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Article ; Online: What is a process evaluation when used alongside a randomised controlled trial?

Bugge, Carol

2024 Volume 27, Issue 2, Page(s) 45–47

MeSH term(s)	Aged ; Humans ; Evidence-Based Nursing ; Homes for the Aged ; Nursing Homes ; Nursing Methodology Research ; Randomized Controlled Trials as Topic
Language	English
Publishing date	2024-03-28
Publishing country	England
Document type	Journal Article
ZDB-ID	1425988-6
ISSN	1468-9618 ; 1367-6539
ISSN (online)	1468-9618
ISSN	1367-6539
DOI	10.1136/ebnurs-2023-103878
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Article ; Online: Pelvic organ prolapse: self-management of pessaries can be a good option.

Saul, Helen / Deeney, Brendan / Swaithes, Laura / Bugge, Carol / Hagen, Suzanne / Kearney, Rohna

BMJ (Clinical research ed.)

2024 Volume 385, Page(s) q866

Abstract: The studyHagen S, Kearney R, Goodman K, et al. Clinical effectiveness of vaginal pessary self-management vs clinic-based care for pelvic organ prolapse (TOPSY): a randomised controlled superiority trial. ...

Abstract	The studyHagen S, Kearney R, Goodman K, et al. Clinical effectiveness of vaginal pessary self-management vs clinic-based care for pelvic organ prolapse (TOPSY): a randomised controlled superiority trial.
MeSH term(s)	Humans ; Pelvic Organ Prolapse/therapy ; Pessaries ; Female ; Self-Management/methods
Language	English
Publishing date	2024-04-25
Publishing country	England
Document type	Journal Article
ZDB-ID	1362901-3
ISSN	1756-1833 ; 0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151
ISSN (online)	1756-1833
ISSN	0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151
DOI	10.1136/bmj.q866
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Article ; Online: Does self-management of vaginal pessaries improve care for women with pelvic organ prolapse?

Bugge, Carol / Dembinsky, Melanie / Kearney, Rohna / Hagen, Suzanne

BMJ (Clinical research ed.)

2021 Volume 372, Page(s) n310

MeSH term(s)	Female ; Humans ; Patient Safety ; Pelvic Organ Prolapse/rehabilitation ; Pessaries ; Quality of Life ; Self Care/methods ; Self-Management ; Telemedicine
Language	English
Publishing date	2021-02-19
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	1362901-3
ISSN	1756-1833 ; 0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151
ISSN (online)	1756-1833
ISSN	0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151
DOI	10.1136/bmj.n310
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Article ; Online: Designing process evaluations using case study to explore the context of complex interventions evaluated in trials.

Grant, Aileen / Bugge, Carol / Wells, Mary

Trials

2020 Volume 21, Issue 1, Page(s) 982

Abstract: Background: Process evaluations are an important component of an effectiveness evaluation as they focus on understanding the relationship between interventions and context to explain how and why interventions work or fail, and whether they can be ... ...

Abstract	Background: Process evaluations are an important component of an effectiveness evaluation as they focus on understanding the relationship between interventions and context to explain how and why interventions work or fail, and whether they can be transferred to other settings and populations. However, historically, context has not been sufficiently explored and reported resulting in the poor uptake of trial results. Therefore, suitable methodologies are needed to guide the investigation of context. Case study is one appropriate methodology, but there is little guidance about what case study design can offer the study of context in trials. We address this gap in the literature by presenting a number of important considerations for process evaluation using a case study design. Main text: In this paper, we define context, the relationship between complex interventions and context, and describe case study design methodology. A well-designed process evaluation using case study should consider the following core components: the purpose; definition of the intervention; the trial design, the case, the theories or logic models underpinning the intervention, the sampling approach and the conceptual or theoretical framework. We describe each of these in detail and highlight with examples from recently published process evaluations. Conclusions: There are a number of approaches to process evaluation design in the literature; however, there is a paucity of research on what case study design can offer process evaluations. We argue that case study is one of the best research designs to underpin process evaluations, to capture the dynamic and complex relationship between intervention and context during implementation. We provide a comprehensive overview of the issues for process evaluation design to consider when using a case study design. Trial registration: DQIP - ClinicalTrials.gov number, NCT01425502 - OPAL - ISRCTN57746448.
MeSH term(s)	Causality ; Humans ; Process Assessment, Health Care
Language	English
Publishing date	2020-11-27
Publishing country	England
Document type	Letter ; Review
ZDB-ID	2040523-6
ISSN	1745-6215 ; 1468-6694 ; 1745-6215
ISSN (online)	1745-6215
ISSN	1468-6694 ; 1745-6215
DOI	10.1186/s13063-020-04880-4
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Should pregnant women know their individual risk of future pelvic floor dysfunction? A qualitative study.

Bugge, Carol / Strachan, Heather / Pringle, Stewart / Hagen, Suzanne / Cheyne, Helen / Wilson, Don

BMC pregnancy and childbirth

2022 Volume 22, Issue 1, Page(s) 161

Abstract: Background: The study aimed to explore: • pregnant women's and healthcare professionals' perspectives on provision of individual risk scores for future Pelvic Floor Dysfunction (PFD), • the feasibility of providing this during routine maternity care, • ... ...

Abstract	Background: The study aimed to explore: • pregnant women's and healthcare professionals' perspectives on provision of individual risk scores for future Pelvic Floor Dysfunction (PFD), • the feasibility of providing this during routine maternity care, • actions women might take as a result of knowing their PFD risk. Methods: Qualitative study. Setting: UK NHS Health Board. Participants: Pregnant women (n = 14), obstetricians (n = 6), midwives (n = 8) and physiotherapists (n = 3). A purposive sample of pregnant women and obstetric healthcare professionals were introduced to the UR-CHOICE calculator, which estimates a woman's PFD risk, and were shown examples of low, medium and high-risk women. Data were collected in 2019 by semi-structured interview and focus group and analysed using the Framework Approach. Results: Women's PFD knowledge was limited, meaning they were unlikely to raise PFD risk with healthcare professionals. Women believed it was important to know their individual PFD risk and that knowledge would motivate them to undertake preventative activities. Healthcare professionals believed it was important to discuss PFD risk, however limited time and concerns over increased caesarean section rates prevented this in all but high-risk women or those that expressed concerns. Conclusion: Women want to know their PFD risk. As part of an intervention based within a pregnant woman/ maternity healthcare professional consultation, the UR-CHOICE calculator could support discussion to consider preventative PFD activities and to enable women to be more prepared should PFD occur. A randomised controlled trial is needed to test the effectiveness of an intervention which includes the UR-CHOICE calculator in reducing PFD.
MeSH term(s)	Adult ; Female ; Health Knowledge, Attitudes, Practice ; Health Personnel/psychology ; Humans ; Maternal Health Services ; Pelvic Floor Disorders/prevention & control ; Pregnancy ; Pregnant Women/psychology ; Qualitative Research ; Risk Assessment/methods ; Risk Factors ; State Medicine ; United Kingdom/epidemiology
Language	English
Publishing date	2022-02-28
Publishing country	England
Document type	Journal Article
ZDB-ID	2059869-5
ISSN	1471-2393 ; 1471-2393
ISSN (online)	1471-2393
ISSN	1471-2393
DOI	10.1186/s12884-022-04490-9
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Article ; Online: Commercial gaming devices for stroke upper limb rehabilitation: The stroke survivor experience.

Thomson, Katie / Pollock, Alex / Bugge, Carol / Brady, Marian C

Journal of rehabilitation and assistive technologies engineering

2020 Volume 7, Page(s) 2055668320915381

Abstract: Introduction: Approximately 30% of stroke survivors experience an upper limb impairment, which impacts on participation and quality of life. Gaming devices (Nintendo Wii) are being incorporated into rehabilitation to improve function. We explored the ... ...

Abstract	Introduction: Approximately 30% of stroke survivors experience an upper limb impairment, which impacts on participation and quality of life. Gaming devices (Nintendo Wii) are being incorporated into rehabilitation to improve function. We explored the stroke survivor experience of gaming as an upper limb intervention. Methods: Semi-structured, individual interviews with stroke survivors living within the UK were completed. Interviews were audio-recorded, transcribed verbatim and analysed using Framework methods. Transcripts were coded and summarised into thematic charts. Thematic charts were refined during analysis until the final framework emerged. Results: We captured experiences of 12 stroke survivors who used Nintendo Wii. Gaming devices were found to be acceptable for all ages but varying levels of enthusiasm existed. Enthusiastic players described gaming as having a positive impact on their motivation to engage in rehabilitation. For some, this became a leisure activity, encouraging self-practice. Non-enthusiastic players preferred sports to gaming. Conclusion: An in-depth account of stroke survivor experiences of gaming within upper limb rehabilitation has been captured. Suitability of gaming should be assessed individually and stroke survivor abilities and preference for interventions should be taken into consideration. There was no indication that older stroke survivors or those with no previous experience of gaming were less likely to enjoy the activity.
Language	English
Publishing date	2020-05-13
Publishing country	England
Document type	Journal Article
ZDB-ID	2819384-2
ISSN	2055-6683 ; 2055-6683
ISSN (online)	2055-6683
ISSN	2055-6683
DOI	10.1177/2055668320915381
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Article ; Online: Translating the Pelvic Organ Prolapse Score into Samoan using a modified back translation methodology.

Dembinsky, Melanie / Boodoosingh, Ramona / Fulu-Aiolupotea, Saunima'a Ma / Lima, Uila Laifa / Ekeroma, Alec / Bugge, Carol / Hagen, Suzanne

BMC women's health

2022 Volume 22, Issue 1, Page(s) 93

Abstract: Background: Although Samoan women have a high prevalence of obesity and multiple parity which are risk factors of pelvic organ prolapse, there is no prevalence data on this condition.: Aims: Translate the Pelvic Organ Prolapse-Symptoms Score (POP-SS) ...

Abstract	Background: Although Samoan women have a high prevalence of obesity and multiple parity which are risk factors of pelvic organ prolapse, there is no prevalence data on this condition. Aims: Translate the Pelvic Organ Prolapse-Symptoms Score (POP-SS) from English into Samoan, MATERIALS AND METHODS: Standardised methods for translating questionnaires, individual face to face audio-recorded interviews in which women completed the POP-SS using a Think Aloud method, analysis using a Framework approach. Results: The POP-SS was successfully translated in to Samoan, an additional information leaflet was developed to support women's understanding of what prolapse is, 14 Samoan women were recruited of which 13 were interviewed and completed the POP-SS, results of POP-SS (scores), results of think aloud, results in terms of research experience. Conclusions: A Samoan version of the POP-SS is now available for further evaluation of its psychometric properties prior to wider use. The team continue to collaborate on their work on establishing the prevalence of prolapse whilst building local research capacity.
MeSH term(s)	Female ; Humans ; Pelvic Organ Prolapse/epidemiology ; Pregnancy ; Psychometrics ; Surveys and Questionnaires ; Translating ; Translations
Language	English
Publishing date	2022-03-27
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2050444-5
ISSN	1472-6874 ; 1472-6874
ISSN (online)	1472-6874
ISSN	1472-6874
DOI	10.1186/s12905-022-01676-3
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Article ; Online: Cost-effectiveness of 2 Models of Pessary Care for Pelvic Organ Prolapse: Findings From the TOPSY Randomized Controlled Trial.

Manoukian, Sarkis / Mason, Helen / Hagen, Suzanne / Kearney, Rohna / Goodman, Kirsteen / Best, Catherine / Elders, Andrew / Melone, Lynn / Dwyer, Lucy / Dembinsky, Melanie / Khunda, Aethele / Guerrero, Karen Lesley / McClurg, Doreen / Norrie, John / Thakar, Ranee / Bugge, Carol

Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research

2024

Abstract: Objectives: Pelvic organ prolapse is the descent of one or more reproductive organs from their normal position, causing associated negative symptoms. One conservative treatment option is pessary management. This study aimed to to investigate the cost- ... ...

Abstract	Objectives: Pelvic organ prolapse is the descent of one or more reproductive organs from their normal position, causing associated negative symptoms. One conservative treatment option is pessary management. This study aimed to to investigate the cost-effectiveness of pessary self-management (SM) when compared with clinic-based care (CBC). A decision analytic model was developed to extend the economic evaluation. Methods: A randomized controlled trial with health economic evaluation. The SM group received a 30-minute SM teaching session, information leaflet, 2-week follow-up call, and a local helpline number. The CBC group received routine outpatient pessary appointments, determined by usual practice. The primary outcome for the cost-effectiveness analysis was incremental cost per quality-adjusted life year (QALY), 18 months post-randomization. Uncertainty was handled using nonparametric bootstrap analysis. In addition, a simple decision analytic model was developed using the trial data to extend the analysis over a 5-year period. Results: There was no significant difference in the mean number of QALYs gained between SM and CBC (1.241 vs 1.221), but mean cost was lower for SM (£578 vs £728). The incremental net benefit estimated at a willingness to pay of £20 000 per QALY gained was £564, with an 80.8% probability of cost-effectiveness. The modeling results were consistent with the trial analysis: the incremental net benefit was estimated as £4221, and the probability of SM being cost-effective at 5 years was 69.7%. Conclusions: Results suggest that pessary SM is likely to be cost-effective. The decision analytic model suggests that this result is likely to persist over longer durations.
Language	English
Publishing date	2024-03-14
Publishing country	United States
Document type	Journal Article
ZDB-ID	1471745-1
ISSN	1524-4733 ; 1098-3015
ISSN (online)	1524-4733
ISSN	1098-3015
DOI	10.1016/j.jval.2024.03.004
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Article ; Online: Sufficiency and relevance of information for inpatients in general ward settings: A qualitative exploration of information exchange between patients and nurses.

Crispin, Vivianne / Bugge, Carol / Stoddart, Kathleen

International journal of nursing studies

2017 Volume 75, Page(s) 112–122

Abstract: Background: Information exchange as part of shared decision-making is widely discussed in research and policy literature as a means of improving patient involvement in treatment and care. To date information exchange between patients and nurses has not ... ...

Abstract	Background: Information exchange as part of shared decision-making is widely discussed in research and policy literature as a means of improving patient involvement in treatment and care. To date information exchange between patients and nurses has not been explored in ward contexts. Objective: To explore the sufficiency of, and intentions behind, information exchanged by patients and nurses in surgical and medical ward settings using a recognised model of shared decision-making. Design: A multiple-case study design was used. Data were collected from 19 cases. Each case comprised one patient, the nurses interacting with that patient, the interactions between them, and their perceptions about the interactions. Settings: The study was undertaken across six surgical, six medical and one rehabilitation ward in a large teaching hospital in the United Kingdom. Participants: Purposive sampling was used to first recruit nurses and then patients. Inclusion criteria included nurses registered with the Nursing and Midwifery Council, and patients who had been in hospital for more than 24h and who could consent to participating. Twenty-two nurses and 19 patients participated. Methods: Interactions from 19 cases were observed and audio-recorded. Individual interviews with patients and nurses followed, and were related to, the observed interactions. Results: Patients and nurses perceived they had exchanged sufficient information for their own needs including patient involvement, due to: information being shared previously and on an ongoing basis; having asked all their questions; therapeutic patient/nurse relationships; and, nurses speaking in lay terms. In contrast, the observational data suggested that insufficient information was exchanged between patients and nurses due to: lost opportunities for sharing information; paternalistic practice; and withholding information. Conclusion: The elements of information exchange within a recognised model of shared decision-making do not adequately fit with patient/nurse interactions in ward settings. Participants generally perceived they had given and received enough information for their own needs. Therefore, the ways in which patients and nurses currently interact, could remain as they are. Policymakers should be aware of the varying contexts where healthcare staff work, and should promote information exchange and shared decision-making more strategically. Due to the complexities of patient/nurse interactions, consideration should be given to situation and context when applying these findings to practice.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Decision Making ; Female ; Hospital Units ; Hospitals, Teaching ; Humans ; Information Services ; Inpatients ; Male ; Middle Aged ; Nurse-Patient Relations ; Qualitative Research ; United Kingdom ; Young Adult
Language	English
Publishing date	2017-10
Publishing country	England
Document type	Journal Article
ZDB-ID	80148-3
ISSN	1873-491X ; 0020-7489
ISSN (online)	1873-491X
ISSN	0020-7489
DOI	10.1016/j.ijnurstu.2017.07.010
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Article: Uncovering the features of negotiation in developing the patient-nurse relationship.

Stoddart, Kathleen / Bugge, Carol

British journal of community nursing

2012 Volume 17, Issue 2, Page(s) 77–80, 82–4

Abstract: Unlabelled: This article describes a study that set out to explore the interaction between patients and nurses in community practice settings, in order to understand the social meanings and understandings brought to the interaction and at play within it. ...

Abstract	Unlabelled: This article describes a study that set out to explore the interaction between patients and nurses in community practice settings, in order to understand the social meanings and understandings brought to the interaction and at play within it. Method: The study used a grounded theory methodology with traditional procedures. Driven by constant comparative analysis, data were collected by non-participant observation and informal and semi-structured interviews in four community health centres. Eighteen patients and 18 registered practice nurses participated. Results: Negotiation was found to be a fundamental process in patient- nurse interaction. Navigation, socio-cultural characteristics and power and control were found to be key properties of negotiation. The negotiation processes for developing understanding required patients and nurses to draw upon social meanings and understandings generated from within and beyond their current interaction. Conclusion: Social meanings and understandings created within and beyond the health-care setting influence negotiation. The developmental nature of negotiation in interaction is an important dimension of the patient- nurse relationship in community practice.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Community Health Centers ; Community Health Nursing ; Female ; Humans ; Male ; Middle Aged ; Narration ; Negotiating ; Nurse-Patient Relations ; Power (Psychology) ; United Kingdom
Language	English
Publishing date	2012-02
Publishing country	England
Document type	Journal Article ; Multicenter Study
ZDB-ID	2146386-4
ISSN	1462-4753
ISSN	1462-4753
DOI	10.12968/bjcn.2012.17.2.77
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