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Background The number of people living with advanced cancer and chronic disease has increased worldwide. Many of these patients could benefit from palliative care, focusing on optimising the quality of life of patients and their families facing problems resulting from life-threatening diseases. However, fragmentation and discontinuity of palliative care services often result in suboptimal palliative care. In order to overcome these problems, models using an integrated care approach are increasingly advocated in palliative care services. Although several models and definitions of Integrated Palliative Care (IPC) have been developed, the effects of integrated care are still under-investigated. Knowledge of the key components that constitute successful palliative care integration is still lacking. This mixed methods study will examine the experiences of patients, family caregivers and professional caregivers in order to provide insight into the mechanisms that constitute successful palliative care integration. Methods/Design Prospective multiple embedded case study. Three to five integrated palliative care initiatives will be selected in Belgium, Germany, Hungary, The Netherlands and the United Kingdom. Data collection will involve Social Network Analysis (SNA), a patient diary, semi-structured interviews, and questionnaires: Palliative care Outcome Scale (POS), Canhelp Lite, Caregiver Reaction Assessment (CRA). Patients and family caregivers will be followed in 4 consecutive contact moments over 3 months. The diary will be kept weekly by patients. One focus group per initiative will be conducted with professional caregivers. Interviews and focus groups will be tape recorded, transcribed and qualitatively analysed using NVivo 10. SPSS Statistics 20 will be used for statistical analysis. Discussion This study will provide valuable knowledge about barriers, opportunities and good practices in palliative care integration in the selected initiatives across countries. This knowledge can be used in the benchmark of integrated palliative care initiatives across Europe. It will add to the scientific evidence for IPC services internationally and will contribute to improvements in the quality of care and the quality of living and dying of severely ill patients and their relatives in Europe. Electronic supplementary material The online version of this article (doi:10.1186/1472-684X-13-52) contains supplementary material, which is available to authorized users.

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.

Purpose Keeping an ICU patient diary has been reported to benefit the patient's recovery. Here, we investigated the families' experience with reading and writing in patient ICU diaries kept by both the family and the staff. Methods We conducted a qualitative study involving 32 semi-structured in-depth interviews of relatives of 26 patients (34% of all family members who visited patients) who met our ICU-diary criterion, i.e., ventilation for longer than 48 hours. Grounded theory was used to conceptualise the interview data via a three-step coding process (open coding, axial coding, and selective coding). Results Communicative, emotional, and humanising experiences emerged from our data. First, family members used the diaries to access, understand, and assimilate the medical information written in the diaries by staff members, and then to share this information with other family members. Second, the diaries enabled family members to maintain a connection with the patient by documenting their presence and expressing their love and affection. Additionally, families confided in the diaries to maintain hope. Finally, family members felt the diaries humanized the medical staff and patient. Conclusions Our findings indicate positive effects of diaries on family members. The diaries served as a powerful tool to deliver holistic patient- and family-centered care despite the potentially dehumanising ICU environment. The diaries made the family members aware of their valuable role in caring for the patient and enhanced their access to and comprehension of medical information. Diaries may play a major role in improving the well-being of ICU-patient families.

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...

Aim: To compare the onset of action of the local antacid Maalox and the systemic H2-antagonist ranitidine, during ‘on demand’ ambulant treatment of a single heartburn episode, using a randomized, parallel group, double-blind, double-dummy design. Methods: Subjects with self-perceived heartburn without known gastrointestinal disease or interfering treatments were selected with questionnaires. The study was performed unsupervised, whenever heartburn required medication. An electronic patient diary gave instructions when to take study medication, and provided visual analogue scales and five-item relief ratings for heartburn, at frequent time intervals activated by an alarm-clock. Results: After a study of the natural history of heartburn and the feasibility of the study procedures in 23 patients, 49 subjects took Maalox and 45 ranitidine. Half of these experienced meaningful heartburn relief within 19 min after Maalox, and within 70 min after ranitidine. One hour after intake, the average heartburn relief score was 3.43 in the Maalox group and 3.04 in the ranitidine group (3 means ‘slight improvement’ and 4 ‘strong improvement’). Heartburn was similar in both groups after 3 h. Conclusions: Maalox provides faster relief of heartburn than ranitidine. Heartburn can be assessed frequently and reliably under ambulant conditions using an electronic patient diary.

The aim of this study was to develop and test the feasibility and validity of a patient questionnaire to assess health care utilization after occupational low-back pain (LBP). Items generated after a literature search were revised and refined on the basis of their face and content validity (judged by a group of practitioners) and pretested with six lay subjects who had LBP. The 73-item questionnaire was then tested in interviews with subjects with acute, subacute, or chronic LBP. Its validity was judged by comparison with a prospective patient diary and with care-provider reports. Chance-corrected agreement was estimated using the kappa statistic. Response rates were 78%, 70%, and 59% for interview, diary, and provider reports, respectively. Eighty of 102 eligible workers completed the interview in an average of 45 minutes (SD = 17.7). Most LBP subjects (90.1%) found it easy to answer. In the opinion of the interviewer, 94.7% of subjects showed adequate comprehension and ability to recall. With a few exceptions, there was moderate to substantial agreement between the interview and the patient diary (most κ values between 0.38 and 0.78). Overall, subjects reported more health care services to the interviewer than they recorded in the diary. Owing to the low response rate from providers, comparison with provider reports had to be restricted to 48 subjects and to physicians’ reports only. Agreement between interviews and physicians’ reports was substantial in use of plain X-rays (κ = 0.79) and computed tomography scans (κ = 0.85), but physicians often reported referrals not volunteered by the subjects. Agreement on prescription medications was fair (κ = 0.29–0.46) with no systematic over reporting or under reporting. Our interviewer-administered questionnaire had better return rate than the patient diary and provider reports. It was easy to administer and understand. On the basis of our comparison with patient diaries and physicians’ reports, we conclude that this questionnaire is a sufficiently valid source of health care utilization data in subjects with LBP.

Compliance is a well recognised but still unresolved health problem; improvement of compliance to treatment would increase cost‐effectiveness. One of the current methods used to measure treatment compliance in a clinical drug trial is through the use of a patient diary. In order to interpret data in these diaries it is important to also assess how compliant patients are in completing diaries. Patient compliance of standard diary completion was measured in 69 patients with perennial rhinitis, who were randomised into a double blind, placebo controlled trial with a new corticosteroid drug. During 3 months the patients were instructed to complete a diary twice a day for the following parameters: rhinitis signs and symptoms, dosage times, concomitant medication, use of rescue medication and comments. Diaries were reviewed by the physician at scheduled visits. Twenty patients (30%) completed their diaries for all items perfectly, while 62 patients (94%) completed more than 95% of all items. The compliance of diary completion in a well controlled trial is high. Overall completion of the diary was not influenced by age, gender, race, use of concomitant medication or treatment failure. Significant correlations were found for study duration and physician. This study suggests that completion of a daily diary is positively correlated with patient compliance in medication intake. Physicians could consider using diaries to try to improve compliance. More explicit investigations are needed.

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.

Background Critical illness can be a psychological stressor for patients and family members. Scandinavian studies have portrayed patient diaries as a supporting catalyst for patients and their families through a process of reflection and fact presentation. However, the small number of randomisation trials exhibits theoretical and methodological limitations. Given the increased interest amongst Australian Critical Care Nurses, further understanding of nurses' perceptions and use of patient diaries was warranted. Objectives To identify nurses' perceptions of patient diary use and to describe their application within Australian ICUs. Method A descriptive, exploratory study design using an online survey of the Australian College of Critical Care Nurses was used. Descriptive statistics illustrated participant responses and textual data were subjected to content analysis for emergent themes. Results Out of the 194 participants, 19% ( n =37) reported patient diary use in their unit, with nine indicating some form of evaluation. Fifty (70%) of the non-diary users, who responded, indicated hesitancy to introduce them. Respondents noted a lack of guiding policies and potential medico-legal ambiguity. Content analysis revealed three themes, considering diaries as: communication tool, patient recovery tool and a family centred care strategy. Conclusion Patient diary use appears to be in its infancy in Australia with a lack of guiding policy for format and processes including evaluation. Nurses using diaries were enthusiastic about the initiative, holding optimistic perceptions about the potential positive impact of diaries on patient and family outcomes. Further research on their efficacy is required.

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

Post-traumatic stress disorder (PTSD) is a well-recognised complication in patients discharged from the ICU. ICU clinics have been recommended to treat physical and psychosocial problems post discharge, with guidelines issued by the Department of Health UK [1]. Recent evidence has advocated the use of patient diaries to reduce the incidence of new-onset PTSD [2]. Family support groups may also play a pivotal role [3]. We performed a national survey via the Intensive Care Society (ICS) to determine the provision of follow-up clinics, patient diary services and family support groups.

Demographic, personal, clinical, and behavioral factors predicting chemotherapy-induced nausea and vomiting (CINV) have been assessed in the past, but inconsistencies exist in the literature, studies have methodological shortcomings, and many risk factors have been examined in cross-sectional studies and univariate analyses.To evaluate the predictive power of personal and treatment-related characteristics in the development of CINV, using a large and prospectively evaluated sample of a heterogeneous group of cancer patients receiving routine chemotherapy.This was a multicountry, multisite prospective study over three cycles of chemotherapy. Adult patients from eight European countries about to receive highly and moderately emetogenic chemotherapy were recruited. Clinicians completed a case report form at or before the initial chemotherapy treatment, recording patient demographic and baseline clinical characteristics. Participants completed a daily patient diary for six days per chemotherapy cycle describing their CINV experience. Baseline patient data also included a history of nausea/vomiting (yes/no), patient expectation of nausea (0-100 mm visual analogue scale [VAS]), prechemotherapy anxiety (0-100 mm VAS), and prechemotherapy nausea (0-100 mm VAS) measured during the 24-hour period before chemotherapy initiation.There were 991 evaluable patients with complete Cycle 1 data, 888 for Cycle 2 data, and 769 for Cycle 3 data. A complex picture of predictor variables was shown, with different contribution of variables to the acute, delayed, and overall phases of CINV. Key predictor variables included the use of antiemetics inconsistent with international guidelines, younger age, prechemotherapy nausea, and no CINV complete response in an earlier cycle (all at P 0.05). Anxiety, history of nausea/vomiting, and expectations of nausea were important predictors for some phases and cycles but not consistently across the CINV pathway.The results of this study provide clarity for the relative contribution of a set of characteristics in the development of CINV. Following evidence-based clinical antiemetic guidelines is of paramount importance, alongside treating patients with increased risk for CINV more aggressively, which both could lead to more optimal CINV management. These data can assist clinicians in making decisions about the antiemetic management of their patients.

Background The occurrence of ‘crises’ – e.g. accidents, agression, dismissal, divorce, suicide – is high among Huntington’s Disease (HD) patients. These ‘crises’, combined with the occurrence of disinhibited behaviour and the degenerative nature of HD, pose high burden on informal caregivers, which frequently results in nursing home admission of the patient. Aims In this study, we aim to evaluate the feasibility of including ambulatory HD patients and their caregivers referred to an outpatient clinic for coordinated multidisciplinary HD care, and on the feasibility of measuring several outcome measures in this patient/caregiver group. If this pilot study is successful, we aim to conduct a larger study to investigate whether outreaching multidisciplinary care for HD patients results in crises-reduction and postponing nursing home admission, and at what costs. Methods Ten HD patients and caregivers, who are newly referred to the outpatient clinic, will be included in the study. At the time of referral and five months after receiving multidisciplinary care coordinated by the outpatient clinic, data will be verbally collected from patients on: crises, quality of life, functioning and experienced problems. Informal caregivers fill out a questionnaire covering burden, quality of life and experienced problems. In addition, data on care consumption, medication use and costs is collected through an online patient diary and by reviewing patient files at general practice. Discussion This session addresses feasibility of the described pilot study. In addition, we will present our preliminary results on characteristics of the patient-informal caregiver couples that are referred to the outpatient clinic.

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.

Despite our knowledge of many effective education techniques, there is little evidence that clinicians have incorporated them into their daily practices. One of the reasons for the underutilization of patient education may be that physicians are expecting the specialist nurses to provide this service, whereas the nurses lack any formal protocol for patient education in standard clinical practice. Self-management programmes are now acknowledged as a key element of quality care. A high priority for research is the development and diffusion of patient education strategies that are tailored to address patient needs and applicable for the standard day to day practice. This paper describes the rationale and design of the ‘Joint Fitness Program’ which is a new patient-based educational programme integrating patient-reported outcome measures (PROMs) and self-management for people with inflammatory arthritis. This education programme, which illustrates how theory can explicitly be translated into practice, addresses PROMs as an objective tool to assess the educational needs of patients with arthritis and uses the PROMs to design an education programme and not just evaluate the disease activity.

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.

Parkinson's disease (PD) is the second most common neurodegenerative disorder with an estimated 4 million patients worldwide. L-dopa is standard, and often initial, therapy for patients with this condition; however, with continued dopaminergic treatment and as the disease progresses, the majority of patients experience complications such as "wearing-off" symptoms, dyskinesias, and other motor complications. These complications may become disabling and profoundly affect quality of life. Treatment modification and combination therapies with L-dopa, dopamine agonists, monoamine oxidase type B inhibitors, and catechol-O-methyltransferase inhibitors are commonly used to manage complications. In recent years regulatory agencies, clinical researchers, and sponsors have widely accepted and utilized changes in "ON" and "OFF" time measured by Patient Hauser Diaries as endpoints for measuring efficacy of therapeutics seeking approval for symptomatic treatment of PD. Successful antiparkinsonian medications have been associated with treatment effects of more than 1 h in either reduction of "OFF" time of increase in "ON" time. Accurate "ON" and "OFF" time registration during clinical studies requires rigorous patient training. Reduced compliance, recall bias and diary fatigue are common problems seen with patient diary reported measures. Electronic diaries may help reducing some of these problems but may be associated with other challenges in large, multicenter studies.

Methods A Smartphone based Personal Allergy Assistant (PAA) allows patients to keep an electronic patient diary by scanning the barcode of the consumed food products. A catalogue of predefined symptoms as well as their medically justifiable time window during which a symptom can manifest itself after the ingestion has been defined. An Electronic Patient Record for Allergies (EPRA) stores results from patient investigations with allergy specific medical knowledge, provided by allergy experts (e.g. cross allergies, seasonal effects, pollen associated FA). Data on the PAA is regularly synchronised with the electronic patient record and the food database. Diaries are evaluated by emphasising the association between food intake and occurred symptoms in order to calculate the relative risk (RR) of a specific food product or nutrition.

Bakgrund: Många patienter uttrycker ett behov av att fylla den minneslucka som finns sedan intensivvårdstiden både vad gäller tid och innehåll. Detta var anledningen till att vårdpersonal på intensivvårdsavdelningar började använda dagbok till kritiskt sjuka patienter. Syfte: Att belysa patienters upplevelser av att ta del av sin dagbok från vårdtiden på intensivvårdsavdelning. Metod: Litteraturöversikt. Artikelsökning utfördes i databaserna CINAHL och PubMed. I resultatet ingick tio vetenskapligt granskade artiklar, sju kvalitativa och tre kvantitativa. Resultat: Patienterna upplevde det som värdefullt att läsa dagboken och att titta på fotografierna eftersom det gav dem en uppfattning om vad som hade hänt och hur sjuka de hade varit. Genom dagboken fick patienterna en större sjukdomsinsikt och en mer realistisk målsättning för tillfrisknandet. Det var krävande och det väcktes starka känslor och reaktioner hos patienterna när de läste i dagboken. Dagboken fungerade som ett stöd för lång tid framöver. Patienterna uppskattade detaljerad och kontinuerligt skriven information och att dagboken var skriven med en personlig och mänsklig ton samt med ett språk som var lätt att förstå. Fotografier upplevdes av de flesta patienterna som positivt och blev ett bevis på vad de gått igenom. Det uppföljande återbesöket på IVA mottagning beskrevs av patienterna som betydelsefullt för att öka förståelsen av innehållet i dagboken och av vad som hänt under vårdtiden på IVA. Slutsats/Konklusion: Tidigare kritiskt sjuka patienter upplever, genom att ta del av dagbok från vårdtiden på intensivvårdsavdelning, större förståelse och bearbetning av sin sjukdomsperiod, vilket skulle kunna medföra förbättrad hälsa och ökad livskvalitet.

William Howard Taft was obsessed with his health—an observation many will find surprising given that he is remembered as the nation’s most obese president. But Taft kept a detailed diary of his diet, exercise, reflux symptoms, and bowel movements. He shared his logs with his personal physician, who used the information to provide feedback and, with this support, Taft lost nearly sixty pounds.1 Now, close to 70 % of Americans track some form of health-related behavior.2 The traditional leather-bound diaries of Taft’s era are less common, but personal journals are more popular than ever in the form of blogs, social media posts, and other online activities. A growing number of sensors, including wearable devices and smartphone apps, collect biometric data passively or with minimal inputs from users, supporting what is called “the quantified self,” with assessments of blood sugar, heart rhythm, or peak respiratory flow.3 The majority of these platforms and devices are never intended to be seen by doctors; by reducing the effort of documenting health, they can help patients self-manage their care, make health goals, and track progress. However, some of these platforms, such as Apple’s new HealthKit, which collect information about diet, exercise, sleep and other health measures, already have the capability to directly interface with electronic medical record (EMR) systems. With the growing use and power of digital diaries, is there anything useful in the immense amount of health information and, if so, how can physicians use it? Many apps and web-based platforms aim to move information from the public to their physicians, but most of these approaches fail important design considerations. Seemingly important information (a heart rate that’s too fast) doesn’t necessarily mean there is a physician prepared to receive or immediately act upon it. In contrast, seemingly unrelated information obtained passively (a measurable decline in the use of social media, or less movement detected by an accelerometer on a smart phone) might provide a clear signal of a health change, and one that someone might be able to act upon. Physicians need data that are accurate, but they also need information that meets standards. These design flaws will hopefully improve by increasing physician engagement in the design process and by smarter dashboards that are able to aggregate, contextualize, and analyze data. How urgently this data is utilized by physicians may be affected by compensation (a similar conundrum that was faced as emailing providers became more commonplace) and the specialty involved. This technology could enable cardiologists to better monitor arrhythmia events, or allow pulmonologists to detect chronic obstructive pulmonary disease (COPD) flares earlier. However, this will be challenging to actualize in the absence of incentives or data demonstrating an improvement in outcomes. Similar to telemedicine consults, the health provider that responds, analyzes or monitors digital diaries may not be the primary provider, but rather an ancillary provider whose primary goal is to make sense of this information. Yet, the ability to act on this data may not always fall on the physician. Careful alarms may contact pre-identified, informed friends, family, or opt-in emergency systems if an abnormality is detected. Other non-critical values could be reviewed by a primary care physician in the EMR at the patient’s next office visit. Finally, digital diaries and wearable devices could potentially be used to reduce readmission rates by monitoring high-risk patients after discharge, allowing doctors to intervene sooner if, for example, a congestive heart failure (CHF) patient’s weight starts to rise at home. Despite these potential benefits, there remain several important questions around this technology that physicians can play a key role in addressing. Is the information provided by the right patients? As with anything new, the early efforts at bringing digital personal health monitoring to the public attracted those individuals who—through a fascination with technology, a tendency toward early adoption, or greater-than-average self-involvement—were willing to engage in the process. In contrast, the people we worry about most are often those patients who would not think to engage in this kind of self monitoring, or are not capable due to their fragile health or social circumstances. Even before health related information became increasingly digital, physicians often characterized those patients bearing notebooks of symptoms and signs as suffering from La Maladie du Petite Papier. The substantive challenge in contemporary journaling is to capture information from those patients who most need close observation, and those patients are often the least likely to participate. These patients particularly need platforms that are effortless, passive, and integrated into their daily lives. There is no one-size-fits-all strategy for engaging disengaged patients, and this is a challenge in all areas of medicine as physicians aim to find new ways to motivate patients, equip them with the right resources, and reduce barriers to achieving health goals. The approach will be similar to other technology interventions and could incorporate behavioral economics and incentives, “gamification,” peer-to-peer support, and other validated techniques used in preventative care. Is the information actionable and provided at the right time? Most questions asked by physicians happen when the patient is in front of them, and the tools for using that information are within reach. Digital information can be transmitted without the patient there and can arrive at inconvenient times. Despite the potential importance of alerting physicians to their patients’ blood sugars or heart rates, a physician can’t comfortably handle a live stream of patient information without established systems of support. This information would be a “hot potato,” leaving the physician with a sense of risk and responsibility, but without a plan to manage either. Most physicians still practice using systems that make patients largely invisible and unapproachable unless they are sitting face-to-face. The best platforms will give integrated data to doctors in settings where they can be used effectively, while also providing appropriate feedback directly to users and potentially their social networks. The best digital journaling will either report on information that can wait, or be paired with systems that can handle emergencies. Is there an established contract for the information? Our health is now revealed in so many indirect ways. Some are obvious (e.g., supermarket purchases reveal diet), while others are subtle. Will slower or less frequent texting on our cell phone help an internist manage depression, or diagnose a movement disorder? Will erratic banking activity reveal cognitive decline? Physicians are accustomed to using the information patients inadvertently reveal (the unsuccessful efforts at hiding memory loss) and not just what they submit for examination. On a much wider scale, big data analysts could find health signals in the tracks left inadvertently by patients (e.g., in their supermarket receipts or banking habits) as patients increasingly broadcast information about their health—information that could be used just as effectively as the information patients unwittingly reveal now when they sit face-to-face with their doctors. Those signals might be strong and valuable, but the social contracts around their acceptance (by patients) or use by doctors are not established. While so much money and attention has focused on the acceleration of electronic health records documenting medical encounters, much of real health-related activity occurs during the 5,000 waking hours patients spend each year engaging in their everyday lives.4 The digital diaries produced in those 5,000 hours offer considerable insight into individual and population health. Much of this data may be valuable only to the diarist (perhaps the process of tracking one’s health is as important as the actual data from the tracking). But the aggregate of these diaries may be a valuable tool to help physicians manage patient care. Just as there are user design considerations in facilitating patient recording of relevant health information, there are user design considerations in facilitating the effective receipt of that information by clinicians. Now that health-related information is collected more easily, and more passively, the intersection between what patients communicate and what physicians can use is growing.5 The best of connected health technologies acknowledge patient privacy and are patient-controlled, transparent, opt-in, and customizable. While many focus on the wearable devices and other technologies that enable this growing use of information, others focus on the big data analytic challenges of finding signals in increasingly complex data structures. Underlying both of these efforts is the need to ensure these processes fit comfortably and acceptably into the patterns of our lives and clinical practice.

This multicenter, double-blind, placebo-controlled study using a randomized withdrawal design evaluated the efficacy and safety of once-daily OROS hydromorphone ER in the treatment of opioid-tolerant patients with chronic moderate-to-severe low back pain (LBP).The primary efficacy assessment was mean change in pain intensity based on patient diary Numeric Rating Scale (NRS) scores from baseline to final visit of the 12-week double-blind phase. Secondary endpoints included mean change from baseline to each visit in patient diary NRS scores; and office NRS scores; time to treatment failure; Patient Global Assessment; rescue medication use; and Roland Morris Disability Questionnaire total scores.ClinicalTrials.gov NCT00549042.For the primary outcome measure, hydromorphone ER significantly reduced pain intensity compared to placebo (p0.001). Median diary NRS score change from baseline to endpoint was significantly lower for OROS [corrected] hydromorphone ER (0.2 units) compared to placebo (1.6 units). [corrected] A significantly higher proportion of hydromorphone ER (60.6%) vs. placebo (42.9%) patients had at least a 30% reduction in diary NRS pain score from screening to endpoint (p0.01). Hydromorphone ER was well-tolerated, although 60 (13%) discontinued during the enrichment phase for adverse events and more active (9, 6.7%) than placebo (4, 3.0%) patients discontinued treatment for adverse events during the randomized phase.These results provide evidence for the efficacy and safety of hydromorphone ER in opioid-tolerant patients with chronic moderate-to-severe LBP. Potential limitations include the shortened dose-conversion/titration phase, limiting the daily allowable dose of hydromorphone ER to 64 mg, and the allowance of limited rescue medication throughout the entire double-blind phase. Other trial design elements such as the use of an enrichment phase and the inclusion of only opioid tolerant patients may limit the generalizability of these results.

Background: Clinical trials are increasingly being designed to collect data directly from patients through the use of paper diaries or electronic diaries (e-diaries). E-diaries can be advantageous over paper diaries, but actual benefits may depend on the particular features of a given e-diary. The objective of this study was to determine which e-diary system features are most important to consider when selecting such a tool. Methods: A 42-question survey was distributed to 295 site coordinators participating in four diabetes clinical trials, using e-diary systems provided by three different vendors. The survey gathered information about the site coordinators’ experience with the e-diary system used. Analyses included a comparison of global satisfaction rating scores and individual survey item responses among the different e-diaries utilized and correlation of individual survey items with the global satisfaction rating for each system. Results: The survey was completed by 131 site coordinators (44% response rate). Mean global satisfaction rating scores varied from 3.4 to 7.2 (p < 0.0001). Individual survey items such as technical problems that cannot be resolved easily, the ability of the help line to fully address problems, and organization and user-friendliness of the ediary’s data management Web site were most closely correlated with the global satisfaction rating. The site coordinators’ prior e-diary experience and years of job experience did not significantly correlate with the global satisfaction rating. Conclusions: This survey highlights features of e-diaries for sponsors to consider in clinical trials, including the importance of minimizing technical problems, assessing vendors’ help line capabilities, and choosing an e-diary system with an efficient and user-friendly data-management Web site.

syn. case record form, data collection form; record of data or other information on subjects in a clinical trial as defined by the protocol; data may be recorded by hard (e.g. NCR (no carbon required) paper) copies, electronic or optical disk methods or any other means, ensuring accurate input and allowing verification against raw data; CRFs are to be considered as documents; EC: “CRFs may be requested by Member States and should therefore always be available”; → see also data transfer, patient diary, electronic CRF, electronic data, raw data.

Exercise rehabilitation is one of the few evidence-based treatments for chronic non-specific low back pain (cLBP), but individual success is notoriously variable and may depend on the patient’s adherence to the prescribed exercise regime. This prospective study examined factors associated with adherence and the relationship between adherence and outcome after a programme of physiotherapeutic spine stabilisation exercises. A total of 32/37 patients with cLBP completed the study (mean age, 44.0 (SD = 12.3) years; 11/32 (34%) male). Adherence to the 9-week programme was documented as: percent attendance at therapy, percent adherence to daily home exercises (patient diary) and percent commitment to rehabilitation (Sports Injury Rehabilitation Adherence Scale (SIRAS)). The average of these three measures formed a multidimensional adherence index (MAI). Psychological disturbance, fear-avoidance beliefs, catastrophising, exercise self-efficacy and health locus of control were measured by questionnaire; disability in everyday activities was scored with the Roland–Morris disability scale and back pain intensity with a 0–10 graphic rating scale. Overall, adherence to therapy was very good (average MAI score, 85%; median (IQR), 89 (15)%). The only psychological/beliefs variable showing a unique significant association with MAI was exercise self-efficacy (Rho = 0.36, P = 0.045). Pain intensity and self-rated disability decreased significantly after therapy (each P

Background: According to the literature on the history of anaesthesia, Finland’s first anaesthesia was given on March 8, 1847 for a ligature of an aneurysm of the subclavian artery. It has, however, not been possible to verify the date with certainty. We therefore wanted to find out whether newspapers might give additional information and how this exceptionally important medical invention had been received by the Finnish newspapers. Methods: Microfilms of the 10 newspapers which appeared in Finland in 1847 were studied at the Helsinki University library. Results: The first report which made reference to English newspapers was published on February 10 by “Borga Tidning”. On March 6, “Helsingfors Tidningar” wrote that two anaesthesias had already been given in Helsinki; the first of them for a difficult varicose veins operation and the second for an exarticulation of a shoulder. But there was no information regarding the dates of the operations. Fortunately, both operations had been recorded in the patient diary of the clinic, although without any information about the anaesthesia. According to the diary, Johan August Orn was operated for varicose veins on February 16 and Anders Gustaf Henrikson had his right arm exarticulated on March 3. Both patients recovered. In total, only six pieces of news on anaesthesia were found. Conclusions: Finland’s first anaesthesia was given on February 16, 1847, which is three weeks earlier than had been previously assumed.

This analysis evaluated the long-term safety, tolerability and efficacy of darifenacin, a muscarinic M3 selective receptor antagonist, in the treatment of overactive bladder (OAB) in patientsor = 65 years of age.Patients who completed one of two 12-week, placebo-controlled, double-blind, feeder studies received once-daily (o.d.) treatment with darifenacin 7.5 mg for the first 2 weeks of the 2-year, open-label extension study. The dose could be subsequently adjusted (7.5 or 15 mg o.d.) according to need. Safety and tolerability were assessed, and efficacy variables/endpoints were evaluated from patient diary data.214 patients (65-89 years) entered and 137 (64.0%) completed the 2-year extension study, amounting to 308 patient-years' drug exposure. Darifenacin was well tolerated with no new safety concerns. The most common adverse events (AEs) were dry mouth and constipation, which infrequently resulted in discontinuation (2.3% and 4.2%, respectively). Darifenacin produced significant improvements in OAB symptoms that were maintained over the 2-year period (median reduction from feeder-study baseline to 2 years: -11.0 [-83.7%] for incontinence episodes/week and -1.2 [-12.4%] for micturitions/day, both p0.05), with 44.4% patients achievingor = 90% reduction in incontinence episodes at 2 years.Darifenacin demonstrated good tolerability and safety in older patients with OAB. The improvement in OAB symptoms was sustained throughout the 2-year extension, resulting in high treatment persistence rates. Results were comparable with those in the overall OAB population from this study, indicating that darifenacin treatment is effective and well tolerated irrespective of age.

Summary Purpose Patients with metastatic bone disease may be treated with bisphosphonates to reduce or delay skeletal complications including pathologic fracture, radiotherapy to bone, and hypercalcemia of malignancy. Nurses can provide important education to patients and support or encourage the use of bisphosphonates throughout therapy. Methods Literature and congress reports were reviewed for relevant efficacy information on bisphosphonates and adverse events that may occur during bisphosphonate therapy. Bisphosphonates can provide meaningful benefits to patients, and zoledronic acid is now approved for the treatment of bone metastases secondary to any solid tumor. Results To optimize care, nurses can monitor pain scores, changes in mobility, adverse events, and serum creatinine levels. A useful tool for recording these parameters is a patient diary. The nurse should fill out the diary at each patient visit and compare it with baseline information before treatment is administered. Patients should also be counseled on the importance of adequate hydration, good dental hygiene, the need for calcium and vitamin D supplements, and how to best manage potential side effects. Conclusions Bisphosphonates are effective in reducing and delaying skeletal complications, and zoledronic acid has demonstrated significant efficacy in preventing skeletal complications across a wide range of solid tumors and multiple myeloma. Nurses play an important role in enabling patients to optimize bisphosphonate therapy and in supporting patients to continue treatment to preserve their functional independence.

Background The new Musculoskeletal Services Framework outlines the importance of health care needs assessment. Our aim was to provide a model for this for knee pain and disability, describing felt need (individual assessment of a need for health care) and expressed need (demand for health care). This intelligence is required by health care planners in order to implement the new Framework. Methods A multi-method approach was used. A population survey (n = 5784) was administered to adults aged 50+ registered with 3 general practices. The questionnaire contained a Knee Pain Screening Tool to identify the prevalence of knee pain and health care use in the population, and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Survey responders who scored "severe" or "extreme" on at least one item on the pain or physical function scale on the WOMAC were categorised into "severe" groups. Qualitative interviews were undertaken with 22 survey responders to explore in detail the experience of living with knee pain and disability. A sample of interviewees (n = 10) completed an open format patient diary to explore the experience of knee pain in everyday life. Results The 12-month period prevalence of knee pain was 49.5%, of which half was severe. Severe difficulties were reported with domestic duties, bending, bathing, climbing stairs and getting in or out of a car. Some self-care is occurring. The majority (53%) of responders with severe pain or disability had not consulted their GP in the last 12 months. The qualitative study revealed reasons for this including a perception that knee pain is part of normal ageing, little effective prevention and treatment is available and the use of medications causes side effects and dependency. Conclusion This study adds to previous work by highlighting a gap between felt and expressed need and the reasons for this mismatch. There is evidence of self-management, but also missed opportunities for effective interventions (e.g. lifestyle advice). A targeted and integrated approach between clinicians and health care planners for primary and secondary prevention is required if aspects of the new Musculoskeletal Services Framework are to be successfully implemented.

Linking mobile phone technology with electronic data collection may facilitate the research experience and improve compliance. We conducted a qualitative interview study using a purposeful sample of 10 patients with asthma and two research staff. Patient diary information was collected twice a day using an electronic peak flow meter linked to a mobile phone with an interactive screen to record current asthma symptoms transmitted to, and stored in, a server. An analysis of the interview data identified key technological adjustments and support factors which would improve the application of the technology in future clinical trials. Patients and staff believed that mobile phone technology would be useful in clinical practice as well as research. Its main uses were seen as identifying poor control more quickly and facilitating communication with healthcare professionals without the need for face-to-face consultation. There was a high degree of acceptability to both patients and staff.

This article reviews the use of the diary method of data collection in health-care research. The characteristics, strengths and limitations of diaries will be discussed, and the author's experience of the diary-interview method will be described.

Objective: To evaluate patient perceptions of a new home diary designed to assess the duration and severity of dyskinesia in patients with Parkinson disease (PD) and to investigate whether the use of a training video and pictograms aids patient understanding of PD terminology. Methods: Fifty advanced PD patients (Hoehn and Yahr stage 2.5-4.0; dyskinesia for >25% of the waking day) from the United States (n = 18), France (n = 12), and Germany (n = 20) were allocated alternately to 1 of 2 groups and shown a training video either with pictograms or without pictograms. The video explained the functional states "asleep," "OFF," "ON without dyskinesia," and "ON with dyskinesia," and how to complete the diary. Patients were given the corresponding version of the diary with or without pictograms to complete over a 24-hour period. Patients then participated in a second interview in which they were shown the alternate version of the video and diary for discussion only. Results: Almost 95% of patients (47/50) reported that the video helped them to understand and clarify terms. Most patients [39/50 (78%)] preferred the diary with pictograms, but there was no evidence that pictograms improved the accuracy of diary completion. Overall, 80% of patients (40/50) completed the diaries correctly. Incorrect diary completion was usually because of confusion about the different functional states. Conclusions: Patients perceive diaries with pictograms as more helpful than those with words alone. Videos, in the patients' primary language, are considered valuable training aids that help patients complete daily diaries.

The North American Pivotal Trial was designed to investigate the efficacy and safety of vardenafil in males with erectile dysfunction (ED).In this randomized, double-blind, placebo-controlled, multicenter, fixed-dose, parallel group, 6-month study, vardenafil at three doses (5 mg, 10 mg, and 20 mg) was compared to placebo with the primary efficacy variables being the International Index of Erectile Function (IIEF) Erectile Function (EF) domain score and per patient diary response success rates for penetration and maintenance of erection through completion of intercourse. Additional efficacy variables included IIEF domain scores measuring intercourse satisfaction, orgasmic function, sexual desire, and overall satisfaction. Diary entries for overall per patient satisfaction rates for hardness and sexual experience were also measured. Improvements in quality of sexual life were assessed using the Fugl-Meyer quality of life (QoL) questionnaire.Compared to placebo, patients taking 10 mg and 20 mg doses of vardenafil showed statistically significantly greater improvement in IIEF domain scores measuring intercourse satisfaction (10.3 and 10.3 vs. 7.7), orgasmic function (7.1 and 6.9 vs. 5.3), overall satisfaction. (7.1 and 7.1 vs. 5.2) for vardenafil 10 mg and 20 mg vs. placebo, respectively, at last observation carried forward (LOCF). Vardenafil 5 mg was statistically significantly better than placebo for the secondary IIEF domain variables of intercourse satisfaction (8.9 vs. 7.7) and overall satisfaction (6.3 vs. 5.2) for vardenafil vs. placebo, respectively, at LOCF. Per patient satisfaction rates for the secondary diary variables measuring erection hardness (38%, 52%, 58% and 18%) and overall satisfaction (45%, 58%, 62% and 23%) were dose dependent and statistically significantly superior for vardenafil at 5 mg, 10 mg and 20 mg compared with placebo, respectively. Patients' answers to the Fugl-Meyer QoL questionnaire assessing improvement in sexual life also indicated statistically significant superiority for all doses of vardenafil vs. placebo treatment. The most frequent adverse events (AE) in the 5 mg, 10 mg, and 20 mg of vardenafil and placebo groups, respectively, were: headache (10%, 22%, 21% and 4%), flushing (5%, 10%, 13% and 0%), dyspepsia (1%, 4%, 6% and1%), and rhinitis (9%, 14%, 17% and 5%). Most AEs were mild or moderate in severity and transient in nature.Vardenafil was superior to placebo for IIEF domain scores, per patient success rates for diary questions, and assessment of quality of sexual life, in a broad range of patients with ED irrespective of etiology or severity. Vardenafil was generally well tolerated, with most AEs being mild or moderate in severity and transient in nature.

Patients requiring prolonged periods of intensive care and mechanical ventilation are termed chronically critically ill. These patients present a challenge to the healthcare team. In the fast-paced environment of the intensive care unit, their slow progress can be a source of frustration. At the University Hospital Geneva, a team, led by a clinical nurse specialist, addressed this problem by implementing a new care program with a goal to better know this patient population and improve their care. Values of emancipatory practice development guided the project, which utilized an action research methodology. Key assessment tools included a nursing focused patient history at admission and weekly nursing rounds, which allowed for periodic holistic assessment and care planning. New interventions focused on communication, physical care, and providing a context of understanding for the patient beyond hospitalisation, operationalised as a patient diary. The structure of the new program allowed the nurses to develop new skills and provided an environment for dynamic reflection. The care of this demanding patient population is beginning to be perceived by nurses as challenging and interesting.

Purpose: To our knowledge there is no index in urology that yields a single, quantifiable and clinically interpretable measure of overactive bladder (OAB) symptoms, including urgency, 24-hour voiding frequency and urge urinary incontinence (UUI). Urgency is the most difficult of these symptoms to measure. The Indevus Urgency Severity Scale (Indevus Pharmaceuticals, Lexington, Massachusetts) was recently developed and validated to capture urgency severity per toilet void. The scale has been combined with 24-hour frequency and UUI episodes to create the OAB Symptom Composite Score (OAB-SCS). We present this composite score. Materials and Methods: Two multicenter trials were performed to determine the effects of trospium chloride given as 20 mg tablets vs placebo. A total of 1,157 patients, including 581 who received placebo and 576 who received trospium, were randomly assigned to treatment. Daily OAB-SCS totals were obtained for each patient for each day during the 7-day diary collection period for every visit. Results: The average baseline OAB-SCS value was 36. The mean change from baseline in the trospium and placebo groups was 5 and 1 OAB-SCS points in patients with mild OAB, 10 and 5 in patients with moderate OAB, and 13 and 9 in patients with severe OAB, respectively. Conclusions: The OAB-SCS discriminated between placebo and pharmacologically treated (trospium chloride) patients with OAB in this study. The OAB-SCS is an improvement over individual symptoms alone. It is easy to implement and interpret and it will prove to be a clinically relevant tool in clinical trials in which patient diary data are captured.

BACKGROUND: In May 2000, AstraZeneca launched a Web service for asthma patients and health-care providers called LinkMedica, which includes an asthma diary for monitoring and self-management. In the diary, the patient enters his or her peak flow, number of doses of rescue medication, and if there have been any asthma symptoms during the previous 24 hours. The patient receives an immediate response from LinkMedica, telling him or her if the asthma is under control and what to do if not, eg, increase the dose of inhaled steroid. Health-care providers have access to the patient diary. OBJECTIVES: The primary objective of the study was to describe patients' and health-care providers' use of LinkMedica. Secondary objectives were to evaluate their perception of the system and how the users' interaction with the system is influenced by their everyday lives. METHODS: Site statistics regarding number of registered users and diary usage were analyzed. An online survey among users (85 respondents), a mailed questionnaire to health-care providers (131 respondents; response rate 26.8%), as well as in-depth interviews with 10 patients and 5 general practitioners, elicited further quantitative and qualitative data on users' perceptions. RESULTS: In February 2003, a total of 7653 users had registered. During 2002, the growth in registered users averaged 50 per month. In the same period, the number of unique diary users per month decreased from 307 to 138. Patients usually stopped using the diary after a short time; the doctors were reluctant to introduce the diary to patients because of time constraints. Several user subtypes were identified among patients and their relatives. CONCLUSION: The self-selected survey responses and in-depth interviews indicated that LinkMedica is generally considered a trustworthy and reliable site by both patients and doctors. However, there was a contrast between users' positive perception of LinkMedica and their unwillingness to use the site for more than short periods. The primary reason for this was that LinkMedica did not fit into their everyday lives because of technical and psychological aspects. A number of recommendations to improve LinkMedica are suggested. [J Med Internet Res 2004;6(3):e23]

Background: Cardiac cryoablation has been used to successfully treat a variety of arrhythmias. Objective: This study documents our experience with a new 9 French (FR) 8 mm cryocatheter for ablation treatment of symptomatic atrial flutter. Methods: A total of 77 consecutive patients with symptomatic atrial flutter were treated. Electrophysiological studies (EPS) were performed with diagnostic catheters and ablation was performed with a 9FR, 8 mm tip, quadripolar cryocatheter (Freezor® MAX catheter, CryoCath Technologies Inc., Kirkland, Canada). Cryoablation at −75°C for 8 minutes was performed, beginning at the inferior rim of the coronary sinus (CS) os and creating a posterior line to the Eustachian ridge. Safety, bidirectional isthmus block at intervention, and recurrence at 3 months post procedure were assessed. Results: There were no adverse events reported. All patients remained free of discomfort on cryoenergy delivery. The acute success rate at intervention was 96% for all patients and 100% for those with common atrial flutter. Follow-up data from 47 patients showed 33 (70%) patients without conduction recurrence on repeat EPS at 3 months. Although, 1 (2%) patient had both symptom and conduction recurrence. Data available from 53 acutely successful patients at 6 month clinical follow-up showed that 48 (91%) patients were asymptomatic and 5 (9%) patients had recurrence documented by ECG and/or patient diary records. Conclusions: Our experience with a new 9FR, 8 mm tip, quadripolar cryocatheter yielded a high success rate at intervention and an excellent safety profile. Although repeat EPS at 3 months post ablation identified conduction recurrence in 30% of patients, at 6 month clinical follow-up only 9% of patients had recurrence. Further monitoring is necessary to assess whether the relatively low recurrence rate observed at 6 month clinical follow-up is maintained over the long term.

Objective: This open-label study investigated the efficacy of sildenafil citrate at 12 hours postdose among prior treatment responders. Patients and Methods: Eight 100-mg doses of sildenafil were provided to 40 eligible patients with erectile dysfunction (ED), who were to record the results of each sexual attempt in a patient diary. Each patient was instructed to make a sexual attempt at 1 and 12 hours postdose on 4 occasions (part 1) and only at 12 hours postdose on 4 subsequent occasions (part 2). Results: Of 40 enrolled patients, 34 (85%) completed the study. In these evaluable patients, 97% and 74% of patients achieved erections that resulted in successful intercourse at 1 hour and 12 hours postdose, respectively. There was a nonsignificant reduction in the percentage of responders at 12 hours during part 1 versus part 2 of this study (71% versus 78%). Conclusions: This study demonstrates that, in the majority of these patients with ED, sildenafil remains clinically active 12 hours after administration. Larger studies may be necessary to confirm and clarify the therapeutic window of sildenafil.

Diabetes mellitus affects an estimated 17 million people in America. A cornerstone to the treatment of this population is appropriate glycemic control, which has been associated with better patient outcomes and cost savings from lack of diabetes complications needing treatment. The patient diary serves as the primary means used by patients and care providers to monitor and ensure glycemic control among this population and as a key component to effective diabetes management. Diabetic patients are encouraged to track continually, in a systematic way, blood glucose levels, dietary intake, activity level, and insulin dose if applicable for use in guiding appropriate care decisions. Traditionally, the recording of such patient experience data has occurred in paper-based diaries. More recently, with the advent of personal digital assistant (PDA) technology, electronic diaries are demonstrating promising benefits over paper-based diaries. To take advantage of this technology, patients must be able to use PDA devices accurately and providers must be knowledgeable about their capabilities. Advanced practice nurses (APNs) in general, and nurse practitioners in the outpatient setting more specifically play a key role in assessing the appropriateness of PDA technology for individual patients, educating patients in various software applications, and ensuring the documentation and trending of data. This article provides an overview of traditional diabetes management record-keeping techniques followed by a review of current PDA technologies and resources that aim to improve the state of diabetic documentation by patients.