Browsing by Person "Kettle, Christine"

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Evaluating Acupuncture and Standard carE for pregnant women with Back pain (EASE Back): a feasibility study and pilot randomised trial
(NIHR Journals Library, 2016-04-01) Foster, Nadine E.; Bishop, Annette; Bartlam, Bernadette; Ogollah, Reuben; Barlas, Panos; Holden, Melanie A.; Ismail, Khaled M. K.; Jowett, Sue; Kettle, Christine; Kigozi, Jesse; Lewis, Martyn; Lloyd, Alison; Waterfield, Jackie; Young, Julie
Background: Many pregnant women experience low back pain. Acupuncture appears to be a safe, promising intervention but evidence is needed about its clinical effectiveness and cost-effectiveness. Objectives: To assess the feasibility of a future large randomised controlled trial (RCT) testing the additional benefit of adding acupuncture to standard care (SC) for pregnancy-related back pain.
Perineal resuturing versus expectant management following vaginal delivery complicated by a dehisced wound (PREVIEW): a nested qualitative study
(2017-02-10) Dudley, L.; Kettle, Christine; Waterfield, Jackie; Ismail, Khaled M. K.
Objective: To explore women's lived experiences of a dehisced perineal wound following childbirth and how they felt participating in a pilot and feasibility randomised controlled trial (RCT). Design: A nested qualitative study using semistructured interviews, underpinned by descriptive phenomenology. Participants and setting: A purposive sample of six women at 6-9 months postnatal who participated in the RCT were interviewed in their own homes. Results: Following Giorgi's analytical framework the verbatim transcripts were analysed for key themes. Women's lived experiences revealed 4 emerging themes: (1) Physical impact, with sub-themes focusing upon avoiding infection, perineal pain and the impact of the wound dehiscence upon daily activities; (2) Psychosocial impact, with sub-themes of denial, sense of failure or self-blame, fear, isolation and altered body image; (3) Sexual impact; and (4) Satisfaction with wound healing. A fifth theme 'participating in the RCT' was 'a priori' with sub-themes centred upon understanding the randomisation process, completing the trial questionnaires, attending for hospital appointments and acceptability of the treatment options. Conclusions: To the best of our knowledge, this is the first qualitative study to grant women the opportunity to voice their personal experiences of a dehisced perineal wound and their views on the management offered. The powerful testimonies presented disclose the extent of morbidity experienced while also revealing a strong preference for a treatment option.
The Role of Qualitative Research in Clinical Trial Development
(2016-07-13) Bartlam, Bernadette; Waterfield, Jackie; Bishop, Annette; Holden, Melanie A.; Barlas, Panos; Ismail, Khaled M. K.; Kettle, Christine; Foster, Nadine E.
This article outlines the rationale for adopting a mixed methods approach within randomized controlled trials (RCTs) and explores challenges associated in doing so. Taking the example of the EASE Back feasibility and pilot study (Evaluating Acupuncture and Standard care for pregnant womEn with BACK pain: ISRCTN49955124), we detail why and how we operationalized a concurrent-sequential mixed methods research design. We present key findings from the exploratory research (focus groups and interviews) and explain how these were integrated with descriptive findings (a national survey of physical therapists) in order to inform and refine the design of the explanatory phase (the pilot RCT). We conclude with a discussion of lessons learned and implications for future research design and conduct.