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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.

Funding: National Institute of Health Research (Research for Patient Benefit Programme) (PB-PG-1013-32047), United Kingdom. Background People severely impaired with progressive multiple sclerosis spend much of their day sitting, with very few options to improve motor function. As a result, secondary physical and psychosocial complications can occur. Effective and feasible self-management strategies are needed to reduce sedentary behaviour and enhance motor function. In this study, we aimed to assess the clinical and cost effectiveness of a home-based, self-managed, standing frame programme. Methods SUMS was a pragmatic, multicentre, randomised controlled superiority trial of people with progressive multiple sclerosis and severe mobility impairment, undertaken in eight centres from two regions in the UK. The study had assessor-blinded outcome assessments with use of clinician-rated and patient-rated measures at baseline, 20 weeks, and 36 weeks. After baseline assessment, participants were randomised (1:1) by computer-generated assignment to either a standing frame programme plus usual care or usual care alone. The intervention consisted of two home-based physiotherapy sessions (60 min each) to set up the standing frame programme, supported by six follow-up telephone calls (15 min per call). Participants were asked to stand for 30 min, three times per week over 20 weeks, and encouraged to continue in the longer term, although no further physiotherapy support was provided. The primary clinical outcome was motor function measured by the Amended Motor Club Assessment (AMCA) score at week 36, analysed in the modified intention-to-treat population (excluding only patients who were deemed ineligible after randomisation, those who withdrew from the trial and were unwilling for their previously collected data to be used, or those who did not provide baseline and week 36 measurements). A 9-point AMCA score change was considered clinically meaningful a priori. Adverse events were collected through a daily preformatted patient diary throughout the 36 weeks and analysed in the modified intention-to-treat population. An economic assessment established the resources required to provide the standing frame programme, estimated intervention costs, and estimate cost effectiveness. This trial is registered with the International Standard Randomised Controlled Trials, number ISRCTN69614598. Findings Between Sept 16, 2015, and April 28, 2017, 285 people with progressive multiple sclerosis were screened for eligibility, and 140 were randomly assigned to either the standing frame group (n=71) or the usual care group (n=69). Of these, 122 completed the primary outcome assessment (61 participants in both groups) for the modified intention-to-treat analysis. The use of the standing frame resulted in a significant increase in AMCA score compared with that for usual care alone, with a fully adjusted between-group difference in AMCA score at 36 weeks of 4·7 points (95% CI 1·9–7·5; p=0·0014). For adverse events collected through patient diaries, we observed a disparity between the two groups in the frequency of short-term musculoskeletal pain (486 [41%] of 1188 adverse events in the standing frame group vs 160 [22%] of 736 adverse events in the usual care group), which was potentially related to the intervention. The musculoskeletal pain lasted longer than 7 days in five participants (two in the standing frame group and three in the usual care group). No serious adverse events related to the study occurred. The standing frame group had a mean 0·018 (95% CI −0·014 to 0·051) additional quality-adjusted life-years (QALYs) compared with those of the usual care group, and the estimated incremental cost-per-QALY was approximately £14 700. Interpretation The standing frame programme significantly increased motor function in people with severe progressive multiple sclerosis, although not to the degree that was considered a priori as clinically meaningful. The standing frame is one of the first physiotherapy interventions to be effective in this population. We suggest that the programme is feasible as a home-based, self-managed intervention that could be routinely implemented in clinical practice in the UK. Publisher PDF

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 Patients surviving critical illness are at risk of developing psychological symptoms that affect quality of life and recovery. Patient diaries may improve psychological outcomes by reducing gaps in memory and contextualising what has happened during admission. Factors including lack of guidelines, lack of awareness and time constraints may lead to poor diary use. Aims This quality improvement project aimed to increase diary provision and overall multidisciplinary team engagement with diaries for all patients admitted for over 72 h to an intensive care unit. Methods Trialled changes implemented via the ‘Plan-Do-Study-Act’ method included adding alerts to the online patient note system, providing education sessions and introducing a guidance document to facilitate entry completion. Results A ‘diary provision’ target of 100% was achieved (from a baseline of 26.1%). Simple changes have proven effective in establishing routine engagement with diaries, and lessons may be used to improve diary systems elsewhere.

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

Patient pathways are a means to structure the care process for patients with complex and long-term diseases in integrated care networks. Simultaneously, they have a stronger emphasis on the patient perspective and engagement than related pathway concepts. Still, there are no common mechanisms for patient engagement concepts in patient pathway models. This paper therefore explores the state-of-the-art of patient engagement tools as well as evidence on their effectivity and feasibility, picking the Option Grid, the Patient Diary, and the Question Prompt Sheet (QPS) as representative examples. Based on this, we propose recommendations for the representation of such tools in patient pathway models and demonstrate them with the application of the QPS in a colorectal cancer patient pathway. To conclude, the evidence on patient engagement tools is still diverse but promising. Anchoring successful tools in patient pathways holds the potential to support their broader application and enhance individualized care.

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).

Supplemental Digital Content is available in the text., Background: To determine the superiority of autologous abdominal tissue (AAT) or tissue-expander implant (TE/I) reconstruction, a robust comparative cohort study is required. This study sought to determine the feasibility of a future large pragmatic cohort study comparing clinical and cost-effectiveness of AAT and TE/I at 12 months postoperative. Methods: Potential participants were screened during consultation with their surgeon. Three health-related quality-of-life scales, the Health Utility Index Mark 3, the 12-Item Short Form Health Survey, and the BREAST-Q were used preoperatively, 1, 6, and 12 months postoperatively. Direct medical costs and postoperative patient/caregiver productivity loss were collected using patient diaries. Feasibility was assessed through patient recruitment rates and compliance of patients and study staff to complete required study documentation. Results: Sixty-three patients consented to participate, 44 completed baseline questionnaires; the feasibility objective of recruiting 80% of eligible patients was not met. A 90% completion rate for patient questionnaires was seen at 1-month follow-up and decreased up to 12 months. Quality-adjusted life years were calculated at 0.77 and 0.89 for the AAT and TE/I group, respectively. Case report form completion by study staff and patient diary completion was moderate and low, respectively. Collaborating with hospital case-costing specialists to identify direct medical costs was reliable and efficient. Conclusions: A future large-scale study is feasible. However, due to a diminishing rate of questionnaire completion, almost twice as many patients need to be recruited than expected to have adequate power. Cost data collection from hospital sources was reliable. Case report forms need to be tailored more toward a busy hospital setting.

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.

In integrative cardiovascular Chinese medicine, clinical visits are considered more successful when patient partner with the health practitioner. ADLs, entries from the patient diary and narrative techniques should be organized into categories such as diet, health vitals monitoring and symptom monitoring.

Objective To compare recovery from tonsillectomy using thermal welding forceps (TWF), controlled ablation (CA), and monopolar electrosurgery (MES) in children. Methods This was a prospective single blinded observational study using data from electronic medical record (EMR) and caregiver completed patient diary, conducted at a community-based children's hospital within an academic program with tonsillectomy performed by attending surgeons. Children aged 3–17 years undergoing tonsillectomy or adenotonsillectomy by TWF, CA, or MES over a 4-year period were included. Demographics, intraoperative time for tonsillectomy, blood loss, patient diary documentation of pain levels, analgesic doses, diet type and events per day were recorded. In addition, EMR documentation of morbidity events (bleeding, visits for bleeding, return to operating room [OR], total visits or admissions, poor oral intake or dehydration) were noted. To assess for differences in baseline characteristics, we utilized analysis of variance and Pearson's χ2 test. To determine primary outcomes, we used a multilevel mixed-effect linear regression model. Results A total of 369 children were enrolled, and 346 who met inclusion criteria underwent tonsillectomy. The children were categorized by the instrument used by the surgeons: CA 32.4% (n = 112), MES 36.7% (n = 127), and TWF 30.9% (n = 107). Mean age overall was 6.8 ± 3.2 years, with 57.4% female and 42.6% male. Diary return rate was 52.3% (n = 181) overall, with CA at 48.2% (n = 54), MES at 44.8% (n = 57), and TWF at 65.4% (n = 70). Average pain on the day of surgery was different between instruments with CA having the lowest level of 2.0 compared to 2.7 for TWF and MES (p = 0.001). Maximum pain level for day of surgery were lowest for CA at 2.7 compared to 3.4 for MES and 3.5 for TWF (p = 0.003). Pain levels were lowest for TWF after postoperative day (POD) 6. Overall rate of bleeding was 9.3%, with 2.6% return to surgery for control of bleeding. TWF had the lowest rate of bleeds (4.7% versus CA 11.6% and MES 11.0%), return to surgery (0.0% versus CA 2.7% and MES 4.7%), the earliest and final return to regular diet at POD 5.8 and 8.1, respectively without reaching statistical significance. Conclusion CA had significantly lowest early pain levels on day 0–1 and trended lowest up to POD 6, after which TWF was lowest but did not reach statistical significance. TWF had the earliest return to regular diet. Children undergoing CA and MES are more likely to have a postoperative bleed and a return to the OR than TWF suggesting improved ability to seal vessels with the latter instrument. Further study with a larger sample is needed.

Background We report on the results of a Japanese postmarketing drug-use survey of suvorexant (Belsomra®) tablets. Methods A survey with a ≤ 6-month observation period after the start of administration was conducted, targeting insomnia patients who were treated with suvorexant for the first time in Japan. Information on the safety and efficacy of the drug product was collected. The evaluation period was July 21, 2015–August 12, 2017, and the target number of patients was 3428. Results The mean administration period for the safety analysis population of 3248 patients was 113 days. At 6 months after the start of treatment, 48.6% (1577/3248) of the patients had been continually receiving treatment, and 51.4% (1671/3248) of the patients discontinued/dropped out of treatment before 6 months. Among the patients who discontinued/dropped out of the treatment, more than 30% discontinued due to improvement. The mean treatment duration for those who had discontinued treatment for this reason was 62 days. The incidence rate of adverse drug reactions among those in the safety analysis population was 9.7%, and the common adverse drug reactions were somnolence (3.6%), insomnia (1.2%), dizziness (1.1%), and nightmare (0.8%), all of which are described in the product label. No additional noteworthy events were observed. In 2439 patients with a final overall global assessment of sleep judged by physicians, the ‘improved’ rate was 74.0%. Among 2424 patients who provided a final overall global assessment, the improvement rate was 73.2%, which was comparable with the improvement rate judged by physicians. Regarding clinical effects (based on patient diary data or physician’s assessment), reduction in median sleep latency and increase in median total sleep time (reduction from 60 to 50 min and increase from 300 to 360 min compared with baseline, respectively) were observed at 1 week after the start of treatment and onwards, and the effect was maintained after the start of treatment for 6 months. A similar effect was observed irrespective of age groups or reasons for using suvorexant. Conclusion This survey was an exploratory observational study without a control group; the interpretation of results may require the consideration of factors that may have caused bias in the results, such as demographic characteristics and effects of other drugs. However, the results suggest that suvorexant can be a useful drug in daily clinical practice for treating insomnia.

Background Androgen deprivation therapy (ADT) is commonly used to treat prostate cancer. However, side effects of ADT often lead to reduced quality of life and physical function. Existing evidence demonstrates that exercise can ameliorate multiple treatment-related side effects for men on ADT, yet adherence rates are often low. The method of exercise delivery (e.g., supervised group in-centre vs. individual home-based) may be important from clinical and economic perspectives; however, few studies have compared different delivery models. Additionally, long-term exercise adherence and an understanding of predictors of adherence are critical to achieving sustained benefits, but such data are lacking. The primary aim of this multi-centre phase III non-inferiority randomized controlled trial is to determine whether a home-based delivery model is non-inferior to a group-based delivery model in terms of benefits in fatigue and fitness in this population. Two other key aims include examining cost-effectiveness and long-term adherence. Methods Men diagnosed with prostate cancer of any stage, starting or continuing on ADT for at least 6 months, fluent in English, and living close to a study centre are eligible. Participants complete five assessments over 12 months (baseline and every 3 months during the 6-month intervention and 6-month follow-up phases), including a fitness assessment and self-report questionnaires. Biological outcomes are collected at baseline, 6, and 12 months. A total of 200 participants will be randomized in a 1:1 fashion to supervised group training or home-based training supported by smartphones, health coaches, and Fitbit technology. Participants are asked to complete 4 to 5 exercise sessions per week, incorporating aerobic, resistance and flexibility training. Outcomes include fatigue, quality of life, fitness measures, body composition, biological outcomes, and program adherence. Cost information will be obtained using patient diary-based self-report and utilities via the EQ-5D. Discussion To disseminate publicly funded exercise programs widely, clinical efficacy and cost-effectiveness have to be demonstrated. The goals of this trial are to provide these data along with an increased understanding of adherence to exercise among men with prostate cancer receiving ADT. Trial registration The trial has been registered at clinicaltrials.gov (Registration # NCT02834416). Registration date was June 2, 2016. Electronic supplementary material The online version of this article (10.1186/s12885-018-4937-x) contains supplementary material, which is available to authorized users.

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.

Summary Background Writing a diary for intensive care patients has been shown to facilitate patientrecovery and prevent post-traumatic stress following hospitalisation. Aim This study aimed to describe the experiences of critical care nurses’ (CCNs’) in writing personal diaries for ICU patients. Method The study was conducted with a qualitative design. Ten CCNs from two hospitals participated. Data were collected with semi-structured interviews and analysed using a qualitative thematic content analysis. Findings The result consists of a theme: Patient diary: a complex nursing intervention in all its simplicity, as well as four categories: Writing informatively and with awareness shows respect and consideration; The diary is important for both patient and CCN; To jointly create an organisation that facilitates and develops the writing; Relatives’ involvement in the diary is a matter of course. Conclusion CCNs are aware of the diary’s importance for the patient and relatives, but experience difficulties in deciding which patients should get this intervention and how to prioritize it. Writing a personal diary for an ICU patient is a nursing intervention that is complicated in its simplicity.

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.

Introdução: O câncer é consequência de falhas nos mecanismos de controle do ciclo celular. É uma doença genética multifatorial, que pode ser tratada de inúmeras maneiras. A quimioterapia tem sido a forma mais comum de tratamento, entretanto, age de forma indiscriminada em todas as células, causando efeitos adversos. Dessa forma, a enfermagem tem papel fundamental na educação e orientação desses pacientes, bem como em tornar esse indivíduo protagonista de seu tratamento. Objetivo: Propor um modelo de orientação ao paciente oncológico acerca do tratamento quimioterápico, por meio de um informativo impresso e da criação do “diário do paciente”. Método: Trata-se de um recorte de uma pesquisa exploratória, do tipo pesquisa-ação, realizado a partir da identificação das necessidades do ambulatório de quimioterapia adulto de um hospital de ensino, referência em oncologia. Resultados: Após a identificação das necessidades da unidade, e de reuniões com as enfermeiras do serviço, foi criado um novo fluxo de trabalho, um informativo com orientações sobre os efeitos adversos relacionados ao tratamento e o “diário do paciente”, a fim de envolver o indivíduo no seu tratamento. Conclusão: A proposta e a elaboração dos instrumentos foram estratégias de grande relevância na educação em saúde ao paciente, uma vez que auxiliam e instrumentalizam o profissional nesse processo e possibilitam que o paciente participe ativamente de seu tratamento.

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.

Objective: (1) To determine the treatment seeking behaviour of STI clients. (2) To ascertain the relationship of socio-demographic factors and sexual behaviours with the treatment seeking component in STI clients. Methods: This cross-sectional study was conducted in Department of Dermatology, Faculty of Medical Sciences, King George's Medical University, Lucknow, Uttar Pradesh. After obtaining approval from the Institutional Ethical Committee, the data collected daily from master register, STI/RTI patient wise register and counsellor's patient diary during the study period August 2013 to July 2015 was processed by Microsoft Excel program. The counsellor also recorded the source of information regarding STI Clinic. The information collected regarding bio-social characteristics, high risk sexual behaviours and source of knowledge about Suraksha clinic was analysed. Results: Our results showed that literacy, male sex, urban residence and employment were some of the parameters which significantly improved the health seeking behaviour of STI clients. These variables were associated with higher odds for seeking treatment when adjusted for other variables. Similarly group with bisexual and homosexual behaviour had significantly lower odds for seeking treatment when adjusted for other variables. Conclusion/Key Message: The optimal use of information, education and communication (IEC) techniques needs to be strengthened to further improve the utilization of STI clinic services at tertiary care teaching hospitals.

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.

Background Chronic urticaria (CU) is a condition characterized by recurrent itchy hives and/or angioedema for ≥6 weeks. Most of the data about CU come from western countries with very little information available about CU in Asia, Africa, and the Middle East. Methods AWARE-AMAC is a 24-month prospective, observational, real-world, non-interventional study in patients aged ≥18 years from Asia, the Middle East, and Africa (AMAC) with CU refractory to H1-antihistamines (H1-AH). The main objective was to describe the real-world experience with CU, including clinical characteristics, presence of angioedema, treatment patterns (shifts between treatment classes and changes within a treatment class), investigator-assessed disease control, and the impact on quality of life. Subgroups of interest were type of CU at Baseline and treatment class (based on 2013 urticaria guidelines). There were no mandatory visits and diagnostic/monitoring procedures additional to routine practice, except the patient diary (7-day Urticaria Activity Score) and patient reported outcome assessments. Results The focus of the current manuscript is on patients with chronic spontaneous urticaria (CSU), who formed 98% of the sample. Patients were predominantly female (69.6% female, mean age ± SD 39.8 ± 13.29 years). Time since current diagnosis (Mean ± SD) was 28.6 ± 49.06 months. Amongst patients with CSU, 31.0% had comorbid chronic inducible urticaria (CINDU) and 46.4% had a history of angioedema. 91.9% received H1-AH therapy (±other treatments). The most frequently prescribed treatment classes at Baseline were any/combination of medications, not classified under the other 7 treatment classes, named "Others" (30.5%) followed by, omalizumab (OMA; 23.6%) and second-generation H1-AH monotherapy (sgAH; 15.1%). At Month 12, the most prescribed treatment classes (>15%) for patients were OMA (23.5%) and "Other" (21.3%); 19.7% received "No drug". At Month 24, OMA (22.5%), and "Other" (17.9%) were most frequently prescribed; 28.6% received "No drug". Overall, 79.5% of patients had some type of change in treatment. Over the study period, improvement in self-reported QoL increased, which was mirrored by better disease control. Conclusion In AMAC countries, the non-recommended "Other" treatment class played a major role in the initial management of CU patients. High usage of H1-AH (±other treatments) and OMA was observed. Treatment changes were observed in a majority of patients. Treatment escalation from sgAH was mostly via OMA. Improvement of disease control and QoL was achieved during the study period. Trial registration Observational study (NA).

The purpose of this study was to determine the intrapatient (within the same patient) variability of tacrolimus in adherent patients. Daily tacrolimus trough levels were obtained at home using dried blood spot technology in kidney and liver transplant recipients. Patients were randomized to receive 3 formulations of tacrolimus, each for two 1-week periods. Adherence was monitored by patient diary, pill counts, and use of the Medication Event Monitoring System (MEMS). Variability was quantified as the coefficient of variation (CV). Comparison of CV between groups was by independent t test or one-way ANOVA as appropriate. The population was found to be adherent with a rate of 99.9% with a mean interval between the evening and morning dose of tacrolimus of 11.86 hours. The median CV for the entire population was 15.2% (range 4.8%-110%). There were no differences in CV by allograft type or tacrolimus formulation. The multivariate analysis did not identify any demographic characteristics associated with a CV > 30%. In a highly adherent population, tacrolimus did not display high intrapatient variability. Given the association between IPV and poor allograft outcomes, future studies are needed to quantitate the influence of adherence and establish target IPV goals.

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 Structured patient education programs are a key element of patient care in many chronic diseases. They are often based on the Stanford University chronic disease self-management program and aim to empower patients and to improve compliance and coping abilities. However, not in every condition self-management education programs yield the expected benefit. 1 Objectives To develop a structured patient education program for SSc patients and to prove training-specific effects on patients’ quality of life and disability. Methods We developed a structured patient education program. The content of the program was created by a team of rheumatologists and dermatologists. The program consists of three modules focusing on general knowledge about the disease, gastrointestinal involvement, digital ulcers (DU), skin and wound care and a patient diary on disease symptoms. Patients were either included in the intervention or in the control group. Disease symptoms and severity as well as clinical parameters were assessed at baseline (intervention and control), at the follow-up visit at month 3 (intervention only) and at the final follow-up visit at month 6. In the intervention group satisfaction with the education program was analysed. Primary outcome measures were SHAQ, SF-12, BFI, SHAQ_DU. Secondary outcome measure was the satisfaction survey. For comparisons between different times analysis of variance for repeated measures was used. For description of cohorts Mann-Whitney Wilcoxon test was used. Results 58 SSc patients were included, 27 received the educational program (intervention group) and 31 patients served as a control group. Both groups were matched regarding demographics and disease subtype. Incidence of DUs was significantly higher in patients from intervention group resulting in a more frequent administration of vasoactive therapies. SHAQ, SF-12, BFI, SHAQ_DU were comparable between control and intervention group. However, patients in the intervention group rated the training program as helpful and reported an increase in knowledge about their disease afterwards. A positive impact of the training program on SHAQ, SF-12, BFI, SHAQ_DU was observed in individual patients. Conclusions Patients who participated in the training were overall satisfied with the program. However, no significant effects on quality of life after the intervention were observed. One reason for this finding might be the disease duration (mean 11.5 years). This needs to be further analysed in a consecutive study considering patients with shorter disease duration. Reference [1] Warsi, et al. “Self-management Education Programs in Chronic Disease: A Systematic Review and Methodological Critique of the Literature”Archives of Internal Medicine2004. Disclosure of Interest None declared