scholarly journals Exploring psychiatrists’ perspectives of working with patients with dissociative seizures in the UK healthcare system as part of the CODES trial: a qualitative study

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e026493 ◽  
Author(s):  
Harriet Jordan ◽  
Sarah Feehan ◽  
Iain Perdue ◽  
Joanna Murray ◽  
Laura H Goldstein
Keyword(s):  
Qualitative Study ◽  
Patient Group ◽  
Controlled Trial ◽  
Improve Patient Care ◽  
Knowledge Gap ◽  
Link Type ◽  
Interpersonal Difficulties ◽  
Randomised Controlled ◽  
The Uk ◽  
Dissociative Seizures

ObjectiveThere is currently limited research exploring healthcare professionals’ (HCPs) experiences of working with patients with dissociative seizures (DS). Existing studies do not focus on the role of psychiatrists in treating this complex condition. The objective of this study was to gain an understanding of UK-based psychiatrists’ experiences of the DS patient group. Against the backdrop of a UK-wide randomised controlled trial (RCT), the focus was broadened to encompass issues arising in everyday practice with the DS patient group.Design, participants and methodsA qualitative study using semistructured interviews was undertaken with 10 psychiatrists currently working with DS patients within the context of a large RCT investigating treatments for DS. Thematic analysis was used to identify key themes and subthemes.SettingThe psychiatrists were working in Liaison or Neuropsychiatry services in England.ResultsThe key themes identified were other HCPs’ attitudes to DS and the challenges of the DS patient group. There is a clear knowledge gap regarding DS for many HCPs and other clinical services can be reluctant to take referrals for this patient group. Important challenges posed by this patient group included avoidance (of difficult emotions and help), alexithymia and interpersonal difficulties. Difficulties with alexithymia meant DS patients could struggle to identify triggers for their seizures and to express their emotions. Interpersonal difficulties raised included difficulties in attachment with both HCPs and family members.ConclusionsA knowledge gap for HCPs regarding DS has been identified and needs to be addressed to improve patient care. Given the complexity of the patient group and that clinicians from multiple disciplines will come into contact with DS patients, it is essential for any educational strategy to be implemented across the whole range of specialties, and to account for those already in practice as well as future trainees.Trial registration numberISRCTN05681227;NCT02325544; Pre-results.

Stressing the personal benefits of the covid-19 vaccine might encourage more people to accept it

BMJ ◽  
2021 ◽  
pp. n2923
Author(s):  
Helen Saul ◽  
Deniz Gursul
Keyword(s):  
Public Health ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Vaccine Hesitancy ◽  
Link Type ◽  
Parallel Group ◽  
Different Types ◽  
Randomised Controlled ◽  
The Uk ◽  
Single Blind

The study Freeman D, Loe BS, Yu LM, et al. Effects of different types of written vaccination information on COVID-19 vaccine hesitancy in the UK (OCEANS-III): a single-blind, parallel-group, randomised controlled trial. Lancet Public Health 2021;6:416-27. To read the full NIHR Alert, go to: https://evidence.nihr.ac.uk/alert/stressing-personal-benefits-of-covid-vaccine-could-reduce-hesitancy

scholarly journals Hope for the best …but expect the worst: a qualitative study to explore how women with recurrent miscarriage experience the early waiting period of a new pregnancy

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e029354 ◽  
Author(s):  
Sarah Louise Bailey ◽  
Jacky Boivin ◽  
Ying C Cheong ◽  
Ellen Kitson-Reynolds ◽  
Christopher Bailey ◽  
...  
Keyword(s):  
Qualitative Study ◽  
Recurrent Miscarriage ◽  
Controlled Trial ◽  
Initial Period ◽  
Health Service Provision ◽  
Waiting Period ◽  
Referral Hospitals ◽  
Registration Number ◽  
Randomised Controlled ◽  
The Uk

ObjectiveTo investigate how women experience the initial period of a new pregnancy after suffering recurrent miscarriage (RM).DesignA qualitative study, nested within a randomised controlled feasibility study of a coping intervention for RM, used semi-structured face-to-face interviews. Interviews were audio-recorded, transcribed verbatim and analysed using a thematic network approach.SettingParticipants were recruited from the Recurrent Miscarriage Clinic and Early Pregnancy Unit in two tertiary referral hospitals in the UK.Participants14 women with RMs and who had previously participated in the randomised controlled trial (RCT) feasibility component of the study were recruited.ResultsSeven organising themes emerged from the data: (1) turmoil of emotions, (2) preparing for the worst, (3) setting of personal milestones, (4) hypervigilance, (5) social isolation, (6) adoption of pragmatic approaches, (7) need for professional affirmation.ConclusionsThe study established that for women with a history of RM, the waiting period of a new pregnancy is a traumatic time of great uncertainty and emotional turmoil and one in which they express a need for emotional support. Consideration should be given to the manner in which supportive care is best delivered within the constraints of current health service provision.Trial registration numberISRCTN43571276

scholarly journals Experiences and perceptions of trial participants and healthcare professionals in the UK Frozen Shoulder Trial (UK FROST): a nested qualitative study

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e040829
Author(s):  
Cynthia Srikesavan ◽  
Francine Toye ◽  
Stephen Brealey ◽  
Lorna Goodchild ◽  
Matthew Northgraves ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Qualitative Study ◽  
Healthcare Professionals ◽  
Controlled Trial ◽  
Frozen Shoulder ◽  
Routine Practice ◽  
Randomised Controlled ◽  
The Uk ◽  
And Function ◽  
Trial Participants

ObjectivesTo explore the experiences and perceptions of trial participants and healthcare professionals in the UK Frozen Shoulder Trial (UK FROST), a multicentre randomised controlled trial that compared manipulation under anaesthesia (MUA), arthroscopic capsular release (ACR) with a 12-week early structured physiotherapy programme (ESP) in people with unilateral frozen shoulder referred to secondary care.DesignNested qualitative study with semistructured interviews. We used constant comparison method to develop our themes.SettingThis qualitative study was nested within the UK FROST.Participants44 trial participants (ESP: 14; MUA: 15; ACR: 15), and 8 surgeons and 8 physiotherapists who delivered the treatments in the trial.ResultsTrial participants found UK FROST treatments acceptable and satisfactory in terms of content, delivery and treatment benefits. Participants in all arms experienced improvements in pain, shoulder movements, and function. Participants said they would choose the same treatment that they received in the trial.Surgeons and physiotherapists felt that the content and delivery of UK FROST treatments was not significantly different to their routine practice except for the additional number of physiotherapy sessions offered in the trial. They had mixed feelings about the effectiveness of UK FROST treatments. Both stressed the value of including hydrodilatation as a comparator of other treatment options. Physiotherapists raised concerns about the capacity to deliver the number of UK FROST physiotherapy sessions in routine clinical settings.Shared perceptions of trial participants, surgeons and physiotherapists were: (1) Pain relief and return of shoulder movements and function are important outcomes and (2) Adherence to exercises leads to better outcomes.ConclusionIn general, our findings indicated that trial participants, and surgeons and physiotherapists who delivered the treatments had positive experiences and perceptions in the UK FROST. Early qualitative investigations to explore the feasibility of delivering treatments in real-world settings are suggested in future trials in the frozen shoulder.Trial registration numberInternational Standard Randomised Controlled Trial Register, ID: ISRCTN48804508. Registered on 25 July 2014; Results

scholarly journals Lay perspectives of the open-label placebo rationale: a qualitative study of participants in an experimental trial

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e053346
Author(s):  
Cosima Locher ◽  
Sarah Buergler ◽  
Antje Frey Nascimento ◽  
Linda Kost ◽  
Charlotte Blease ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Qualitative Study ◽  
Controlled Trial ◽  
Open Label ◽  
Link Type ◽  
Semistructured Interviews ◽  
Lay Perspectives ◽  
Registration Number ◽  
Definition Of ◽  
Randomised Controlled

ObjectivesTo analyse participants’ concepts about the open-label placebo (OLP) effect; to explore their views about the discussion points that are applied in conventional OLP trials and to examine their experiences of taking part in an OLP trial.DesignA qualitative study using thematic analysis of semistructured interviews that were nested within a randomised controlled trial investigating experimental OLP analgesia (registered at ClinicalTrials.gov: NCT02578420).Participants30 healthy adults who took part in the randomised controlled trial.ResultsParticipants mostly conceptualised placebo as something that is inert and requires deception in order to be effective. Interviewees used a broad definition of placebos, going beyond a conventional notion of sugar pills. In contrast to the conventional OLP rationale, participants seldom emphasised classical conditioning as a mechanism of placebo effects, stressing a variety of other well-established components through which placebos might be therapeutic, whereas the conventional OLP disclosures state that ‘a positive attitude helps but is not necessary’, participants in our study applied other attitudes, such as ‘it’s worth a try’. When asked about their experiences during the trial, the majority emphasised that the concept of OLP was completely novel to them. Participants were rather sceptical about the efficacy of the intervention.ConclusionIntegrating lay perspectives into the scientific rationale of OLP treatments might enhance the plausibility and credibility of the rationale in ethical treatments.Trial registration numberNCT02578420.

scholarly journals Morita Therapy for depression (Morita Trial): an embedded qualitative study of acceptability

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e023873
Author(s):  
Holly Victoria Rose Sugg ◽  
Julia Frost ◽  
David A Richards
Keyword(s):  
Qualitative Study ◽  
Large Scale ◽  
Controlled Trial ◽  
Future Research ◽  
Treatment As Usual ◽  
Morita Therapy ◽  
Semistructured Interviews ◽  
Framework Approach ◽  
Randomised Controlled ◽  
The Uk

ObjectiveTo explore the views of UK-based recipients of Morita Therapy (MT) on the acceptability of MT.DesignQualitative study nested within a pilot randomised controlled trial of MT (a Japanese psychological therapy largely unknown in the UK) versus treatment as usual, using post-treatment semistructured interviews analysed with a framework approach.Setting and participantsParticipants who received MT as part of the Morita Trial, recruited for the trial from General Practice record searches in Devon, UK. Data from 16 participants were purposively sampled for analysis.ResultsWe identified five themes which, together, form a model of how different participants viewed and experienced MT. Overall, MT was perceived as acceptable by many participants who emphasised the value of the approach, often in comparison to other treatments they had tried. These participants highlighted how accepting and allowing difficulties as natural phenomena and shifting attention from symptoms to external factors had facilitated symptom reduction and a sense of empowerment. We found that how participants understood and related to the principles of MT, in light of their expectations of treatment, was significantly tied to the extent to which MT was perceived as acceptable. Our findings also highlighted the distinction between MT in principle and practice, with participants noting challenges of engaging with the process of therapy such as fear and discomfort around rest, needing sufficient support from the therapist and others, and the commitment of treatment.ConclusionsPeople in the UK can accept the premise of MT, and consider the approach beneficial and novel. Therefore, proceeding to a large-scale trial of MT is appropriate with minor modifications to our clinical protocol. Participants’ expectations and understandings of treatment play a key role in acceptability, and future research may investigate these potential moderators of acceptability in MT.Trial registration numberCISRCTN17544090; Pre-results.

scholarly journals The long-term (24-month) effect on health and well-being of the Lifestyle Matters community-based intervention in people aged 65 years and over: a qualitative study

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e016711 ◽  
Author(s):  
Robin Chatters ◽  
Jennifer Roberts ◽  
Gail Mountain ◽  
Sarah Cook ◽  
Gill Windle ◽  
...  
Keyword(s):  
Qualitative Study ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Well Being ◽  
Lifestyle Choices ◽  
Randomised Controlled ◽  
The Uk ◽  
Occupational Therapy Intervention ◽  
Health And Well Being

ObjectivesTo assess the long-term effect on health and well-being of the Lifestyle Matters programme.DesignQualitative study of a subset of intervention arm participants who participated in the Lifestyle Matters randomised controlled trial (RCT).SettingThe intervention took place at community venues within two sites in the UK.ParticipantsA purposeful sample of 13 participants aged between 66 and 88 years from the intervention arm of the RCT were interviewed at 24 months post randomisation. Interviews aimed to understand how participants had used their time in the preceding 2 years and whether the intervention had any impact on their lifestyle choices, participation in meaningful activities and well-being.InterventionLifestyle Matters is a 4-month occupational therapy intervention, consisting of group and individual sessions, designed to enable community living older people to make positive lifestyle choices and participate in new or neglected activities through increasing self-efficacy.ResultsInterviews revealed that the majority of interviewed participants were reportedly active at 24 months, with daily routines and lifestyles not changing significantly over time. All participants raised some form of benefit from attending Lifestyle Matters, including an improved perspective on life, trying new hobbies and meeting new friends. A number of intervention participants spoke of adapting to their changing circumstances, but there were significant and lasting benefits for 2 of 13 intervention participants interviewed.ConclusionThe majority of those who experienced the Lifestyle Matters intervention reported minor benefits and increases in self-efficacy, but they did not perceive that it significantly improved their health and well-being. The two participants who had experienced major benefits also reported having had life-changing events, suggesting that this intervention is most effective at the time when lifestyle has to be reconsidered if mental well-being is to be sustained.Trial registrationISRCTN,ISRCTN67209155, post results.

scholarly journals An external pilot cluster randomised controlled trial of a theory-based intervention to improve appropriate polypharmacy in older people in primary care (PolyPrime): study protocol

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Audrey Rankin ◽  
◽  
Cathal A. Cadogan ◽  
Heather E. Barry ◽  
Evie Gardner ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Older People ◽  
Usual Care ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Online Video ◽  
Link Type ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background The use of multiple medications (polypharmacy) is a concern in older people (≥65 years) and is associated with negative health outcomes. For older populations with multimorbidity, polypharmacy is the reality and the key challenge is ensuring appropriate polypharmacy (as opposed to inappropriate polypharmacy). This external pilot cluster randomised controlled trial (cRCT) aims to further test a theory-based intervention to improve appropriate polypharmacy in older people in primary care in two jurisdictions, Northern Ireland (NI) and the Republic of Ireland (ROI). Methods Twelve GP practices across NI (n=6) and the six counties in the ROI that border NI will be randomised to either the intervention or usual care group. Members of the research team have developed an intervention to improve appropriate polypharmacy in older people in primary care using the Theoretical Domains Framework of behaviour change. The intervention consists of two components: (1) an online video which demonstrates how a GP may prescribe appropriate polypharmacy during a consultation with an older patient and (2) a patient recall process, whereby patients are invited to scheduled medication review consultations with GPs. Ten older patients receiving polypharmacy (≥4 medications) will be recruited per GP practice (n=120). GP practices allocated to the intervention arm will be asked to watch the online video and schedule medication reviews with patients on two occasions; an initial and a 6-month follow-up appointment. GP practices allocated to the control arm will continue to provide usual care to patients. The study will assess the feasibility of recruitment, retention and study procedures including collecting data on medication appropriateness (from GP records), quality of life and health service use (i.e. hospitalisations). An embedded process evaluation will assess intervention fidelity (i.e. was the intervention delivered as intended), acceptability of the intervention and potential mechanisms of action. Discussion This pilot cRCT will provide evidence of the feasibility of a range of study parameters such as recruitment and retention, data collection procedures and the acceptability of the intervention. Pre-specified progression criteria will also be used to determine whether or not to proceed to a definitive cRCT. Trial registration ISRCTN, ISRCTN41009897. Registered 19 November 2019. ClinicalTrials.gov, NCT04181879. Registered 02 December 2019.

Protocol for a feasibility randomised controlled trial comparing cognitive functional therapy with usual physiotherapy care in people with persistent low back pain

2021 ◽  
pp. 1-14
Author(s):  
Christopher Newton ◽  
Gurpreet Singh ◽  
David Nolan ◽  
Vicky Booth ◽  
Claire Diver ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Low Back ◽  
Functional Therapy ◽  
Randomised Controlled ◽  
The Uk ◽  
Feasibility Rct

BACKGROUND: Combined physical and psychological programmes (CPPP) are recommended for people with disabling low back pain (LBP). Cognitive Functional Therapy (CFT) is a physiotherapist-led low intensity CPPP with positive effects in previous studies. The clinical and cost effectiveness of CFT has not previously been evaluated in a randomised controlled trial (RCT) in the United Kingdom (UK) National Health Service (NHS). Before a definitive RCT can be completed it is necessary to determine if completing such a study is possible. PURPOSE: To determine the feasibility of completing a definitive RCT, that will evaluate the clinical and cost-effectiveness of CFT in comparison to usual physiotherapy care for people with persistent LBP in the UK NHS. METHODS: A pragmatic two-arm parallel feasibility RCT comparing CFT with usual physiotherapy care for people with persistent LBP will be completed. Sixty participants will be randomly allocated to receive CFT or usual physiotherapy care. The primary outcome will be feasibility of completing a definitive RCT. Participant reported outcome measures will be recorded at baseline, three, six and twelve-month follow-up, including disability, pain intensity, quality of life and psychosocial function. Data will be analysed descriptively. A qualitative process evaluation will explore the acceptability of the research processes and interventions. DISCUSSION: The rationale and methodological design of a mixed methods feasibility RCT is presented. This study aims to inform the planning, design and completion of a future definitive RCT in the UK NHS. The results will be disseminated through peer reviewed open access journal publication.

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