Utilization of Preliminary Feasibility Study Results in Budget Decision

2020 ◽  
Vol 23 (4) ◽  
pp. 27-48
Author(s):  
Hyun-Jung Lee ◽  
Jae Hoon Kim
Keyword(s):  
Feasibility Study ◽  
Study Results ◽  
Budget Decision

scholarly journals Protocol for a feasibility trial for improving breast feeding initiation and continuation: assets-based infant feeding help before and after birth (ABA)

BMJ Open ◽  
2018 ◽  
Vol 8 (1) ◽  
pp. e019142 ◽  
Author(s):  
Kate Jolly ◽  
Jenny Ingram ◽  
Joanne Clarke ◽  
Debbie Johnson ◽  
Heather Trickey ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Infant Feeding ◽  
Feasibility Study ◽  
Breast Feeding ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Study Results ◽  
Service Staff ◽  
Before And After ◽  
Randomised Controlled

IntroductionBreast feeding improves the health of mothers and infants; the UK has low rates, with marked socioeconomic inequalities. While trials of peer support services have been effective in some settings, UK trials have not improved breast feeding rates. Qualitative research suggests that many women are alienated by the focus on breast feeding. We propose a change from breast feeding-focused interactions to respecting a woman’s feeding choices, inclusion of behaviour change theory and an increased intensity of contacts in the 2 weeks after birth when many women cease to breast feed. This will take place alongside an assets-based approach that focuses on the positive capability of individuals, their social networks and communities.We propose a feasibility study for a multicentre randomised controlled trial of the Assets feeding help Before and After birth (ABA) infant feeding service versus usual care.Methods and analysisA two-arm, non-blinded randomised feasibility study will be conducted in two UK localities. Women expecting their first baby will be eligible, regardless of feeding intention. The ABA infant feeding intervention will apply a proactive, assets-based, woman-centred, non-judgemental approach, delivered antenatally and postnatally tailored through face-to-face contacts, telephone and SMS texts. Outcomes will test the feasibility of delivering the intervention with recommended intensity and duration to disadvantaged women; acceptability to women, feeding helpers and professionals; and feasibility of a future randomised controlled trial (RCT), detailing recruitment rates, willingness to be randomised, follow-up rates at 3 days, 8 weeks and 6 months, and level of outcome completion. Outcomes of the proposed full trial will also be collected. Mixed methods will include qualitative interviews with women/partners, feeding helpers and health service staff; feeding helper logs; and review of audio-recorded helper–women interactions to assess intervention fidelity.Ethics and disseminationStudy results will inform the design of a larger multicentre RCT. The National Research Ethics Service Committee approved the study protocol.Trial registration numberISRCTN14760978; Pre-results.

scholarly journals Protocol for a feasibility study: a brief self-compassion intervention for adolescents with type 1 diabetes and disordered eating

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e034452 ◽  
Author(s):  
Anna L Boggiss ◽  
Nathan S Consedine ◽  
Craig Jefferies ◽  
Karen Bluth ◽  
Paul L Hofman ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Glycaemic Control ◽  
Disordered Eating ◽  
Feasibility Study ◽  
Clinical Care ◽  
Eating Behaviour ◽  
Control Group ◽  
Self Compassion ◽  
Study Results

IntroductionAdolescents with type 1 diabetes are at a higher risk of developing psychiatric disorders, particularly eating disorders, compared with their healthy peers. In turn, this increases the risk for sub-optimal glycaemic control and life-threatening diabetes-related complications. Despite these increased risks, standard diabetes care does not routinely provide psychological support to help prevent or reduce mental health risks. There is an urgent need to develop ‘clinically usable’ psychosocial interventions that are acceptable to patients and can be realistically integrated into clinical care. This study aims to examine the feasibility and acceptability of a brief self-compassion intervention for adolescents with type 1 diabetes and disordered eating behaviour.Methods and analysisThis feasibility study will examine the effectiveness of a brief self-compassion intervention, compared with a waitlist control group. Participants aged 12–16 years will be recruited from three diabetes outpatient clinics in Auckland, New Zealand. The brief self-compassion intervention is adapted from the standardised ‘Making Friends with Yourself’ intervention and will be delivered in a group format over two sessions. Apart from examining feasibility and acceptability through the flow of participants through the study and qualitative questions, we will assess changes to disordered eating behaviour (primary outcome), self-care behaviours, diabetes-related distress, self-compassion, stress and glycaemic control (secondary outcomes). Such data will be used to calculate the required sample size for a fully powered randomised controlled trial.Ethics and disseminationThis trial has received ethics approval from the Health and Disability Ethics Committee (research project number A+8467). Study results will be disseminated through peer-reviewed journals and conferences.Trial registration numberANZCTR (12619000541101).

30 MWe PHOEBUS feasibility study: results of system engineering

1991 ◽  
Vol 24 (1-4) ◽  
pp. 95-107 ◽  
Author(s):  
Wolfgang Meinecke ◽  
Michael Kiera ◽  
Peter Wehowsky
Keyword(s):  
Feasibility Study ◽  
System Engineering ◽  
Study Results

Feasibility study: Results of treatment of primary and recurrent adenocarcinoma of the corpus uteri with Californium-252

1985 ◽  
Vol 11 (6) ◽  
pp. 1199-1208 ◽  
Author(s):  
Yosh Maruyama ◽  
Richard Kryscio ◽  
Constance Wood ◽  
John R. van Nagell ◽  
Elvis Donaldson ◽  
...  
Keyword(s):  
Feasibility Study ◽  
Results Of Treatment ◽  
Corpus Uteri ◽  
Study Results

scholarly journals Protocol for a feasibility randomised trial of low-intensity interventions for antenatal depression: ADAGIO trial comparing interpersonal counselling with cognitive behavioural therapy

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e032649
Author(s):  
Jenny Ingram ◽  
Debbie Johnson ◽  
Sarah Johnson ◽  
Heather A O'Mahen ◽  
David Kessler ◽  
...  
Keyword(s):  
Cognitive Behavioural Therapy ◽  
Feasibility Study ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Well Being ◽  
Behavioural Therapy ◽  
Advisory Group ◽  
Low Intensity ◽  
Cognitive Behavioural ◽  
Study Results

IntroductionOne in eight women suffer from depression during pregnancy. Currently, low-intensity brief treatment based on cognitive behavioural therapy (CBT) is the only talking treatment widely available in the National Health Service (NHS) for mild and moderate depression. CBT involves identifying and changing unhelpful negative thoughts and behaviours to improve mood. Mothers in our patient advisory groups requested greater treatment choice. Interpersonal counselling (IPC) is a low-intensity version of interpersonal therapy. It may have important advantages during pregnancy over CBT because it targets relationship problems, changes in role and previous losses (eg, miscarriage). We aim to compare CBT and IPC for pregnant women with depression in a feasibility study.Methods and analysisA two-arm non-blinded randomised feasibility study of 60 women will be conducted in two UK localities. Women with depression will be identified through midwife clinics and ultrasound scanning appointments and randomised to receive six sessions of IPC or CBT. In every other way, these women will receive usual care. Women thought to have severe depression will be referred for more intensive treatment. After 12 weeks, we will measure women’s mood, well-being, relationship satisfaction and use of healthcare. Women, their partners and staff providing treatments will be interviewed to understand whether IPC is an acceptable approach and whether changes should be introduced before applying to run a larger trial.Several groups of patients with depression during pregnancy have contributed to our study design. A patient advisory group will meet and advise us during the study.Ethics and disseminationStudy results will inform the design of a larger multicentre randomised controlled trial (RCT). Our findings will be shared through public engagement events, papers and reports to organisations within the NHS. National Research Ethics Service Committee approved the study protocol.Trial registration numberISRCTN11513120.

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