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1.
JAMA ; 330(19): 1862-1871, 2023 11 21.
Artigo em Inglês | MEDLINE | ID: mdl-37824132

RESUMO

Importance: Bleeding is the most common cause of preventable death after trauma. Objective: To determine the effectiveness of resuscitative endovascular balloon occlusion of the aorta (REBOA) when used in the emergency department along with standard care vs standard care alone on mortality in trauma patients with exsanguinating hemorrhage. Design, Setting, and Participants: Pragmatic, bayesian, randomized clinical trial conducted at 16 major trauma centers in the UK. Patients aged 16 years or older with exsanguinating hemorrhage were enrolled between October 2017 and March 2022 and followed up for 90 days. Intervention: Patients were randomly assigned (1:1 allocation) to a strategy that included REBOA and standard care (n = 46) or standard care alone (n = 44). Main Outcomes and Measures: The primary outcome was all-cause mortality at 90 days. Ten secondary outcomes included mortality at 6 months, while in the hospital, and within 24 hours, 6 hours, or 3 hours; the need for definitive hemorrhage control procedures; time to commencement of definitive hemorrhage control procedures; complications; length of stay; blood product use; and cause of death. Results: Of the 90 patients (median age, 41 years [IQR, 31-59 years]; 62 [69%] were male; and the median Injury Severity Score was 41 [IQR, 29-50]) randomized, 89 were included in the primary outcome analysis because 1 patient in the standard care alone group declined to provide consent for continued participation and data collection 4 days after enrollment. At 90 days, 25 of 46 patients (54%) had experienced all-cause mortality in the REBOA and standard care group vs 18 of 43 patients (42%) in the standard care alone group (odds ratio [OR], 1.58 [95% credible interval, 0.72-3.52]; posterior probability of an OR >1 [indicating increased odds of death with REBOA], 86.9%). Among the 10 secondary outcomes, the ORs for mortality and the posterior probabilities of an OR greater than 1 for 6-month, in-hospital, and 24-, 6-, or 3-hour mortality were all increased in the REBOA and standard care group, and the ORs were increased with earlier mortality end points. There were more deaths due to bleeding in the REBOA and standard care group (8 of 25 patients [32%]) than in standard care alone group (3 of 18 patients [17%]), and most occurred within 24 hours. Conclusions and Relevance: In trauma patients with exsanguinating hemorrhage, a strategy of REBOA and standard care in the emergency department does not reduce, and may increase, mortality compared with standard care alone. Trial Registration: isrctn.org Identifier: ISRCTN16184981.


Assuntos
Oclusão com Balão , Exsanguinação , Humanos , Masculino , Adulto , Feminino , Exsanguinação/complicações , Teorema de Bayes , Estudos Retrospectivos , Hemorragia/etiologia , Hemorragia/terapia , Aorta , Oclusão com Balão/efeitos adversos , Oclusão com Balão/métodos , Ressuscitação/métodos , Escala de Gravidade do Ferimento , Serviço Hospitalar de Emergência , Reino Unido
2.
Trials ; 24(1): 157, 2023 Mar 02.
Artigo em Inglês | MEDLINE | ID: mdl-36864520

RESUMO

BACKGROUND: Trials in pre-hospital trauma care are relatively uncommon. There are logistical and methodological challenges related to designing and delivering trials in this setting. Previous studies have assessed challenges reported in individual trials rather than across the pre-hospital trial landscape to identify over-arching factors. The aim of this study was to investigate the challenges and opportunities related to the set-up, design and conduct of pre-hospital trauma trials from across the pre-hospital trial landscape and a specific pre-hospital trauma feasibility study. METHODS: Semi-structured interviews were conducted with two cohorts of participants: research personnel who had experience of pre-hospital trials, either through direct involvement in conduct or through strategic oversight of national initiatives (n = 7), and clinical staff (n = 16) involved in recruitment to a pre-hospital trauma feasibility study. Thematic analyses were used to assess the barriers and enablers of conducting pre-hospital trauma trials. Two frameworks (The Capability Opportunity Motivation-Behaviour and the Theoretical Domains Framework) were used to guide analyses. RESULTS: The barriers and enablers reported were relevant to several TDF domains and COM-B components. Across both cohorts, challenges associated with opportunities were reported and included the lack of research experience amongst pre-hospital staff, team dynamics within a rotating shift schedule, and the involvement of external organisations with diverse institutional priorities and infrastructures (e.g. Air Ambulances). The infrequency of eligible cases was also reported to affect the trial design, set-up, and conduct. Other barriers reported related to clinical equipoise amongst staff and institutional pressures, which affected motivation. CONCLUSIONS: This study has highlighted that pre-hospital trials face many context-specific but also generic challenges. Pre-hospital trauma trial teams could consider the findings to develop targeted, behaviourally focused, solutions to the challenges identified in order to enhance the set-up and conduct of trials in this setting. TRIAL REGISTRATION: NCT04145271. Trial registration date: October 30, 2019. Note that this paper does not report results from a specific trial but does include participants who were involved in the conduct of a registered pre-hospital feasibility study.


Assuntos
Resgate Aéreo , Hospitais , Humanos , Medicamentos Genéricos , Instalações de Saúde , Motivação
3.
PLoS One ; 18(1): e0280086, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36603013

RESUMO

BACKGROUND: Healthcare technologies are becoming more commonplace, however clinical and patient perspectives regarding the use of technology in the management of childhood asthma have yet to be investigated. Within a clinical trial of asthma management in children, we conducted a qualitative process evaluation that provided insights into the experiences and perspectives of healthcare staff and families on (i) the use of smart inhalers to monitor medication adherence and (ii) the use of algorithm generated treatment recommendations. METHODS: We interviewed trial staff (n = 15) and families (n = 6) who were involved in the trial to gauge perspectives around the use of smart inhalers to monitor adherence and the algorithm to guide clinical decision making. FINDINGS: Staff and families indicated that there were technical issues associated with the smart inhalers. While staff suggested that the smart inhalers were good for monitoring adherence and enabling communication regarding medication use, parents and children indicated that smart inhaler use increased motivation to adhere to medication and provided the patient (child) with a sense of responsibility for the management of their asthma. Staff were open-minded about the use of the algorithm to guide treatment recommendations, but some were not familiar with its' use in clinical care. There were some concerns expressed regarding treatment step-down decisions generated by the algorithm, and some staff highlighted the importance of using clinical judgement. Families perceived the algorithm to be a useful technology, but indicated that they felt comforted by the clinicians' own judgements. CONCLUSION: The use of technology and individual data within appointments was considered useful to both staff and families: closer monitoring and the educational impacts were especially highlighted. Utilising an algorithm was broadly acceptable, with caveats around clinicians using the recommendations as a guide only and wariness around extreme step-ups/downs considering contextual factors not taken into account.


Assuntos
Asma , Criança , Humanos , Asma/tratamento farmacológico , Adesão à Medicação , Nebulizadores e Vaporizadores , Pais , Pesquisa Qualitativa
4.
BMJ Open ; 12(11): e067427, 2022 11 11.
Artigo em Inglês | MEDLINE | ID: mdl-36368747

RESUMO

OBJECTIVES: The effective implementation of a fast-changing healthcare delivery innovation, such as robotic-assisted surgery (RAS), into a healthcare system, can be affected (both positively and negatively) by external contextual factors. As part of a wider project investigating ways to optimise the implementation of RAS, this qualitative study aimed to uncover current issues of RAS and predictions about the future of robotic surgery. We refer to 'current issues' as the topical and salient challenges and opportunities related to the introduction of RAS in the UK healthcare system, from the perspectives of key stakeholders involved in the delivery and implementation of RAS. DESIGN: Semi-structured interviews and focus groups were conducted. A thematic analysis was conducted to summarise salient issues that were articulated by the participants. SETTING AND PARTICIPANTS: The interview sample (n=35) comprised surgeons, wider theatre staff and other relevant personnel involved in the introduction and delivery of RAS services across the UK, including service managers and policymakers/commissioners. Two focus groups were also conducted with surgical trainees (n=7) and members of the public (n=8), respectively. RESULTS: The results revealed a largely positive attitude towards the introduction of RAS technology and an expectation of continued rapid expansion. Areas perceived to be particularly pertinent and requiring ongoing attention were also highlighted, including the need to achieve improved quality control, expertise quantification and training issues and the need to educate the public. Issues of centralisation, service organisation and equity of access were also emphasised. CONCLUSIONS: Our study has highlighted a range of issues perceived to be particularly pertinent to the current and future provision of RAS which should be addressed. The areas outlined can enable healthcare managers and surgeons to plan for the adoption and/or expansion of RAS services.


Assuntos
Procedimentos Cirúrgicos Robóticos , Humanos , Pesquisa Qualitativa , Atenção à Saúde , Grupos Focais
5.
Trials ; 23(1): 870, 2022 Oct 12.
Artigo em Inglês | MEDLINE | ID: mdl-36224619

RESUMO

BACKGROUND: The evidence on what strategies can improve recruitment to clinical trials in maternity care is lacking. As trial recruiters, maternity healthcare professionals (MHCPs) perform behaviours (e.g. talking about trials with potential participants, distributing trial information) they may not ordinarily do outside of the trial. Most trial recruitment interventions do not provide any theoretical basis for the potential effect (on behaviour) or describe if stakeholders were involved during development. The study aim was to use behavioural theory in a co-design process to develop an intervention for MHCPs tasked with approaching all eligible potential participants and inviting them to join a maternity trial and to assess the acceptability and feasibility of such an intervention. METHODS: This study applied a step-wise sequential mixed-methods approach. Key stages were informed by the Theoretical Domains Framework and Behaviour Change Techniques (BCT) Taxonomy to map the accounts of MHCPs, with regard to challenges to trial recruitment, to theoretically informed behaviour change strategies. Our recruitment intervention was co-designed during workshops with MHCPs and maternity service users. Acceptability and feasibility of our intervention was assessed using an online questionnaire based on the Theoretical Framework of Acceptability (TFA) and involved a range of trial stakeholders. RESULTS: Two co-design workshops, with a total of nine participants (n = 7 MHCP, n = 2 maternity service users), discussed thirteen BCTs as potential solutions. Ten BCTs, broadly covering Consequences and Reframing, progressed to intervention development. Forty-five trial stakeholders (clinical midwives, research midwives/nurses, doctors, allied health professionals and trial team members) participated in the online TFA questionnaire. The intervention was perceived effective, coherent, and not burdensome to engage with. Core areas for future refinement included Anticipated opportunity and Self-efficacy. CONCLUSION: We developed a behaviour change recruitment intervention which is based on the accounts of MHCP trial recruiters and developed in a co-design process. Overall, the intervention was deemed acceptable. Future evaluation of the intervention will establish its effectiveness in enabling MHCPs to invite all eligible people to participate in a maternity care trial, and determine whether this translates into an increase in maternity trial recruitment rates.


Assuntos
Serviços de Saúde Materna , Atitude do Pessoal de Saúde , Terapia Comportamental , Ensaios Clínicos como Assunto , Feminino , Pessoal de Saúde , Humanos , Gravidez , Inquéritos e Questionários
6.
PLoS One ; 17(8): e0273696, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36037179

RESUMO

BACKGROUND: Implementation of Robotic Assisted Surgery (RAS) is complex as it requires adjustments to associated physical infrastructure, but also changes to processes and behaviours. With the global objective of optimising and improving RAS implementation, this study aimed to: 1) Explore the barriers and enablers to RAS service adoption, incorporating an assessment of behavioural influences; 2) Provide an optimised plan for effective RAS implementation, with the incorporation of theory-informed implementation strategies that have been adapted to address the barriers/enablers that affect RAS service adoption. METHODS: Semi-structured interviews were conducted with RAS personnel and stakeholders, including: surgeons, theatre staff, managers, industry representatives, and policy-makers/commissioners. The Theoretical Domains Framework (TDF) and the Consolidated Framework for Implementation Research (CFIR) was used to identify barriers and enablers that represent individual behaviours, capabilities, attitudes, beliefs, and external organisational factors that influence the implementation of RAS. RESULTS: Findings suggest that implementation planning has three separate phases-pre-, early, and late implementation. For pre-implementation, barriers and enablers identified included the cost of RAS equipment and issues of economic viability, weak outcome evidence for RAS, a preponderance of an eminence driven model, the clinician/manager relationship, and views around the uptake and expansion of RAS in the future. Early implementation findings revealed role changes for theatre personnel and an enhanced team approach, reliance on industry for training provision, and changes in skill sets and attentional processes. Late implementation factors included equipment maintenance costs, technological limitations, changes to cognition during RAS routine use, and benefits to institutions/healthcare professionals (such as ergonomic improvement). CONCLUSION: Together, findings suggest the factors that affect RAS implementation are multi-faceted and change across the life-cycle of intervention adoption. Theory-informed strategies are suggested which can optimise implementation of RAS. Optimisation strategies need planning from the outset.


Assuntos
Procedimentos Cirúrgicos Robóticos , Pessoal Administrativo , Atitude do Pessoal de Saúde , Terapia Comportamental , Pessoal de Saúde , Humanos , Pesquisa Qualitativa
7.
Trials ; 23(1): 398, 2022 May 12.
Artigo em Inglês | MEDLINE | ID: mdl-35550599

RESUMO

BACKGROUND: Clinical trials comprise multiple processes at various stages of the trial lifecycle. These processes often involve complex behaviours such as recruiting vulnerable patient populations and clinicians having to deliver complex trial interventions successfully. Few studies have utilised a behavioural framework to assess challenges and develop strategies for effective trial recruitment and delivery of trial interventions. This study reports the application of an innovative methodological approach to understand core trial processes, namely recruitment and intervention delivery, using a behavioural science approach to develop strategies designed to mitigate trial process problems. METHODS: The UK-REBOA trial aims to evaluate the clinical and cost-effectiveness of resuscitative endovascular balloon occlusion of the aorta (a novel intervention) in injured patients with exsanguinating haemorrhage. A behavioural investigation ('diagnosis') was conducted using theory-informed (Theoretical Domains Framework, TDF) semi-structured interviews with site staff from the UK-REBOA trial to examine trial processes which could be improved in relation to trial recruitment and delivery of the intervention. Interviews were analysed using the TDF to identify influences on behaviour, which were then mapped to techniques for behaviour change and developed into potential solutions. RESULTS: The behavioural diagnosis of the challenges experienced during trial processes highlighted factors relevant to a range of TDF domains: Skills, Environmental context and resources, Beliefs about capabilities, Beliefs about consequences, Social influences, and Memory, attention, and decision-making processes. Within the solution development phase, we identified 24 suitable behaviour change techniques that were developed into proposed solutions to target reported process problems with the aim of changing behaviour to improve recruitment and/or intervention delivery. Proposed solutions included targeted changes to trial training content, suggestions to restructure the environment (e.g. reinforced the purpose of the trial with information about the social and environmental consequences) and other strategies to reduce barriers to recruitment and intervention delivery. CONCLUSIONS: This study demonstrates the feasibility of applying a behavioural approach to investigate ('diagnose') behavioural trial process problems and subsequently develop and implement targeted solutions ('treatment') in an active trauma trial. Understanding the factors that affected behaviour, attitudes and beliefs in this trauma trial allowed us to implement theoretically informed, evidence-based solutions designed to enhance trial practices. TRIAL REGISTRATION: ISRCTN 16,184,981.


Assuntos
Terapia Comportamental , Ensaios Clínicos como Assunto , Humanos , Reino Unido
8.
BMJ Open ; 12(3): e054854, 2022 03 09.
Artigo em Inglês | MEDLINE | ID: mdl-35264354

RESUMO

OBJECTIVES: To identify studies that applied behavioural approaches to issues of recruitment and/or retention to trials; to describe these approaches; and to identify gaps for future research. DESIGN: Systematic mapping review of research undertaken in clinical trials within peer-reviewed sources. Review participants were individuals involved in clinical trials, including trial staff, participants, potential participants and former participants. DATA SOURCES: MEDLINE, EMBASE, CINAHL, ERIC, PsycINFO, Web of Science and ASSIA from inception to 15 January 2020 with no date or language restrictions. ELIGIBILITY CRITERIA: Studies within the context of clinical trials reporting the barriers/facilitators to recruitment and retention, or developing/evaluating solutions to said barriers/facilitators, using a behavioural approach. RESULTS: 31 articles were included. Recruitment-focused studies (n=22, 71%) represented the majority. Studies tended to focus on participant behaviours (n=22, 71%). Underserved populations (n=11, 35%) were a notable subset of studies. Most studies (n=23, 74%) were exploratory but those that evaluated interventions (n=8, 26%) often did so within underserved populations (n=6). A majority of studies (n=30, 97%) did not specify their behaviours consistent with guidelines from behavioural scientists. The most used approaches were social cognitive theory (n=8, 26%), the theory of planned behaviour (n=6, 19%) and the theoretical domains framework (n=5, 16%). CONCLUSIONS: A range of behavioural approaches have been applied to recruitment and retention to trials. The multitude of recruitment research here is consistent with trials research generally and emphasises the need for research into retention. Authors report target behaviours minimally, which is not conducive to replication. Further research should build on lessons here, such as clearly specifying behaviours. Increased methodological rigour and transparency will lead to robust evidence bases and less research waste in poor recruitment and retention. Overall, trials informed by behavioural approaches promises to be efficient and more participant focused.

9.
Lancet Respir Med ; 10(6): 584-592, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-35101183

RESUMO

BACKGROUND: The benefit of fractional exhaled nitric oxide (FeNO) in guiding asthma treatment is uncertain. We evaluated the efficacy of adding FeNO to symptom-guided treatment in children with asthma versus only symptom-guided treatment. METHODS: RAACENO was a multicentre, parallel, randomised, controlled, phase 3 trial done in 35 secondary care centres and 17 primary care recruitment sites (only seven primary care sites managed to recruit patients) in the UK. Patients with a confirmed asthma diagnosis, aged 6-15 years, prescribed inhaled corticosteroids, and who received a course of oral corticosteroids for at least one asthma exacerbation during the 12 months before recruitment were included. Participants were randomly assigned to either FeNO plus symptom-guided treatment (intervention) or symptom-guided treatment alone (standard care) using a 24 h in-house, web-based randomisation system. Participants and the clinical and research teams were not masked to the group allocation. A web-based algorithm gave treatment recommendations based on the Asthma Control Test (ACT) or Childhood ACT (CACT) score; current asthma treatment; adherence to study treatment in the past 3 months; and use of FeNO (in the intervention group). Follow-up occurred at 3-month intervals for 12 months. The primary outcome was any asthma exacerbation treated with oral corticosteroids in the 12 months after randomisation, assessed in the intention-to-treat population. This study is registered with the International Standard Randomised Controlled Trial Registry, ISRCTN67875351. FINDINGS: Between June 22, 2017, and Aug 8, 2019, 535 children were assessed for eligibility, 20 were ineligible and six were excluded post-randomisation. 509 children were recruited and at baseline, the mean age of participants was 10·1 years (SD 2·6), and 308 (60·5%) were male. The median FeNO was 21 ppb (IQR 10-48), mean predicted FEV1 was 89·6% (SD 18·0), and median daily dose of inhaled corticosteroids was 400 µg budesonide equivalent (IQR 400-1000). Asthma was partly or fully controlled in 256 (50·3%) of 509 participants. The primary outcome, which was available for 506 (99%) of 509 participants, occurred in 123 (48·2%) of 255 participants in the intervention group and 129 (51·4%) of 251 in the standard care group, the intention-to-treat adjusted odds ratio (OR) was 0·88 (95% CI 0·61 to 1·27; p=0·49). The adjusted difference in the percentage of participants who received the intervention in whom the primary outcome occurred compared with those who received standard care was -3·1% (-11·9% to 5·6%). In 377 (21·3%) of 1771 assessments, the algorithm recommendation was not followed. Adverse events were reported by 27 (5·3%) of 509 participants (15 in the standard care group and 12 in the intervention group). The most common adverse event was itch after skin prick testing (reported by eight participants in each group). INTERPRETATION: We found that the addition of FeNO to symptom-guided asthma treatment did not lead to reduced exacerbations among children prone to asthma exacerbation. Asthma symptoms remain the only tool for guiding treatment decisions. FUNDING: National Institute for Health Research.


Assuntos
Antiasmáticos , Asma , Adolescente , Corticosteroides , Asma/tratamento farmacológico , Biomarcadores , Criança , Feminino , Humanos , Masculino , Óxido Nítrico
10.
J Clin Epidemiol ; 145: 81-91, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-35081447

RESUMO

OBJECTIVE: To conduct a behavioral investigation, using the Theoretical Domains Framework (TDF), to identify barriers and enablers to maternity healthcare professionals (HCP) inviting all eligible women to participate in a maternity care trial. STUDY DESIGN AND SETTING: We invited HCP recruiters from maternity care trials in high priority research areas including, diabetes, preeclampsia and breastfeeding, from across Ireland and the UK, to take part in a semi-structured interview. Data collection was informed by the TDF, followed by inductive thematic analysis and deductive mapping to the TDF. RESULTS: Twenty-two recruiters including midwives, nurses, allied health professionals and doctors were interviewed online or by telephone phone. Thematic analysis generated four global themes; Availability and accessibility of resources, Navigating the recruitment pathway, Prioritising clinical responsibilities over research responsibilities and The influence of colleagues and peers. Themes were mapped to the TDF, identifying 13 domains relevant to the behaviour. CONCLUSION: This paper identifies the factors enabling or inhibiting maternity HCP recruiters to invite all eligible women to participate in a maternity care trial. The findings provide guidance for researchers designing trials for this population and the essential first step in developing a recruiter-focused behaviour change intervention to support recruitment to trials in maternity care.


Assuntos
Atitude do Pessoal de Saúde , Serviços de Saúde Materna , Feminino , Pessoal de Saúde , Humanos , Gravidez , Pesquisa Qualitativa , Pesquisadores
11.
J Gerontol B Psychol Sci Soc Sci ; 77(2): 332-340, 2022 02 03.
Artigo em Inglês | MEDLINE | ID: mdl-34036302

RESUMO

OBJECTIVES: Older adults tend to have poorer Theory of Mind (ToM) than their younger counterparts, and this has been shown in both Western and Asian cultures. We examined the role of working memory (WM) in age differences in ToM, and whether this was moderated by education and culture (the United Kingdom vs. Malaysia). METHODS: We used 2 ToM tests with differing demands on updating multiple mental states (false belief) and applying social rules to mental state processing (faux pas). We also looked at the role of education, socioeconomic status, and WM. A total of 298 participants from the United Kingdom and Malaysia completed faux pas, false belief, and WM tasks. RESULTS: Age effects on some aspects of ToM were greater in the Malaysian compared to the UK sample. Malaysian older adults were poorer at faux pas detection, aspects of false belief, and WM compared to young adults. In subsequent moderated mediation analyses, we found that, specifically in the Malaysian sample, the mediating effects of WM on the age and ToM relationship occurred at the lowest levels of education. DISCUSSION: This pattern of results may reflect changes in the familiarity and cognitive load of explicit mental state attribution, along with cultural differences in the pace and nature of cognitive aging. Cultural differences in education and WM should be considered when researching age differences in ToM.


Assuntos
Envelhecimento Cognitivo/psicologia , Etnopsicologia/métodos , Memória de Curto Prazo , Teoria da Mente , Idoso , Antecipação Psicológica , Cognição , Cultura , Escolaridade , Função Executiva , Feminino , Humanos , Malásia , Masculino , Classe Social , Reino Unido
12.
Front Psychol ; 12: 631458, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33692728

RESUMO

Planning ability is important in everyday functioning, and a key measure to assess the preparation and execution of plans is the Tower of London (ToL) task. Previous studies indicate that older adults are often less accurate than the young on the ToL and that there may be cultural differences in performance on the task. However, potential interactions between age and culture have not previously been explored. In the current study we examined the effects of age on ToL performance in an Asian culture (Malaysia) and a Western culture (British) (n = 191). We also explored whether working memory, age, education, and socioeconomic status explained variance in ToL performance across these two cultures. Results indicated that age effects on ToL performance were greater in the Malaysian sample. Subsequent moderated mediation analysis revealed differences between the two cultures (British vs Malaysians), in that the age-related variance in ToL accuracy was accounted for by WM capacity at low and medium education levels only in the Malaysian sample. Demographic variables could not explain additional variance in ToL speed or accuracy. These results may reflect cultural differences in the familiarity and cognitive load of carrying out complex planning tasks.

13.
J Clin Epidemiol ; 137: 1-13, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-33727134

RESUMO

OBJECTIVES: To use the Theoretical Domains Framework (TDF) to identify barriers and enablers to participant retention in trials requiring questionnaire return and/or attendance at follow-up clinics. STUDY DESIGN AND SETTING: We invited participants (n = 607) from five pragmatic effectiveness trials, who missed at least one follow-up time point (by not returning a questionnaire and/or not attending a clinic visit), to take part in semistructured telephone interviews. The TDF informed both data collection and analysis. To establish what barriers and enablers most likely influence the target behavior the domain relevance threshold was set at >75% of participants mentioning the domain. RESULTS: Sixteen participants (out of 25 showing interest) were interviewed. Overall, seven theoretical domains were identified as both barriers and enablers to the target behaviors of attending clinic appointments and returning postal questionnaires. Barriers frequently reported in relation to both target behaviours stemmed from participants' knowledge, beliefs about their capabilities and the consequences of performing (or not performing) the behavior. Two domains were identified as salient for questionnaire return only: goals; and memory, attention and decision-making. Emotion was identified as relevant for clinic attendance only. CONCLUSION: This is the first study informed by behavioural science to explore trial participants' accounts of trial retention. Findings will serve as a guiding framework when designing trials to limit barriers and enhance enablers of retention within clinical trials.


Assuntos
Atitude Frente a Saúde , Ensaios Clínicos como Assunto/estatística & dados numéricos , Sujeitos da Pesquisa/estatística & dados numéricos , Humanos , Ensaios Clínicos Pragmáticos como Assunto/estatística & dados numéricos
14.
Psychol Health ; 35(7): 824-837, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-31757171

RESUMO

Objective: People with multiple sclerosis (pwMS) who experience higher levels of anger also report poorer quality of life (QoL). This qualitative study explored the subjective experience of anger amongst pwMS, and how anger influenced their lives.Methods: A series of semi-structured, face-to-face interviews were conducted with 20 pwMS. Interviews were recorded, transcribed and then Interpretative Phenomenological Analysis was used to analyse the emerging themes.Results: The most common experience of anger was frustration that MS-related symptoms restricted participation in everyday activities. Also, some experiences of anger-with-self were focused on frustration at the inability to overcome symptom-related activity limitations. Participants reported frustration with others' insensitivity to the effects of the disease process, as well as usual daily irritations with family and colleagues. Some of the participants reported the use of coping strategies to deal with anger episodes.Conclusion: Many pwMS experience frustration at the restrictions that the disease places on them, self-directed anger, and irritation with others' attitude towards them. Much research in MS focuses on physical symptoms, but current results indicate that there is a need to better understand the emotional challenges faces by pwMS, and to provide more support for those who are experiencing frustration.


Assuntos
Ira , Esclerose Múltipla/psicologia , Atividades Cotidianas/psicologia , Adaptação Psicológica , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pesquisa Qualitativa , Qualidade de Vida/psicologia
15.
Artigo em Inglês | MEDLINE | ID: mdl-29447561

RESUMO

Older adults perceive less intense negative emotion in facial expressions compared to younger counterparts. Prior research has also demonstrated that mood alters facial emotion perception. Nevertheless, there is little evidence which evaluates the interactive effects of age and mood on emotion perception. This study investigated the effects of sad mood on younger and older adults' perception of emotional and neutral faces. Participants rated the intensity of stimuli while listening to sad music and in silence. Measures of mood were administered. Younger and older participants' rated sad faces as displaying stronger sadness when they experienced sad mood. While younger participants showed no influence of sad mood on happiness ratings of happy faces, older adults rated happy faces as conveying less happiness when they experienced sad mood. This study demonstrates how emotion perception can change when a controlled mood induction procedure is applied to alter mood in young and older participants.


Assuntos
Afeto , Emoções , Expressão Facial , Tristeza , Percepção Social , Adolescente , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Feminino , Felicidade , Humanos , Masculino , Pessoa de Meia-Idade , Adulto Jovem
16.
Conscious Cogn ; 63: 89-98, 2018 08.
Artigo em Inglês | MEDLINE | ID: mdl-29966861

RESUMO

Perceiving oneself as agentic is dependent upon the integration of conscious intention, a corresponding outcome, and body-congruent sensorimotor information. Altering these critical cues, such as the vantage point from which an event is viewed, can have a notable impact on one's sense of agency, including an increased sense of ownership over another person's actions or a reduced sense of responsibility (or control) over one's own actions. In three studies, we investigated whether mentally simulated and written perspectives could have similar effects. Participants were asked to consider ambiguous actions from either a first-person or a third-person perspective. Results revealed that third-person perspectives reduced judgments of personal responsibility for positive and negative actions. Perceptions of personal action execution as well as the perceived overlap between one's real and imagined self were identified as mediators of the reduced sense of responsibility that characterized negative, but not positive, events constructed from a third-person perspective.


Assuntos
Autoimagem , Responsabilidade Social , Adolescente , Adulto , Idoso , Feminino , Humanos , Julgamento , Masculino , Pessoa de Meia-Idade , Adulto Jovem
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