Electronic Daily Diary Research Articles

Once-Daily Triple Therapy in Patients with Advanced COPD: Healthcare Resource Utilization Data and Associated Costs from the FULFIL Trial.

IntroductionChronic obstructive pulmonary disease is associated with a high healthcare resource and cost burden. Healthcare resource utilization was analyzed in patients with symptomatic chronic obstructive pulmonary disease at risk of exacerbations in the FULFIL study. Patients received either once-daily, single inhaler triple therapy (fluticasone furoate/umeclidinium/vilanterol) 100 µg/62.5 µg/25 µg or twice-daily dual inhaled corticosteroid/long-acting beta agonist therapy (budesonide/formoterol) 400 µg/12 µg.MethodsFULFIL was a phase III, randomized, double-blind, double-dummy, multicenter study. Unscheduled contacts with healthcare providers were recorded by patients in a daily electronic diary; the costs of healthcare resource utilization were calculated post hoc using UK reference costs.ResultsOver 24 weeks, slightly fewer patients who received fluticasone furoate/umeclidinium/vilanterol (169/911; 18.6%) required contacts with healthcare providers compared with budesonide/formoterol (180/899; 20.0%). Over 52 weeks in an extension population, fewer patients who received fluticasone furoate/umeclidinium/vilanterol required unscheduled contacts with healthcare providers compared with budesonide/formoterol (25.2% vs. 32.7%). Non-drug costs per treated patient per year were lower in the fluticasone furoate/umeclidinium/vilanterol group than the budesonide/formoterol group over 24 and 52 weeks (£653.80 vs. £763.32 and £749.22 vs. £988.03, respectively), with the total annualized cost over 24 weeks being slightly greater for fluticasone furoate/umeclidinium/vilanterol than budesonide/formoterol (£1,289.35 vs. £1,267.45).ConclusionsThis healthcare resource utilization evidence suggests that, in a clinical trial setting over a 24- or 52-week timeframe, non-drug costs associated with management of a single inhaler fluticasone furoate/umeclidinium/vilanterol are lower compared with twice-daily budesonide/formoterol.Trial RegistrationClinicalTrials.gov number: NCT02345161.FundingGSKElectronic supplementary materialThe online version of this article (doi:10.1007/s12325-017-0604-x) contains supplementary material, which is available to authorized users.

Intimacy in Romanian Couples. Implications for the Psychological Health of the Family

In the variety of processes that shape a healthy couple relationship, intimacy plays a leading role as a determiner of commitment. The issue of understanding intimacy is even more up to date considering the increased number of separations during the past years and also the increased interest for therapy. The present study aims at investigating intimacy in 32 Romanian couples, the connection it has to positive emotions, dyadic satisfaction and commitment to the relationship. The main method used in the present study is a daily electronic diary, completed by each partner of the couple in the course of a week. The diary was developed on the basis of validated instruments and transformed in an electronic, user-friendly variant. The collected data encapsulates information relevant for the understanding of the dynamics of Romanian couples. The daily discussion subjects and other fill-in data that have been gathered on a daily basis, portrait the map of discussions and interests in Romanian couples, very important details regarding intimacy, self-disclosure and emotions within the couple that lead to the strong, positive bond of a healthy family. How to cite : Apostu, M. N. & Turliuc, M. N. (2017). Intimacy in Romanian Couples. Implications for the Psychological Health of the Family. Logos Universality Mentality Education Novelty, Section: Social Sciences , VI(1), 63-72. DOI: http://dx.doi.org/10.18662/lumenss.2017.0601.06

Flibanserin Efficacy and Safety in Premenopausal Women With Generalized Acquired Hypoactive Sexual Desire Disorder.

Flibanserin is a postsynaptic 5-HT-1A agonist and 5-HT-2A antagonist for the treatment of generalized acquired hypoactive sexual desire disorder in premenopausal women. To review and evaluate the efficacy and safety of flibanserin. We review and critique the appropriateness of the co-primary and secondary end points used in the flibanserin pivotal trial research program. We review the efficacy and safety parameters of this drug based on the published literature and related sources. Pivotal trial primary and secondary end points and safety profile data from theflibanserin development program. Our review identified instances of poor fit of two primary trial pivotal trial end points with the hypoactive sexual desire disorder construct: satisfying sexual events and electronic daily diary assessments of the most intense level of sexual desire experienced each day. Efficacy findings of the flibanserin pivotal trials program were positive for satisfying sexual events, not positive for electronic daily diary assessments of the most intense level of sexual desire experienced, and positive for secondary end points of the Female Sexual Function Index desire domain and overall measurements and the Female Sexual Distress Scale-Revised desire-specific and overall measurements. Safety data from the clinical trial program showed a reasonable safety profile. Flibanserin has demonstrated efficacy on appropriate measurements of the hallmarks of hypoactive sexual desire disorder-experience of absent or decreased sexual desire that is persistent over time and distressing-and the safety profile of flibanserin is acceptable. Fisher WA, Pyke RE. Flibanserin Efficacy and Safety in Premenopausal Women With Generalized Acquired Hypoactive Sexual Desire Disorder. Sex Med Rev 2017:5;445-460.

Measurement Properties of the Psoriasis Symptom Inventory Electronic Daily Diary in Patients with Moderate to Severe Plaque Psoriasis.

The Psoriasis Symptom Inventory (PSI) is a patient-reported outcome instrument that measures the severity of psoriasis signs and symptoms. This study evaluated measurement properties of the PSI in patients with moderate to severe plaque psoriasis. This secondary analysis used pooled data from a phase 3 brodalumab clinical trial (AMAGINE-1). Outcome measures included the PSI, Psoriasis Area and Severity Index (PASI), static Physician's Global Assessment (sPGA), psoriasis-affected body surface area, 36-item Short-Form Health Survey version 2, and the Dermatology Life Quality Index (DLQI). The PSI was evaluated for dimensionality, item performance, reliability (internal consistency and test-retest), construct validity, ability to detect change, and agreement between PSI response and response measures based on the PASI, sPGA, and DLQI. Results supported unidimensionality, good item fit, ordered responses, and PSI scoring. The PSI demonstrated reliability: baseline Cronbach's alpha ≥ 0.92 and intraclass correlation coefficients ≥ 0.95. Correlations between PSI total score and DLQI item 1 (r = 0.86), DLQI symptoms and feelings (r = 0.87), and 36-item Short-Form Health Survey version 2 bodily pain (r = -0.61) supported convergent validity. PSI scores differed significantly (P < 0.001) among severity groups based on the PASI (< 12/≥ 12), sPGA (0-1/2-3/4-5), body surface area (< 5%/5%-10%/> 10%), and DLQI (≤ 5/> 5) at weeks 8 and 12. At week 12, the PSI detected significant changes in severity based on PASI responses (< 50/50- < 75/≥ 75) and sPGA (0-1/≥ 2), and showed good agreement (k ≥ 0.66) between PSI response and PASI, sPGA, and DLQI responses. The PSI demonstrated excellent validity, reliability, and ability to detect change in the severity of psoriasis signs and symptoms.

Patient-reported outcomes from a phase III study of baricitinib in patients with conventional synthetic DMARD-refractory rheumatoid arthritis

ObjectivesTo evaluate the effect of baricitinib on patient-reported outcomes (PROs) in patients with active rheumatoid arthritis (RA) and an inadequate response or intolerance to conventional synthetic disease-modifying antirheumatic drugs.MethodsIn this...

OP019 Correlation of clinical and endoscopic outcomes in patients with active Crohn's disease treated with mongersen (GED-0301)

Background: Mongersen (GED-0301), an antisense oligodeoxynucleotide complementary to the sequence of Smad7 mRNA, is being evaluated for the treatment (tx) of patients (pts) with active Crohn's disease (CD) (Monteleone et al. N Engl J Med 2015;372:1104–13). It is formulated as a gastro-resistant, delayed-release, pH-dependent tablet that delivers active substance to the distal GI tract with negligible systemic exposure. We explored the correlation between clinical and endoscopic indices in a phase 1b study. Methods: Pts with active CD (CD Activity Index score [CDAI] = 220–450, total simple endoscopic score for CD [SES-CD] ≥7, or ileal disease SES-CD ≥4) were randomised to 4, 8, or 12 wks of oral mongersen 160 mg daily, followed by an observation period without study drug. Centrally read endoscopic assessments were performed at baseline (BL) and Wk 12. Daily electronic diary records were used to collect CD symptoms; a clinical evaluation, including CDAI determination, occurred at monthly visits through Wk 12. Results: 63 pts were enrolled; at BL, mean age was 41.5 yrs, mean SES-CD was 11.2, mean CDAI was 294, and mean CD duration was 11.6 yrs; 46% had prior TNF-α exposure, and 33% had prior CD surgery. Improvement in clinical outcomes occurred as early as wk 2 in the 4-, 8-, and 12-wk tx groups: clinical response (CDAI decrease ≥100), 21%, 26%, and 29%; clinical remission (CDAI <150), 16%, 17%, and 19%; and mean change from BL in CDAI, −77.9, −77.2, and −78.6. These improvements were maintained across all 3 tx groups over 12 wks of tx, with the highest rates observed in the 12-wk tx group: clinical response, 53%, 44%, and 67%; clinical remission, 32%, 35%, and 48%; and mean change from BL CDAI, −124, −113, and −133. In all, 52 pts had evaluable endoscopies at Wk 12; of these, 37% had endoscopic response (≥25% reduction in SES-CD from BL to Wk 12), with no meaningful difference across tx groups. Among pts with SES-CD >12, 63% had ≥25% and 31% had ≥50% reduction in CDAI. Change in SES-CD (adjusted for BL CDAI, SES-CD, and tx group) showed a moderate correlation with change in CDAI (r=0.37; p=0.01). SES-CD was developed in pts with intact GI anatomy. Examining this relationship in the 32 pts without prior CD surgery showed an improved correlation (r=0.48; p=0.01). Adverse event (AE) rates and serious AE rates were low and similar across tx groups. Mongersen was generally safe and well tolerated. Conclusions: Mongersen showed clinical and endoscopic improvements at Wk 12 for pts with active CD. A moderate correlation was seen between clinical and endoscopic benefit. This correlation improved when the analysis was confined to pts without prior CD surgery. No new safety signals were identified.

Patterns and characterization of COPD exacerbations using real-time data collection

IntroductionPatients with chronic obstructive pulmonary disease often experience exacerbations. These events are important as they are a major cause of morbidity and mortality. Recently, it has been increasingly recognized that patients may experience symptoms suggestive of an exacerbation but do not seek treatment, which are referred to as unreported or untreated exacerbations. Symptom diaries used in clinical trials have the benefit of identifying both treated and untreated exacerbation events.MethodsThe Kamada study was a multicenter, double-blind randomized controlled trial of inhaled augmentation therapy in alpha-1 antitrypsin deficiency (AATD). A retrospective review of daily electronic symptom diary cards was undertaken from the two leading centers to identify symptomatic episodes consistent with a definition of an exacerbation. The aims were to explore the relationship between exacerbation events and classical “Anthonisen” symptoms and to characterize treated and untreated episodes.ResultsForty-six AATD patients with airflow obstruction and history of exacerbations were included in the analysis. Two hundred thirty-three exacerbation episodes were identified: 103 untreated and 130 treated. Untreated episodes were significantly shorter (median 6 days; interquartile range [IQR] 3–10 days) than the treated episodes (median 10 days; IQR 5–18.25 days: P<0.001). Using logistic regression analysis, Anthonisen type and length of dyspnea were significant predictors of the treatment of an exacerbation event.ConclusionReal-time electronic diary cards provide valuable information about the characterization of exacerbations. Untreated episodes are common and are significantly shorter in duration than the treated episodes. Dyspnea is the most important single Anthonisen symptom in the prediction and/or driver of treatment.

The 10-Item Sickle Cell Disease Severity Measure (SCDSM-10): A Novel Measure of Daily SCD Symptom Severity Developed to Assess Benefit of GBT440, an Experimental HbS Polymerization Inhibitor

Introduction and Objective: GBT440 inhibits HbS polymerization and reduces hemolysis, and is a promising treatment for Sickle Cell Disease (SCD). The traditional clinical endpoint, vaso-occlusive crisis (VOC) requiring healthcare utilization, is not a sensitive measure of the daily burden of symptoms in patients (the "tip of the iceberg" of severe symptom exacerbations) and poses a barrier to development of new treatments for SCD.The objective was to develop a sensitive measure to detect treatment-related improvements in daily symptoms and exacerbations that define the disease. Existing SCD measures focus on distal impact, not on the core signs and symptoms of disease, and therefore not appropriate for meeting the regulatory standard to prove treatment benefit. Beginning with a hypothesized conceptual framework focused on pain and fatigue, rigorous qualitative and quantitative research was used to develop the content of the Sickle Cell Disease Severity Measure (SCDSM).Methods: The content of the new measure was derived from 1-on-1 open-ended concept elicitation interviews in 56 adults and 10 adolescents with SCD in the US and UK. Participants were aged 12-63 years, 64% female, 44% currently on hydroxyurea treatment, 86% had 1 to 42 VOC in the previous year requiring urgent care. During the interview, 74% reported having a typical or "good" day versus 26% having a crisis or "bad" day.Interview transcripts were coded to identify the most bothersome and frequently mentioned concepts related to both "good" and "bad" days. As hypothesized, patients reported having crisis days more frequently than those crises requiring healthcare utilization (traditional VOC endpoint). Interviews continued until saturation was demonstrated. How items worked individually and together were explored to quantify the full range of SCD severity. Both Classical Test Theory and Rasch Measurement Theory quantitative analyses supported the qualitative data to refine item content. To document content validity, the SCDSM content in its final electronic daily diary format will be evaluated in cognitive debriefing studies. Subsequently, longitudinal evaluation will occur in future clinical trials with GBT440. Translation and cultural adaptation is planned.Results: After eliciting an initial pool of items using open-ended interviews, the items were administered to a small cohort of SCD patients. After analyses of the response data and re-examination of the qualitative data, revisions were made. The revised set was re-administered to a cohort of 50 SCD patients. Qualitative and quantitative analyses provided evidence that a set of 10-items demonstrated content validity in adult and adolescent SCD patients to produce a score which can measure the full range of sickle cell disease severity. The mixed methods process enabled streamlined decision-making concerning measure content. The final content includes items specific to pain, fatigue, concentration and breathlessness. Evidence supports the derived estimate as a reliable and valid measure of SCD symptom severity covering a wide range of experience and providing the ability to differentiate baseline symptoms from severe symptoms. Patient responses to the 10 SCDSM items are combined to generate a single daily estimate of SCD symptom severity. Two "scores" can be computed: an ordinal-level total score can be computed by summing item scores; an interval-level (linear) measure can be derived from item responses using RMT analysis.Conclusions: SCD patients have a high burden of daily symptoms, with severe or "crisis" days occurring more frequently than traditionally defined VOC. The 10-item SCDSM is a promising new measure of daily SCD symptom severity developed to be fit for purpose in clinical trials to determine the treatment effect of new drugs on potential improvement in baseline symptoms and/or prevention of symptom exacerbations. SCDSM will soon be tested in a clinical trial setting to determine its longitudinal measurement characteristics, generate guidelines for measure interpretability, and to explore the clinical benefit of GBT440 in SCD. Qualitative and psychometric findings based on the SCD patient voice will be presented at the meeting to provide evidence of SCDSM validity, reliability, and usefulness in assessing symptom severity in a disease that has heretofore been poorly characterized on a daily basis. DisclosuresBurke:Lora Group: Employment; Global Blood Therapeutics: Consultancy. Hobart:Lora Group: Research Funding. Fox:Lora Group: Research Funding. Lehrer-Graiwer:Global Blood Therapeutics: Employment, Equity Ownership. Bridges:Global Blood Therapetics: Employment, Equity Ownership. Kraus:Global Blood Therapeutics: Employment, Equity Ownership. Ramos:Global Blood Therapeutics: Employment, Equity Ownership.

Analyzing Change Processes Resulting from a Smartphone Maintenance Intervention Based on Acceptance and Commitment Therapy for Women with Chronic Widespread Pain.

This study investigated change processes resulting from a randomized controlled trial smartphone-delivered maintenance intervention with daily electronic diaries and personalized written feedback based on acceptance and commitment therapy (ACT) following a rehabilitation program for patients with chronic widespread pain. This study included 48 women who during a 5-week period completed electronic diaries three times daily, totaling 3372 entries. In response to the completed diaries, they received daily feedback from a therapist for 4weeks (excluding weekends), totaling 799 feedback messages. To analyze the change processes, we explored the associations between feedback and daily ratings of participants' physical activities, positive emotions, pain fear and avoidance, pain acceptance, and self-management. Commitment to physical activities and the participants' evaluation of feedback were also analyzed. Multilevel models were used in the statistical analyses. Participants' average pain fear and avoidance decreased over the intervention period (mean -0.019, P=0.05). Self-management, pain acceptance, and positive feelings increased (mean -0.030, P<0.01; mean -0.015, P<0.01; and mean -0.011, P=0.01, respectively). Participants' performance of physical activities decreased slightly over time, but the level of commitment was high and they evaluated the feedback as supportive for staying sufficiently active. No correlation between diary contents and feedback messages was found, even though most of the participants evaluated the feedback as supportive. No support was found for an association between diary content and feedback based on ACT. However, diary measures were consistent with the ACT model and may have influenced positively the change processes.

Acute migraine medication adherence, migraine disability and patient satisfaction: A naturalistic daily diary study.

Objective To examine the influence of acute migraine medication adherence on migraine disability and acute medication satisfaction. Methods Adults with migraine completed three months of daily electronic diaries assessing headache symptoms, acute medication taken, acute medication satisfaction, and daily migraine disability. Repeated measures mixed-effects models examined the effect of initial medication type [migraine-specific medication (MSM) vs. over-the-counter analgesic (OTC) vs. an opiate/barbiturate], the severity of pain at dosing, and their interaction with daily migraine disability and satisfaction with acute medication. Results Participants (N = 337; 92.5% female; 91.1% Caucasian, non-Hispanic; 84.0% with episodic migraine) recorded 29,722 diary days. Participants took acute medication on 96.5% of 8090 migraine days. MSM was most frequently taken first (58%), followed by OTC (29.9%) and an opiate/barbiturate (12.1%). Acute medication was most frequently taken when pain was mild (41.2%), followed by moderate (37.7%) and severe pain (11.4%). Initially dosing with MSM while pain was mild was associated with the lowest daily disability [medication × pain at dosing F (4, 6336.12) = 58.73, p < .001] and highest acute medication satisfaction [medication × pain at dosing F (4, 3867.36) = 24.00, p < .001]. Conclusion Using an MSM (triptan or ergot) first was associated with the lowest migraine disability and highest acute medication satisfaction.

The migraine postdrome

Objective:To report migraine postdrome symptoms in patients who report nonheadache symptoms as part of their attacks.Methods:A prospective daily electronic diary study was conducted over 3 months in 120 patients with migraine. Nonheadache symptoms before, during, and after headache were collected on a daily basis. Visual analogue scales were used to capture the overall level of functioning and the severity of the headache. The postdrome was defined as the time from resolution of troublesome headache to return to normal.Results:Of 120 evaluable patients, 97 (81%) reported at least one nonheadache symptom in the postdrome. Postdrome symptoms, in order of frequency, included feeling tired/weary and having difficulty concentrating and stiff neck. Many patients also reported a mild residual head discomfort. In most attacks (93%), there was return to normal within 24 hours after spontaneous pain resolved. There was no relationship between medication taken for the headache and the duration of the postdrome. The severity of the migraine was not associated with the duration of the postdrome. Overall state of health scores remained low during the postdrome.Conclusion:Nonheadache symptoms in the postdrome were common and may contribute to the distress and disability in the patients studied. Postdrome symptoms merit larger observational studies and careful recording in clinical trials of acute and preventive migraine treatments.

Psychometric Evaluation of a New Patient-Reported Outcome (PRO) Symptom Diary for Varicose Veins: VVSymQ(®) Instrument.

ObjectiveTo evaluate the psychometric properties of the VVSymQ® instrument, a new 5-item patient-reported outcome (PRO) measure for symptoms of varicose veins.MethodThe VVSymQ® electronic daily diary was administered to outpatients who received routine treatment for varicose veins (N = 40). Compliance with diary administration and item score variability, reliability, construct validity, sensitivity to change, and clinically meaningful change were evaluated.ResultsPatients completed >97 % of scheduled diary assessments (at screening, baseline, and week 8). The VVSymQ® instrument captured patients’ pre-treatment symptoms (all VVSymQ® symptoms were endorsed by ≥75 % of patients at baseline), and the change post-treatment (mean change in score −6.1), with a large Cohen effect size (1.6). Test–retest reliability was high (intraclass correlation coefficient 0.96); internal consistency was good (Cronbach’s alpha ≥0.76; baseline, week 8). VVSymQ® scores were more strongly associated with PRO scores that reflect symptoms and symptom impact (the Venous Insufficiency Epidemiological and Economic Study—Quality of Life/Symptoms [VEINES-QOL/Sym] instrument and the Chronic Venous Insufficiency Quality-of-Life Questionnaire [CIVIQ-20]) than with PRO scores that reflect appearance (the Patient Self-Assessment of Appearance of Visible Varicose Veins [PA-V3]) or clinician-reported outcome scores (the Clinical–Etiology–Anatomy–Pathophysiology [CEAP] Classification of Venous Disorders and Venous Clinical Severity Score [VCSS]), demonstrating construct validity. Patients reporting that symptoms were “moderately” or “much improved” on the Patient Global Impression of Change (PGIC) anchor (i.e., >97 % of patients) had mean improvements of −6.3 VVSymQ® points, while a cumulative distribution curve showed that 50 % of patients improved by ≥−5.8 points; thus, a score change of approximately −6 demonstrated a clinically meaningful change in this study. The clinically meaningful change in the VVSymQ® score was greater in patients with a greater baseline VVSymQ® symptom burden, and the VVSymQ® instrument captured clinically meaningful treatment benefit even in patients with a low baseline symptom burden.ConclusionThe 5-item VVSymQ® instrument is a brief, psychometrically sound, useful tool for evaluating patient-reported varicose veins symptoms.

Impact of Data Imputation Methodology on Pain Assessment over 24 Hours in a Randomized, Placebo-Controlled Study of Gabapentin Enacarbil in Patients with Neuropathic Pain Associated with Postherpetic Neuralgia

To assess the impact of gabapentin enacarbil on primary and secondary pain endpoints using three data imputation methodologies in a randomized phase II study of adult patients with postherpetic neuralgia. The primary endpoint was change from baseline to end of maintenance treatment in mean 24-hour average pain intensity score. Secondary endpoints (daytime/nighttime average pain intensity score, daytime/nighttime current pain intensity score, and daytime/nighttime worst pain intensity score) were based on daily electronic diary assessments. Comparisons of each gabapentin enacarbil dose with placebo were performed using three different statistical methodologies: last observation carried forward, baseline observation carried forward, and mixed-effect model for repeated measures. Of the 376 randomized patients, 371 were in the intent-to-treat population (gabapentin enacarbil 1,200 mg, 107; 2,400 mg, 82; 3,600 mg, 87; placebo, 95). For mean 24-hour average pain intensity score, there were statistically significant improvements from baseline to end of maintenance treatment for all gabapentin enacarbil groups vs placebo using the three analysis methods. Significant improvements were also observed for all secondary endpoints with gabapentin enacarbil 1,200 mg using the three analysis methods. Most secondary endpoints also showed improvements following treatment with gabapentin enacarbil 2,400 mg or 3,600 mg compared with placebo. Gabapentin enacarbil (1,200 mg, 2,400 mg, and 3,600 mg) was effective and well tolerated in patients with postherpetic neuralgia compared with placebo, as confirmed by three different and robust statistical methodologies.

Anger arousal and behavioral anger regulation in everyday life among people with chronic low back pain: Relationships with spouse responses and negative affect.

To determine the degree to which anger arousal and anger regulation (expression, inhibition) in the daily lives of people with chronic pain were related to spouse support, criticism, and hostility as perceived by patients and as reported by spouses. Married couples (N = 105, 1 spouse with chronic low back pain) completed electronic daily diaries, with assessments 5 times/day for 14 days. On these diaries, patients completed items on their own anger arousal, anger expression, and inhibition, and on perceived spouse support, criticism, and hostility. Spouses reported on their responses toward patients and their negative affect. Hierarchical linear modeling tested concurrent and lagged relationships. Patient-reported increases in anger arousal and anger expression were predominantly related to concurrent decreases in patient-perceived and spouse-reported spouse support, concurrent increases in patient-perceived and spouse-reported spouse criticism and hostility, and increases in spouse-reported negative affect. Relationships for anger expression remained significant with anger arousal controlled. These effects were especially strong for male patients. Spouses reported greater negative affect when patients were present than when they were not. Social support may facilitate adjustment to chronic pain, with declining support and overt criticism and hostility possibly adversely impacting pain and function. Results suggest that patient anger arousal and expression may be related to a negative interpersonal environment for married couples coping with chronic low back pain.

Habitual exercise instigation (vs. execution) predicts healthy adults' exercise frequency.

Habit is thought to be conducive to health behavior maintenance, because habits prompt behavior with minimal cognitive resources. The precise role of habit in determining complex behavioral sequences, such as exercise, has been underresearched. It is possible that the habit process may initiate a behavioral sequence (instigation habit) or that, after instigation, movement through the sequence is automated (execution habit). We hypothesized that exercise instigation habit can be empirically distinguished from exercise execution habit and that instigation habit strength is most predictive of future exercise and reflective of longitudinal exercise behavior change. Further, we evaluated whether patterned exercise action-that is, engaging in the same exercise actions from session to session-can be distinct from exercise execution habit. Healthy adults (N = 123) rated their exercise instigation and execution habit strengths, patterned exercise actions, and exercise frequency in baseline and 1-month follow-up surveys. Participants reported exercise engagement via electronic daily diaries for 1 month. Hypotheses were tested with regression analyses and repeated-measures analyses of variance. Exercise instigation habit strength was the only unique predictor of exercise frequency. Frequency profiles (change from high to low or low to high, no change high, no change low) were associated with changes in instigation habit but not with execution habit or patterned exercise action. Results suggest that the separable components of exercise sessions may be more or less automatic, and they point to the importance of developing instigation habit for establishing frequent exercise.

Simvastatin Reduces Frequency of Vaso-Occlusive Pain in Sickle Cell Disease: A Pilot Efficacy Trial

BackgroundSicke cell disease is characterized by progressive vascular injury as a result of vaso-occlusion, ischemia-reperfusion and a sustained state of chronic Inflammation. Despite the broad impact of inflammation on acute and chronic clinical manifestations of SCD, no directed anti-inflammatory therapies for the treatment or prevention of vaso-occlusive events currently exist. Statins (3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors) have been shown to improve vascular function, independent of their lipid-lowering properties, by suppressing the inflammatory response to endothelial injury and restoring nitric oxide (NO) bioavailability. We previously documented a reduction in plasma biomarkers of inflammation and endothelial adhesion in SCD patients treated with short-term simvastatin. The objective of this study was to evaluate the potential clinical efficacy of simvastatin in reducing the frequency of vaso-occlusive pain in SCD.MethodsThis was a single-center, open-label, uncontrolled pilot trial. Subjects (Hb SS or S/beta0 thalassemia, >10 years of age) received once daily oral simvastatin (40mg) for 3 months. The primary outcome measure was frequency and intensity of vaso-occlusive pain, as recorded by daily electronic pain diaries, before and after simvastatin treatment. Clinical laboratory studies and plasma biomarkers (NO metabolites, hs-CRP, sVCAM-1, sICAM-1, sE-selectin, sVEGF) were evaluated at baseline, at 0.5, 1, 2 and 3 months during treatment and one month after discontinuation of simvastatin.ResultsA total of 24 subjects were enrolled (15F/9M; mean age= 19 yrs, range 10-34 yrs). Of these, 5 subjects dropped out (2 lost to follow up, 3 non-adherent to protocol) and 19 subjects completed the study. Simvastatin was well tolerated without toxicity. There were two SAE, unrelated to study drug and one AE, possibly related to simvastatin. Total cholesterol levels decreased by 10% (p=0.005) from baseline during the treatment period. There were no changes from baseline in other clinical safety laboratory parameters, including markers of hemolysis (hemoglobin (Hb), reticulocyte count, lactate dehydrogenase (LDH), total bilirubin). Average adherence with daily pain diaries was 73% (range, 47%- 97%). Pain rate (proportion of pain days) decreased by 32% (p=0.02) from baseline, while pain intensity did not change in response to treatment. The effect of simvastatin on soluble markers of inflammation was demonstrated by a 59% reduction in hs-CRP (p=0.003), 18% reduction in sE-selectin (p=0.01), 5% in sICAM-1 (p=0.03). Treatment with simvastatin had no effect on plasma levels of nitric oxide (NOx), sP-selectin, sVEGF.ConclusionsThese results, showing a reduction in the frequency of vaso-occlusive pain and a corresponding decrease in serum biomarkers of inflammation, provide preliminary clinical data to support a larger trial of simvastatin in SCD. DisclosuresStyles:Pharmacyclics LLC, an AbbVie Company: Employment.

Subject Recommendations for Improving Their Compliance and Engagement in Completing Daily Electronic Diaries in Osteoarthritis Clinical Trials

Subject Recommendations for Improving Their Compliance and Engagement in Completing Daily Electronic Diaries in Osteoarthritis Clinical Trials

The Communal Coping Model of Pain Catastrophizing in Daily Life: A Within-Couples Daily Diary Study

The Communal Coping Model characterizes pain catastrophizing as a coping tactic whereby pain expression elicits assistance and empathic responses from others. Married couples (N = 105 couples; 1 spouse with chronic low back pain) completed electronic daily diary assessments 5 times/day for 14 days. In these diaries, patients reported pain catastrophizing, pain, and function, and perceived spouse support, perceived criticism, and perceived hostility. Non-patient spouses reported on their support, criticism, and hostility directed toward patients, as well as their observations of patient pain and pain behaviors. Hierarchical linear modeling tested concurrent and lagged (3 hours later) relationships. Principal findings included the following: a) within-person increases in pain catastrophizing were positively associated with spouse reports of patient pain behavior in concurrent and lagged analyses; b) within-person increases in pain catastrophizing were positively associated with patient perceptions of spouse support, criticism, and hostility in concurrent analyses; c) within-person increases in pain catastrophizing were negatively associated with spouse reports of criticism and hostility in lagged analyses. Spouses reported patient behaviors that were tied to elevated pain catastrophizing, and spouses changed their behavior during and after elevated pain catastrophizing episodes. Pain catastrophizing may affect the interpersonal environment of patients and spouses in ways consistent with the Communal Coping Model. PerspectivePain catastrophizing may represent a coping response by which individuals’ pain expression leads to assistance or empathic responses from others. Results of the present study support this Communal Coping Model, which emphasizes interpersonal processes by which pain catastrophizing, pain, pain behavior, and responses of significant others are intertwined.

The Association of Pain With Smoking and Quit Attempts in an Electronic Diary Study of Cancer Patients Trying to Quit.

The purpose of this electronic daily diary study was to examine the relation of pain to smoking and quit attempts among 34 cancer patients with pain enrolled in a smoking cessation program. Electronic daily diary assessments of pain and smoking were collected at the end of each day for a 2-week period during smoking cessation treatment. Pain experienced throughout the day was measured on a scale from 1 to 5, from "no pain" to "pain as bad as you can imagine." Smoking was defined as the number of cigarettes smoked per day. Linear multilevel modeling was used in examining associations between pain and smoking. A within-person pain and smoking association was found, such that greater daily pain was linked to greater daily smoking within individuals, controlling for baseline symptoms, nicotine dependence, smoking urge, age, and gender. No between-person pain and smoking association was observed. Additionally, cancer patients with higher average pain across the 2-week assessment period were less likely to make a quit attempt (defined as a day on which participants smoked no cigarettes) during the study period. The findings of this study add to a nascent literature on pain and smoking by providing initial evidence that pain may be a barrier to quitting among cancer patients who smoke and have pain. Future research examining the effectiveness of integrated pain and smoking cessation treatment in this population may be warranted.

Anger arousal and behavioral anger regulation in everyday life among patients with chronic low back pain: Relationships to patient pain and function.

The objective of this study was to determine the degree to which patient anger arousal and behavioral anger regulation (expression, inhibition) occurring in the course of daily life was related to patient pain and function as rated by patients and their spouses. Married couples (N = 105) (one spouse with chronic low back pain) completed electronic daily diaries, with assessments 5 times/day for 14 days. Patients completed items on their own state anger, behavioral anger expression and inhibition, and pain-related factors. Spouses completed items on their observations of patient pain-related factors. Hierarchical linear modeling was used to test concurrent and lagged relationships. Patient-reported increases in state anger were related to their reports of concurrent increases in pain and pain interference and to spouse reports of patient pain and pain behavior. Patient-reported increases in behavioral anger expression were related to lagged increases in pain intensity and interference and decreases in function. Most of these relationships remained significant with state anger controlled. Patient-reported increases in behavioral anger inhibition were related to concurrent increases in pain interference and decreases in function, which also remained significant with state anger controlled. Patient-reported increases in state anger were related to lagged increases in spouse reports of patient pain intensity and pain behaviors. Results indicate that in patients with chronic pain, anger arousal and behavioral anger expression and inhibition in everyday life are related to elevated pain intensity and decreased function as reported by patients. Spouse ratings show some degree of concordance with patient reports.