Examining the patient's subjective experience in prospective clinical comparative effectiveness research (CER) of oncology treatments or process interventions is essential for informing decision ...making. Patient-reported outcome (PRO) measures are the standard tools for directly eliciting the patient experience. There are currently no widely accepted standards for developing or implementing PRO measures in CER. Recommendations for the design and implementation of PRO measures in CER were developed via a standardized process including multistakeholder interviews, a technical working group, and public comments. Key recommendations are to include assessment of patient-reported symptoms as well as health-related quality of life in all prospective clinical CER studies in adult oncology; to identify symptoms relevant to a particular study population and context based on literature review and/or qualitative and quantitative methods; to assure that PRO measures used are valid, reliable, and sensitive in a comparable population (measures particularly recommended include EORTC QLQ-C30, FACT, MDASI, PRO-CTCAE, and PROMIS); to collect PRO data electronically whenever possible; to employ methods that minimize missing patient reports and include a plan for analyzing and reporting missing PRO data; to report the proportion of responders and cumulative distribution of responses in addition to mean changes in scores; and to publish results of PRO analyses simultaneously with other clinical outcomes. Twelve core symptoms are recommended for consideration in studies in advanced or metastatic cancers. Adherence to methodologic standards for the selection, implementation, and analysis/reporting of PRO measures will lead to an understanding of the patient experience that informs better decisions by patients, providers, regulators, and payers.
Suatu misi penginjilan dapat berhasil apabila dilaksanakan secara kontekstual. Salah satu lembaga misi yang berhasil menjalankan penginjilan secara kontekstual adalah Crossline Family yang ...melaksanakan misi kepada anak punk. Penelitian ini bertujuan menggali metode penginjilan yang digunakan Crossline Family terhadap anak punk. Metode yang dipakai adalah kualitatif deskriptif. Informan adalah pemimpin dan anggota Crossline Family. Data diambil melalui teknik wawancara dan analisa sejarah perjalanan pelayanan Crossline Family yang telah didokumentasikan melalui video. Penelitian menemukan adanya tiga metode yang digunakan Crossline Family dalam penginjilan terhadap anak punk yaitu: 1) berelasi tanpa menghakimi, 2) pro-aktif berada di tengah-tengah kehidupan mereka dan menjadi teladan; 3) menyampaikan Firman Tuhan melalui genre lagu anak punk.
Background
There is an impression of poor management of pregnancy sickness in Australia, specifically an apparent total reliance on metoclopramide, as a first‐line choice.
Aims
To determine what ...management options are commonly used in by distributing a survey to Fellows and Diplomates of RANZCOG.
Methods
A web‐based survey questionnaire distributed using an email list obtained from RANZCOG.
Results
A total of 495 responses were received (23%). For morning sickness, 89% of those replying give dietary advice frequently or always, and 70% prescribe metoclopramide frequently or always, whereas 59% advise pyridoxine and 10% prescribe doxylamine. For hyperemesis gravidarum, 86% prescribe metoclopramide and 75% ondansetron.
Conclusions
Despite guidelines suggesting the use of antihistamines and dopamine agonists (phenothiazines), very few practitioners in this region make use of these in any numbers.
This report describes the performance of a wireless electronic diary (e-diary) system for data collection and enhanced patient-investigator interactions during intensive insulin management in ...diabetes clinical trials.
We implemented a customized electronic communication system featuring an e-diary and a Web portal in three global, randomized, controlled Phase 3 clinical trials testing basal insulin peglispro compared with insulin glargine, both combined with prandial insulin lispro, in patients with type 1 or type 2 diabetes mellitus (T1DM and T2DM, respectively). We collected data during 28 weeks of study e-diary use for the report.
Patients (n=2,938) in 31 countries used e-diaries to transmit 2,439,087 blood glucose (BG) values, 96% of which were associated by the patient with a protocol time point during the 72-h response window. Of 208,192 hypoglycemia events captured, 96% had a BG value, and 95% had treatments and outcomes entered by patients within the 72-h window. Patients recorded administration of 1,964,477 insulin doses; 93% of basal insulin doses were adherent with the investigator prescription. Investigators adjusted 13 basal and 92 bolus insulin prescriptions per patient-year using the e-diary system. After 26 weeks of treatment and e-diary use in the combined study arms, hemoglobin A1c values decreased by 0.6% or 1.6% and fasting BG decreased by 7.8 or 28 mg/dL in patients with T1DM or T2DM, respectively.
The e-diary system enabled comprehensive data collection and facilitated communication between investigators and patients for intensive insulin management in three global clinical trials testing basal insulins.
Computer tailored, Web-based interventions have emerged as an effective approach to promote physical activity. Existing programs, however, do not adjust activities according to the participant's ...compliance or physiologic adaptations, which may increase risk of injury and program attrition in sedentary adults. To address this limitation, objective activity monitor (AM) and heart rate data could be used to guide personalization of physical activity, but improved Web-based frameworks are needed to test such interventions.
The objective of this study is to (1) develop a personalized physical activity prescription (PPAP) app that combines dynamic Web-based guidance with multi-sensor AM data to promote physical activity and (2) to assess the feasibility of using this system in the field.
The PPAP app was constructed using an open-source software platform and a custom, multi-sensor AM capable of accurately measuring heart rate and physical activity. A novel algorithm was written to use a participant's compliance and physiologic response to aerobic training (ie, changes in daily resting heart rate) recorded by the AM to create daily, personalized physical activity prescriptions. In addition, the PPAP app was designed to (1) manage the transfer of files from the AM to data processing software and a relational database, (2) provide interactive visualization features such as calendars and training tables to encourage physical activity, and (3) enable remote administrative monitoring of data quality and participant compliance. A 12-week feasibility study was performed to assess the utility and limitations of the PPAP app used by sedentary adults in the field. Changes in physical activity level and resting heart rate were monitored throughout the intervention.
The PPAP app successfully created daily, personalized physical activity prescriptions and an interactive Web environment to guide and promote physical activity by the participants. The varied compliance of the participants enabled evaluation of administrative features of the app including the generation of automated email reminders, participation surveys, and daily AM file upload logs.
This study describes the development of the PPAP app, a closed-loop technology framework that enables personalized physical activity prescription and remote monitoring of an individual's compliance and health response to the intervention. Data obtained during a 12-week feasibility study demonstrated the ability of the PPAP app to use objective AM data to create daily, personalized physical activity guidance, provide interactive feedback to users, and enable remote administrative monitoring of data quality and subject compliance. Using this approach, public health professionals, clinicians, and researchers can adapt the PPAP app to facilitate a range of personalized physical activity interventions to improve health outcomes, assess injury risk, and achieve fitness performance goals in diverse populations.
Electronic data collection for monitoring pain has become increasingly popular in clinical research. Past research has shown that electronic diaries improve the timeliness of receipt of data, ...contribute to higher rates of compliance, and are preferred by patients over paper diaries, and this research suggests that electronic diaries that capture current pain at the moment of reporting result in more reliable ratings than recalled pain ratings. This study compared differences of momentary pain intensity ratings on an electronic visual analog scale (VAS) with weekly recalled pain on a 0 to 10 scale. We asked 21 patients with chronic low back pain to monitor their current pain at least once a day by using a VAS for up to 1 year with a palmtop computer. They were also called once a week and asked to rate their recalled weekly pain orally on a numeric scale from 0 to 10. Patients entered data electronically on average 357 times, for an average of 7.8 times a week. We found that (1) weekly recalled pain agreed highly (r > .90) with averaged momentary pain assessments, (2) neither frequency of electronic monitoring nor variability in momentary pain ratings (high standard deviations) contributed to degree of agreement between momentary and recalled pain, and (3) a ceiling effect was observed in VAS pain ratings as compared with numeric pain ratings. These findings suggest that, among many individuals, weekly recalled pain might be just as useful as momentary data collected through electronic data entry.
Some believe that remembered pain is problematic because of recall bias and that data from frequent momentary pain ratings with electronic diaries are more valid. This study demonstrates that recalled pain is as valid as momentary data for many patients.
The visual analogue scale (VAS) is an established, validated, self-report measure usually consisting of a 10 cm line on paper with verbal anchors labeling the ends. Palmtop computers (PTCs also known ...as personal digital appliances) have incorporated VAS entry by use of a touch screen. However, the validity and psychophysical properties of the electronic VAS have never been formally compared with the conventional paper VAS. The aim of this study is to determine the agreement between the electronic (eVAS) and paper (pVAS) modes. Twenty-four healthy volunteers were recruited for this study. Each study participant provided input using both measurement methods by marking the eVAS and pVAS in response to two kinds of stimuli, cognitive and sensory. A verbal rating scale of seven descriptors of intensity represented the cognitive stimuli. Participants were asked to mark the location that best corresponded to the pain intensity described by each word on scales from 'no pain' to 'worst possible pain'. The sensory stimuli used were a set of test weights consisting of plastic containers ranging from 7 to 129 g. The VAS for sensory stimuli ranged from 0 (no weight) to 'reference weight' (the heaviest weight outside the range of test weights). There were two types of input stimuli and two modes for recording responses for a total of four experimental conditions. Two evaluators independently measured and recorded all the pVAS forms to the nearest millimeter. A total of 2016 stimuli were rated. The overall correlation for ratings of both sensory and cognitive stimuli on eVAS and pVAS was r = 0.91. For paired verbal stimuli the correlation was r = 0.97. For paired sensory stimuli the correlation was r = 0.86. The correlation between group eVAS and pVAS ratings to common verbal stimuli was r = 0.99. For common sensory stimuli the group correlation was r = 0.99. The median of correlations comparing eVAS and pVAS ratings was 0.99 for verbal stimuli and 0.98 for sensory stimuli. Multivariate analyses showed equivalent stimuli to be rated much the same whether entered on paper VAS or PTC touch screen VAS (P < 0.0001). Support was found for the validity of the computer version of the VAS scale.
Electronic data collection for monitoring pain has become increasingly popular in clinical research. However, no direct comparison has been made between electronic diaries and self-report paper ...diaries or phone interviews. We asked 36 patients with chronic low back pain to monitor their pain for 1 year; 20 of them used both a palmtop computer and paper diaries, and 16 used paper diaries alone. All patients were called once a week and asked to rate their pain. Regression analyses with a measurement error model were run on hourly pain scores recorded by both palmtop computer and paper diaries. Ratings of pain intensity were highly reliable between data recorded with a palmtop computer and with data from paper diaries. Patients who monitored their pain with the palmtop computer entered data on average 6.75 times a week and were 89.9% compliant with daily monitoring throughout the year. Two-way messaging available through the palmtop computer seemed to encourage continued use of the device. Internal consistency of reporting and correlations with phone reports and standardized measures were highly significant, suggesting that data from electronic diaries are both reliable and valid. Patients using electronic diaries preferred them to paper diaries and showed much higher rates of compliance and satisfaction over the 1-year trial.
PDF
