Improvements In HRQoL Research Articles

Health-related quality of life changes following renal transplantation in children.

Studies of HRQoL after kidney transplant have yielded conflicting results. We sought to assess the impact of kidney transplant on HRQoL. We performed a retrospective study using the PedsQL3.0ESRD module during dialysis and at 3 and 12months following kidney transplant in 56 recipients. For the entire cohort, we described HRQoL scores at each time point and used ANOVA models to test for associations between demographic and transplant-related factors and post-transplant scores. We used linear mixed models to investigate interactions between transplant and demographic and transplant-related factors and to estimate differences between mean pre- and post-transplant scores. Longitudinal changes in HRQoL were assessed by t test. We found increases in all mean total scores, including subscales, at each assessed time period from dialysis to 3months post-transplant to 12months post-transplant. Post-transplant total scores did not differ by gender, race, proximity to hospital, allograft source, or dialysis modality, but did differ by recipient age. Among participants with both pre- and post-transplant observations, total scores increased for both recipients and parent-proxies. This study affirms the association between kidney transplant and improvement in HRQoL in the first year following transplant. Future research should further explore outcomes over the longer-term and factors contributing to HRQoL among this population.

Conducting an observational study during an economic crisis: analysis of the treatment and follow-up phase of Greek patients participating in the ExFOS study.

We present the subanalysis of the Greek cohort of the Extended Forsteo Observational Study (ExFOS), a multicenter, non-interventional, prospective, observational study evaluating the effect of teriparatide on fractures, back pain (BP), health-related quality of life (HR-QoL), and safety and compliance, in patients with osteoporosis treated for up to 24months, with a post-treatment follow-up of at least 18months. A total of 439 osteoporotic patients (92.2% female) were enrolled in Greece. New or worsened fractures, based on their physicians' assessment, as well as patients' self-assessment of HR-QoL and BP, compliance, and safety profile, were captured by validated questionnaires. In the ExFOS Greek cohort, fracture rates were low and mean bone mineral density (BMD) was numerically improved. Compliance with teriparatide remained high throughout the study, with 81.5% of subjects completing treatment. Only 0.7% of patients reported discontinuation due to adverse effects. A sustainable improvement in patient-perceived BP and HRQoL throughout treatment and follow-up was similar to that achieved by the European Forsteo Observational Study (EFOS). A lower than expected percentage of patients using antiresorptives following teriparatide was recorded. ExFOS reproduces the outcomes of EFOS, with a 6.5-year time interval between studies, in comparable cohorts of osteoporotic patients. Data should be interpreted in the context of observational study data collection, although summary statistics computed at each time point may overstate drug effect.

The Impact of Inflammatory Bowel Disease in Canada 2018: Quality of Life

Inflammatory bowel disease (IBD) has a substantial impact on quality of life. It causes considerable personal, emotional and social burdens. The impact of IBD on quality of life cannot readily be quantified as a cost; however, the impact places a significant burden on the patient and caregivers. Numerous studies have shown that health-related quality of life is impaired in patients living with IBD as compared with the general population. While disease activity and severity is an important driver of physical and mental health–related quality of life, patients may experience psychological distress even during clinical remission. Reduced quality of life can impact persons living with IBD as they pursue employment, family planning and personal milestones. Further, the impact of IBD extends to the patient influencing the quality of lives of those around them, including their caregivers. Improving quality of life requires a multidisciplinary approach that includes screening for and managing psychological distress. Adaptive coping mechanisms help manage illness perceptions and reduce psychosocial distress.HighlightsHealth-related quality of life (HRQOL) is an important measure of the global impact of IBD on a person’s physical, mental and emotional well-being.Persons living with IBD have significantly lower HRQOL compared with that of the general population.Inflammatory bowel disease often affects individuals as they pursue employment, family building and personal milestones.Inflammatory bowel disease affects the quality of life (QOL) of those afflicted and their caregivers.Access to multidisciplinary, collaborative, chronic disease models of care improves the HRQOL of people living with IBD.Key Summary PointsInflammatory bowel disease impairs HRQOL by inhibiting need fulfillment (i.e., self-esteem, relationships, nutrition, hygiene and security) and causing psychological distress.Inflammatory bowel disease impairs interpersonal relationships, life activities, social participation and mental well-being.Patient symptoms like diarrhea and abdominal pain reduce HRQOL.While disease severity is an important driver of physical and mental HRQOL, patients experience psychological distress even during clinical remission.Psychological distress impairs work productivity and disrupts social activities and relationships.Patients with IBD experience emotional distress relating to factors such as loss of bowel control, impairment of body image, fear of sexual inadequacy, social isolation, fear of dependency, concern about not reaching one’s full potential and fear of stigmatization.Families with children with IBD have impaired QOL as a collective—for example, parental stress from medical factors and child’s perceived stress.Patients’ perception of their illness affects their ability to adjust to a diagnosis of IBD. Adaptive coping mechanisms help manage illness perceptions and reduce psychosocial distress.Biologics are associated with improvement in long-term HRQOL in people with IBD.Patients with IBD should have access to multidisciplinary care, including mental health practitioners, to screen for and manage psychological distress.Gaps in Knowledge and Future DirectionsPatients with IBD experience emotional distress that reduces HRQOL. Clinical tools are necessary to identify the key factors causing psychological distress in patients with IBD.HRQOL is reduced in individuals with IBD and their families. Studies should evaluate the cumulative burden of IBD on HRQOL in patients with IBD and their caregivers.Patient self-perception of their IBD influences their HRQOL. Clinical studies of interventions that improve adaptive coping are needed to reduce psychosocial distress.Multidisciplinary care including a psychologist to screen for and manage psychosocial risk and psychological distress should be evaluated in IBD clinics.

Exercise training improves quality of life in women with subclinical hypothyroidism: a randomized clinical trial.

The aim was to evaluate the quality of life (HRQoL) in women with subclinical hypothyroidism (sHT) after 16 weeks of endurance training. In the first phase, a cross-sectional study was conducted in which 22 women with sHT (median age: 41.5 (interquartile range: 175) years, body mass index: 26.2 (8.7) kg/m2, thyroid stimulating hormone > 4.94 mIU/L and free thyroxine between 0.8 and 1.3 ng/dL were compared to a group of 33 euthyroid women concerned to HRQoL. In the second phase, a randomized clinical trial was conducted where only women with sHT were randomly divided into two groups: sHT-Tr (n = 10) - participants that performed an exercise program - and sHT-Sed (n = 10) - controls. Exercise training consisted of 60 minutes of aerobic activities (bike and treadmill), three times a week, for 16 weeks. The HRQoL was assessed by the SF-36 questionnaire in the early and at the end of four months. Women with sHT had lower scores on functional capacity domain in relation to the euthyroid ones (770 ± 23.0 vs. 88.8 ± 14.6; p = 0.020). The sHT-Tr group improved functional capacity, general health, emotional aspects, mental and physical component of HRQoL after training period, while the sHT-Sed group showed no significant changes. After 16 weeks of aerobic exercise training, there were remarkable improvements in HRQoL in women with sHT.

PMH74 - QUALITY OF LIFE ACCORDING TO TEMPORAL ILLICIT OPIOID USE AND RESPONDER RATE IN ADULTS RECEIVING BUPRENORPHINE DEPOT INJECTIONS (CAM2038) TO TREAT OPIOID USE DISORDER IN A 48-WEEK OPEN LABEL STUDY

Investigational weekly and monthly buprenorphine depot (CAM2038) for treatment of opioid use disorder (OUD) offers a novel approach to patient management. The potential of CAM2038 to improve health related quality of life (hrQoL) and Quality Adjusted Life Years (QALYs) are important criteria for decision makers to consider in evaluating cost effectiveness of new treatments in OUD and is assessed in this research. The long-term safety of investigational CAM2038 was evaluated in a Phase 3, 48-week, open-label study in patients with moderate to severe OUD. A post hoc responder rate was defined according to the proportion of urine toxicology tests testing negative for illicit opioids including self-reported (SR) illicit opioid use, evaluated at quartiles(q1-4). HrQoL was evaluated with the EQ-5D-5L in order to derive QALYs for each responder rate. Trends in EQ-5D-5L scores were evaluated descriptively with respect to responder rates and temporal abuse. A total of 188 subjects (out of 228 enrolled, 82%) with at least a single EQ-5D-5L survey were included for analysis. The surveys were collected from week 20 to week 48 with an average of 6.7 surveys per participant. EQ-5D-5L index scores were positively correlated to clean urine toxicology test/SR with an average of 0.05 +/- 0.01 points higher hrQoL score for clean urine toxicology tests/SR (p = 0.01). The subjects were split in responder groups defined by response of q1 (n = 26, 14%), q2 (n = 21, 11%), q3 (n = 18, 10%), and q4 (n = 123, 65%). The responder groups EQ-5D-5L averages were 0.88, 0.86, 0.90, and 0.92 respectively and statistically different (p < 0.001). Although careful interpretation is warranted due to trial design, this analysis demonstrated hrQoL and QALY improvement related to both individual temporal illicit opioid use as well as overall groups of responders.

Aspectos psicosociales de la calidad de vida en supervivientes pediátricos de tumores en el sistema nervioso central

Introducción: Los supervivientes de tumores del sistema nervioso central (TSNC) presentan peor calidad de vida en relación a la salud (CVRS) que los supervivientes de otras neoplasias y la población normativa. El tipo y gravedad de las secuelas no parecen tener un impacto claro en la CVRS, pero la afectación del cociente intelectual (CI) sí podría modular la CVRS. Además, las estrategias de afrontamiento del paciente y de los progenitores y el malestar emocional parental podrían también actuar sobre la CVRS. Objetivo: Determinar si las estrategias de afrontamiento del adolescente y su CI, y las estrategias de afrontamiento, el estrés general y el malestar emocional parental, modulan las dimensiones psicosociales de la CVRS del superviviente. Método: Estudio transversal descriptivo-correlacional. Se reclutaron 37 adolescentes (12-19 años) que llevaban ≥1 año fuera de tratamiento oncológico y 44 progenitores. Resultados: En la CVRS valorada por los adolescentes, las dimensiones Relación con los Padres y Vida Familiar, Amigos y Apoyo Social, y Entorno Escolar dependen de la estrategia de afrontamiento de resolución del problema usada por el adolescente. La dimensión Aceptación Social depende del estilo de afrontamiento improductivo del adolescente y del estilo de búsqueda de ayuda social de los padres. La CVRS valorada por los padres depende de las secuelas, el CI del adolescente y, el tipo de tratamiento oncológico recibido. Discusión y conclusiones: Las estrategias de afrontamiento centradas en la resolución del problema, deben ser consideradas para valorar e intervenir en la mejora de la CVRS de los supervivientes TSNC.

Anxiety, Depression and Quality of Life Improve After One Month and Three Months of Home Parenteral Nutrition: A Pilot Study in a Canadian Population.

BackgroundPatients receiving home parenteral nutrition (HPN) have a reduced quality of life (QoL), but it is unknown if this is associated with psychiatric comorbidities such as anxiety or depression.AimThe aim of this study was to assess anxiety, depression and QoL in patients transitioning from hospital to HPN.MethodsWe conducted a prospective study in adult patients receiving parenteral nutrition (PN) during transition from hospital to home. We assessed anxiety and depression (Hospital Anxiety and Depression Scale; HADS), health-related quality of life (HRQoL; SF-36) and health status (EQ-5D) before discharge and again later at one and three months after HPN was started.ResultsOf the 29 patients, 15 had an underlying malignancy. At baseline, 93% of patients with malignancy had anxiety or depression (HADS A and/or HADS D >7) or both, while of the patients without malignancy, 60% had anxiety, and 40% had depression. Questionnaires were completed by 21 patients at one month and by 15 at three months. Anxiety and depression scores decreased significantly after one month of HPN (mean difference [MD] anxiety: 4.3; 95% CI, 1.2–7.5, P = 0.004; MD depression: 4.0; 95% CI, 1.5–6.5, P = 0.001), and the decrease persisted at three months (MD anxiety: 35; 95% CI, 0.35–6.6, P = 0.02; MD depression: 2.5; 95% CI, 0.06–5.0, P = 0.04). Overall, patients reported an improvement in HRQoL (SF-36) after one month of HPN, and this improvement was maintained at three months in those patients who survived.ConclusionHome parenteral nutrition is associated with improvements in anxiety, depression and HRQoL at one month and three months after discharge from hospital. The improvements in Qol, anxiety and depression seem greater in patients with underlying malignancy.

Delivering problem-solving treatment in low-vision rehabilitation: A pilot feasibility study.

To explore the feasibility and preliminary effectiveness of Problem-Solving Treatment for Primary Care (PST-PC) delivered by low-vision rehabilitation (LVR) practitioners to adult clients with depressive symptoms. A single-group pre/postintervention study. Eighteen adult LVR clients with depressive symptoms (Patient Health Questionnaire-9 [PHQ-9] score of ≥5) received 6-8 weekly telephone sessions of PST-PC delivered by expertly trained practitioners (n = 14). Feasibility was determined via participating client and practitioner recruitment and intervention retention rates. Depressive symptoms (PHQ-9), health-related quality of life (HRQoL; Assessment of QoL Instrument-7D), and confidence in one's ability to cope using problem-solving strategies (Coping Self-Efficacy Scale) were assessed using pre/posttelephone assessments. Participating client recruitment and retention rates were 71% and 40%, respectively. Seventy percent of practitioners completed supervised training in PST-PC and demonstrated satisfactory levels of fidelity and competency. Postintervention, we observed a 53% improvement in depressive symptoms (p < .001), a 23% improvement in HRQoL (p = .001), and an 18% improvement in participants' confidence to use problem-focused coping strategies (p = .001). Telephone-PST-PC delivered by a trained LVR practitioner may be an effective intervention for clients of LVR services who exhibit depressive symptoms. A randomized controlled trial is now needed to confirm these preliminary findings and establish longer-term effectiveness. (PsycINFO Database Record

The Association Between Increased Levels of Patient Engagement With an Internet Support Group and Improved Mental Health Outcomes at 6-Month Follow-Up: Post-Hoc Analyses From a Randomized Controlled Trial.

BackgroundWe recently reported that depressed and anxious primary care patients randomized to a moderated internet support group (ISG) plus computerized cognitive behavioral therapy (cCBT) did not experience improvements in depression and anxiety over cCBT alone at 6-month follow-up.ObjectiveThe 1% rule posits that 1% of participants in online communities generate approximately 90% of new user-created content. The aims of this study were to apply the 1% rule to categorize patient engagement with the ISG and identify whether any patient subgroups benefitted from ISG use.MethodsWe categorized the 302 patients randomized to the ISG as: superusers (3/302, 1.0%), top contributors (30/302, 9.9%), contributors (108/302, 35.8%), observers (87/302, 28.8%) and those who never logged in (74/302, 24.5%). We then applied linear mixed models to examine associations between engagement and 6-month changes in health-related quality of life (HRQoL; Short Form Health Survey Mental Health Component, SF-12 MCS) and depression and anxiety symptoms (Patient-Reported Outcomes Measurement Information System, PROMIS).ResultsAt baseline, participant mean age was 42.6 years, 81.1% (245/302) were female, and mean Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder scale (GAD-7), and SF-12 MCS scores were 13.4, 12.6, and 31.7, respectively. Of the 75.5% (228/302) who logged in, 61.8 % (141/228) created ≥1 post (median 1, interquartile range, IQR 0-5); superusers created 42.3 % (630/1488) of posts (median 246, IQR 78-306), top contributors created 34.6% (515/1488; median 11, IQR 10-18), and contributors created 23.1 % (343/1488; median 3, IQR 1-5). Compared to participants who never logged in, the combined superuser + top contributor subgroup (n=33) reported 6-month improvements in anxiety (PROMIS: –11.6 vs –7.8; P=.04) and HRQoL (SF-12 MCS: 16.1 vs 10.1; P=.01) but not in depression. No other subgroup reported significant symptom improvements.ConclusionsPatient engagement with the ISG was more broadly distributed than predicted by the 1% rule. The 11% of participants with the highest engagement levels reported significant improvements in anxiety and HRQoL.Trial RegistrationClinicalTrials.gov NCT01482806; https://clinicaltrials.gov/ct2/show/NCT01482806 (Archived by WebCite at http://www.webcitation.org/708Bjlge9).

Safety and effectiveness of percutaneous electrical nerve stimulation on pain reduction in patients suffering from neuropathic or mixed pain

Pain is a harmful symptom, strongly influencing HRQoL and rehabilitative treatment and often refractory to pharmacological and non-pharmacological therapeutic strategies. In recent years, percutaneous electrical nerve stimulation (PENS) has been proved to be an effective procedure in the management of refractory neuropathic pain and some conditions of refractory mixed pain like low back pain. However, up to date, evidences in literature about the effectiveness of PENS in terms of pain reduction and HRQoL improvement in the rehabilitation field are scarce. Therefore, aim of our study was to evaluate safety and effectiveness of PENS on short-term pain reduction in patients suffering from neuropathic or mixed pain, non-responders to conventional therapies in a rehabilitative setting. This retrospective study was performed on a cohort of 75 adults (25 men and 50 women), mean aged 70.05 ± 14.16 years, suffering from neuropathic or mixed pain non responsive for more than 3 months to both pharmacological and non-pharmacological therapies. From 2014 to 2017, patients were treated by subcutaneous needle-electrode insertion in the sore area and return-on-skin electrode placement, both connected to a generator (AS SUPER 4 digital by TÜV Rheinland) for a 40-minute session at alternate frequencies of 2 and 100 Hz. Pain was assessed by Numerical Rating Scale (NRS) before and immediately after the treatment. Five patients experienced self- limiting and short-term pain mainly due to subcutaneous needle placement. No complication affected the continuation of the procedure. There was a significant reduction in NRS (defined as > 50%) after treatment in 70% of patients. PENS has been proven to be a safe and effective procedure in the treatment of neuropathic and mixed pain in patients non-responders to both pharmacological and non-pharmacological treatments. Its use in Physical and Rehabilitative Medicine should be encouraged and supported by other studies.

Effects of Teriparatide in Patients with Osteoporosis in Clinical Practice: 42-Month Results During and After Discontinuation of Treatment from the European Extended Forsteo\xae Observational Study (ExFOS)

This study aimed to describe clinical outcomes in patients prescribed teriparatide and followed up for 18 months after stopping the drug in real-life conditions. The Extended Forsteo® Observational Study analysed incident clinical fractures in 6-month intervals using logistic regression with repeated measures. Changes in back pain (visual analogue scale) and health-related quality of life (HRQoL; EQ-5D questionnaire) were analysed using mixed models for repeated measures. Patients were analysed if they had a post-baseline visit, regardless of whether and for how long they took teriparatide. Of 1531 patients analysed (90.7% female, mean age: 70.3 years), 76 (5.0%) never took teriparatide. Median treatment duration was 23.6 months. The adjusted odds of clinical fracture decreased by 47% in the > 12- to 18-month treatment period (p = 0.013) compared with the first 6-month period, with no statistically significant reduction in the > 18- to 24-month interval. The clinical fracture rate remained stable during the 18 months’ post-teriparatide, when approximately 98% of patients took osteoporosis medication (51% bisphosphonates). Clinical vertebral fractures were reduced at every time period compared with the first 6 months. Adjusted mean back pain scores decreased and EQ-5D scores increased significantly at each post-baseline observation. In a real-life clinical setting, the risk of clinical fractures declined during 24 months of teriparatide treatment. This reduction was maintained 18 months after stopping teriparatide. In parallel, patients reported significant improvements in back pain and HRQoL. The results should be interpreted in the context of the non-controlled design of this observational study.

Patient-reported outcomes in European spondyloarthritis patients: a systematic review of the literature.

ObjectiveThis review aims to summarize the current literature on patient-reported outcomes (PROs) in spondyloarthritis (SpA).Patients and methodsWe performed a systematic literature review to identify studies (original articles and narrative and systematic reviews) regarding PROs (health-related quality of life [HRQoL], satisfaction, preferences, adherence/compliance, and persistence) in SpA patients published in the European Union through December 2016. International databases (Medline/PubMed, Cochrane Library, ISI Web of Knowledge, Scopus) were searched using keywords in English. The methodological quality of the studies was assessed using the Oxford Centre for Evidence-Based Medicine criteria.ResultsA total of 26 publications met the inclusion criteria. Generally, studies indicated that SpA has a negative impact on patients’ HRQoL. In patients with ankylosing spondylitis, physical domains were more affected than emotional ones, whereas for psoriatic arthritis, both physical and psychological factors were strongly affected by the disease. Data indicated that biological agents (BAs) greatly contributed to improvement in HRQoL in both ankylosing spondylitis and psoriatic arthritis patients. Findings on compliance with BAs were heterogeneous. However, persistence rates exceeded 50% irrespective of the BA administered. Results on preferences indicated that most SpA patients prefer being involved in decisions regarding their treatment and that besides efficacy and safety, frequency and route of administration may influence patients’ preferences for BAs.ConclusionImplementing management programs for SpA patients focuses on the physical, emotional, and social consequences of the disease, in addition to assessing and including patient preferences in the treatment decision-making process, could be crucial to improve patients’ HRQoL and ensure their satisfaction and compliance with treatment.

Patient-reported outcomes in patients with overactive bladder treated with mirabegron and tolterodine in a prospective, double-blind, randomized, two-period crossover, multicenter study (PREFER)

BackgroundThe PREFER study was an assessment of medication tolerability, treatment preference and symptom improvement during treatment with mirabegron (M) and tolterodine (T) extended release (ER) in patients with overactive bladder (OAB). In this analysis of PREFER, patient-reported outcomes (PROs) were assessed during treatment.MethodsPREFER was a two-period, 8-week crossover, double-blind, phase IV study (NCT02138747) of treatment-naïve adults with OAB ≥3 months randomized to 1 of 4 treatment sequences (M/T; T/M; M/M; T/T), separated by a 2-week washout. Tolterodine ER was dosed at 4 mg for 8 weeks and mirabegron was dosed at 25 mg for 4 weeks then increased to 50 mg for the next 4 weeks. At each visit, PROs related to treatment satisfaction, quality of life and symptom bother were assessed using the OAB Satisfaction (OAB-S; 3 independent scales/5 single-item overall assessments), OAB-q (total health-related QoL [HRQoL] and subscales [Sleep, Social, Coping, Concern] and Symptom Bother scale) and Patient Perception of Bladder Condition (PPBC) questionnaires. Responder rates were reported for OAB-q subscales based on a minimal important difference (MID; ≥ 10-point improvement) and OAB-S Medication Tolerability score ≥ 90.ResultsIn total, 358 randomized patients received ≥1 dose of double-blind study medication and completed ≥1 post-baseline value (OAB-S scale, OAB-q, PPBC): M/T (n = 154), T/M (n = 144), M/M (n = 30) or T/T (n = 30). At end of treatment (EoT), mirabegron and tolterodine ER were associated with similar mean improvements in 7 of the 8 OAB-S scores investigated, OAB-q scales and PPBC. A higher percentage of patients achieved clinically relevant improvements (MID) in OAB-q scales and OAB-S Medication Tolerability score during treatment with mirabegron than tolterodine ER.ConclusionsOn average, patients with OAB experienced improvements in treatment satisfaction, HRQoL and symptom bother that were of a similar magnitude during treatment with mirabegron or tolterodine ER. However, during mirabegron treatment, patients were more likely to achieve clinically relevant improvements in tolerability and HRQoL (as measured by the MID for the OAB-q or an OAB-S Medication Tolerability score ≥ 90) than during tolterodine ER treatment.Trial registrationNCT02138747; registered May 13, 2014.

New Calcipotriol/Betamethasone Dipropionate Foam Formulation for the Treatment of Psoriasis: An Overview

Psoriasis is a chronic, inflammatory, immune-mediated, potentially disfiguring and disabling skin disorder, affecting over 100 million individuals worldwide. Calcipotriol plus betamethasone fixed-combination (0.005% Cal/0.064% BD) is the recommended topical treatment for psoriasis. However, topical treatments are associated to lack of efficacy and low adhesion rates due to poor cosmetic characteristics’ formulations, and vehicle issues. To answer the need for improving patients’ acceptability and adherence, an innovative Cal/BD aerosol foam formulation was developed for the topical treatment of adults with plaque psoriasis. Phase II and III clinical trials have consistently shown that the two-compound formulation is more effective and safer than its individual ingredients in the same vehicle. Cal/BD aerosol foam formulation has proved higher efficacy in clinical studies, and a pooled analysis of the main clinical studies has demonstrated that this does not occur at the safety profile expense. Furthermore, Cal/BD aerosol foam has shown a significantly improved efficacy compared with more traditional formulations, such as ointments, gels, and lotions. The improved efficacy and safety profile of this new formulation, together with the once-daily treatment, a more acceptable tolerability profile, and an early and rapid response, offers improved convenience and better acceptance over the twice- -daily applications required for the respective monotherapies, which may improve adherence to treatment, leading to faster and greater improvements in HR-QoL, representing a useful therapeutic option to the management of patients with plaque psoriasis. Further clinical investigations to explore the possibility of Cal/BD aerosol foam treatment ability to provide long-term psoriasis’ management are required.

PATIENT‑ORIENTED ASSESSMENT OF BLOOD PRESSURE TELEMONITORING AND REMOTE COUNSELING IN HYPERTENSIVE PATIENTS: A PILOT PROJECT

Objective. To evaluate patient-oriented endpoints and antihypertensive effectiveness of blood pressure (BP) monitoring and distant counseling (TMDC) among outpatients with uncontrolled hypertension (HTN). Design and methods . Programs of TMDC with different duration of follow-up (1, 3, 6, 12 months) were developed (with obligatory initial and final clinic visits). The demand in TMDC was assessed by a preliminary survey among cardiologists (n = 73) and hypertensive patients (n = 540) referred to Almazov National Medical Research Centre. Patients with uncontrolled HTN who signed informed consent were enrolled in the study being assigned to TMDC or to the age, sex and BP level-matched control group; the latter ones were given standard recommendations (outpatient visits once every 3 months). None of the patients had any serious comorbidities requiring frequent face-to-face visits. On a baseline clinic visit TMDC patients were given detailed technical instructions on BP selfmonitoring and request for counseling through web-site and mobile application. Office BP levels were evaluated twice, at baseline and at the final clinic visit. In the TMDC group BP level, the frequency and reasons for the consultations were assessed. For evaluation of patient-reported outcomes questionnaires of the Hospital Anxiety and Depression Scale («HADS») and «SF-36» were provided at the first and final visits. Results. According to initial survey, 12 (16 %) of 73 cardiologists and 184 (34 %) among 540 patients at Almazov National Medical Research Centre gave a positive opinion regarding TMDC. Most patients (n = 129; 70 %) chose a three-month TMDC plan. Of these, 110 patients (74 men, mean age 51,2 ± 17,0 years) completed follow-up period; control group consisted of 80 sex-, age- and BP-matched patients. TMDC group demonstrated a more pronounced decrease in office systolic (SBP) and diastolic (DBP) BP levels as compared to the control group: Δ –22 ± 12,4 versus Δ –8,6 ± 22,4 mmHg for SBP (p = 0,005) and Δ –13,6 ± 10,8 versus Δ –7 ± 11,3 mm Hg for DBP (p = 0,02). At final visit target office BP level (< 140/90 mmHg) was achieved in 82 patients (75 %) and 16 patients (20 %) in the TMDC and control groups, respectively (χ 2 = 20,8; p < 0,01). For the entire follow-up period, everyone in TMDC group required at least 1 remote doctor’s advice and in 36 cases (33 %) antihypertensive therapy correction was necessary. Aside, TMDC group showed reduction in anxiety and depression according to HADS (–1,2 and –1,8 score, respectively, p < 0,05) and improvement in physical HRQoL (+ 9 ± 3,3 points SF-36, p = 0,04). Conclusion . Results demonstrated that a simple and safe telehealth tool for patients with uncontrolled HTN is easily applicable in routine daily clinical practice, provides additional antihypertensive effect and improves patientreported outcomes. However, it needs additional support measures for higher acceptance in routine practice.

Improvement of quality of life and its relationship with neuropsychiatric outcomes in patients with multiple sclerosis starting treatment with natalizumab: A 3-year follow-up multicentric study

BackgroundHealth-related quality of life (HRQoL) is impaired in multiple sclerosis (MS) but can be improved by disease-modifying therapies such as natalizumab. However, the predictive factors and neuropsychiatric correlates of HRQoL improvement are unknown. MethodsIn this study, 48 patients with relapsing-remitting MS were included in a 3-year open-label, single group, multicenter, clinical trial (NCT01392872). HRQoL was measured by the disease-specific MusiQoL questionnaire, together with physical disability, cognition, fatigue, anxiety and depression scores at baseline, 6months, 12months, 18months and 36months after starting natalizumab therapy. ResultsCompared to baseline, global HRQoL, as measured with the index of the MusiQoL, was significantly increased 6months after the beginning of natalizumab therapy, with medium effect-size (58.6±16.2 vs 69.8±18.9, p<0.001, Cohen's d=0.63). This improvement was maintained over time for up to 3years and mainly concerned activity of daily living, psychological well-being, symptoms and coping (p<0.001 for every dimensions). The variation of global HRQoL after 3years was negatively correlated with the variation of fatigue score (r=−0.44, p=0.015). Furthermore, a higher fatigue score at baseline was correlated with improvement in global HRQoL 3years afterwards (r=0.34, p=0.041), independently of age, educational level, disease duration and disability at baseline (β=2.45, p=0.020). Disability at baseline, cognitive impairment, anxiety and depression failed to predict or correlate with global HRQoL improvement in multivariate analyses. ConclusionNatalizumab improved HRQoL quickly and sustainably in patients with relapsing-remitting MS. In terms of HRQoL, natalizumab seems to benefit mostly patients with more marked fatigue at baseline.

PDB15 - IMPACT OF WEIGHT LOSS (WL) ON HEALTH-RELATED QUALITY OF LIFE (HRQOL) AMONG LATIN AMERICAN (LA) SUBJECTS WITH TYPE 2 DIABETES MELLITUS (T2DM) IN PHASE 3 STUDIES OF CANAGLIFLOZIN (CANA)

Treatments that improve key biomarkers related to T2DM management are desirable, especially in LA, where patients are responsible for medication choices. CANA, an SGLT2 inhibitor, lowers glucose and BP in people with T2DM, along with the recognizable benefit of WL, which may reinforce performance of self-care behaviors. This analysis assessed the impact of WL on HRQoL in people with T2DM from LA. Post hoc pooled data from LA subjects in 4 CANA trials (vs placebo, sitagliptin, or glimepiride) on metformin ± sulfonylurea were used. Satisfaction with weight (SW) and physical health (SP) measured by the Current Health Satisfaction Questionnaire, burden of weight on HRQoL measured by the Impact of Weight on Quality of Life–Lite, and physical and mental function measured by SF-36 were analyzed. Patients were classified based on weight loss (L) or gain (G) patterns from baseline to Week 26 and Week 26 to Week 52 (ie, LL, LG, GL, GG). Logistic regression was used to determine the relationship between baseline characteristics and weight change and HRQoL at 52 weeks. Compared with subjects from the rest of the world (n=2,030), LA subjects (N=449; CANA, n=291; placebo/active comparators, n=158) had lower BMI (30.4 vs 31.6 kg/m2), higher SW (33.0% vs 17.4%), and higher SP (27.9 vs 24.7) at baseline (all P<0.001). At Week 52, 70% of LA subjects lost weight; of these, more received CANA (100/300 mg; 79%) vs placebo/active comparators (21%). Lower baseline HRQoL was associated with a significantly greater likelihood of improvement in most measures of HRQoL at Week 52 (P<0.001). Subjects who experienced the LL pattern were more likely to have improved SW compared with those who had a GG pattern (P=0.009). WL produces meaningful HRQoL improvements for people with T2DM in LA, which may lead to increased performance of healthy behaviors.

Evaluating financial toxicity (FT) interventions.

e21673 Background: FT has been defined as an adverse event of cancer treatments. Several patient (pt)-level interventions have been developed to mitigate FT. However, due to the lack of longitudinal studies, the impact of these interventions has not been established. Methods: Pts with cancer receiving Co-Pay Assistance (CPA) from the Patient Access Network Foundation were approached at baseline, 1 and 3 months post-CPA. We assessed the use of pt navigators, social workers, financial counselors, support groups, and transportation vouchers by pts. The outcomes were improvements in disease-specific HRQoL measures, global HRQoL measure (FACTG, lower values are worse) and improvement in FT, as measured by the COST (lower values are worse). Multivariable regression was used to identify whether these interventions were associated with the outcomes. Results: 308 pts with cancer were assessed at baseline (prior to CPA) and at 1 and 3 months after. 275 pts (89%) had an improvement in their FT over 3 months. A majority of these pts had multiple myeloma (MM, 86 pts, 28%). Navigators were used by 179 pts (42%), social workers by 106 (34%), financial counselors by 107 (35%), support groups by 94 (31%), and transportation vouchers by 50 (16%). None of these interventions increased the odds of FT or HRQoL improvement at the 0.05 significance level. Conclusions: The selected population of cancer pts who received CPA for their treatments had a significant improvement in FT over time. Yet, this improvement was not associated with additional interventions, suggesting CPA as the main intervention. The FT improvement was not clearly translated into significant HRQoL improvements, likely due to the multidimensional HRQoL construct (which includes other symptoms) versus the unidimensional aspect of a financial event. [Table: see text]

Long-term opioid therapy in Denmark: A disappointing journey.

Longitudinal population-based studies of long-term opioid therapy (L-TOT) in chronic non-cancer pain (CNCP) patients are sparse. Our study investigated incidence and predictors for initiating L-TOT and changes in self-rated health, pain interference and physical activities in long-term opioid users. Data were obtained from the national representative Danish Health and Morbidity Surveys and The Danish National Prescription Registry. Respondents with no dispensed opioids the year before the survey were followed from 2000 and from 2005 until the end of 2012 (n=12,145). A nationally representative subsample of individuals (n=2015) completed the self-administered questionnaire in both 2000 and 2013. Collected information included chronic pain (≥6months), health behaviour, self-rated health, pain interference with work activities and physical activities. Long-term users were defined as those who were dispensed at least one opioid prescription in six separate months within a year. The incidence of L-TOT was substantially higher in CNCP patients at baseline than in others (9/1000 vs. 2/1000 person-years). Smoking behaviour and dispensed benzodiazepines were significantly associated with initiation of L-TOT in individuals with CNCP at baseline. During follow-up, L-TOT in CNCP patients increased the likelihood of negative changes in pain interference with work (OR 9.2; 95% CI 1.9-43.6) and in moderate activities (OR 3.7; 95% CI 1.1-12.6). The analysis of all individuals indicated a dose-response relationship between longer treatment duration and the risk of experiencing negative changes. Individuals on L-TOT seemed not to achieve the key goals of opioid therapy: pain relief, improved quality of life and functional capacity. Long-term opioid therapy does not seem to provide pain relief, improvement in HRQOL and physical capacity in CNCP patients in a general population.

The effects of cognitive-behavioral therapy for eating disorders on quality of life: A meta-analysis.

Meta-analyses have documented the efficacy of cognitive-behavioral therapy (CBT) for reducing symptoms of eating disorders. However, it is not known whether CBT for eating disorders can also improve quality of life (QoL). This meta-analysis therefore examined the effects of CBT for eating disorders on subjective QoL and health-related quality of life (QoL). Studies that assessed QoL before and after CBT for eating disorders were searched in the PsycInfo and Medline database. Thirty-four articles met inclusion criteria. Pooled within and between-groups Hedge's g were calculated at post-treatment and follow-up for treatment changes on both subjective and HRQoL using a random effects model. CBT led to significant and modest improvements in subjective QoL and HRQoL from pre to post-treatment and follow-up. CBT led to greater subjective QoL improvements than inactive (i.e., wait-list) and active (i.e., a combination of bona fide therapies, psychoeducation) comparisons. CBT also led to greater HRQoL improvements than inactive, but not active, comparisons. Prepost QoL improvements were larger in studies that delivered CBT individually and by a therapist or according to the cognitive maintenance model of eating disorders (CBT-BN or CBT-E); though this was not replicated at follow-up CONCLUSIONS: Findings provide preliminary evidence that CBT for eating disorders is associated with modest improvements in QOL, and that CBT may be associated with greater improvements in QOL relative to comparison conditions.