scholarly journals Establishing and augmenting views on the acceptability of a paediatric critical care randomised controlled trial (the FEVER trial): a mixed methods study

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e041952
Author(s):  
Elizabeth Deja ◽  
Mark J Peters ◽  
Imran Khan ◽  
Paul R Mouncey ◽  
Rachel Agbeko ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Focus Groups ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Theoretical Framework ◽  
Mixed Methods Study ◽  
Temperature Thresholds ◽  
Site Staff ◽  
Randomised Controlled

ObjectiveTo explore parent and staff views on the acceptability of a randomised controlled trial investigating temperature thresholds for antipyretic intervention in critically ill children with fever and infection (the FEVER trial) during a multi-phase pilot study.DesignMixed methods study with data collected at three time points: (1) before, (2) during and (3) after a pilot trial.SettingEnglish, Paediatric Intensive Care Units (PICUs).Participants(1) Pre-pilot trial focus groups with pilot site staff (n=56) and interviews with parents (n=25) whose child had been admitted to PICU in the last 3 years with a fever and suspected infection, (2) Questionnaires with parents of randomised children following pilot trial recruitment (n=48 from 47 families) and (3) post-pilot trial interviews with parents (n=19), focus groups (n=50) and a survey (n=48) with site staff. Analysis drew on Sekhon et al’s theoretical framework of acceptability.ResultsThere was initial support for the trial, yet some held concerns regarding the proposed temperature thresholds and not using paracetamol for pain or discomfort. Pre-trial findings informed protocol changes and training, which influenced views on trial acceptability. Staff trained by the FEVER team found the trial more acceptable than those trained by colleagues. Parents and staff found the trial acceptable. Some concerns about pain or discomfort during weaning from ventilation remained.ConclusionsPre-trial findings and pilot trial experience influenced acceptability, providing insight into how challenges may be overcome. We present an adapted theoretical framework of acceptability to inform future trial feasibility studies.Trial registration numbersISRCTN16022198 and NCT03028818.

Habits-GDM mobile application in managing gestational diabetes in Singapore: A mixed-methods study (Preprint)

2020 ◽  
Author(s):  
Shilpa Surendran ◽  
Chang Siang Lim ◽  
Gerald Choon Huat Koh ◽  
Tong Wei Yew ◽  
E Shyong Tai ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Gestational Diabetes ◽  
Healthcare Professionals ◽  
Controlled Trial ◽  
Perceived Usefulness ◽  
Mixed Methods Study ◽  
Automatic Data ◽  
Glucose Testing ◽  
Randomised Controlled

BACKGROUND The prevalence of gestational diabetes mellitus (GDM) is increasing in Singapore and the cost of providing traditional care for GDM is high. Mobile health (mHealth) applications may act as useful tools in the management of GDM. OBJECTIVE The objective of this mixed-methods study was to measure the usage behaviour and explore users’ perceived usefulness of the Habits-GDM application when managing GDM in a randomised controlled trial. METHODS We conducted a quantitative analysis of the application usage behaviour in 170 Habits-GDM application users and 14 semi-structured interviews with users from a randomised controlled trial. RESULTS The convenience of automatic data transfer of weight values to the Habits-GDM application helped users (116/170, 68%) log their weight at least once a week. However, when the application had usability challenges, users avoided using that feature, i.e. users logged only an average of less than one meal/week out of the recommended six meals/week. Of the usability challenges, many users (12/14, 85.7%) mentioned food items not worded in the commonly known way and limited ethnic food database as the primary barriers. Only half of the users (84/170, 49.4%) accessed the educational lessons, but many (9/14, 64%) identified the provision of always available, valuable health-related information as an advantage of the educational lessons. ‘Healthy eating’ and ‘Why exercise’ were the most (56/84, 66.67%) and least (38/84, 45.24%) frequently accessed educational lessons, respectively. Users (10/14, 71.4%) reported sending messages to the coach via the chat interface only when they faced logistic issues and 86.45% of all the coach messages were replies typed by the research coordinator in response to the logistics issues (i.e. a request for blood glucose testing strips and appointment confirmation) raised by the users. Healthcare professionals lack of access to the coach’s dashboard discouraged users from asking queries related to GDM via the e-coaching feature. CONCLUSIONS The findings suggest that mHealth application acts as a useful tool in managing GDM. Culturally sensitive mHealth applications with a provision for women to interact with healthcare professionals should be developed in cooperation with the users. CLINICALTRIAL Not applicable.

scholarly journals Implementing self-management: a mixed-methods study of women’s experiences of a postpartum hypertension intervention (SNAP-HT)

2020 ◽  
Author(s):  
Alexandra Elspeth Cairns ◽  
Katherine L. Tucker ◽  
Carole Crawford ◽  
Richard J. McManus ◽  
John Powell
Keyword(s):  
Blood Pressure ◽  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Blood Pressure Monitoring ◽  
Controlled Trial ◽  
Mixed Methods Study ◽  
Self Management ◽  
Normalisation Process Theory ◽  
Pilot Randomised Controlled Trial ◽  
Randomised Controlled

Abstract Background Self-management strategies are effective in a number of medical conditions; however, implementation studies have demonstrated adoption into clinical practice can be problematic. The process of implementation was explored during a pilot randomised controlled trial evaluating postpartum blood pressure self-management, in women with medicated hypertensive disorders of pregnancy. Methods A mixed methods study using semi-structured interviews with a qualitative and a scored (quantitative) component were undertaken as part of a pilot randomised controlled trial (SNAP-HT) in postnatal women with medicated gestational hypertension or pre-eclampsia. Women were randomised to usual care or blood pressure self-management. Self-management entailed daily home blood pressure monitoring and automated medication reduction via telemonitoring. Women from both groups optionally consented to participate in audio-recorded interviews, at four weeks and six months postpartum. Interview questions were developed to explore the proposed benefits of self-management and the constructs of Normalisation Process Theory. Participants provided a score (Likert scale 1-5) for each question and were encouraged to expand upon these answers through further discussion. The interviews were transcribed and analysed using the framework approach. Results Sixty-eight women, 34 from each randomised group, completed at least one audio-recorded interview. Several overarching themes emerged from analysis of 126 interview transcripts: control; convenience; confidence, communication and knowledge; concern; constraints; and components of the intervention. In the scored component of the analysis, both groups reported feeling more in control of their condition postpartum compared to during pregnancy, more so in those self-managing at both four weeks and six months: adjusted differences 0.6 (95% confidence interval (CI) 0.2 to 1.1) and 0.7 (95% CI 0.3 to 1.2) respectively. Conclusions Interviews and quantitative data showed that self-management enhanced women’s sense of control, and improved their blood pressure-related anxiety. Prior to taking part, a few women anticipated that home monitoring might increase anxiety, but stated that it had the opposite effect. Self-management was perceived as more flexible, reactive and as enabling more targeted down-titration of medication. These data provide considerable support for blood pressure self-management postpartum, and reinforce the effectiveness of the intervention used in this study. Trial registration Prospectively registered with ClinicalTrials.gov on 07/01/2015 (NCT02333240) https://clinicaltrials.gov/ct2/show/NCT02333240.

scholarly journals Implementing self-management: a mixed-methods study of women’s experiences of a postpartum hypertension intervention

2019 ◽  
Author(s):  
Alexandra Elspeth Cairns ◽  
Katherine L. Tucker ◽  
Carole Crawford ◽  
Richard J. McManus ◽  
John Powell
Keyword(s):  
Blood Pressure ◽  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Blood Pressure Monitoring ◽  
Controlled Trial ◽  
Mixed Methods Study ◽  
Self Management ◽  
Normalisation Process Theory ◽  
Pilot Randomised Controlled Trial ◽  
Randomised Controlled

Abstract Background Self-management strategies are effective in a number of medical conditions; however, implementation studies have demonstrated that adoption into clinical practice can be problematic. The process of implementation was explored during a pilot randomised controlled trial evaluating postpartum blood pressure self-management, in women with medicated hypertensive disorders of pregnancy. Methods A mixed methods study using semi-structured interviews with both a qualitative and a scored (quantitative) component were undertaken as part of a pilot randomised controlled trial in postnatal women with medicated gestational hypertension or pre-eclampsia. Women were randomised to usual care or blood pressure self-management. Self-management entailed daily home blood pressure monitoring and automated medication reduction via telemonitoring. Women from both groups consented to participate in audio-recorded interviews, at four weeks and six months postpartum. Interview questions were developed to explore the proposed benefits of self-management and the constructs of Normalisation Process Theory. Participants provided a score (Likert scale 1-5) for each question and were encouraged to expand upon these answers through further discussion. The interviews were transcribed and analysed using the framework approach. Results Sixty-eight women, 34 from each randomised group, completed at least one audio-recorded interview. Several overarching themes emerged from analysis of 126 interview transcripts: control; convenience; confidence, communication and knowledge; concern; constraints; and components of the intervention. In the scored component of the analysis, both groups reported feeling more in control of their condition postpartum compared to during pregnancy, more so in those self-managing at both four weeks and six months: adjusted differences 0.6 (95% confidence interval (CI) 0.2 to 1.1) and 0.7 (95% CI 0.3 to 1.2) respectively. Conclusions Interviews and quantitative data showed that self-management enhanced women’s sense of control, and improved their blood pressure-related anxiety. Prior to taking part, a few women anticipated that home monitoring might increase anxiety, but stated that it had the opposite effect. Self-management was perceived as more flexible, reactive and as enabling more targeted down-titration of medication. These data provide considerable support for blood pressure self-management postpartum, and reinforce the effectiveness of the intervention used in this study. Trial registration Prospectively registered with ClinicalTrials.gov on 07/01/2015 (NCT02333240) https://clinicaltrials.gov/ct2/show/NCT02333240.

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