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1.
Soc Sci Med ; 62(9): 2279-90, 2006 May.
Artigo em Inglês | MEDLINE | ID: mdl-16290917

RESUMO

For some perinatal trials, parents can be asked to make important decisions about trial participation within limited timeframes in highly stressful circumstances. This qualitative study explores the pace of decision-making for 78 parents associated with one or more of four such trials in the UK. The themes associated with rapid decisions were concern for their baby, reactions to staff, and perceptions of the benefits and risks associated with the trial. Those who took longer to decide whether or not to participate often described similar emotions to those who made rapid decisions, but their slower decisions were because more time was available, they wanted further discussion or they found the decision particularly difficult. The majority of those who made rapid decisions felt that there were no risks associated with the trial in question, in contrast to the majority of those who made slower decisions who felt there were risks. The parents did not appear to view rapid decisions as problematic. Although there was evidence of parental vulnerability in each trial context, they largely felt that they acted swiftly and responsibly in the best interests of their child in accordance with the timeframes that were set for them.


Assuntos
Tomada de Decisões , Pais , Assistência Perinatal , Ensaios Clínicos Controlados Aleatórios como Assunto , Feminino , Humanos , Pesquisa Qualitativa , Fatores de Tempo , Reino Unido
2.
Br J Gen Pract ; 56(524): 198-205, 2006 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-16536960

RESUMO

BACKGROUND: Miscarriage affects around one in six pregnancies. Much research has taken place identifying the consequences of this for parents but is mainly quantitative. Of the limited qualitative studies, none have explored women's experiences of the methods of miscarriage management received. AIM: To assess the social and personal impact of different management methods (expectant, medical and surgical) on women's experience of first trimester miscarriage. DESIGN OF STUDY: Qualitative interviews using a topic guide with a purposive cohort of four categories of women (each management method plus non-participants) 6 months to 1 year after first trimester miscarriage. Focus groups with both research participants and health workers. SETTING: Women from three hospitals in the South West of England that participated in the Miscarriage Treatment (MIST) trial. METHOD: Seventy-two interviews were undertaken between September 1999 and June 2000. There were also five focus groups (47 participants) and two feedback sessions (8 participants) with written feedback from 12 women. Interviews lasted 0.5-2.5 hours generating over 2000 A4 pages of transcripts. The transcripts were analysed for common themes, using standard proformas, which were filled in by individual team members and then discussed by the whole research team. Iterative readings in the light of new emerging issues ensured that new themes could be identified throughout the analytical process. All transcripts were then encoded for the identified themes using NUDIST. RESULTS: Common themes emerged across all management options although some were specific to just one or two management options. The five major themes arising out of the data analysis were: intervention; experiences of care; finality; the 'baby'; and pain and bleeding. CONCLUSIONS: Women's experiences and beliefs vary widely and their preferences need to be considered in their early miscarriage management. The three methods have different benefits and problems from the women's point of view. Competence and caring from professionals are especially important.


Assuntos
Aborto Espontâneo/psicologia , Aborto Espontâneo/terapia , Adaptação Psicológica , Adulto , Atitude Frente a Saúde , Comportamento de Escolha , Competência Clínica , Estudos de Coortes , Dilatação e Curetagem/psicologia , Feminino , Humanos , Pessoa de Meia-Idade , Gravidez , Primeiro Trimestre da Gravidez/psicologia , Qualidade da Assistência à Saúde , Ensaios Clínicos Controlados Aleatórios como Assunto
3.
Clin Child Psychol Psychiatry ; 21(3): 368-80, 2016 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-26907460

RESUMO

Access to needed mental health services can be particularly difficult for newly arrived refugee and asylum-seeking adolescents, although many attend school. This study examined young refugees' impressions and experience of mental health services integrated within the school system. Semi-structured interviews were conducted with 40 adolescent refugees discharged by three school-based mental health services across the United Kingdom. Two-thirds preferred to be seen at school. Rumination and worry about insecurity in the asylum process had a negative impact particularly on the adolescents' social functioning and ability to focus at school. The important role played by teachers in supporting and mediating contact with mental health services was valued by those interviewed. The study confirms that schools offer an important location for mental health services for adolescent refugees and provide an important portal for integration of services.


Assuntos
Serviços de Saúde Mental , Saúde Mental , Refugiados/psicologia , Serviços de Saúde Escolar , Ajustamento Social , Feminino , Acessibilidade aos Serviços de Saúde , Humanos , Masculino , Instituições Acadêmicas , Reino Unido
4.
Midwifery ; 21(1): 84-95, 2005 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-15740820

RESUMO

OBJECTIVE: to examine the circumstances, experiences and needs of a local sample of low-income, childbearing women of Bangladeshi origin in the UK. DESIGN: qualitative interviews using a semi-structured questionnaire to obtain the interviewees' own accounts of the period around the birth of a baby. SETTING: a deprived area in the City of Leeds in the North of England. PARTICIPANTS: nine women of Bangladeshi origin who were pregnant or had a baby under 1 year of age were interviewed as part of a larger study of the needs and experiences of 52 low-income, childbearing women. The nine women were recruited from a neighbourhood project set up to respond to the needs of Sylheti-speaking women with limited English fluency in the area. FINDINGS: the women's constrained material circumstances limit their access to resources, services and good health. This is related to their limited education, qualifications and English fluency. The lack of an adequate income particularly affects families with new babies. However, their relatively positive experiences of maternity care and benefit claim, compared with women with similar characteristics in other studies, may be related to access to advice, support and concrete help offered by the neighbourhood project. IMPLICATIONS FOR PRACTICE: social and health research, policy and practice might address information and support needs of low-income Bangladeshi women around the birth of a baby, and systematically take forward the idea of providing and evaluating integrated services, language support and advocacy between voluntary and state agencies.


Assuntos
Atitude Frente a Saúde/etnologia , Características Culturais , Tocologia/normas , Mães , Avaliação em Enfermagem/normas , Parto/etnologia , Adulto , Bangladesh/etnologia , Emigração e Imigração , Inglaterra , Feminino , Humanos , Recém-Nascido , Mães/educação , Mães/psicologia , Avaliação das Necessidades/normas , Papel do Profissional de Enfermagem , Pesquisa Metodológica em Enfermagem , Pobreza/psicologia , Gravidez , Fatores de Risco , Apoio Social , Fatores Socioeconômicos , Inquéritos e Questionários
5.
J Epidemiol Community Health ; 58(9): 794-800, 2004 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-15310807

RESUMO

Methods for systematic reviews are well developed for trials, but not for non-experimental or qualitative research. This paper describes the methods developed for reviewing research on people's perspectives and experiences ("views" studies) alongside trials within a series of reviews on young people's mental health, physical activity, and healthy eating. Reports of views studies were difficult to locate; could not easily be classified as "qualitative" or "quantitative"; and often failed to meet seven basic methodological reporting standards used in a newly developed quality assessment tool. Synthesising views studies required the adaptation of qualitative analysis techniques. The benefits of bringing together views studies in a systematic way included gaining a greater breadth of perspectives and a deeper understanding of public health issues from the point of view of those targeted by interventions. A systematic approach also aided reflection on study methods that may distort, misrepresent, or fail to pick up people's views. This methodology is likely to create greater opportunities for people's own perspectives and experiences to inform policies to promote their health.


Assuntos
Atitude Frente a Saúde , Pesquisa sobre Serviços de Saúde/métodos , Saúde Pública , Literatura de Revisão como Assunto , Adolescente , Criança , Dieta/psicologia , Comportamentos Relacionados com a Saúde , Promoção da Saúde , Humanos , Saúde Mental , Atividade Motora
6.
Br J Gen Pract ; 53(493): 614-9, 2003 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-14601337

RESUMO

BACKGROUND: Screening for postnatal depression using the Edinburgh Postnatal Depression Scale (EPDS) has been widely recommended and implemented in primary care, although little is known about how acceptable it is to women. AIM: To explore the acceptability to women of postnatal screening by health visitors with the EPDS. DESIGN OF STUDY: Qualitative interview study. SETTING: Postnatal patients from 22 general practices within the area of Oxford City Primary Care Group. METHOD: Thirty-nine postnatal women from a purposive sample were interviewed, chosen on the basis of different general practices, EPDS results at eight weeks and eight months postnatal, and whether 'listening visits' were received. The interviews were analysed using the constant comparative method. RESULTS: Just over half of the women interviewed found screening with the EPDS less than acceptable, whatever their postnatal emotional health. The main themes identified were problems with the process of screening and, in particular, the venue, the personal intrusion of screening and stigma. The women interviewed had a clear preference for talking about how they felt, rather than filling out a questionnaire. CONCLUSION: For this sample, routine screening with the EPDS was less than acceptable for the majority of women. This is of concern, as universal screening with the EPDS for the detection of postnatal depression is already recommended and widespread in primary care.


Assuntos
Depressão Pós-Parto/diagnóstico , Programas de Rastreamento/métodos , Aceitação pelo Paciente de Cuidados de Saúde , Adulto , Depressão Pós-Parto/psicologia , Feminino , Humanos , Entrevistas como Assunto , Escalas de Graduação Psiquiátrica
7.
BMC Womens Health ; 2(1): 7, 2002 Jul 19.
Artigo em Inglês | MEDLINE | ID: mdl-12133195

RESUMO

BACKGROUND: This study assessed women and providers' satisfaction with a new evidence-based antenatal care (ANC) model within the WHO randomized trial conducted in four developing countries. The WHO study was a randomized controlled trial that compared a new ANC model with the standard type offered in each country. The new model of ANC emphasized actions known to be effective in improving maternal or neonatal health, excluded other interventions that have not proved to be beneficial, and improved the information component, especially alerting pregnant women to potential health problems and instructing them on appropriate responses. These activities were distributed within four antenatal care visits for women that did not need any further assessment. METHODS: Satisfaction was measured through a standardized questionnaire administered to a random sample of 1,600 pregnant women and another to all antenatal care providers. RESULTS: Most women in both arms expressed satisfaction with ANC. More women in the intervention arm were satisfied with information on labor, delivery, family planning, pregnancy complications and emergency procedures. More providers in the experimental clinics were worried about visit spacing, but more satisfied with the time spent and information provided. CONCLUSIONS: Women and providers accepted the new ANC model generally. The safety of fewer visits for women without complications with longer spacing would have to be reinforced, if such a model is to be introduced into routine practice.

8.
BMC Public Health ; 3: 17, 2003 May 20.
Artigo em Inglês | MEDLINE | ID: mdl-12756055

RESUMO

BACKGROUND: The results of a qualitative study carried out in four developing countries (Cuba, Thailand, Saudi Arabia and Argentina) are presented. The study was conducted in the context of a randomised controlled trial to test the benefits of a new antenatal care protocol that reduced the number of visits to the doctor, rationalised the application of technology, and improved the provision of information to women in relation to the traditional protocol applied in each country. METHODS: Through focus groups discussions we were able to assess the concepts and expectations underlying women's evaluation of concepts and experiences of the care received in antenatal care clinics. 164 women participated in 24 focus groups discussion in all countries. RESULTS: Three areas are particularly addressed in this paper: a) concepts about pregnancy and health care, b) experience with health services and health providers, and c) opinions about the modified Antenatal Care (ANC) programme. In all three topics similarities were identified as well as particular opinions related to country specific social and cultural values. In general women have a positive view of the new ANC protocol, particularly regarding the information they receive. However, controversial issues emerged such as the reduction in the number of visits, particularly in Cuba where women are used to have 18 ANC visits in one pregnancy period. CONCLUSION: Recommendations to improve ANC services performance are being proposed. Any country interested in the application of a new ANC protocol should regard the opinion and acceptability of women towards changes.


Assuntos
Atitude Frente a Saúde/etnologia , Cuidado Pré-Natal/normas , Mulheres/psicologia , Adulto , Argentina , Cuba , Cultura , Países em Desenvolvimento , Feminino , Grupos Focais , Humanos , Ocupações/classificação , Visita a Consultório Médico , Educação de Pacientes como Assunto , Relações Médico-Paciente , Guias de Prática Clínica como Assunto , Cuidado Pré-Natal/organização & administração , Cuidado Pré-Natal/estatística & dados numéricos , Arábia Saudita , Valores Sociais , Tailândia
9.
Midwifery ; 20(3): 251-60, 2004 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-15337281

RESUMO

OBJECTIVE: to explore how women experience breast-feeding difficulties. This theme emerged unexpectedly during a study of women's experiences of screening with the Edinburgh postnatal depression scale (EPDS) and subsequent care from primary health-care professionals. DESIGN: qualitative in-depth interview study. SETTING: postnatal women of 22 general practices within Oxford City Primary Care Group area. PARTICIPANTS: 39 postnatal women from a purposeful sample were interviewed at an average of 15 months postnatal. They were chosen from different general practices and with a range of emotional difficulties after birth, judged using EPDS results at eight weeks and eight months postnatal, and whether they received 'listening visits' from health visitors. MEASUREMENTS AND FINDINGS: a qualitative thematic analysis was used, including searches for anticipated and emergent themes. Fifteen women had breast-feeding difficulties. Five themes emerged which explore the difficulties. Firstly, commitment to breast feeding and high expectations of success; secondly, unexpected difficulties; thirdly, seeking professional support for difficulties; fourthly, finding a way to cope; and fifthly, guilt. KEY CONCLUSIONS: in this study breast-feeding difficulties were common, caused emotional distress and interactions with professionals could be difficult. Current breast-feeding policy, such as the 'Baby Friendly Initiative', may be a contributing factor. This needs to be explored in a further study.


Assuntos
Aleitamento Materno , Aleitamento Materno/psicologia , Depressão Pós-Parto/psicologia , Tocologia/normas , Mães/psicologia , Papel do Profissional de Enfermagem , Estresse Psicológico/enfermagem , Adulto , Aleitamento Materno/efeitos adversos , Inglaterra , Feminino , Humanos , Recém-Nascido , Relações Mãe-Filho , Relações Enfermeiro-Paciente , Pesquisa Metodológica em Enfermagem , Cuidado Pós-Natal/métodos , Gravidez , Estresse Psicológico/etiologia , Inquéritos e Questionários
10.
Midwifery ; 18(1): 21-4, 2002 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-11945049

RESUMO

OBJECTIVES: to investigate women's experiences of problems with vaginal loss from 28 days to three months postnatally and to describe the treatment and referral patterns for women who consult their GP about such problems during the first three months postnatally. DESIGN: a longitudinal questionnaire study of consecutively delivered postnatal women and a report-card survey of GP consultations by women with problems with postnatal vaginal loss. SETTING: two health districts in the south of England. PARTICIPANTS: women delivering in the two health districts during specified recruitment periods in 1995 and 1996. For the GP study, with her consent, the GP returned an anonymous registration card for each woman presenting. FINDINGS: in the survey of women, 20% (64/325) reported problems with postnatal loss occurring between 28 days and three months after the birth. Around a half of these consulted a GP. The GP study was disappointing in that only 26% (30/115) of practices agreed to take part and 16% (18/115) returned notification cards. Forty-eight women were included from 18 practices. The most common presenting symptoms were excessive bleeding (29/48; 60%) and prolonged bleeding (26/48; 54%). The commonest form of treatment was antibiotics alone (15/48; 31%) but 12 women (25%) were neither treated nor referred. Referral (n=19) was for hospital admission, out-patient appointment or direct referral for an ultrasound scan. KEY CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: morbidity related to abnormalities of postnatal vaginal fluid loss (lochia) has been shown to be significant, yet nothing was known about the outcome of related GP consultations during the first three months postnatally. A variety of treatment and referral patterns were revealed, highlighting the need for a systematic review of the literature on the management of secondary postpartum haemorrhage. Health care workers need to be aware of the significant morbidity experienced by postnatal women in relation to their lochial loss.


Assuntos
Cuidado Pós-Natal/normas , Hemorragia Pós-Parto/diagnóstico , Hemorragia Pós-Parto/terapia , Adolescente , Adulto , Inglaterra , Medicina de Família e Comunidade/normas , Feminino , Humanos , Estudos Longitudinais , Padrões de Prática Médica , Qualidade da Assistência à Saúde , Encaminhamento e Consulta , Inquéritos e Questionários , Fatores de Tempo
11.
Med. interna Méx ; 33(1): 99-108, ene.-feb. 2017. graf
Artigo em Espanhol | LILACS | ID: biblio-894238

RESUMO

Resumen La fiebre es consecuencia de una respuesta inflamatoria sistémica que puede ser provocada por numerosos estímulos y puede ser un arma de doble filo, debido a que puede tener efectos benéficos, como mejorar la respuesta inmunológica y suprimir el crecimiento bacteriano, pero también tiene efectos dañinos, como aumento de incluso seis veces la tasa metabólica, provocar hiperdinamia, que en pacientes cardiópatas es poco tolerada, e incluso, incrementa el daño pulmonar mediado por citocinas. Por ello, surgen diversas interrogantes acerca de cómo y cuándo debe controlarse la fiebre en el paciente séptico; sin embargo, la evidencia actual es limitada, aunque puede concluirse que el control térmico debe realizarse con temperaturas mayores de 38.5oC con medios físicos y en caso de que no ceda, se sugiere administrar antipiréticos.


Abstract Fever is the result of a systemic inflammatory response that can be triggered by numerous stimuli, which can be a double-edged sword, because it can have beneficial effects, such as improved immune response and suppress bacterial growth, but also harmful effects, such as up to six times higher metabolic rate, causing hyperdynamia that in cardiac patients is poorly tolerated and even increases lung damage mediated by cytokines. Therefore several questions arise about how and when to control fever in septic patient; however, current evidence is limited, but it can be concluded that the thermal control must be performed with temperatures above 38.5oC with physical means and if not, give antipyretics is suggested.

12.
Sociol Health Illn ; 29(7): 1003-22, 2007 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-18092980

RESUMO

This paper explores the special nature of bereavement in the case of first trimester miscarriage. It is theoretically informed by the sociological literature concerning death and bereavement and is empirically grounded in interviews with 79 women. We argue that the 'scientisation of death' in modern societies contributes to the uncertainty and isolation which distinguish early miscarriage as a unique form of loss. In the absence of clear cultural scripts to draw upon, many women interviewed gave meaning to their loss as 'what might have been' or what we call 'the loss of possibility'. Some women juxtaposed the failure of their pregnancy with that of modern medicine either to prevent the loss or provide a credible explanation for their miscarriage. Little research has been conducted in this area, since the pioneering work of Lovell (1983) and Cecil (1984). Our research draws on one of the largest and most systematic bodies of data ever collected on early miscarriage, and provides continued evidence of the traumas of miscarriage. The strategies employed by women to make sense of, and come to terms with, their experience of miscarriage are explored, employing a typology of pre-modern, modern and postmodern responses.


Assuntos
Aborto Espontâneo/psicologia , Luto , Morte Fetal , Ciência , Feminino , Humanos , Gravidez , Primeiro Trimestre da Gravidez , Pesquisa Qualitativa , Sociologia Médica
13.
Trials ; 8: 37, 2007 Nov 20.
Artigo em Inglês | MEDLINE | ID: mdl-18028537

RESUMO

BACKGROUND: Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. METHODS: Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. RESULTS: The case study demonstrates that trials need various categories of people to buy in - hence, to be successful, trialists must embrace marketing strategies to some extent. CONCLUSION: The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

14.
Paediatr Perinat Epidemiol ; 20(5): 392-402, 2006 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-16911017

RESUMO

A population case-control study was used to determine risk factors for excessive and/or prolonged vaginal bleeding (described collectively as vaginal loss problems) and uterine infection from 24 h to 3 months postpartum. Data were obtained from women whose maternity care took place in one of two health districts in the south of England. The cases were women remaining in or admitted to hospital with excessive or prolonged vaginal blood loss from 24 h to 3 months postpartum. Two controls for each case were identified; these were women whose delivery was the nearest in time and in the same location as the case delivery. Medical and midwifery records were searched retrospectively to cover hospital admissions for vaginal blood loss problems or uterine infection in postpartum women from 1 January 1994 to 31 December 1995. Data were analysed for 243 cases and 486 controls. Univariable analysis identified 28 variables associated with being a case. Using multivariable analysis, nine factors remained in the final model, with a history of secondary postpartum haemorrhage (PPH) being the most strongly predictive (OR [95% confidence interval] 6.0 [2.1, 16.8]). Vaginal bleeding prior to 24 weeks' gestation (OR 3.0 [1.6, 5.9]), third trimester hospital admission (OR 2.0 [1.4, 2.8]), maternal smoking (OR 2.7 [1.8, 3.9]), a prolonged (OR 3.1 [1.2, 7.5]) or incomplete third stage (OR 2.1 [1.0, 4.4]), and primary PPH (OR 4.7 [1.9, 11.6]) for blood loss >500 mL, were predictive of becoming a case. No significant association was identified for parity (OR 1.1 [0.8, 1.5]) or method of delivery, spontaneous (OR 1.0 [0.7, 1.3]), instrumental (OR 1.4 [0.9, 2.2]) or operative (OR 1.2 [0.8, 1.9]). This is a neglected area of women's health after childbirth, and the value of this study is in the identification of potential risk factors for postpartum morbidity related to vaginal blood loss. Where morbidity occurs, early diagnosis, management and treatment are likely to reduce its extent or duration. It is considered that raising awareness about these factors, both among healthcare professionals and women themselves, may play an important part in the recognition and treatment of postpartum morbidity.


Assuntos
Hospitalização , Hemorragia Pós-Parto/etiologia , Adolescente , Adulto , Aleitamento Materno , Estudos de Casos e Controles , Parto Obstétrico , Feminino , Humanos , Recém-Nascido de Baixo Peso , Recém-Nascido , Recém-Nascido Prematuro , Complicações do Trabalho de Parto , Paridade , Gravidez , Fatores de Risco , Fumar/efeitos adversos , Fatores de Tempo
15.
Trials ; 7: 34, 2006 Dec 21.
Artigo em Inglês | MEDLINE | ID: mdl-17184521

RESUMO

BACKGROUND: Securing and managing finances for multicentre randomised controlled trials is a highly complex activity which is rarely considered in the research literature. This paper describes the process of financial negotiation and the impact of financial considerations in four UK multicentre trials. These trials had met, or were on schedule to meet, recruitment targets agreed with their public-sector funders. The trials were considered within a larger study examining factors which might be associated with trial recruitment (STEPS). METHODS: In-depth semi-structured telephone interviews were conducted in 2003-04 with 45 individuals with various responsibilities to one of the four trials. Interviewees were recruited through purposive and then snowball sampling. Interview transcripts were analysed with the assistance of the qualitative package Atlas-ti. RESULTS: The data suggest that the UK system of dividing funds into research, treatment and NHS support costs brought the trial teams into complicated negotiations with multiple funders. The divisions were somewhat malleable and the funding system was used differently in each trial. The fact that all funders had the potential to influence and shape the trials considered here was an important issue as the perspectives of applicants and funders could diverge. The extent and range of industry involvement in non-industry-led trials was striking. Three broad periods of financial work (foundation, maintenance, and resourcing completion) were identified. From development to completion of a trial, the trialists had to be resourceful and flexible, adapting to changing internal and external circumstances. In each period, trialists and collaborators could face changing costs and challenges. Each trial extended the recruitment period; three required funding extensions from MRC or HTA. CONCLUSION: This study highlights complex financial aspects of planning and conducting trials, especially where multiple funders are involved. Recognition of the importance of financial stability and of the need for appropriate training in this area should be paralleled by further similar research with a broader range of trials, aimed at understanding and facilitating the conduct of clinical research.

16.
Trials ; 7: 9, 2006 Apr 07.
Artigo em Inglês | MEDLINE | ID: mdl-16603070

RESUMO

BACKGROUND: A commonly reported problem with the conduct of multicentre randomised controlled trials (RCTs) is that recruitment is often slower or more difficult than expected, with many trials failing to reach their planned sample size within the timescale and funding originally envisaged. The aim of this study was to explore factors that may have been associated with good and poor recruitment in a cohort of multicentre trials funded by two public bodies: the UK Medical Research Council (MRC) and the Health Technology Assessment (HTA) Programme. METHODS: The cohort of trials was identified from the administrative databases held by the two funding bodies. 114 trials that recruited participants between 1994 and 2002 met the inclusion criteria. The full scientific applications and subsequent trial reports submitted by the trial teams to the funders provided the principal data sources. Associations between trial characteristics and recruitment success were tested using the Chi-squared test, or Fisher's exact test where appropriate. RESULTS: Less than a third (31%) of the trials achieved their original recruitment target and half (53%) were awarded an extension. The proportion achieving targets did not appear to improve over time. The overall start to recruitment was delayed in 47 (41%) trials and early recruitment problems were identified in 77 (63%) trials. The inter-relationship between trial features and recruitment success was complex. A variety of strategies were employed to try to increase recruitment, but their success could not be assessed. CONCLUSION: Recruitment problems are complex and challenging. Many of the trials in the cohort experienced recruitment difficulties. Trials often required extended recruitment periods (sometimes supported by additional funds). While this is of continuing concern, success in addressing the trial question may be more important than recruitment alone.

17.
Clin Trials ; 1(2): 170-8, 2004.
Artigo em Inglês | MEDLINE | ID: mdl-16281889

RESUMO

BACKGROUND: It is considered to be a fundamental ethical premise of human experimentation, that it should be carried out only where the effects of an intervention are unclear. The point at which it is considered that there is insufficient scientific and medical evidence to clearly state the superiority of an intervention has been termed equipoise. This concept has been the subject of much recent impassioned debate but little empirical research about the views of people involved in recruitment to randomized controlled trials (RCTs), and none in the particularly emotive area of neonatal intensive care. METHODS: Thirty neonatologists recruiting into one or both of two neonatal RCTs in five centres in England were interviewed using a semi-structured schedule to explore their involvement in randomised trials. The interviews were tape-recorded and transcribed. Equipoise was one among a range of topics covered. Concepts relating to equipoise were identified by close reading of the entire interviews. Themes emerging from the data were noted in their contexts then discussed between the co-authors. Interviewees also completed a brief questionnaire about their demographic background, and their experience of research and RCTs. RESULTS: Almost all the neonatologists used the concept of equipoise [using words and phrases such as uncertainty, lack of knowledge (or ignorance), strengths of views, and balancing of pros and cons] in their interview and, for most of them, equipoise seemed to be a useful term. They explored ideas about equipoise at the individual and community levels, and some linked equipoise with notions of the responsibility that should be exercised by the scientific and professional communities. They differed in the importance they gave to individual equipoise, and in how they reacted to threats to equipoise. Feelings of doubt about a trial and disturbed equipoise were more often expressed by more junior doctors. CONCLUSIONS: Our findings suggest that the concept of equipoise goes beyond the idea of uncertainty. In part this is because it includes the balancing of benefit and harm; this balancing is part of a professional obligation and requires engagement with 'expert' knowledge. Equipoise could therefore be seen as 'active' or 'responsible' uncertainty. Elucidation of this difficult concept may help to facilitate recruitment for both clinicians and parents in future trials and thereby help to find answers to important clinical questions.


Assuntos
Atitude do Pessoal de Saúde , Neonatologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Incerteza , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Seleção de Pacientes , Papel do Médico , Medição de Risco , Resultado do Tratamento
18.
J Public Health Med ; 25(2): 113-9, 2003 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-12848399

RESUMO

BACKGROUND: Evidence from outside the United Kingdom points to several socio-demographic factors associated with late initiation of antenatal care or fewer antenatal visits, but it is not clear how generalizable these studies are to the UK context. This systematic review addresses the question of whether there are social or ethnic inequalities in attendance for antenatal care in the United Kingdom. METHODS: We identified and reviewed UK studies assessing attendance for antenatal care according to any measure of social class, social deprivation or ethnicity. A wide range of electronic databases was searched for published and unpublished studies. Further studies were identified from reference lists, citation searches and key organizations. RESULTS: From over 1300 identified papers, 20 were potentially relevant. Nine were included in the review. Most studies were of poor quality, with only one study controlling for the effect of potential confounders such as age, parity and clinical risk factors. All but one were based on data collected around 20 years ago. Three of the five studies looking at antenatal attendance and social class found that women from manual classes were more likely to book late for antenatal care and/or make fewer antenatal visits than other women. All four studies reporting on antenatal attendance and ethnicity found that women of Asian origin were more likely to book late for antenatal care than white British women. CONCLUSIONS: There is little good quality evidence on social and ethnic inequalities in attendance for antenatal care in the United Kingdom. Recommendations for further research are suggested.


Assuntos
Aceitação pelo Paciente de Cuidados de Saúde/etnologia , Cuidado Pré-Natal/estatística & dados numéricos , Classe Social , Feminino , Humanos , Gravidez , Gestantes/etnologia , Reino Unido
19.
BJOG ; 109(1): 44-56, 2002 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-11843373

RESUMO

OBJECTIVE: To review systematically and critically evidence to derive estimates of costs and cost effectiveness of routine ultrasound screening for fetal abnormalities. DESIGN: A systematic review of the literature using explicit criteria for inclusion of primary research studies, a stated electronic strategy to identify relevant material, and an explanation of why apparently relevant studies have not been included. SETTING: All countries of origin were included. The results of this review are important to obstetricians and to health service managers in the allocation of resources, and others who are considering conducting further research in this area. MAIN OUTCOME MEASURE: Formal economic evaluations and cost studies of routine ultrasound screening. Costs of routine anomaly scans and costs of other procedures carried out as part of antenatal screening by ultrasound. RESULTS: One hundred and ninety-nine studies were identified in total, 24 reaching the final stage of the review. Nine studies were formal economic evaluations and 15 reported costs studies or clinical effectiveness studies with some assessment of cost. The studies were carried out mainly in Europe and in the United States. After quality criteria were applied, data were extracted from six of the economic evaluations and six of the costs studies. One economic evaluation conducted alongside a randomised trial concluded that screening for fetal abnormalities by ultrasound in the second trimester was cost effective, compared with routine antenatal care. The costs of routine scans ranged from Pound Sterling 18 to Pound Sterling 204 and for non-routine ranged from Pound Sterling 32 to Pound Sterling 113. CONCLUSIONS: There is a lack of good quality primary studies of the costs of ultrasound screening in pregnancy. Typically, economic evaluations of ultrasound screening have been based on poor quality evidence of clinical effectiveness. There is a need for more published data on the costs and cost effectiveness of routine ultrasound screening for fetal anomalies, and of the longer term consequences of screening for anomalies.


Assuntos
Anormalidades Congênitas/diagnóstico por imagem , Ultrassonografia Pré-Natal/economia , Anormalidades Congênitas/economia , Análise Custo-Benefício , Custos e Análise de Custo , Feminino , Humanos , Programas de Rastreamento/economia , Programas de Rastreamento/métodos , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto
20.
Health Expect ; 5(1): 63-83, 2002 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-11906542

RESUMO

OBJECTIVE: To review trials of the effectiveness of interventions aimed at improving communication between health professionals and women in maternity care. SEARCH STRATEGY: The electronic databases Medline, PsycLit, The Cochrane Library, BIDS Science and Social Science Indexes, Cinahl and Embase were searched. Final searches were carried out in April 2000. INCLUSION CRITERIA: Controlled trials of interventions explicitly aimed at improving communication between health professionals and women in maternity care were included. Other trials were included where two reviewers agreed that this was at least part of the aim. DATA EXTRACTION AND SYNTHESIS: 95 potentially eligible papers were identified, read by one reviewer and checked against the inclusion criteria. The 11 included trials were read, assessed for quality and summarized in a structured tabular form. RESULTS: The included trials evaluated interventions to improve the presentation of information about antenatal testing, to promote informed choice in maternity care, woman-held maternity records and computer-based history taking. Four trials in which women were provided with extra information about antenatal testing in a variety of formats suggested that this was valued by women and may reduce anxiety. Communication skills training for midwives and doctors improved their information giving about antenatal tests. The three trials of woman-held maternity records suggested that these increase women's involvement in and control over their care. CONCLUSIONS: The trials identified by this review addressed limited aspects of communication and focused solely on antenatal care. Further research is required in several areas, including trials of communication skills training for health professionals in maternity care and other interventions to improve communication during labour and in the postnatal period.


Assuntos
Comunicação , Serviços de Saúde Materna/normas , Relações Profissional-Paciente , Ensaios Clínicos Controlados como Assunto , Feminino , Pesquisa sobre Serviços de Saúde , Humanos , Serviços de Saúde Materna/organização & administração , Gravidez , Reino Unido
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