; 49/78 (63%) 95% CI 52-73; p = 0.16]. At 2 months, the buprenorphine group reported fewer days of illicit opioid use [1.1 (95% CI 0.6-1.6)] versus referral [1.8 (95% CI 1.2-2.3)] and brief intervention [2.0 (95% CI 1.5-2.6), p = 0.04]. No significant differences in illicit opioid use were observed at 6 or 12 months. There were no significant differences in HIV risk or rates of opioid-negative urine results at any time.Conclusions: ED-initiated buprenorphine was associated with increased engagement in addiction treatment and reduced illicit opioid use during the 2-month interval when buprenorphine was continued in primary care. Outcomes at 6 and 12 months were comparable across all groups. [ABSTRACT FROM AUTHOR]

Background: It is important to understand which components of successful multifaceted interventions are responsible for study outcomes, since some components may be more important contributors to the intervention effect than others.Objective: We conducted a mediation analysis to determine which of seven factors had the greatest effect on change in systolic blood pressure (BP) after 6 months in a trial to improve hypertension control.Design: The study was a preplanned secondary analysis of a cluster-randomized clinical trial. Eight clinics in an integrated health system were randomized to provide usual care to their patients (n = 222), and eight were randomized to provide a telemonitoring intervention (n = 228).Participants: Four hundred three of 450 trial participants completing the 6-month follow-up visit were included.Interventions: Intervention group participants received home BP telemonitors and transmitted measurements to pharmacists, who adjusted medications and provided advice to improve adherence to medications and lifestyle modification via telephone visits.Main Measures: Path analytic models estimated indirect effects of the seven potential mediators of intervention effect (defined as the difference between the intervention and usual care groups in change in systolic BP from baseline to 6 months). The potential mediators were change in home BP monitor use, number of BP medication classes, adherence to BP medications, physical activity, salt intake, alcohol use, and weight.Key Results: The difference in change in systolic BP was 11.3 mmHg. The multivariable mediation model explained 47 % (5.3 mmHg) of the intervention effect. Nearly all of this was mediated by two factors: an increase in medication treatment intensity (24 %) and increased home BP monitor use (19 %). The other five factors were not significant mediators, although medication adherence and salt intake improved more in the intervention group than in the usual care group.Conclusions: Most of the explained intervention effect was attributable to the combination of self-monitoring and medication intensification. High adherence at baseline and the relatively low intensity of resources directed toward lifestyle change may explain why these factors did not contribute to the improvement in BP. [ABSTRACT FROM AUTHOR]

Background/objectives: Vitamin D insufficiency in cystic fibrosis is common. Vitamin D3 is currently preferred over D2. We aimed to study the efficacy of vitamin D2 and D3 at increasing serum 25-hydroxyvitamin D (s25OHD) concentrations and their effect on respiratory health in cystic fibrosis.Subjects/methods: Sixteen CF patients were randomized to receive vitamin D2 or D3 or to serve as controls. The starting dose of 5000 IU (<16 years old) or 7143 IU/day (⩾16 years old) was further individually adjusted. Three months of intervention were followed by two of washout (ClinicalTrials.gov NCT01321905).Results: To increase s25OHD, the mean daily dose of vitamin D2 and D3 had to be increased up to 15650 and 8184 IU, respectively. The combined group of vitamin D2 and D3 treated patients decreased plasma IL-8 (P<0.05). Patients provided vitamin D3 improved FVC at the end of the trial (P<0.05). Change in s25OHD was positively correlated with changes in the adult Quality-of-Life respiratory score at the end of supplementation (P=0.006, r=0.90), and with changes in FEV1 (P=0.042, r=0.62) and FVC (P=0.036, r=0.63) at one month of washout.Conclusions: Vitamin D supplementation may contribute to reduced inflammation and improved lung function in CF. [ABSTRACT FROM AUTHOR]

The objective and background is to confirm in a double-blind, placebo-controlled study the high triptan response rates we had previously reported in an open study in migraine patients with unilateral cranial autonomic symptoms. In this randomized, double-blind, placebo-controlled study 80 migraineurs with unilateral cranial autonomic symptoms were assigned to receive rizatriptan 10 mg wafer or placebo (ratio 1:1) and treated for a single moderate or severe migraine attack. The primary endpoints were pain freedom at 2 h and total migraine freedom at 2 h. Secondary endpoints included pain relief, no associated symptoms and sustained pain freedom or relief. Significantly more patients reported pain freedom at 2 h after taking rizatriptan (54 %) than after placebo (8 %) (therapeutic gain 46 % [28 %; 64 %]; P < 0.001). Similarly, significantly more patients reported total migraine freedom at 2 h after rizatriptan (51 %) than after placebo (8 %) (therapeutic gain 43 % [26 %; 61 %]; P < 0.001). Rizatriptan was also more effective than placebo on most secondary endpoints. We confirm in a placebo-controlled study our previous data suggesting that the presence of unilateral cranial autonomic symptoms in migraineurs predicts a positive response to triptans, probably owing to intense trigeminal peripheral afferent activation which strongly recruits peripheral neurovascular 5-HT1B/1D receptors. Acute and preventive pharmacological trials in migraine should focus also on this subset of migraine patients. [ABSTRACT FROM AUTHOR]

The objectives of this study are to assess the efficacy and safety of frovatriptan, and rizatriptan in the subgroup of women with menstrually related migraine of a multicenter, randomized, double blind, cross-over study. Each patient received frovatriptan 2.5 mg or rizatriptan 10 mg in a randomized sequence: after treating 3 episodes of migraine in not more than 3 months with the first treatment, the patient had to switch to the other treatment. Menstrually related migraine was defined according to the criteria listed in the Appendix of the last IHS Classification of Headache disorders. 99 out of the 125 patients included in the intention-to-treat analysis of the main study were of a female gender: 93 had regular menstrual cycles and were, thus, included in this analysis. A total of 49 attacks classified as menstrually related migraine were treated with frovatriptan and 59 with rizatriptan. Rate of pain relief at 2 h was 58% for frovatriptan and 64% for rizatriptan ( p = NS), while rate of pain free at 2 h was 31 and 34% ( p = NS), respectively. At 24 h, 67 and 81% of frovatriptan-treated, and 61 and 74% of rizatriptan-treated patients were pain free and had pain relief, respectively ( p = NS). Recurrence at 24 h was significantly ( p < 0.01) lower with frovatriptan (10 vs. 32% rizatriptan). Frovatriptan was as effective as rizatriptan in the immediate treatment of menstrually related migraine attacks while showing a favorable sustained effect with a lower rate of migraine recurrence. These results need to be confirmed by randomized, double-blind, prospective, large clinical trials. [ABSTRACT FROM AUTHOR]

Background: Blood pressure (BP) control remains elusive for many Americans. Although home health nurses are uniquely positioned to help vulnerable individuals achieve BP control, hypertension (HTN) management has not been a high priority in post-acute care.Objective: To examine the effects of two home-based interventions designed to improve BP outcomes among high-risk African-American patients.Design: Cluster randomized controlled trial.Participants: A total of 845 newly admitted patients with uncontrolled HTN (JNC7 stages 1 or 2).Interventions: The "basic" intervention delivered key HTN information to clinicians and patients, and a home BP monitor to patients, while the patients received usual post-acute care. The "augmented" intervention provided more intensive and extensive HTN information, monitoring and feedback for 3 months beyond the index home care admission.Measures: Primary: BP control. Secondary: reductions in mmHG SBP and DBP, improvements in proportions improving JNC7 stage or achieving clinically meaningful reductions in SBP and DBP.Methods: Multivariate regression models.Key Results: The basic intervention produced no significant BP improvements; the augmented intervention significantly improved stage 2 patients' outcomes. Among stage 2 patients, the augmented intervention increased BP control by 8.7 percentage points relative to usual care (8.9% vs. 17.6%; p=0.01), yielded an 8.3 mmHG relative reduction in SBP (p=0.01), and increased the proportion achieving at least a 20 mmHG reduction in SBP by 16.4 percentage points (p=0.01).Conclusion: Among stage 2 patients, a nurse-led intervention providing additional HTN medication review and patient self-management support during the 3-month post-acute care period yielded significant improvements in 3-month BP control, plus improvements in secondary BP outcomes. [ABSTRACT FROM AUTHOR]

Background: The debate continues regarding the best management for women with low-grade abnormal cervical cytology attending colposcopy. We compared psychosocial outcomes of alternative management policies in these women.Methods: In all, 989 women, aged 20-59 years, with low-grade abnormal cytology, were randomised to immediate large loop excision (LLETZ) or two to four targeted punch biopsies taken immediately with recall for LLETZ if these showed cervical intra-epithelial neoplasia 2/3. At 6 weeks after the last procedure, women completed the hospital anxiety and depression scale (HADS) and the impact of event scale (IES). At 12, 18, 24 and 30 months post recruitment, women completed the HADS and process outcome specific measure (POSM). Prevalence of significant depression (≥ 8), significant anxiety (≥ 11) and distress (≥ 9) and median POSM scores were compared between arms. Multivariate odds ratios (ORs) for immediate LLETZ vs biopsy and recall were computed.Results: Over the entire follow-up, there was no significant difference between arms in cumulative prevalence or risk of significant depression (OR=0.78, 95% CI 0.52-1.17) or significant anxiety (OR=0.83, 95% CI 0.57-1.19). At 6 weeks post procedure, distress did not differ significantly between arms. At later time points, 8-11% had significant depression and 14-16% had significant anxiety but with no differences between arms. The POSM scores did not differ between the arms.Conclusions: There is no difference in long- or short-term psychosocial outcomes of immediate LLETZ and punch biopsies with selective recall. [ABSTRACT FROM AUTHOR]

Background: Referral from primary care to the mental health specialty sector is important but poorly understood.Objective: Identify physician characteristics influencing mental health referral.Design: Randomized controlled trial using Standardized Patients (SPs).Setting: Offices of primary care physicians in 3 cities.Participants: One hundred fifty-two family physicians and general internists recruited from 4 broad practice settings; 18 middle aged Caucasian female actors.Intervention: Two hundred and ninety-eight unannounced SP visits, with assignments constrained so physicians saw 1 SP with major depression and 1 with adjustment disorder.Measurements: Mental health referrals via SP written reports; physician and system characteristics through a self-administered physician questionnaire.Results: Among 298 SP visits, 107 (36%) resulted in mental health referral. Referrals were less likely among physicians with greater self-confidence in their ability to manage antidepressant therapy (adjusted odds ratio [AOR] 0.39, 95% confidence interval [CI] 0.17 to 0.86) and were more likely if physicians typically spent > or =10% of professional time on nonclinical activities (AOR 3.42, 95% CI 1.45 to 8.07), had personal life experience with psychotherapy for depression (AOR 2.74, 95% CI 1.15 to 6.52), or usually had access to mental health consultation within 2 weeks (AOR 2.94, 95% CI 1.26 to 6.92).Limitation: The roles portrayed by SPs may not reflect the experience of a typical panel of primary care patients.Conclusions: Controlling for patient and health system factors, physicians' therapeutic confidence and personal experience were important influences on mental health referral. Research is needed to determine if addressing these factors can facilitate more appropriate care. [ABSTRACT FROM AUTHOR]

Objective: This study examined the prevalence, impact on health-related quality of life (HRQoL), and outcome of physical symptoms in depressed patients during 9 months of antidepressant therapy.Design: Open-label, randomized, intention-to-treat trial with enrollment occurring April through November 1999.Setting: Thirty-seven primary care clinics within a research network.Patients: Five hundred seventy-three depressed patients started on one of three selective serotonin reuptake inhibitors (SSRIs) by their primary care physician and who completed a baseline interview.Interventions: Patients were randomized to receive fluoxetine, paroxetine, or sertraline.Measurements and Main Results: Outcomes assessed included physical symptoms, depression, and multiple domains of HRQoL. Prevalence of physical symptoms was determined at baseline and after 1, 3, 6, and 9 months of treatment. Stepwise linear regression models were used to determine the independent effects of physical symptoms and depression on HRQoL domains. Of the 14 physical symptoms assessed, 13 were present in at least a third to half of the patients at baseline. Each symptom showed the greatest improvement during the initial month of treatment. In contrast, depression continued to show gradual improvement over a 9-month period. Physical symptoms had a predominant effect on pain (explaining 17% to 18% of the variance), physical functioning (13%), and overall health perceptions (13% to 15%). Depression had the greatest impact on mental (26% to 45%), social (14% to 32%), and work functioning (9% to 32%).Conclusions: Physical symptoms are prevalent in depressed patients and initially improve in the first month of SSRI treatment. Unlike depression, however, improvement in physical symptoms typically plateaus with minimal resolution in subsequent months. [ABSTRACT FROM AUTHOR]