Jo Garcia

Making sense of randomization; responses of parents of critically ill babies to random allocation of treatment in a clinical trial

Randomized controlled trials (RCTs) are widely accepted by the scientific community as the most rigorous way of evaluating interventions in health care. Although their central feature, random allocation of treatment, is generally seen as methodologically appropriate, its application has caused much debate amongst health professionals and ethicists. This paper describes the views of parents who consented that their critically ill newborn baby should be enrolled in a neonatal trial. In-depth interviews were used to determine their response to the trial and randomization. The nature of the trial was often poorly understood. The random basis of the allocation of treatment and the rationale behind this approach were also problematic issues. Some parents did not perceive a random element in the process at all. These findings advance understanding of the perceptions of trial participants and raise important issues for those concerned with RCTs. Greater understanding of participants views provides the potential to improve the management of future trials and so the experience of those agreeing to take part.

Zelen randomization: attitudes of parents participating in a neonatal clinical trial.

Recruitment to randomized controlled trials can be difficult for all parties involved. An alternative to the standard process has been suggested for trials in which the control group receives standard treatment or nontreatment. In this approach (the Zelen design), randomization precedes consent, which is only sought from those allocated to the experimental arm of a trial. The control group is thus unaware that randomization has taken place. As a controversial method, this approach has been often suggested but rarely used. Here we describe how 44 parents recruited to a difficult neonatal trial that used conventional randomization reacted to the idea of Zelen randomization. The arguments they gave for and against the method pertain to four areas: the giving or withholding of information, the effect on decision making, the use of data without parental knowledge, and the long-term impact for parents. The parents were evenly divided in accepting or rejecting the method. Further analysis showed that those rejecting Zelen randomization were more likely to be parents of infants allocated to the control group. This suggests that those from whom consent would not be sought, the group that this approach is primarily meant to protect, are most likely to find it unacceptable.

Womens' opinions on antenatal care in developing countries: results of a study in Cuba, Thailand, Saudi Arabia and Argentina.

BackgroundThe 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.MethodsThrough focus groups discussions we were able to assess the concepts and expectations underlying womens evaluation of concepts and experiences of the care received in antenatal care clinics. 164 women participated in 24 focus groups discussion in all countries.ResultsThree 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.ConclusionRecommendations 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.

Are women and providers satisfied with antenatal care? Views on a standard and a simplified, evidence-based model of care in four developing countries

BackgroundThis 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.MethodsSatisfaction was measured through a standardized questionnaire administered to a random sample of 1,600 pregnant women and another to all antenatal care providers.ResultsMost 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.ConclusionsWomen 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.

Antenatal ultrasound screening for fetal abnormalities: a systematic review of studies of cost and cost effectiveness.

Objective To review systematically and critically evidence to derive estimates of costs and cost effectiveness of routine ultrasound screening for fetal abnormalities.

Future Research on Work in Pregnancy

In this chapter we shall review studies which deal with the association between paid employment and pregnancy outcome and end by proposing lines for further research. Although we do not deal with specific work place hazards, we shall mention particular aspects of work which seem to be associated with pregnancy outcomes.

The need to talk after birth: evaluating new services

There has been a growing interest in providing women with the opportunity to discuss their birth experience, and many new initiatives have been set up to address this. In part, this is the result of an awareness that some women continue to have unresolved emotional distress linked to the birth. In addition, there is an increased appreciation that it is the woman’s perception of the labour and birth, rather than how the birth is assessed by care-givers, that is of importance (Crompton 1996a, 1996b). In this chapter, we explore how these themes are related, considering the material under three headings: n n nWomen’s varied needs for information and discussion about birth events; n n nThe current range of services being offered; n n nThe need for evaluation of what is being offered. n n n nFigure 2.1 is intended to illustrate the linked topics that underpin this complex area.

Routine clinical care in the immediate postnatal period

This chapter aims to look at the clinical components of the care given by midwives to postnatal women. The postnatal daily examination requires the midwife to observe and record the state of health and recovery of the postnatal mother. The form this examination takes has become a routine midwifery procedure described in standard textbooks. There has been little, if any, evaluation of the value that this form of care has for the majority of women.