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BACKGROUND: Cryoballoon ablation (CBA) as a first-line rhythm control strategy is superior to antiarrhythmic drugs (AADs) for preventing atrial fibrillation (AF) recurrence; the impact of first-line CBA on quality of life (QoL) and symptoms has not been well characterized. METHODS: Patients aged 18 to 75 with symptomatic paroxysmal AF naïve to rhythm control therapy were randomized (1:1) to CBA (Arctic Front Advance, Medtronic) or AAD (Class I or III). Symptoms and QoL were assessed at baseline, 1, 3, 6, 9, and 12 months using the EHRA classification and Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) and SF-36v2 questionnaires. Symptomatic palpitations were evaluated via patient diary. RESULTS: Overall, 107 patients were randomized to CBA and 111 to AAD; crossovers occurred in 9%. Larger improvements in the AFEQT summary, subscale and treatment satisfaction scores were observed at 12 months with CBA vs AAD (all P

BackgroundA recent systematic review and meta-analysis identified a paucity of randomised-controlled trials (RCTs) investigating the use of probiotics to reduce or prevent mucositis and infection in children with cancer.ObjectiveThis study evaluated the feasibility of undertaking an RCT and investigated the efficacy of probiotics for reducing or preventing mucositis and infection in children with cancers.SettingThe Paediatric Oncology and Haematology department at Leeds Teaching Hospital, UK.PatientsChildren aged 1 year or older, receiving chemotherapies likely to cause mucositis.InterventionsParticipants were randomised to receive the probiotic or placebo on day 1–14 of a chemotherapy cycle. Participants were also required to complete a patient diary for 21 days.Main outcome measuresTo assess whether it is feasible to recruit children diagnosed with cancer who are at risk of developing mucositis to an adequately powered RCT.ResultsBetween May and November 2019, 34 out of 39 eligible participants were approached. Ten patients were recruited (4 probiotic and 6 placebo) of which 2 participants withdrew. Seven participants partially completed the diary but only two participants completed 80% or more. Eligible participants appeared to prefer giving informal verbal feedback when in direct contact with research and healthcare professionals.ConclusionThis study demonstrated that recruitment needs to be improved prior to undertaking an adequately powered RCT.Trial registration numberNCT03785938.

Background Migraine is a prevalent and disabling headache disorder that affects more than 1.04 billion individuals world-wide. It can result in reduction in quality of life, increased disability, and high socio-economic burden. Nevertheless, and despite the availability of evidence-based national and international guidelines, the management of migraine patients often remains suboptimal, especially for chronic migraine (CM) patients. Methods My-LIFE anamnesis project surveyed 201 General practitioners (GPs) from 5 European countries (France, Germany, Italy, Spain, and the UK) with the aim of understanding chronic migraine (CM) patients’ management in the primary care setting. Results In our survey, GPs diagnosed episodic migraine (EM) more often than CM (87% vs 61%, p Conclusions There is a need of guidance in the primary care setting to both leverage the management of CM patients and earlier referral to specialists, when appropriate.

© 2020 The Authors. Annals of Clinical and Translational Neurology published by Wiley Periodicals LLC on behalf of American Neurological Association. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited., We describe the longest period of subcutaneous EEG (sqEEG) monitoring to date, in a 35-year-old female with refractory epilepsy. Over 230 days, 4791/5520 h of sqEEG were recorded (86%, mean 20.8 [IQR 3.9] hours/day). Using an electronic diary, the patient reported 22 seizures, while automatically-assisted visual sqEEG review detected 32 seizures. There was substantial agreement between days of reported and recorded seizures (Cohen's kappa 0.664), although multiple clustered seizures remained undocumented. Circular statistics identified significant sqEEG seizure cycles at circadian (24-hour) and multidien (5-day) timescales. Electrographic seizure monitoring and analysis of long-term seizure cycles are possible with this neurophysiological tool., This work was supported by the Epilepsy Foundation’s Epilepsy Innovation Institute My Seizure Gauge Project. MPR is supported by the NIHR Biomedical Research Centre; the MRC Centre for Neurodevelopmental Disorders (MR/N026063/1); the EPSRC Centre for Predictive Modelling in Healthcare (EP/N014391/1); the RADAR‐CNS project (www.radar‐cns.org, grant agreement 115902).

Aim Adherence to medication is important in older patients with non-communicable diseases, and there is a need to investigate various interventions to enhance adherence in our Indian setting. This pilot randomized controlled trial aimed at testing the effectiveness of systematic education and behavioral intervention in enhancing medication adherence among older adults. Methods It was a single center, open label, parallel arm, randomized controlled trial carried out among older (age >60 years) inpatients of general medicine wards diagnosed with select non-communicable diseases, such as diabetes, hypertension, dyslipidemia and coronary artery disease. Participants were randomized either to receive the usual standard of care or the intervention that comprises of systematic education, patient diary to mark daily medicine intake and periodic telephone reminders. Barriers to medication adherence were identified and interventions were tailored according to the identified barriers over a 6-month follow-up period. The primary end-points were change in the reported pill count (RPC) within groups and between groups at the third and sixth month. Results The RPC in control and intervention arms at the thrid month were 78.20% and 91.88% (P = 0.007), whereas at 6 months they were 68.64% and 83.08% (P = 0.003), respectively. Similarly, change in RPC in intervention arm between baseline and the third month (mean difference 24.08%, P = 0.001), and between baseline and the sixth month (mean difference 15.280%, P = 0.006) were statistically significant. However, the RPC between the third and sixth month showed a significant decline (mean difference 8.8%, P = 0.016). Conclusion In this pilot study, we prove that behavioral interventions have improved medication adherence among older adults, and it is feasible to carry out such studies among older adults in India. Geriatr Gerontol Int 2020; 20: 1079-1084.

Background Non-medical data, such as the amount of time that patients and caregivers spend managing their condition, may be relevant when assessing therapeutic strategies. For chronic pediatric conditions, the time that patients and caregivers spend in seeking and providing care (which are the indirect costs in an economic evaluation) can be significantly different depending on the treatment arm. To explore methods for collecting information on the care burden for caregivers and patients, we investigated whether a patient diary provided additional information compared to retrospective investigator-led interviews and whether a diary that was completed intermittently produced more or less information than a diary completed continually. The main objective of this study was to identify which type of data collection was most effective for measuring the time spent by caregivers and for estimating indirect treatment costs over 9 months. Methods Start-In! is a randomized controlled trial comparing the efficacy of three strategies of real-time continuous glucose monitoring for 12 months in children and adolescents with type 1 diabetes. We designed an ancillary study to assess methods of collecting information on the time spent by patients and caregivers in managing their condition (indirect costs). Data were entered retrospectively in case report forms (CRFs) by investigators during quarterly follow-up visits, which were supplemented with diaries completed prospectively by children or caregivers either continuously or intermittently. Data about absences from school and work as well as the time that caregivers spent on diabetes care were collected and the three collection methods were compared. Results At the end of the 9-month study, 42% of the study participants failed to return their diary. For the diaries that were received, less than 10% of expected data were collected versus 82% during investigators'interviews. Based on all the information collected, we calculated that over 9 months, caregivers lost on average 3.9 days of working time (€786) and 4 days of personal time, i.e. the equivalent of €526, and spent around 15 min of time on care per day, i.e. the equivalent of €1700. Conclusions The CRFs completed by investigators during quarterly visits cannot be replaced by a diary. Completing the diaries appeared to represent an important additional burden to children and their caregivers, and the diaries provided little additional information compared to investigators’ entries in the CRF. Trial registration ClinicalTrials.gov, NCT00949221. Registered on 30 July 2009. Registry name: Study of Insulin Therapy Augmented by Real Time Sensor in Type 1 Children and Adolescents (START-IN!).

Purpose In China, although insulin has been prescribed for decades, glucagon-like peptide 1 receptor agonists (GLP-1-RAs) have been available as an injectable treatment for patients with type 2 diabetes mellitus (T2DM) since 2009. GLP-1 RAs are listed as second-line treatment in the 2017 Chinese Guideline for patients with T2DM in whom prior oral antidiabetic therapy has failed. This study compares the baseline characteristics of Chinese patients with T2DM taking different prescriptions of first injectable therapy (GLP-1-RA or insulin). Methods The IQVIA Patient Diary Study database, which captures data from a patient medical record–based physician online survey, was the data source used in this study. Cross-sectional patient data were collected from hospitals in 15 major Chinese cities from June 1, 2016, to June 30, 2018. Adults with T2DM commencing either GLP-1-RA or insulin use as their first injectable antidiabetic therapy were included. Baseline demographic and clinical characteristics were compared between the GLP-1-RA and insulin treatment groups, using t tests and χ2 or Fisher exact tests. Findings Overall, 563 patients using GLP-1-RAs and 2387 using insulin were identified. In general, patients using GLP-1-RA were younger (mean [SD], 49.6 [10.8] years vs 59.3 [10.9] years), had lower mean (SD) glycosylated hemoglobin levels (8.5% [1.2%] vs 9.6 [1.7%]), had lower mean (SD) fasting plasma glucose levels (9.0 [1.9] mmol/L vs 10.8 [2.6] mmol/L), higher mean (SD) body mass indexes (29.4 [3.9] kg/m2 vs 24.6 [3.1] kg/m2), had higher comorbidity of obesity (75% vs 15%), had a higher occurrence of hyperlipidemia (63% vs 44%), and had lower occurrence of neuropathy (13% vs 34%) when compared with those using insulin (P Implications Significant differences were identified between selected baseline characteristics of patients initiating GLP-1-RA and insulin therapy, suggesting that these medicines are more likely to be prescribed to different types of patients with T2DM in China. These findings may help to inform Chinese physicians regarding the characteristics of those patients with T2DM who are initiating treatment with a GLP-1-RA or insulin. Because the Patient Diary Study data were collected from hospitals in 15 major cities in China, one noteworthy limitation is that the results may not represent the overall treatment pattern in rural areas of China.

Background Migraine affects 80.8 million people in Western Europe and is the first cause of disability among people between ages 15 and 49 worldwide. Despite being a highly prevalent and disabling condition, migraine remains under-diagnosed and poorly managed. Methods An international, online survey was conducted among 201 general practitioners (GPs) from 5 European countries (France, Germany, Italy, Spain and the UK) who are experienced in the management of headache disorders. Results The majority of GPs (82%) did not refer patients with chronic migraine (CM) to migraine specialists. Among those patients, the participants estimated that around 55% received preventive medication. Some differences between countries were observed regarding referral rate and prescription of preventive treatment. Most GPs (87%) reported a lack of training or the need to be updated on CM management. Accordingly, 95% of GPs considered that a migraine anamnesis guide could be of use. Overall, more than 95% of GPs favoured the use of a patient diary, a validated diagnostic tool and a validated scale to assess impact of migraine on patients’ daily life. Similarly, 96% of the GPs considered that the inclusion of warning features (red flags) in an anamnesis guide would be useful and 90% favoured inclusion of referral recommendations. Conclusions The results from this survey indicate that more education on diagnosis and management of CM is needed in primary care. Better knowledge on the recognition and management of migraine in primary care would improve both prognosis and diagnosis and reduce impact of migraine on patients’ lives, healthcare utilization and societal burden.

Background Subjective symptom complaints often do not match the expert’s ratings in focal dystonia. Nonetheless, perceived symptom intensities drive compliance and outcome of botulinum neurotoxin (BoNT) treatment. Methods Perception of symptom development across a BoNT cycle was obtained in 21 cervical dystonia (CD) and 15 hemifacial spasm (HFS) patients at four time points during a BoNT cycle. Subjective assessments were recorded by means of a quality‐of‐life questionnaire and a patient diary containing items related to subjective severity of disease, mood, pain, social impairment, and quality of life. Medical investigation used the Tsui score and TWSTRS, and a HFS rating score, respectively. Results In both patient groups, subjective intensities were strongly associated with psychological variables. Only in CD did objective assessment moderately correlate with subjective ratings solely at the beginning and the end of the BoNT cycle. Overall, the beneficial effects of BoNT treatment were only loosely associated with subjective experiences in both groups. Conclusion The emotional situation should be assessed regularly in patients undergoing BoNT therapy., Our study revealed that there was only moderate and no correlation of subjective and objective rating of symptom severity in cervical dystonia and hemifacial spasm, respectively, during a therapy cycle of Botulinum neurotoxin. Of note, no correlation was found at the intermediate time points when Botulinum neurotoxin therapy is supposed to work. However, subjective intensities were strongly associated with psychosocial variables in cervical dystonia and hemifacial spasm.

Flaminia Coluzzi,1,2 Domenico Alvaro,3 Augusto Tommaso Caraceni,4 Walter Gianni,5 Franco Marinangeli,6 Giuseppe Massazza,7 Carmine Pinto,8 Giustino Varrassi,9 Fabio Lugoboni10 1Department of Medical and Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, LT, Italy; 2Anesthesiology, Intensive Care, and Pain Medicine Unit, Sant’Andrea University Hospital, Rome, RM, Italy; 3Department of Translational and Precision Medicine, Gastroenterology Division, Sapienza University of Rome, Rome, RM, Italy; 4Palliative Care, Pain Therapy, and Rehabilitation Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, MI, Italy; 5Department of Internal Medicine and Geriatric Medicine, University Hospital Policlinico Umberto I, Rome, RM, Italy; 6Department of Anesthesiology, Pain Medicine, and Palliative care, University of L’Aquila, L’Aquila, AQ, Italy; 7Division of Physical Medicine and Rehabilitation, Department of Surgical Sciences, University of Turin and “Città della Salute e della Scienza” University Hospital, Torino, TO, Italy; 8Medical Oncology Unit, Clinical Cancer Center, AUSL-IRCCS of Reggio Emilia, Reggio Emilia, RE, Italy; 9Fondazione Paolo Procacci, Rome, RM, Italy; 10Department of Medicine, Addiction Unit, University Hospital of Verona, Verona, VR, ItalyCorrespondence: Flaminia ColuzziDepartment of Medical and Surgical Sciences and Biotechnologies, Sapienza University of Rome, Polo Pontino, Latina, Corso della Repubblica 79, Latina, LT, 04100, ItalyTel +39 06 33775673Email flaminia.coluzzi@uniroma1.itBackground: Opioid-induced constipation (OIC) remains an important clinical obstacle despite the availability of several guidelines and pharmacological options for its management. Here, we surveyed common practices and perceptions about OIC among physicians who prescribe opioids in Italy.Methods: The online survey included 26 questions about OIC. Responses were analyzed descriptively and aggregated by physician specialty.Results: A total of 501 physicians completed the survey. Most respondents (67%) did not feel adequately educated about OIC despite general consensus regarding interest in the topic. Overall, 62– 75% of physicians regularly evaluated intestinal function or OIC symptoms in patients receiving opioid therapy. The most common method for assessment was patient diary; few physicians used a validated instrument such as the Rome IV criteria. Psychiatrists and addiction specialists showed the lowest interest and poorest practices. Most respondents (78%) preferred macrogol prophylaxis followed by macrogol plus another laxative for first-line treatment of OIC symptoms. Peripheral-acting mu opioid receptor antagonists (PAMORAs) were not widely used among physicians; 61% had never prescribed a PAMORA for OIC.Conclusion: Our findings reveal important differences in clinical practice for OIC across physician specialties. Additional formative efforts are necessary to improve awareness about best practices in OIC.Keywords: chronic pain, opioid, opioid-induced constipation, peripherally acting mu opioid receptor antagonist

Background Home haemodialysis (HHD), has shown improved clinical outcomes, as well as a better quality of life, compared to conventional in-centre haemodialysis (ICHD) but still has a global low prevalence among end-stage renal disease patients. Haemodialysis (HD) patients tend to be sedentary but only few studies, mainly in North American ICHD patients, have evaluated the level of activity in HD patients. Methods SeCoIA is an observational, longitudinal, prospective, international, multicentric, study, conducted in metropolitan France and Belgium. The main objective of the study is to quantify the physical activity measured by the total daily number of steps, in HHD patients compared to ICHD patients. The SeCoIA study will include 80 HHD patients and 80 ICHD patients,. Secondary objectives will be to characterize the HHD population and to confirm HHD efficiency on clinical parameters, as well as quality of life (QoL), in current practice. Physical activity will be measured by a 3-axis accelerometer. Accelerometers have been shown to provide accurate information, on both physical activity and sedentary behaviour. Patients will be instructed to wear the device and complete a patient diary 7 consecutive days after inclusion and the first week of each month for 12 months. Decision to undergo HDD or ICHD is independent of the study and follow-up frequency remains at the discretion of the physician/centre. QoL and quality of sleep will be respectively assessed by the Kidney Disease Quality of Life 1.2 (KDQOL™) and the Pittsburg Sleep Quality index (PSQI) questionnaires at inclusion, 6- and 12-month visits. Patients presenting a restless leg syndrome (RLS) will also complete the International Restless Legs Syndrome rating scale (IRLS) questionnaire. Discussion The SeCoIA study will be the first large cohort study (160 patients) evaluating physical activity, objectively measured with a 3-axis accelerometer, in HHD versus ICHD patients. The present study will also include a comparison of QoL with a focus on RLS between HHD and ICHD. It is anticipated that HHD patients will have an improved physical activity and QoL which should encourage physicians to further promote HHD. Trial registration Clinical trial NCT03737578 study registered on November 9, 2018 (Retrospectively registered).

To investigate possible associations between rheumatoid arthritis (RA) patient-expressed preferences over anti-tumour necrosis factor (anti-TNF) treatment and clinical and patient-reported outcomes.PANORAMA was a non-interventional, prospective, multicentre, cohort study of 12 months duration, in patients with moderate-to-severe RA who initiated or switched to anti-TNF treatment. After initiation of anti-TNF, patients completed a preferences questionnaire on attributes related to anti-TNF treatment. Satisfaction with treatment was assessed with the Treatment Satisfaction Questionnaire for Medication (TSQM); compliance and persistence to treatment were recorded via a patient diary. Univariate and multivariate analyses were applied to assess correlations between patients' preferences over treatment with clinical and patient-reported outcomes.A total of 254 patients were enrolled; 66.1% (168/254) had highly active disease (DAS28-ESR 5.1), while 65.4% (166/254) were biological-naïve. The 12-month drug-survival rate was 72.3%, while the respective rates of good EULAR response and remission (DAS28-ESR 2.6) were 56.5% and 40.8%, respectively. By univariate analysis, fulfilment of patient preferences over treatment was associated with increased probability of remaining on therapy (p = 0.019), good EULAR response (p 0.001) and satisfaction with treatment (p 0.001). By multivariate analysis, fulfilment of patient preferences was the most important predictor for good EULAR response (OR 5.56, p 0.001; finding confirmed and after propensity scoring matching), while seropositivity (HR 1.18, p = 0.047) and a high ESR ( 35 mm/h, HR 1.16, p = 0.071) predicted drug survival.In anti-TNF-treated RA patients, fulfilment of treatment preferences was independently associated with a good EULAR response and correlated with drug persistence at 12 months, emphasising the importance of patient preferences in treatment outcomes. Key Points • In anti-TNF treated RA patients, fulfilment of patients' treatment preferences is associated with a good clinical response at 12 months. • A shared decision-making process can maximise treatment's outcome in anti-TNF treated patients.

Introduction: It is considered that the variability of respiratory symptoms in chronic obstructive pulmonary disease (COPD) is low or nonexistent; however, some authors state that there may be fluctuations. Objectives: To describe the variability of symptoms in patients with COPD throughout the day and night during four weeks using a patient diary, and to validate a questionnaire created for such purpose (the Colombian instrument for symptoms variability in COPD - COPD-CoVaSy). Materials and methods: Cohort study conducted in 96 patients with COPD treated between June and December, 2016, at the Centro de Atención Pulmonar - CAP, in Barranquilla, Colombia, who completed the patient diary for four weeks and, after this period, the self-administered COPD-CoVaSy instrument. The independence and comparison of frequencies of categorical and continuous variables were established using the chi-square and the Fisher's exact tests and the Pearson's correlation coefficient, respectively. A MANOVA was performed, using linear regression models, to determine the correlations between the results of the diary and those of the instrument. Results: Participants’ mean age was 73.3±8.3 years and 71.87% were male. According to the analysis of the diaries, the average scores (visual analog scale) for all symptoms and the performance of daily activities ranged between 0.5 and 2.5, being higher in the morning (with average scores between 1.5 and 2.5) than in the afternoon and evening (with average scores between 0.5 and 1.5); however, symptom variability was minimal. These results were similar to those obtained in the COPD-CoVaSy instrument, evidencing a high correlation between both instruments, which allowed confirming that COPD-CoVaSy is useful tool to measure such variability. Conclusions. Based on the findings of the present study, it can be concluded that there is a slight variability in COPD symptoms throughout the day, which should be considered when establishing treatment regimens for this disease. Likewise, it was determined that the COPD-CoVaSy is valid to measure such variability in Colombian patients with COPD.

Background: Knee osteoarthritis is a major cause of knee pain. Conservative therapy resources are limited due to adverse effects. Therefore, alternative non-invasive therapy approaches to reduce pain medications are gaining importance. The current study analyses if electrical auricular acupuncture (EAA) or low frequency modulated electric current therapy (LFMECT) could support analgesic treatment. Methods: In a randomized pilot trial patients with painful knee OA were treated with EAA (group 1) or LFMECT (group 2) additional to standard pharmacological analgesic treatment. In total 19 female and 10 male patients with a mean age of 59.1 years (standard deviation &plusmn, 13.6) and a mean BMI of 28.9 kg/m2 (&plusmn, 5.2) were included. Patients were randomly assigned to one of the groups stratified for age, gender and BMI. Before starting of the active study period and collecting of the initial data on day 1, all patients received a pharmacological analgesic baseline therapy for one week. At the next study stage patients started their randomly assigned treatment protocol for 42 days and final follow-up was set on day 70. Patients recorded their pain intensity (numerical rating scale, NRS) using a standardized patient diary. The pain free walking time in min was recorded and range of motion was assessed. Results: Rescue medication intake was comparable between both groups on day 42 (p = 0.55) and day 70 (p = 0.35). After the active study period (day 42) pain scores decreased significantly in both groups (group 1 p = 0.02, group 2 p = 0.0006). At follow up median pain scores further decreased in group 1 (p = 0.0002) and remained at a low level in group 2 (p = 0.001). Level of pain decreased in about 50% in both groups and was comparable during the study period. Total mean range of motion (ROM) increased in both groups (group 1 p = 0.0003, group 2 p = 0.02). Group 1 had more improvement of mean total ROM compared to group 2 (p = 0.034). Pain-free walking time increased in both groups and was comparable between both groups (p = 0.31). Any adverse effects due to EAA or LFMECT were not observed. Conclusions: Data of the current study indicates that implementation of EAA or LFMECT seems to be beneficial to reduce knee pain and improve knee function in patients with knee osteoarthritis.

Background Patients with cancer are at significantly higher risk of developing, and dying from, venous thromboembolism (VTE). The CLOT and CATCH trials demonstrated the superiority of low-molecular-weight heparins (LMWH) over warfarin for recurrent VTE and established LMWH as the standard of care for cancer-associated VTE. Purpose The aim of the present study was to determine the number of admissions and the cost of the management of VTE events occurring in patients with lung cancer (LC) or prostate cancer (PC). Material and methods This was a multicentre, observational, ambispective pharmacoeconomic study involving six third-level hospitals. Patients with LC or PC who had suffered a first episode or a recurrent symptomatic or incidental VTE recurrence and who were receiving treatment with LMWH were included. The data was collected through medical records and/or the discharge reports, as well as the information provided by the patient during the study visit as well as the information the patient collected in their patient diary during the follow-up period. All hospitalisations and ambulatory cost related to VTE (primary diagnosis or related diagnosis) were recorded. Anticancer therapy was not collected. Costs were estimated through the consumption of resources collected in the eCRF and derivatives of the information from the patient’s diaries associated with the handling of the episode of VTE. Results Fifty-five patients were included from October 2017 to April 2018. The last patient visit was recorded in October 2018. The results will be presented during the EAHP 2019. Conclusion Among the solid tumours with higher absolute risk of VTE are PC and LC that in our country represented the second and third most prevalent cancer according to the GLOBOCAN 2012 report. VTE represents a great economic burden on health systems and society, mainly due to the treatment of initial and recurrent events that require hospitalisation. References and/or acknowledgements No conflict of interest.

Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system requiring long-term treatment, which is often hampered by non-adherence to self-applicable therapies, provoking continued disease activity and health care system burdens. This study assessed the influence of a personal digital assistant (PDA) with diary function (n = 339 patients) on persistence and adherence to an interferon beta treatment regimen in comparison to a paper patient diary (n = 330 patients).Patients who recently started with subcutaneous injections of interferon beta-1b were recruited in this prospective, non-interventional, national cohort study for an observational period of 2 years after successful completion of the initial dose escalation.Therapy persistence as assessed by the drop-out rate within 104 weeks was about 50% in both study cohorts. In male patients, the drop-out rate was 10% lower when using a PDA compared to the non-PDA group. Use of a PDA with an injection reminder function increased adherence to the injection schedule (every other day) by a mean of 24.5 injections over 24 months in comparison to use of a PDA without injection reminder function.Persistence in this study was in the published range of observational MS studies. Furthermore, in male patients continuation of therapy might be positively influenced by use of a PDA, and both female and male patients might benefit from an integrated reminder function. In conclusion, electronic diaries reminding patients of upcoming injections can promote an improved adherence to MS therapy.ClinicalTrials.gov identifier: NCT00902135.Bayer Vital GmbH.

Introduction: Individuals with sickle cell disease (SCD) experience vaso-occlusive crises (VOCs) - acute episodes of severe pain caused by vaso-occlusion. Vaso-occlusion typically causes complications, including ischemic damage to tissues resulting organ failure (Piel 2017). Historically, VOC events were assessed only through medical utilization, thereby excluding events managed by patients strictly at home. Thus, many VOC events are never recorded in the medical system, and the treatment benefit of new SCD therapies may be underestimated when relying on medical utilization alone. Objective: The goal was to develop and validate a daily diary for patients with SCD to accurately report their VOC status. Methods: A pilot patient diary was developed from qualitative interviews with patients with SCD and their caregivers and implemented as an electronic daily diary (eDiary) in a longitudinal, 6-month, non-interventional Phase 0 study of pain biomarkers in adolescents and adults (ELIPSIS Study; Callaghan et al 2017). The eDiary included a description of SCD pain crisis, which was followed by questions on: 1) pain crisis in the past 24 hours (ie, VOC Day question); 2) worst pain; 3) tiredness; and, 4) ability to perform usual physical activities. If a patient responded "yes" to the VOC Day question, they were asked how they treated their pain (eg, emergency room, hospitalized, called or visited doctor, treated self at home). Interviews were conducted among patients and caregivers in ELIPSIS to evaluate their understanding of the eDiary. All face-to-face interviews followed a semi-structured interview guide, were audio-recorded, and transcribed. Qualitative interview data were analyzed using content analysis. Quantitative analyses were conducted using the ELIPSIS data. A VOC Day was recorded when a patient responded "yes" to the VOC Day question. A VOC event was a sequence of VOC Days that could also include single intervening days with no reported pain crisis. Each VOC event was classified by the highest level of treatment received during the event. Psychometric analysis of the ELIPSIS data was performed to validate the VOC Day concept. Mean symptoms and activities scores on the first or last VOC Day of an event were compared using t-tests with the mean of the 3 non-VOC days: 1) prior to the first reported VOC Day of an event, or 2) following the event to examine each score's sensitivity to change in patient VOC status. Results: Thirty-five patients with SCD (mean [± SD] age 24.7 [± 9.5] years) participated in ELIPSIS; 51.4% were female. A majority (62.3%) of VOC events in ELIPSIS were treated at home, while 18.4% culminated in a hospitalization, 17.5% resulted in direct healthcare utilization, and the remaining patients (1.8%) had indirect healthcare utilization. Thirty-one patients reported ≥ 1 VOC Day. The mean number of VOC Days per patient was 11.2 ± 19.3 (1.0-91.0), and mean duration of VOC events was 2.7 ± 3.3 days (1.0-14.7). Mean severity of symptoms and activities scores on all VOC Days compared to all non-VOC Days were higher (worst pain: 7.6 vs. 2.6; tiredness: 6.3 vs. 4.1; usual physical activities: 3.6 vs. 2.6), with significant mean differences between first/last VOC Days and respective 3 non-VOC Days (all p Fifteen SCD patients and 9 caregivers completed an interview following ELIPSIS. Nearly all (93% of patients; 89% of caregivers) confirmed that the eDiary definition of pain crisis accurately described the experience of a SCD pain crisis, and participants expressed confidence in differentiating SCD crisis pain from everyday pain. Conclusions: These results demonstrate that patients can reliably report their experiences with VOC-related pain crises on an eDiary by responding to the VOC Day question. Qualitative data demonstrated that ELIPSIS patients: 1) differentiated between everyday pain and SCD crisis pain, and 2) endorsed the SCD pain crisis description included in the eDiary. The high proportion of patient-reported VOC events treated at home indicates that relying on operational VOC definitions requiring medical utilization results in a substantial number of missed VOC events. By broadening the VOC definition to include patient-reported, non-medical utilization VOC events, future studies can evaluate the impact of new therapies and their efficacy in reducing VOC events. The daily VOC Day question is a critical tool for capturing the VOC experience of patients with SCD. Disclosures Coyne: Evidera: Current Employment; Pfizer: Consultancy. Currie:Evidera: Current Employment; Pfizer: Consultancy. Callaghan:Pfizer: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Site Investigator/sub-I Clinical Trial, Research Funding; Alnylum: Current equity holder in publicly-traded company; Bioverativ: Membership on an entity's Board of Directors or advisory committees; Octapharma: Honoraria, Membership on an entity's Board of Directors or advisory committees; Biomarin: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Site Investigator/sub-I Clinical Trial, Speakers Bureau; Sancillio: Other; Hema Biologics: Honoraria, Membership on an entity's Board of Directors or advisory committees; NovoNordisk: Other, Speakers Bureau; Bayer: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Global Blood Therapeutics: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other, Speakers Bureau; Grifols: Honoraria, Membership on an entity's Board of Directors or advisory committees; Spark: Honoraria, Membership on an entity's Board of Directors or advisory committees; Roche/Genentech: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Site Investigator/sub-I Clinical Trial, Speakers Bureau; Shire: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau. Wyrwich:Pfizer: Current Employment, Current equity holder in publicly-traded company. Pease:Pfizer: Current Employment, Current equity holder in publicly-traded company. Baker:Pfizer: Current Employment, Current equity holder in publicly-traded company. Arkin:Pfizer: Current Employment, Current equity holder in publicly-traded company, Other: own stock/options in the company. Pittman:Pfizer: Current Employment, Current equity holder in publicly-traded company.

A 44-week, multinational RCT compared efficacy, safety, and subject preference for bolus insulin initiation using a wearable bolus insulin delivery patch (Patch, Calibra Medical) vs. an insulin pen (Pen, NovoLog FlexPen®) in 278 T2D subjects on basal insulin (0.52 U/kg) (A1C: mean ± SD, 8.7% ± 1.0, BMI: 32.6 kg/m2, duration: 15 y), using insulin titration algorithms incorporated into a patient diary. At randomization, basal insulin dose was divided 1:1, basal:bolus. Subjects used SMBG patterns weekly to adjust insulin doses. The diary also included algorithms for adjusting bolus insulin at each meal if SMBG was above or below target and if meal size was larger or smaller than usual. At 44 weeks there was significant (p In summary, by making weekly insulin adjustments based on simple algorithms embedded in a patient glucose diary, T2D subjects can significantly improve A1C values and 7-point glucose profiles. Disclosure M.L. Johnson: Research Support; Self; Calibra Medical, Medtronic, Sanofi, Novo Nordisk Inc., Abbott, POPS! Diabetes Care, National Institute of Diabetes and Digestive and Kidney Diseases, Dexcom, Inc., Hygieia, JDRF. D.M. Dreon: Employee; Self; Calibra Medical. B.L. Levy: Employee; Self; LifeScan, Inc. R.M. Bergenstal: Research Support; Self; Johnson & Johnson Services, Inc.. Consultant; Self; Johnson & Johnson Services, Inc.. Research Support; Self; Abbott. Advisory Panel; Self; Abbott. Research Support; Self; Becton, Dickinson and Company. Consultant; Self; Becton, Dickinson and Company. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., AstraZeneca, Takeda Pharmaceuticals U.S.A., Inc., Dexcom, Inc.. Stock/Shareholder; Self; Merck & Co., Inc.. Research Support; Self; Eli Lilly and Company, Sanofi. Advisory Panel; Self; Sanofi, Roche Pharma. Research Support; Self; Novo Nordisk Inc.. Advisory Panel; Self; Novo Nordisk Inc.. Research Support; Self; Medtronic. Consultant; Self; Medtronic. Research Support; Self; Hygieia. Advisory Panel; Self; Hygieia, Glooko, Inc.. Research Support; Self; JAEB Center For Health Research, JDRF, National Institute of Diabetes and Digestive and Kidney Diseases.

Background Route and frequency of administration of treatment options may be an important differentiator between drugs that are used to treat RA and patient preferences may influence adherence to and outcomes of therapy. Objectives The objective of this study was to assess the correlation between the fulfillment of patient preferences and clinical and patient reported outcomes. Methods PANORAMA was a non-interventional, prospective, multicenter, cohort study. Patients were either biologic naive or experienced who initiated/switched to anti-TNF at enrollment. Post physician9s anti-TNF choice, patients completed a preferences questionnaire over attributes related to anti-TNF treatment. Satisfaction with treatment was assessed with the TSQM questionnaire and compliance (proportion of full doses/planned) was recorded via the use of a patient diary. Persistence was defined as the time period between first and last anti-TNF administration. The observational period was 12 months, with study visits every 3 months. Results A total of 254 patients were enrolled in the study. The mean patient age was 58.3±13.4 years, 82.7% were female, 65.4% were biologic naive and 66.1% had severe disease (DAS-28 ESR>5.1).The mean DAS-28 and HAQ-DI scores at enrollment were 5.5±1.1 and 1.4±0.6 respectively, while mean disease duration was 6.7±6.2 years with 53.2% of patients being seropositive (RF (+):49.2%, Anti-CCP (+): 40.5%). A monthly administration was most preferred by patients (65.7% vs. 20.1% for twice per month, 11.8% for once per week and 3.9% for twice per week), and the large majority of patients (75.2%) preferred the subcutaneous mode of administration. The mean compliance and 12-month persistence rates were 97.0% and 72.3% respectively. At 12 months, good EULAR response rate was achieved by 56.5% of patients and 40.8% were in DAS-28 remission. Univariate analysis demonstrated that fulfillment of patient preferences was correlated to good EULAR response (p 35 mm/h (HR 0.587, p=0.071)). Conclusions In anti-TNF treated RA patients, fulfillment of expressed treatment preferences was independently associated with a good EULAR response and correlated with drug persistence at 12 months, emphasizing the importance of patient preferences in treatment outcomes. Acknowledgements The study was funded by Merck Sharp & Dhome S.A., Greece Disclosure of Interest None declared

SUMMARY Objective: To assess the usefulness of a patient diary card of symptoms for monitoring the evolution of an exacerbation of chronic bronchitis (CB) and chronic obstructive pulmonary disease (COPD) in primary care. Method: Multicentre, observational study. Patients with an exacerbation filled out a diary every day before bedtime during 10 days. The diary score ranged from 0 (best) to 28 (worst). A visit was performed at day 15 to collect the patient diaries. Results: Of the 1101 patients studied 921 returned the diaries (83.7%). Clinical failure was found in 236 patients (25.6%). The mean global score on day 1 was 21.5 ± 3.8. Patients considered as cured at day 10 presented a lower score at day 1 (21.1 ± 3.9) vs. those who failed (22.6 ± 4.2; p < 0.001). When no reduction was observed in the score from days 1 to 3, the percentage of failures was 36.1%, being only 11.6% with a reduction of 5 points or more (p < 0.001). The strongest correlation with failure was observed with general status, breathing, symptom scale and the need for extra inhaler doses. Conclusion: A symptom diary card seems to be a valuable tool to monitor the evolution of an acute exacerbation of CB ⁄COPD in primary care. What’s known The use of symptom diaries has been shown to help physicians monitor patient progress. However, the prognostic value of the changes in diary scores during an exacerbation of chronic bronchitis and chronic obstructive pulmonary disease has seldom been assessed.

Summary Introduction Migraine is a complex disorder of the brain characterized by severe headache, photophobia, phonophobia, and nausea. This case report demonstrated the reduction of a 49-year-old female's chronic migraine symptoms after 12 weeks of Vojta/Dynamic Neuromuscular Stabilization (DNS) therapy. Methods Vojta/DNS treatment occurred either in the office or at home over a 12-week period. Symptoms were tracked via a patient diary, a VAS pain scale, and a Headache Disability Index (HDI). Results The patient's migraine symptoms were typically of 3 days duration, a frequency of 8–10 times per month, and an intensity of 10/10 on a VAS pain scale. After a 12-week trial of Vojta/DNS care, subjective improvements were noted, with a reduction in frequency to 1–2 times per month, duration of 12h at most, and decreased intensity to a 2/10 on a VAS pain scale. HDI scores dropped from 48% to 34%. Discussion This therapy reduced the patient migraine sysmptoms in frequency, duration and intensity. This therapy is not well-known in North America despite its use for over 40 years in Europe. Conclusion This case demonstrated that Vojta/DNS treatment over a 12-week period helped manage the patient's migraines and could be a possible treatment option for future research.

Background There is a need for a standardized, valid, and reliable instrument for quantifying exacerbations of COPD. The objective of this study was to identify symptom items that characterize COPD exacerbations to form a new patient diary for evaluating exacerbation frequency, severity, and duration. Methods Twenty-three symptom items identified from patient interviews were administered to 410 patients with COPD aged (mean ± SD) 65 ± 10 years with stable FEV 1 of 51% predicted ± 20% predicted and 1.8 ± 1.8 exacerbations in the preceding 12 months. A total of 222 patients had a physician-diagnosed exacerbation; 188 were stable. Item-level analyses (floor and ceiling effects, criterion keying, item-total correlation) were used in the first stage of item reduction. Further reduction was conducted using Rasch model and descriptive item analyses. Exploratory factor analysis was performed on the items that survived the exclusion process. Results No item behaved differently between stable and exacerbation conditions. One item was removed after item-level analysis, and eight were removed following Rasch analysis. Together, the surviving 14 items met the criteria for a unidimensional measure of exacerbation severity. Internal consistency (person separation index) was excellent at 0.92. Post hoc exploratory factor analysis revealed one dominant factor, with three domains (breathlessness, cough and sputum, and chest symptoms) that accounted for 68% of the variance. Conclusions An exacerbation appears to be a quantitative rather than qualitative change from the stable state. This analysis identified a range of symptoms that form a unidimensional construct of overall exacerbation severity. The 14 items identified form the Exacerbations of Chronic Pulmonary Disease Tool (EXACT), a daily diary for detecting and quantifying exacerbation severity in COPD.

Aliment Pharmacol Ther 2011; 33: 1028–1035 Summary Background Rapid resolution of rectal bleeding and stool frequency are important goals for ulcerative colitis therapy and may help guide therapeutic decisions. Aim To explore patient diary data from ASCEND I and II for their relevance to clinical decision making. Methods Data from two randomised, double-blind, Phase III studies were combined. Patients received mesalazine (mesalamine) 4.8 g/day (Asacol 800 mg MR) or 2.4 g/day (Asacol 400 mg MR). Time to improvement or resolution of rectal bleeding and stool frequency was assessed and the proportion of patients experiencing symptom improvement or resolution at day 14 evaluated using survival analysis. Symptoms after 14 days were compared to week 6. A combination of prespecified and post hoc analyses were used. Results Median times to resolution and improvement of both rectal bleeding and stool frequency were shorter with 4.8 g/day than 2.4 g/day (resolution, 19 vs. 29 days, P = 0.020; improvement, 7 vs. 9 days, P = 0.024). In total, 73% of patients experienced improvement in both rectal bleeding and stool frequency by day 14 with 4.8 g/day, compared to 61% with 2.4 g/day. More patients achieved symptom resolution by day 14 with 4.8 g/day than 2.4 g/day (43% vs. 30%; P = 0.035). Symptom relief after 14 days was associated with a high rate of symptom relief after 6 weeks. Conclusions High-dose mesalazine 4.8 g/day provides rapid relief of the cardinal symptoms of moderately active ulcerative colitis. Symptom relief within 14 days was associated with symptom relief at 6 weeks in the majority of patients. Day 14 is a practical timepoint at which response to treatment may be assessed and decisions regarding therapy escalation made (Clinicaltrials.gov: NCT00577473, NCT00073021).

Postoperative pain is a concern for patients seeking hemorrhoid surgery. Stapled hemorrhoidopexy is popular due to better patient-reported outcomes (PROs). Pain is the index of PROs. Posthemorrhoidectomy patients usually opt for a spice-free diet due to fear of pain or anal pruritus induced by spices. Curcumin and peprin (spice constituents) have powerful antiinflammatory and antioxidant properties. Ability to resume a normal taste-habituated meal may improve PRO quality of life. Thus, spice-related paradoxic conservatism in stapled hemorrhoidopexy, which involves no open wound, needed to be studied. A prospective open-ended study (July 2008 to August 2009) investigated consecutive candidates for day-care stapled hemorrhoidopexy randomized by the date of birth method into a controlled group (receiving a spices-free diet) and a study group (receiving a spicy diet) after an ethics and informed consent protocol. A standard perioperative protocol was followed. At discharge, the patients were advised to resume a normal diet (spicy or bland) and instructed to maintain a pain diary (100-point visual analog scale [VAS]) and an analgesic diary. Paracetamol 650 mg was used for pain exceeding a VAS score of 25. Patients were followed on day 3 and weeks 1 and 3. Failure to be discharged from day care, failure to maintain patient diary, and squamous epithelium in the rectal donut were the withdrawal criteria. A total of 67 patients were randomized. The groups were well matched for demographics, comorbidities, types of anesthesia, hemorrhoidal grades, and withdrawal. Statistically significant improvement in PROs (P

OAKLEY C., JOHNSON J. & REAM E. (2010) European Journal of Cancer Care19, 21–28 Developing an intervention for cancer patients prescribed oral chemotherapy: a generic patient diary Oral chemotherapy is playing a prominent role in the development of new cancer treatments. Research suggests that although oral chemotherapy is viewed as easier to manage and more cost effective than intravenous alternatives, patients do not always find it easier to cope with. The research reported in this paper comprised three phases, a review of the literature, an ethnographic study and a feasibility study. The ethnographic study focused on the experience of patients undergoing oral chemotherapy and demonstrated that patients, carers and family members found managing the treatment challenging. Many highlighted that a patient held diary would assist them with maintaining adherence, recording doses taken and identifying side effects. The authors worked closely with stakeholders, including patients, to corroborate what key elements should be included in such a diary. A generic diary was then introduced into clinical practice and its acceptability explored through a feasibility study. The results of this study showed that patients found the diary effective and useful. Trends emerged showing an association between effective symptom management and increased self-efficacy. The research also highlighted that the diary should be supported by a model of care to enhance education and reiterate information. Use of the diary, and a model of care to support it, could enable concerns highlighted about patient safety and the risks associated with oral chemotherapy to be addressed.

Summary. On-demand or prophylactic home-treatment is currently the treatment of choice for haemophilia patients. To allow physicians to monitor the amount of factor concentrates administered, the patients document each factor injection in a paper-diary. Nevertheless, because of the fact that most patients visit their physicians only two to four times a year, there could be considerable delay in detecting medication problems. The aim of this pilot study was to assess whether an electronic documentation tool could successfully replace traditional paper-diaries for haemophilia A patients and enable the physician to have a timely overview of the patient’s treatment. An electronic, hand-held documentation tool, Haemoassist™, was developed. In this study, patients using prophylaxis and on-demand therapies documented their factor consumption both electronically and on paper-diaries. Documentations were compared and descriptively evaluated. Patients also completed a survey to evaluate the feasibility and gather their opinions on the Haemoassist™ system. Ten patients from two haemophilia treatment centres in Germany submitted a total of 548 records via hand-held device during the observation period, from March 2006 to February 2007. Comparison of electronic and paper-based records showed differing responses among patients with some patients entering more electronic and some others more paper-based documentations. In the questionnaires on feasibility and usefulness of Haemoassist™, three patients preferred the electronic tool, two patients wanted to continue using paper-based diaries, and one had no preference. The study shows that an electronic documentation system is feasible for haemophilia patients and provides the physician with the opportunity to more closely monitor patients. However, not all patients seem to be qualified for using an electronic tool, and the tool has to run reliably without major errors for ensuring reliability and acceptability. In the future, Haemoassist™ might support quality assurance in haemophilia treatment and improve guidance in the home-care setting.

Objectives To evaluate the reliability, responsiveness, and validity of a four-graded symptom severity scale (none, mild, moderate, severe) and an eight-graded frequency scale (number of days with symptoms during past week) for assessment of heartburn severity and frequency in patients with symptoms of heartburn but without esophagitis. Methods Data were taken from two 4-week clinical trials comparing esomeprazole 20 mg and/or 40 mg to omeprazole 20 mg. Both scales were analyzed in terms of mean scores and treatment success rates, after dichotomization to "treatment success" variables. Results Heartburn severity reliability was higher when assessed by patient diary cards than by the investigator (intraclass correlation coefficients were 0.79 and 0.59, respectively; corresponding figures for heartburn frequency were 0.77 and 0.78). There was good agreement between investigator and diary card assessments for the dichotomized variables "complete resolution" and "adequate relief" from heartburn. High correlation between investigator- and diary card-assessed heartburn severity and frequency was apparent. Responsiveness was high, as shown by comparing 4-week treatment success rates to the patients' perception of treatment effect according to the Overall Treatment Effect questionnaire. Construct validity was good (kappa values approximately 0.70 for agreement between complete resolution and the dichotomized Gastrointestinal Symptom Rating Scale [GSRS] Heartburn item). Correlations between heartburn severity and frequency and the GSRS Heartburn item were similarly high. Conclusion The four-graded heartburn severity and eight-graded frequency scales are reliable, responsive, and valid when used in clinical trials of patients with symptoms of gastroesophageal reflux disease, irrespective of the type of assessment (investigator assessment or patient diary cards).

Summary Introduction Migraine is a prevalent neurological disorder that can be alleviated by specific treatment for acute headaches, in particular, the triptans, including naratriptan. France has developed official guidelines for the use of triptans as part of migraine management. This pharmacoepidemiological study sought to evaluate how naratriptan is prescribed and used in community medicine in France. Methods The protocol called for general practitioners to be randomly selected from a list of all physicians in France and for each to include two patients with migraine. Data came from questionnaires completed by the physician and by the patient (including HIT-6 and QVM to assess headache impact and quality of life) as well as a patient diary. Results In all, 2530 physicians included 3863 patients: 54.3% were treated with naratriptan, 22.4% with another triptan and 23.3% with a non-triptan medication. Of the patients receiving naratriptran, 82.3% were women. Migraine impact was greater and quality of life worse in the patients receiving triptans than those treated with other medications (p Discussion Data from this cross-sectional study indicate that triptans in general and naratriptan in particular are most often prescribed for patients with the most severe migraines. Consistent with official French guidelines, physicians often recommend taking naratriptan after and only if a NSAID fails to provide relief. Nonetheless, one patient in three starts treatment late, which may significantly reduce the efficacy rate, increase the risk of recurrence and side effects, and prolong the headache. Conclusion Naratriptan is generally prescribed in accordance with official guidelines. Delay in taking medication by around one third of patients probably reduces its efficacy.

Traumatic brain injury (TBI) is a growing health concern affecting civilians and military personnel. In this review, treatments for the chronic TBI patient are discussed, including pharmaceuticals, nutraceuticals, cognitive therapy, and hyperbaric oxygen therapy. All available literature suggests a marginal benefit with prolonged treatment courses. An emerging modality of treatment is near-infrared (NIR) light, which has benefit in animal models of stroke, spinal cord injury, optic nerve injury, and TBI, and in human trials for stroke and TBI. The extant literature is confounded by variable degrees of efficacy and a bewildering array of treatment parameters. Some data indicate that diodes emitting low-level NIR energy often have failed to demonstrate therapeutic efficacy, perhaps due to failing to deliver sufficient radiant energy to the necessary depth. As part of this review, we present a retrospective case series using high-power NIR laser phototherapy with a Class IV laser to treat TBI. We demonstrate greater clinical efficacy with higher fluence, in contrast to the bimodal model of efficacy previously proposed. In ten patients with chronic TBI (average time since injury 9.3 years) given ten treatments over the course of 2 months using a high-power NIR laser (13.2 W/0.89 cm2 at 810 nm or 9 W/0.89 cm2 at 810 nm and 980 nm), symptoms of headache, sleep disturbance, cognition, mood dysregulation, anxiety, and irritability improved. Symptoms were monitored by depression scales and a novel patient diary system specifically designed for this study. NIR light in the power range of 10–15 W at 810 nm and 980 nm can safely and effectively treat chronic symptoms of TBI. The clinical benefit and effects of infrared phototherapy on mitochondrial function and secondary molecular events are discussed in the context of adequate radiant energy penetration., Video abstract

Objectives To describe the development of an enhanced recovery after surgery (ERAS) protocol for people undergoing surgery for head and neck cancer. Design Service improvement project. Participants Head and neck oncology patients. Methods The programme was developed in a series of structured meetings over a 6-month period. Stakeholders included oral and maxillofacial surgeons, otolaryngologists, anaesthetists, dieticians, physiotherapists, speech and language therapists (SALT) and nursing staff. Based on evidence within current literature and a consensus among the group, an ERAS programme for head and neck surgery patients was formulated. A 12-month study of compliance with the ERAS programme was undertaken from February 2014 to January 2015. Results The process has resulted in the realisation of a head and neck ERAS programme. Key elements include a patient diary, nutritional optimisation, avoiding tracheostomy when possible, goal-directed fluid therapy intra-operatively and a specific head and neck postoperative pain management protocol. Overall compliance was high. Important areas showed lower levels of compliance – only 55% of people were given an explanation of the ERAS programme preoperatively, 75% took preoperative carbohydrate drinks, 10% had individualised goal-directed fluid therapy, and 7% were mobilised in the first 24 h after surgery. The mean length of hospital stay was 14.55 days (sd 7.48). Conclusions The ERAS programme developed is now embedded in the care pathway for people undergoing head and neck cancer surgery in our unit. The mean length of hospital stay has reduced since the introduction of the programme.

Xiao and colleagues in China reported successful restoration of bladder control in patients with spinal cord injury (SCI) by establishing a somatic-autonomic reflex pathway through lumbar-to-sacral ventral root nerve rerouting. We evaluated long-term results in eight patients who underwent this procedure at a German university clinic between 2005 and 2007. The primary outcome was the occurrence of voiding upon stimulation of the skin, with normalization of bladder pressure when filling, as assessed with videourodynamics at each visit. Videourodynamic variables, urinary tract infections, and bladder/stool events recorded in a patient diary were stored in a prospective database and reviewed retrospectively. Intraoperative testing indicated successful nerve rerouting in all eight patients. Duration of follow-up was 71 mo (range: 56–86). No patient reached the primary goal of voluntary voiding with normalization of detrusor pressure at any point during follow-up. No improvements in videourodynamic or diary variables regarding bladder function were observed. In view of the lack of short (12–18 mo) and long-term (71 mo) success in our patients and others, the risks of any surgical procedure using general anesthesia, and potential for unmet expectations to wreak havoc on patient emotional well-being, we cannot recommend this procedure for patients with SCI. Patient summary Although the hope was to improve long-term outcomes of spinal cord injury patients, intraspinal nerve rerouting did not improve or normalize bladder function. In view of the lack of success, we cannot recommend this procedure until proven in clinical studies.

Before, during and after autologous hematopoietic stem cell transplantation (HD-ASCT) patients suffer from significant loss of physical function, and experience multiple complications during and after hospitalization. Studies regarding safety and feasibility of physical exercise interventions for patients undergoing treatment with HD-ASCT are missing.Forty patients referred to HD-ASCT treatment, suffering from multiple myeloma, lymphoma or amyloidosis aged 23-70 years were enrolled in a prospective longitudinal study. The study consisted of a home-based exercise program for use in the ambulatory setting and supervised exercise sessions Monday to Friday for 30-40 minutes during admission. Safety of the exercise program and physical tests were assessed by using a weekly questionnaire and report of inadvertent incidences. Adherence to the home-based exercise program was reported by using a patient diary, weekly questionnaire and count of daily attendance in supervised sessions during hospital stay. Data collection was scheduled shortly after diagnosis, admission, discharge and eight weeks after discharge. Success criteria were: no severe adverse events in relation to exercise program and assessments; performance of three days of physical exercises during ambulatory period and hospital stay and 150 minutes of weekly physical activity.Of the 25 patients who completed the exercise program during the ambulatory period prior to HD-ASCT a mean weekly attendance to home exercises of 5.3 (± 2.8) days and a median weekly physical activity of 240 (± 153.8) minutes was found. During hospital stay the median attendance was 9 (± 3.9) days of 10 (± 6.9) possible. Two months after discharge the patients reported a median weekly physical activity of 360 (2745.5) minutes. No severe adverse events in relation to the exercise program or assessments were reported.Based on the enrolled number of patients the physical exercise intervention for patients undergoing HD-ASCT seems promising regarding feasibility and safety.

Summary: Purpose: There are only few studies on the costs of epilepsy in Germany. Therefore, we performed a pilot study to estimate the direct and indirect costs of refractory epilepsy in a German epilepsy center. Methods: A “prevalence-based,” cross-sectional convenience sample of adults with active epilepsy attending the outpatient clinic of our tertiary epilepsy center was evaluated. Seizure-free patients and patients presenting with their first seizure were excluded. Direct and indirect costs were prospectively recorded over a three-month period using questionnaires and a patient diary. Cost driving factors were identified. Results: One hundred one patients were included (40.7 ± 15.2 years; disease duration: 18.1 ± 15.3 years; 6 patients had focal epilepsy with simple partial seizures only, 28 with complex partial seizures, 43 with secondarily generalized tonic–clonic seizures; 20 had idiopathic generalized epilepsy with generalized tonic–clonic seizures). The total costs of epilepsy per patient were in average € 2610 ± 4200 over the three-month period. Direct cost contributed 39% to the total costs. Costs of anticonvulsant medication were the main contributor to the direct costs while indirect costs were caused mainly by losses due to early retirement. Cost driving factors included higher seizure frequency, longer disease duration, ictal falls, and situationally inappropriate complex behavior during or after the seizure. Conclusions: Indirect costs were higher than direct costs in adult patients with active epilepsy attending a German epilepsy center. Medication contributed the most to the direct costs and early retirement was the main factor for the indirect costs. The costs of poorly controlled epilepsy in this German study were above average of the European costs of epilepsy.

We assessed the efficacy of chronic stimulation of the subthalamic nucleus (STN-DBS) in 20 patients with Parkinson's disease (PD) by means of clinical assessments and patient diaries 12 months after surgery. STN-DBS reduced the UPDRS part III off-medication score by 33%, and successively improved complete daily on-time without dyskinesia at 12 months significantly. In conclusion, our study demonstrates the efficacy of chronic STN-DBS on motor features in a selected population of advanced PD patients. In addition to clinical assessments, patients' diaries serve as an essential tool to evaluate the functional motor status after STN-DBS. (c) 2006 Elsevier Ltd. All rights reserved.

In spite of extreme childhood sexual and violent abuse, a 22-year-old young woman, Anna, healed during holistic existential therapy. New and highly confrontational therapeutic tools were developed and used to help this patient (like acceptance through touch and acupressure through the vagina). Her vulva and introitus were scarred from repeated brutal rape, as was the interior of her mouth. During therapy, these scars were gently contacted and the negative emotional contents released. The healing was in accordance with the advanced holistic medical toolbox that uses (1) love, (2) trust, (3) holding, and (4) helping the patient to process and integrate old traumas.The case story clearly revealed the philosophical adjustments that Anna made during treatment in response to the severe childhood abuse. These adjustments are demonstrated by her diary, where sentences contain both the feelings and thoughts of the painful present (the gestalt) at the time of the abuse, thus containing the essence of the traumas, making the repression of the painful emotions possible through the change in the patient’s philosophical perspective. Anna's case gives a unique insight into the process of traumatization (pathogenesis) and the process of healing (salutogenesis). At the end of the healing, Anna reconnected her existence to the outer world in a deep existential, suicidal crisis and faced her choice of life or death. She decided to live and, in this process, assumed existential responsibility, which made her able to step out of her mental disease. The advanced holistic toolbox seems to help patients heal even from the worst childhood abuse. In spite of the depth of the existential crisis, holistic existential therapy seems to support existential responsibility well and thus safe for the patients.

Background: Multidisciplinary heart failure programs including patient education and self-management strategies such as daily recording of body weight and use of a patient diary decrease hospital readmissions and improve quality of life. However, the degree of uptake of individual components of these programs and their contribution to patient benefit are uncertain. Methods: Patients with heart failure admitted to Auckland Hospital were randomised into the management or usual care groups of the Auckland heart failure management study (AHFMS). Patients in the management group were given a heart failure diary for the recording of daily weights, attended a heart failure clinic and were encouraged to attend three education sessions. Patients in the usual care group received routine clinical care, mainly from general practitioners. Patients were followed to 12 months. This study investigated the uptake of self-management by assessing diary use and self-weighing behaviour in the group receiving the heart failure intervention, and compared the level of knowledge of heart failure self-management of the management group to the control group after 12 months. Results: Of the 197 patients in the AHFMS, 100 patients were included in the management group and received a diary and education about heart failure self-management including monitoring weight daily. Of these patients, 76 patients used the diary. These patients were on more medication; were more likely to attend the education sessions, heart failure clinic, and primary care, and had a lower mortality rate over the course of the study. Variables independently associated with use of the diary included less severe symptoms (OR 15, 95% confidence intervals 1.7, 144), frequent attendance at the heart failure clinic (OR 15, 95% CI 3, 78) and attendance at an education session (OR 8, 95% CI 1.5, 42). Of the 76 patients who used the diary, 51 weighed themselves regularly. More of these patients owned scales at home; they were also more likely to attend the education sessions, and experienced fewer hospital admissions than those patients who did not weigh themselves regularly. Variables independently associated with regular self-weighing included the presence of scales at home (OR 6.3, 95% CI 1.7, 14.1), left ventricular ejection fraction >30% (OR 4.3, 95% CI 1.1, 17.5), and attendance at the education session(s) (OR 6.3, 95% CI 1.7, 14.1). Patients in the management group exhibited higher levels of knowledge at 12 months of follow-up and were more likely to monitor their condition using daily weighing, compared to the control group. Conclusions: At 12 months of follow-up, implementation of self-management strategies including daily weight monitoring and level of education on self-management was significantly higher in the management group than the control group. For the patients in the management group, not using the diary or inability to perform daily weighing were associated with less frequent attendance at the heart failure clinic and education sessions and poorer health outcomes. In this study, attendance at the education sessions was associated with the adoption of self-management, underlining the importance of education in multidisciplinary heart failure programmes. Self-weighing could be increased by provision of scales to all patients. The subset of patients who did not adopt self-management strategies in this study were at high risk of death or readmission.

Objective.—To evaluate the impact on costs and outcomes of early migraine treatment with sumatriptan while pain is mild versus sumatriptan treatment of moderate to severe pain. Background.—Migraines result in substantial pain, impairment, and costs. Recent clinical studies have shown that early treatment with sumatriptan when migraine pain is mild is more effective than sumatriptan treatment when pain is moderate to severe. Design/Methods.—We developed a decision analytical model to assess the costs and outcomes per treated migraine attack, comparing early treatment while pain is mild versus delayed treatment when pain may become moderate/severe using 50 and 100 mg of sumatriptan. Parameters for the model were derived from published literature and analysis of migraine patient diary data. For each patient group the model determined the duration of mild and moderate/severe migraine pain, the proportion of patients pain free at 4 hours after initial therapy with no recurrence, medical care costs, and work loss costs (from migraine-related absenteeism and decreased productivity) during a 24-hour period. Total costs were calculated as the sum of medical care costs plus work loss costs. Results.—Early treatment with sumatriptan when migraine pain is mild resulted in substantially decreased total costs per treated attack as compared with treatment when pain is moderate/severe. Early treatment also resulted in decreased time with headache pain, an increased proportion of patients pain free at 4 hours without recurrence, and decreased physician and emergency department visits. Treatment with 100 mg sumatriptan resulted in better outcomes than did treatment with 50 mg sumatriptan, but outcomes with either dose for early treatment of mild pain were superior to those for either dose in delayed treatment when pain may be moderate/severe. Conclusions.—Model-based results indicate that on a treated attack basis, early treatment of migraine with sumatriptan while pain is mild leads to decreased costs and improved outcomes compared to delayed sumatriptan treatment.

Recent clinical studies have shown that nasogastric tube feeding is safe in the majority of patients with acute pancreatitis. Patient-reported outcomes are important, but the impact of nasogastric tube feeding on the quality of life has not been investigated. This study aims to compare quality of life between nasogastric tube feeding and nil-by-mouth groups during and after hospitalization.Patient-reported outcomes were recorded daily in a patient diary during hospitalization. The Abdominal Surgery Impact Scale questionnaire was used to determine patients' quality of life. The patients were then followed up at 1 week and 1, 3, and 6 months after discharge.While 17 patients were randomized to nasogastric tube feeding, 18 were put on nil-by-mouth. The overall quality of life and individual domains did not differ significantly between the groups during hospitalization (P = .500) or follow-up. For the entire cohort, individual quality-of-life domains during hospitalization improved significantly, including functional impairment (P.001), pain (P.001), sleep (P = .035), and psychological function (P.001). Quality of life further improved for all patients from time of hospital discharge to 3 (P = .002) and 6 months follow-up (P.001) but not to 1 week and 1 month.The use of nasogastric tube feeding, in comparison with nil-by-mouth, does not impair patients' quality of life. Given the clinical benefits of nasogastric tube feeding, nasogastric feeding should be considered the first-line approach in all acute pancreatitis patients requiring enteral nutrition.

Background & Objectives: Integration of Clinical Decision Support Systems (CDSS) in mobile and smart environments helps to improve the quality of life of people with health problems. CDSS are used to derive clinical conclusions from patient data, in order to automate and help the process of diagnosing and treating the patient. One way that CDSS can be implemented is to formalize a clinical guideline (document detailing best practices for diagnosing and treating patients) and use it on a knowledge base containing the patient's data. An interesting perspective is to use CDSS in a smart home (SH) setting, where data for the remote CDSS can be obtained from SH services and mobile devices using ambient and wearable sensors. However, in order to maintain minimum quality of service for CDSS decision support, the CDSS decision process must be deployed locally as a SH service an on mobile devices. An ideal example domain for this integration scenario is the diagnosis of sleep apnea. Sleep Apnea has several symptoms that include recurrent awakening, loud snoring, choking episodes, non-restorative sleep and daytime sleepiness. Usually, an individual with sleep apnea is not aware of having difficulty breathing, and is often recognized by others witnessing the individual during sleep apnea episode or is suspected because of the observed symptoms. Sensors could detect such episodes automatically without the need for a human intervention, or recognitions of said symptoms. The objectives are to illustrate the feasibility of CDSS as SH service and on mobile devices by using the Sleep Apnea CDSS. Methods: The sleep apnea CDSS decision process uses Semantic Web tools and rule-based reasoning, in order to formalize the current Canadian guideline for the recognition of sleep apnea. A total of 9 rules were derived. A patient dataset comprises health factors related to sleep apnea, including clinically relevant personal information, clinical measures and observations, and symptoms specific to sleep apnea. To validate the decision process of a CDSS integrated with smart homes, we implemented the Sleep Apnea CDSS decision process on an Android smartphone (Samsung Galaxy SIII). For this validation, we assume that we have received data from the patient diary application, the SH services or local smartphone monitoring services. We generated datasets containing clinical data (measurements), whereby fact values were created based on ranges encompassing both clinically normal situations as well as abnormal situations. We have 7 dataset configurations (1 to 7 days of data), with 10 generated datasets by configuration (70 datasets). Results: The validation shows promising results for using CDSS on mobile phone: loading data and rules (140-425 ms), executing rules (45-82 ms) and memory usage for the reasoning process (174-350 KB). Conclusions: The results show that a guideline compliant CDSS system can be implemented on currently available mobile devices. While this validation was limited in scope, as we did not tackle the precise derivation of sensor data into the used clinical facts, it shows nonetheless that with such set of inferred clinical facts, interesting and clinically relevant problems can be tackled.

Atrial fibrillation (AF) is the most common abnormality of cardiac rhythm. There is growing evidence advocating an integrated multi-disciplinary approach to delivery of AF care facilitates which has led to improved care and outcomes and reductions in hospitalizations. In this research program, we have implemented a patient-centered and community-focused AF management program—termed as IMPACT-AF—to provide specialized AF care at the primary care level. Our approach is to exploit state-of-the-art e-Health technologies to: (a) computerize Canadian clinical practice guidelines as a web-based clinical decision support accessible to primary care providers to deliver evidence-informed AF diagnostic and therapeutic interventions at the primary care level; (b) monitor the patient in a home-based setting and proactively generate alerts and reminders to family physicians in response to adverse trends in the patient condition; and (c) engage patients through m-Health (mobile health) tools to self-manage their condition and undergo behaviour modification. Two research themes have been pursued in the development of the IMPACT-AF program: (1) Translation of AF Clinical Guidelines to Achieve Evidence-Informed AF Management: This theme involved three main tasks: (i) Computerization of the AF guidelines using ontology based knowledge models; (ii) Localization of the computerized AF guidelines to implement the local clinical pathways; and (iii) Operationalization of the computerized AF guidelines into practice through a computerized decision support system to provide evidence-informed patient care at the point-of-care. (2) Patient Engagement to Achieve Home-Based AF Management: This theme focused on the implementation of innovative AF self-management and behaviour modification interventions delivered to patients using mobile devices. We computerized theoretical behaviour modification model—i.e. Social Cognition Theory (SCT)—to generate personalized and mobile patient care plans. Using an AF (mobile) patient diary patients record their vitals and other AF related symptoms, and in turn receive educational messages, alerts, reminders and behaviour modification plans. The primary outcome of the IMPACT-AF project is reduction in AF related CV hospitalization. The secondary outcome is at two levels: (i) Process of Care: Reduction in specialist consultation, echo, catheter ablations; and, (ii) Economic: Reduction in health care costs and utilization for AF services. The clinical decision support systems developed by the IMPACT-AF project is deployed across the province of Nova Sctioa, engaging 200 primary care providers to deliver evidence informed AF management at the primary care level. We are gearing for a cluster randomized study involving 4000 patients across the province--the study will permit measurement and comparison of the clinical decision support system pre- and post-intervention, and across cases. The overall result will be cost-efficient improvement of care and outcomes for AF patients. In summary, the IMPACT-AF solution offers an innovative strategy to address two critical knowledge gaps —i.e. primary care physicians are often ill-equipped to provide evidence-based care for chronic conditions, and likewise patients are underprepared to apply the 'right' self-management and behaviour modification strategies to achieve meaningful outcomes in response to a longitudinal care plan. IMPACT-AF exploits state-of-the-art e-health technologies to develop an integrated and mobile clinical decision support systems to provide evidence-based AF care.

The reality of a Parkinson’s Disease patient involves coping with the condition 24 hours a day for the rest of her or his life. A continuous decay of physical and sometimes cognitive functions makes activities of daily life progressively more difficult to accomplish. Many keep a diary where they take note of feelings, relevant events related to the daily routines, reaction to the medication, etc. Such diaries may prove extremely useful for a better understanding of the disease progression, both by the patient and by the doctor. The SENSE-PARK project went a step forward: it combines the patient diary notes (self-reported) with information gathered from movement sensors (automatic measurement) and a visualization mechanism combining the two. A system has been designed, prototyped and tested. Parkinson’s medical specialists, user experience experts, technologists and most important the patients themselves, were involved in this process.

Objective: As in a prospective, randomized, placebo-controlled, multicenter, double-blind trial in fibromyalgia [FMS] a significant reduction of pain especially, but of other symptoms as well, could be gained after 10 days of peroral daily treatment with 5 mg tropisetron, the question was evaluated as to whether quicker and better effects could be achieved with intravenous application of 2 mg tropisetron daily for a limited period of time.Methods: In the first cohort, 18 FMS patients received a single bolus intravenous [i.v.] injection of 2 mg tropisetron, in the second cohort 24 FMS patients were treated with 2 mg i.v. bolus injection tropisetron daily for five days. Pain intensity was measured with the visual analog scale and the painscore; pain at the tenderpoints and control points [dolorimeter] was evaluated as well as 17 ancillary symptoms before and after treatment; furthermore, pain intensity was followed up by means of a patient diary, until pain recurrence.Results: Even with a single i.v. inject...

We have examined the relations among three common treatment outcome measures in irritable bowel syndrome (IBS): end of treatment global ratings by a physician, end of treatment patient global ratings, and measures derived from a daily symptom diary completed by the patient. Eighty-four IBS patients (53 female, 31 male) participated in a randomized controlled evaluation of three psychological treatment conditions for IBS. Treatment outcome measures from this trial (Blanchard et al., 1992) were used in the present methodological study. Physician global ratings were significantly correlated with patient global ratings (r = .45, p < .01). Both of these global ratings also correlated significantly with a composite score from patient diary ratings. Multiple regression analyses revealed that reductions in bloating and constipation account for 18% of the variance in patient global ratings. Global ratings at end of treatment by either patient or physician were only partially related to symptom relief as measured by a daily diary.

Recent data from the Dosing Observational Study in Hemophilia diary study has described home treatment with recombinant activated factor VII (rFVIIa) in congenital haemophilia with inhibitors (CHwI). The current analysis compares prescribed and patient/caregiver-reported rFVIIa administration in paediatric and adult CHwI patients in this study. Patients with ≥ 4 bleeding episodes within a 3-month period prescribed rFVIIa as first-line therapy for bleeding episodes were eligible. Patients/caregivers completed a diary for ≥ 90 days or until the patient experienced four bleeds. Initial, total and mean rFVIIa doses reported for each bleeding episode were calculated and compared with the physician-prescribed doses. Of 52 enrolled patients (25 children; 27 adults), 39 (75%) completed the study. Children and adults had similar mean durations of bleeding episodes. Both patient groups were administered higher initial rFVIIa doses for joint bleeds than prescribed: median (range) 215.2 (74.1-400.0) mcg kg(-1) vs. 200.0 (61.0-270.0) mcg kg(-1) for children, and 231.3 (59.3-379.7) mcg kg(-1) vs. 123.0 (81.0-289.0) mcg kg(-1) for adults. The median infused dose for joint bleeds was higher in adults than children (175.2 vs. 148.0 mcg kg(-1) ), but children received significantly more doses per joint bleed than adults (median 6.5 vs. 3.0). The median total dose per joint bleed was higher in children than adults (1248.7 vs. 441.6). For children and adults, both initial and additional doses administered for bleeds were higher than prescribed. Children received higher total doses per bleed due to an increased number of infusions per bleed.

Objectives: It remains to be determined whether the benefits of botulinum toxin type A (BoNT-A) on cervical dystonia (CD) motor symptoms extend to improvements in patient’s quality of life (QoL). This analysis of a large, multicentre study was conducted with the aim of investigating changes in QoL and functioning among de novo patients receiving 500 U BoNT-A (abobotulinumtoxinA; Dysport) for the treatment of the two most frequent forms of CD, predominantly torticollis and laterocollis. Design: A prospective, open-label study of Dysport (500 U; Ipsen Biopharm Ltd) administered according to a defined intramuscular injection algorithm. Setting: German and Austrian outpatient clinics. Participants: 516 male and female patients (aged ≥18 years) with de novo CD. The majority of patients had torticollis (78.1%). 35 patients had concomitant depression (MedDRA-defined). Main outcome measures: Change from baseline to weeks 4 and 12 in Craniocervical Dystonia Questionnaire (CDQ-24) total and subscale scores, patient diary items (‘day-to-day capacities and activities’, ‘pain’ and ‘duration of pain’) and global assessment of pain. Results: Significant improvements were observed in CDQ-24 total and subscale scores at week 4 and were sustained up to week 12 (p

Background Lesinurad (RDEA594) is a selective uric acid reabsorption inhibitor (SURI) investigated for the treatment of gout in combination with xanthine oxidase inhibitors. In two Phase 3 clinical trials examining lesinurad in combination with allopurinol, patients with non-tophaceous gout demonstrated a reduction in gout flares over the 12-month study periods. Objectives Investigate the relationship between gout flares and patient-reported assessments of pain and disability during the first 3 and last 3 months of two 1-year clinical trials assessing lesinurad in non-tophaceous gout patients with inadequate response to standard of care (NCT01510158 and NCT01493531). Methods CLEAR 1 and CLEAR 2 were 12-month, randomized, double-blind, phase III trials to evaluate lesinurad (200 mg or 400 mg oral, daily) in combination with allopurinol (ALLO) vs ALLO + placebo. Gout flares were collected using an electronic patient diary and all flares reported in the diary were assessed. Patient-reported assessments of pain and disability included a Global Pain Scale and the HAQ-DI. A global measure of health utilty, the SF-6D, was derived from the SF-36v2. A pooled analysis of non-tophaceous patients in CLEAR 1 and CLEAR 2 assessed patient-reported measures for those with 0 flares, 1 flare, 2 flares and 3 or more flares, across treatment arms, during the first 3 months of the study (months 1 to 3) and during the final 3 months of the study (months 10 to 12), irrespective of treatment. Results Patients in the CLEAR 1 and CLEAR 2 clinical trials (N=1062) were primarily male (94.8%), mean±SD age was 51.5±11.1 years and duration since gout diagnosis was 11.1±9.1 years. Most patients (87.8%) received ALLO 300 mg (range: 200–900 mg) daily. Irrespective of treatment, during the first 3 months of the study 41%, 22%, 15% and 22% patients reported 0, 1, 2 and 3 or more flares, respectively. During the final 3 months of the study 61%, 19%, 9% and 11% patients reported 0, 1, 2 and 3 or more flares, respectively. For both the HAQ-DI and Pain VAS, during the first 3 months and last 3 months of the study, the best (lowest) HAQ-DI and Pain VAS scores were reported in patients with 0 flares and the worst (highest) scores were reported in patients with 3 or more flares. The best (highest) SF-6D health utility scores, during the first 3 months and last 3 months of the study, were found in patients with no flares and the worst (lowest) scores were found in those with 3 or more flares. Conclusions Non-tophaceous patients with the lowest number of flares, during the first and last 3 months of treatment, reported the most favorable HAQ-DI, pain and health utility measures. A majority of patients experiences zero flares during the final 3 months of the study period. Acknowledgement Research sponsored by Ardea Biosciences/AstraZeneca. Editorial support was provided by PAREXEL and funded by AstraZeneca. Disclosure of Interest P. Khanna Grant/research support from: AstraZeneca, S. Baumgartner Employee of: Ardea Biosciences, Inc., a member of the AstraZeneca Group, J. Robinson Employee of: Ardea Biosciences, Inc., a member of the AstraZeneca Group, E. Tafesse Employee of: AstraZeneca, R. Morlock Employee of: AstraZeneca

Study objective Efficacy and safety of willow bark extract for pain reduction in patients suffering from musculoskeletal disorders (MSD) has been shown in clinical short term trials. Therefore this observational study over 6 months should evaluate patterns of treatments like mono- or combinations therapy, dosage and safety during long-term treatment under pragmatic conditions with the aqueous willow bark extract STW 33-I, (Proaktiv ® ; drug-extract-ratio 16–23:1). Patients and methods The patients were treated with STW 33-I; comedication with other NSAIDs and opioids was allowed. An extensive case report form including pain questionnaires and patient diary was used for outcome evaluation. Results Four hundred and thirty-six patients with rheumatic pain mainly due to osteoarthritis (56.2%) and back pain (59.9%) were included. During the study the mean reductions from baseline value 58.4 ± 22.6–31.8 ± 22.5 after 24 weeks in the pain intensity scale (VAS 0–100 mm) were significant even after 3 weeks with a reduction by 26 mm (45.6% of the baseline value) at the end of the study. The relative reductions of the weekly means of the daily patient self-rated scores of the pain (6-point Likert-scales) were between 33% and 44% of the baseline values during the course of the study. We present results of subgroups according their analgetic/antiphlogistic comedication. The distribution and specification of the main adverse events and the ratings of the treatment showed a good tolerability. No relevant drug interactions were reported. Conclusion These data suggest that STW 33-I can be used as a basic treatment in the long-term therapy of painful musculoskeletal disorders and that it can be combined with NSAIDs and opioids if necessary.

Respicard is a clinical scoring system used during tele-assistance of patients with chronic obstructive pulmonary disease (COPD) in order to assess variations during nurse phone contacts. Strategies to prevent occurrence of unreported COPD exacerbations are needed. We evaluated (1) comparison between administration of Respicard by the nurse during phone calls with self-administration by the patient and (2) patient compliance with Respicard use.From January to June 2011, every week for 6 months, patients with COPD enrolled in a tele-assistance program in Italy were invited to fill in Respicard at home according to their symptoms. Concurrently, on a weekly basis, a nurse telephoned the patients and filled in a similar card. The scoring of both Respicards was compared. At the end of the study, the patient's subjective utility and ease in implementing or discomfort in recording Respicard was assessed.In the 39 patients studied, the mean value of recorded nurse cards was 3.7±2.9, and the mean time spent by nurses to measure the first 52 cards was 7.7±2.7 min. Patient compliance was 78.2±33.4%. There was a significant positive correlation between nurse and patient card scores (R=0.98; p0.0001). A similar correlation was observed when data from patients with or without exacerbations and with high or poor adherence to the program were considered (p0.0001). Patients' acceptance of the self-recording was good.In patients with COPD with sufficient self-autonomy and followed up with tele-assistance, Respicard is a reliable system for recording symptoms of COPD and could be a good cost-cutting modality for continuing management of patients.

Current clinical methods for the assessment of Parkinson's disease suffer from inconvenience, infrequency and subjectivity. WiiPD is an approach for the objective home based assessment of Parkinson's disease which utilizes the intuitive and sensor rich Nintendo Wii Remote. Combined with an electronic patient diary, a suite of mini-games, a metric analyzer, and a visualization engine, we propose that this system can complement existing clinical practice by providing objective metrics gathered frequently over extended periods of time. In this paper we detail the approach and introduce a series of metrics deemed capable of quantifying the severity of tremor and bradykinesia in those with Parkinson's disease. The system has been tested on a 71 year old participant with Parkinson's disease over a period of 15 days, a 72 year old control user without Parkinson's disease, and a group of 8 young adults. Results indicate a clear correlation between patient self rating scores of tremor severity and metric values obtained, in addition to clear differences in metrics obtained from each user group. These results suggest that this approach is capable of indicating the presence and severity of the motor symptoms of Parkinson's disease that affect arm motor control.

Levodopa-carbidopa intestinal gel (LCIG) delivered continuously via percutaneous endoscopic gastrojejunostomy (PEG-J) tube has been reported, mainly in small open-label studies, to significantly alleviate motor complications in Parkinson's disease (PD). A prospective open-label, 54-week, international study of LCIG is ongoing in advanced PD patients experiencing motor fluctuations despite optimized pharmacologic therapy. Pre-planned interim analyses were conducted on all enrolled patients (n = 192) who had their PEG-J tube inserted at least 12 weeks before data cutoff (July 30, 2010). Outcomes include the 24-h patient diary of motor fluctuations, Unified Parkinson's Disease Rating Scale (UPDRS), Clinical Global Impression-Improvement (CGI-I), Parkinson's Disease Questionnaire (PDQ-39), and safety evaluations. Patients (average PD duration 12.4 yrs) were taking at least one PD medication at baseline. The mean (±SD) exposure to LCIG was 256.7 (±126.0) days. Baseline mean "Off" time was 6.7 h/day. "Off" time was reduced by a mean of 3.9 (±3.2) h/day and "On" time without troublesome dyskinesia was increased by 4.6 (±3.5) h/day at Week 12 compared to baseline. For the 168 patients (87.5%) reporting any adverse event (AE), the most common were abdominal pain (30.7%), complication of device insertion (21.4%), and procedural pain (17.7%). Serious AEs occurred in 60 (31.3%) patients. Twenty-four (12.5%) patients discontinued, including 14 (7.3%) due to AEs. Four (2.1%) patients died (none deemed related to LCIG). Interim results from this advanced PD cohort demonstrate that LCIG produced meaningful clinical improvements. LCIG was generally well-tolerated; however, device and procedural complications, while generally of mild severity, were common.