Diverse veterans' pre- and post-intervention perceptions of home telemental health for posttraumatic stress disorder delivered via tablet.

Objectives Home telemental health services have the potential to overcome many individual and systemic barriers to care facing military veterans with posttraumatic stress disorder. However, little is known about the home telemental health-related attitudes and experiences of highly underserved rural or ethnically, racially diverse veterans. This study evaluated whether ethnically/racially diverse U.S. veterans residing in the rural Pacific Islands would find the delivery of evidence-based treatment for posttraumatic stress disorder via home telemental health tablet devices useful and helpful. Method Clinicians located in a central urban location delivered Cognitive Processing Therapy for posttraumatic stress disorder directly into patients' homes via a tablet device and secure WiFi connection. Pre- and post-treatment measures were collected from a clinical sample of 47 veterans (average age: 49.3 years). Most (74.4%) self-identified as being of ethnic/racial minority background. Attitudinal, satisfaction, and usability scales were collected from home telemental health engaging ( n = 29) and non-engaging ( n = 18) veterans. Results Ratings on measures of home telemental health comfort, satisfaction with care, and usability were uniformly positive. Veterans were equally open to receiving mental health services at home via home telemental health or in the clinic. In the case of services for a physical problem, however, veterans preferred in-clinic care. Following treatment, veterans' attitudinal scores increased on items such as "There is enough therapist contact in home telemental health interventions." However, a small portion of veterans (7%) reported having technical or privacy concerns. Conclusion The provision of evidence-based posttraumatic stress disorder treatment directly into the patients' homes proved feasible and was well received by the large majority of rural ethnically/racially diverse veterans.

Responsiveness of the Endometriosis Health Profile-30 questionnaire in a Swedish sample: an observational study.

OBJECTIVE: The objective was to evaluate the responsiveness of the Endometriosis Health Profile-30 (EHP-30) questionnaire in a Swedish sample. MATERIALS AND METHODS: Forty-two patients with endometriosis were included in a prospective observational study. MAIN OUTCOME MEASURES: The changes on the EHP-30 questionnaire after pertubation treatment were compared with the patients' self-estimated change in pain intensity. The responsiveness to change was evaluated with effect sizes and significance of change (paired t-test). The changes in scores between those who improved / not improved were compared with independent t-test. RESULTS: The changes in the scores were significant for all dimensions on the core questionnaire (p = 0.04-0.0002) for improved patients in contrast to the patients in the stable group where there were no significant changes in any dimension (p = 0.16-0.63). The effect sizes were large (> 0.8) on all core scales except for self-image (0.51) for the improved patients and small on all scales in the non-improved (stable) group (- 0.17-0.35). There were significant differences between the improved and the stable group considering change in most of the core EHP-30 scores. CONCLUSIONS: The EHP-30 is responsive to improvement on all core scales and is acceptable, understandable, and applicable in this Swedish sample.

Frequent administration of levodopa/carbidopa microtablets vs levodopa/carbidopa/entacapone in healthy volunteers.

OBJECTIVES: An oral dispersible microtablet formulation of levodopa/carbidopa 5/1.25 mg (LC-5) was developed for individualized repeated dosing. The aim was to compare pharmacokinetic profiles of LC-5 and levodopa/carbidopa/entacapone (LCE). MATERIALS AND METHODS: A randomized, crossover study was carried out in 11 healthy subjects. Plasma concentrations of levodopa, carbidopa and 3-O-methyldopa were determined after intake of 300 mg levodopa during the day, either as three intakes of 100/25/200 mg LCE or as a morning dose of 75/18.25 mg followed by five repeated doses of 45/11.25 mg LC-5. RESULTS: Repeated dosing (2.4-hourly) with LC-5 microtablets compared to LCE (6-hourly) avoided long periods with low plasma levodopa levels. Time to maximum plasma concentrations was significantly shorter for LC-5. LC-5 showed lower fluctuation index (FI) in plasma compared to LCE (ANOVA P = 0.0028). FI for dose 2-5 was on average 1.26 for levodopa in LC-5, and 2.23 for dose 1-2 of LCE. The ratio between the two mean FI:s is 0.565; that is, LC-5 gave nearly half the FI as compared to LCE. CONCLUSIONS: Fractionation of levodopa with LC-5 into small, frequent administrations as compared to standard administrations of LCE decreased the FI in plasma for both levodopa and carbidopa by nearly half.

Pertubation with lignocaine as a new treatment of dysmenorrhea due to endometriosis: a randomized controlled trial.

BACKGROUND: Endometriosis is a chronic inflammatory disease of unknown aetiology that can cause severe dysmenorrhea. Lignocaine has anti-inflammatory properties and exerts effects on nerve endings and intra-peritoneal macrophages. The objective of this study was to evaluate the effect of pertubation with Ringer-Lignocaine on dysmenorrhea in women with endometriosis. METHODS: A double-blind randomized controlled trial (RCT) was carried out at three sites in Stockholm, Sweden. Eligible patients had endometriosis as diagnosed by laparoscopy, dysmenorrhoic pain >VAS 50 mm (visual analogue scale) and patent Fallopian tubes. The study patients were randomized sequentially to preovulatory pertubations with placebo (n= 18) or study treatment (n= 24) during three consecutive menstrual cycles. The pertubation procedure comprised passing study solution through the uterine cavity and the Fallopian tubes via an intra-cervical balloon catheter. The effect on pain was evaluated with VAS scales before and after the treatments and up to nine menstrual cycles after the last pertubation. Success was defined as a reduction of ≥ 50% on the VAS scale after the third pertubation. The success rate between the treatment and the placebo group was compared with Fisher's exact test. RESULTS: In the intention-to-treat analysis, the success rate was 41.7% (10 of 24) in the treatment group compared with 16.7% (3 of 18) in the placebo group (P= 0.10, 95% CI -7.3 to 36.2%). In the per protocol analysis, the success rate in the treatment group was 45% (9 of 20) compared with 7.1% (1 of 14) in the placebo group (P= 0.024, 95% CI -2.6 to 44.8%). Of the nine patients in the lignocaine group who fulfilled the criteria for success after three pertubations, 4 (44%) had an effect persisting after nine months. The treatments were well tolerated. CONCLUSIONS: This small RCT indicates that pertubation with lignocaine is a non-hormonal treatment option for patients with dysmenorrhea and endometriosis. ClinicalTrials.gov identifier: NCT01329796.

Safety, pharmacokinetics and efficacy of factor VIIa formulated with PEGylated liposomes in haemophilia A patients with inhibitors to factor VIII--an open label, exploratory, cross-over, phase I/II study.

Recombinant activated factor VIIa (FVIIa) is a bypassing agent used to treat bleeding episodes in haemophilia patients with inhibitors to factor VIII (FVIII) and factor IX. The pharmacological effect of FVIIa is short-lived and therefore with the recommended dose of 90 µg kg(-1), a bleeding episode is treated with multiple injections. A long-acting form of FVIIa that can ensure adequate haemostasis with a single infusion, without increasing the thrombotic risk, would therefore be beneficial. PEGylated liposomes (PEGLip) have been shown to bind FVIIa and to improve haemostatic efficacy in preclinical experiments. In the present phase I/II clinical trial, we assessed the safety and efficacy of PEGLip-formulated FVIIa in severe haemophilia A patients (FVIII≤1%) with inhibitors to FVIII. Each patient received one prophylactic infusion of standard FVIIa and one prophylactic infusion of PEGLip-formulated FVIIa. The order of the infusions was randomized and the two infusions were separated by a ten-day washout period. Efficacy assessed by thromboelastography revealed that PEGLip-FVIIa induced significantly shorter clotting times and produced higher clot firmnesses than standard FVIIa. Thrombin generation assays showed that PEGLip-FVIIa induced faster thrombin generation and higher peak levels of thrombin than standard FVIIa. These effects lasted up to 5 h postinfusion. Measurements of D-dimer, prothrombin fragment 1+2 and fibrinogen showed no significant differences between the PEGLip-FVIIa and standard FVIIa treatments. PEGLip-FVIIa therefore showed improved haemostatic efficacy without increased risk of thrombosis and may be further developed for the treatment for bleeding episodes in haemophilia patients with inhibitors.

Involving family members in cancer care: focus group considerations of patients and oncological providers.

Family members are an integral part of a patient's cancer care from the moment the diagnosis is delivered to the conclusion of treatment. Family members bring with them a range of emotional reactions, interpersonal dynamics and expectations for the care the patient receives. This study is part of a multi-institutional project to continue to improve the process of cancer care. In this study, 19 focus groups (11 patient and 8 provider) were conducted concerning issues related to doctor-patient communication in eight cancer centers in the United States. The content of the conversations was analyzed and thematic categories emerged that highlight the various strengths and difficulties associated with family involvement. The focus groups' comments support the need for explicit conversations between professional caregivers, patients and their loved ones, in order to negotiate the expectations and needs of each team member. Implications for clinical practice and strategies for working with family members are offered.

Recombinant, B-domain deleted factor VIII (r-VIII SQ): pharmacokinetics and initial safety aspects in hemophilia A patients.

The pharmacokinetics of a second-generation recombinant B-domain deleted factor VIII (FVIII) preparation (r-VIII SQ) were studied in 36 patients with severe hemophilia A. In contrast to full-length recombinant FVIII, no albumin needs to be added to stabilize the final formulation of this B-domain deleted FVIII preparation. The in vivo recovery and half-life of r-VIII SQ were similar to those of plasma-derived (pd) FVIII (mean half-life of r-VIII SQ, 11.7 h). The volume of distribution and clearance were slightly, but significantly, higher for r-VIII SQ than for pdFVIII (p < 0.05). Peak plasma levels of FVIII were consistently related to the administered dose of r-VIII SQ (r = 0.94, p < 0.0001). The pharmacokinetic profile of r-VIII SQ remained essentially unchanged in a dose range of 25-100 IU/kg body weight and could be reproduced after repeated doses. r-VIII SQ was well tolerated. In conclusion, deletion of the B-domain of FVIII does not influence its in vivo pharmacokinetics.