Dataset Information

How to collect non-medical data in a pediatric trial: diaries or interviews.

ABSTRACT: 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!).

SUBMITTER: Le Jeannic A

PROVIDER: S-EPMC6947947 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

How to collect non-medical data in a pediatric trial: diaries or interviews.

Le Jeannic Anaïs A Maoulida Hassani H Guilmin-Crépon Sophie S Alberti Corinne C Tubiana-Rufi Nadia N Durand-Zaleski Isabelle I

Trials 20200107 1

<h4>Background</h4>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 ...[more]

PMID: 31910885

Similar Datasets

Project description:BackgroundThe richness of patients? experiences warrants thoughtful and careful examination. While standardized surveys or other structured approaches can be useful when the goal is to count or summarize relatively uncomplicated experiences, they may be less appropriate when the objective is to study sensitive topics, such as medical errors during cancer care. This abstract describes and evaluates a flexible, patient-centered approach to interviewing patients.MethodsUsing a patient-centered telephone interview guide, we interviewed cancer patients who had experienced a problem during their care. Participants were first asked to fully describe their experience; follow-up questions probed for details relevant to the study questions. Question order varied, consistent with a conversational approach. Interviews lasted 60?90 minutes and were digitally recorded. We calculated the percentage of words uttered by participants (compared to the interviewer) as a measure of participant engagement, and noted whether participants corrected the interviewer. Strengths and limitations of this approach are also identified.ResultsSeventy-eight patients were interviewed; 96% (75/78) were female, mean age was 57.7 [SD 10.6]. Overall, participants uttered an average of 77% (6,190/8,001) of the words in the interview. Participants corrected the interviewer at least once in 80% (62/78) of the interviews. Question order was flexible, and probes were used at the discretion of the interviewer. Thus, the interviewer could adapt her questioning to follow the participant?s lead, and sensitively encourage and support participants in sharing details of painful experiences. One benefit of this technique was that it allowed the interviewer to convey interest and respect, which enhanced rapport early in the interview. It also enabled participants to recall details that may otherwise have been forgotten. The drawbacks of this approach include longer interview times; discussion of unrelated topics (by participants) and increased time required for data analyses.ConclusionsPatient-centered conversational interviewing can facilitate investigation of emotionally-charged, personal experiences. This approach appears more effective than standardized interviewing techniques when the goal is to fully understand patients? experiences, such as those of cancer survivors who believe that an error occurred during their cancer care.

Project description:BACKGROUND:An increasing prevalence of having survived a myocardial infarction increases the importance of medical secondary prevention. Although preventive medication reduces mortality, prescribing and adherence are known to be frequently insufficient. General practitioners are the most important prescriber. However, their perspective on prescribing and medical non-adherence following myocardial infarction has not yet been explored. Thus, the aim of this study was to explore the general practitioners' perspective on long-term care after myocardial infarction focussing on medical prevention. METHODS:In this qualitative interview study we conducted episodic interviews with sixteen general practitioners from rural and urban surgeries in Germany. Framework analysis with focus on general practitioners' prescribing and patients' non-adherence was performed. RESULTS:Almost all general practitioners reported following guidelines for myocardial infarction aftercare and prescribing the medication that was initiated in the hospital; however, they described deviating from guidelines because of drugs' side effects or patients' intolerances. Some questioned the benefits of medical secondary prevention for the oldest of patients. General practitioners perceived good adherence among their patients who had had an MI while they regarded their methods for assessing medical non-adherence as limited. They perceived diverse reasons for non-adherence, particularly side effects, patients' freedom from symptoms and patients' indifference to health. They attributed mainly negative characteristics, like lack of knowledge and understanding, to non-adherent patients. These characteristics contribute to the difficulty of convincing these patients to take medications as prescribed. General practitioners improved adherence by preventing side effects, explaining the medication's necessity, facilitating intake and involving patients in decision-making. However, about half of the general practitioners reported threatening their patients with negative consequences of non-adherence. CONCLUSIONS:General practitioners should be aware that discharge medication can be insufficient and thus, should always check hospital recommendations for accordance with guideline recommendations. Improving physicians' communication skills and informing and motivating patients in an adequate manner, for example in simple language, should be an important goal in the hospital and the general practitioner setting. General practitioners should assess patients' motivations through motivational interviewing, which no general practitioner mentioned during the interviews, and talk with them about adherence and long-term treatment goals regularly.

Project description:BackgroundConsumer-generated health data (CGHD) are any clinically relevant data collected by patients or their carers (consumers) that may improve health care outcomes. Like patient experience measures, these data reflect the consumer perspective and is part of a patient-centric agenda. The use of CGHD is believed to enhance diagnosis, patient engagement, and thus foster an improved therapeutic partnership with health care providers.ObjectiveThe aim of this study was to further identify how these data were used by consumers and how it influences engagement via a validated framework. In addition, carer data has not been explored for the purpose of engagement.MethodsStudy 1 used interviews with CGHD-experienced patients, carers, and doctors to understand attitudes about data collection and use, developing an ontological framework. Study 2 was a pilot trial with carers (parents) of children undergoing laparoscopic appendectomy. For 10 days carers generated and emailed surgical site photographs to a tertiary children's hospital. Subsequently, carers were interviewed about the engagement framework. In total, 60 interviews were analyzed using theme and content analysis.ResultsThis study validates a framework anchored in engagement literature, which categorizes CGHD engagement outcomes into 4 domains: physiological, cognitive, emotional, and behavioral. CGHD use is complex, interconnected, and can be organized into 10 themes within these 4 domains.ConclusionsCGHD can instigate an ecosystem of engagement and provide clinicians with an enhanced therapeutic relationship through an extended view into the patient's world. In addition to clinical diagnosis and efficient use of health care resources, data offer another tool to manage consumers service experience, especially the emotions associated with the health care journey. Collection and use of data increases consumers sense of reassurance, improves communication with providers, and promotes greater personal responsibility, indicating an empowering consumer process. Finally, it can also improve confidence and satisfaction in the service.

Dataset Information

How to collect non-medical data in a pediatric trial: diaries or interviews.

Publications

How to collect non-medical data in a pediatric trial: diaries or interviews.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets