Are birth kits a good idea? A systematic review of the evidence.

OBJECTIVE: to identify the current state of knowledge regarding the effects of births kits on clean birth practices and on newborn and maternal outcomes. DESIGN: the scoping review was informed through a systematic literature review; a call for information distributed to experts in maternal and child health, relevant research centres and specialist libraries; and a search of the web sites of groups working in the area of maternal and child health. Data were synthesised to produce a summary of the state of knowledge regarding birth kits. Meta-analysis was not attempted because of the varied study designs and the heterogeneous nature of the interventions. PARTICIPANTS: births kit use was identified in 51 low resource countries, but evaluations were scarce, with only nine studies reporting effects of intervention packages including births kits. FINDINGS: the quality of evidence for inferring causality was weak, with only one randomised controlled trial. In two studies, births kit use along with co-interventions resulted in a statistically significant increase in the likelihood of the attendant having clean hands. The impact on other aspects of cleanliness was less clear. Intervention packages which include births kits were associated with reduced newborn mortality (three studies), omphalitis (four studies), and puerperal sepsis (three studies). The one study that considered maternal mortality was not large enough to estimate relative reduction with much precision. None of the studies reported any adverse effects; however, none explicitly described looking for negative consequences. CONCLUSION: providing birth kits to facilitate clean practices seems commonsense, but there is no evidence to indicate effects, positive or negative, separate from those achieved by a broader intervention package. More robust methods and knowledge systems are needed to understand the contextual factors and share relevant implementation lessons.

Lessons regarding the use of birth kits in low resource countries.

OBJECTIVE: To synthesise implementation lessons regarding birth kits in terms of the context, the user, requirements for use and the logistics of supplying kits. DESIGN: The scoping review was informed through a systematic literature review; a call for information distributed to experts in maternal and child health, relevant research centres and specialist libraries; a search of the web sites of groups working in the area of maternal and child health; and data extraction from DHS surveys. Data synthesis involved the production of a simple descriptive summary of the state of knowledge regarding birth kits. PARTICIPANTS: The 28 articles included in the review described a total of 21 birth kits used in 40 different countries and in many cases the kits were part of a package of interventions. FINDINGS: Although birth kits are available in more than 50 low resource countries, evidence regarding implementation is limited. Levels of birth kit use vary considerably (8-99%); with higher levels being reported where birth kits are distributed free as part of a research programme. Identifying the user of the birth kit was difficult in most reports and the evidence regarding training requirements for birth kit use was conflicting. Limited information exists regarding facilitators and barriers to birth kit use, and how birth kits fit within the wider service delivery of maternal and child health. CONCLUSION: Despite widespread use of birth kits, implementation lessons are hard to identify. The fact that birth kits are predominantly used in non-facility settings, and probably by non-skilled attendants, poses further challenges in synthesising the evidence. It would seem logical that government run programmes would increase utlisation rates; however in these countries national level data are not yet available. Such data are crucial to identifying how women obtain and use birth kits. The importance of context cannot be over emphasised, and better descriptive methods are needed to capture contextual factors that may impact on the implementation process. IMPLICATIONS FOR PRACTICE: Birth kits are a promising technology to achieve MDG 5, however further research is needed before making recommendations to scale up mother held birth kits or to expand kit contents.

An option for measuring maternal mortality in developing countries: a survey using community informants.

BACKGROUND: The maternal mortality ratio (MMR) remains high in most developing countries. Local, recent estimates of MMR are needed to motivate policymakers and evaluate interventions. But, estimating MMR, in the absence of vital registration systems, is difficult. This paper describes an efficient approach using village informant networks to capture maternal death cases (Maternal Deaths from Informants/Maternal Death Follow on Review or MADE-IN/MADE-FOR) developed to address this gap, and examines its validity and efficiency. METHODS: MADE-IN used two village informant networks - heads of neighbourhood units (RTs) and health volunteers (Kaders). Informants were invited to attend separate network meetings - through the village head (for the RT) and through health centre for the kaders. Attached to the letter was a form with written instructions requesting informants list deaths of women of reproductive age (WRA) in the village during the previous two years. At a 'listing meeting' the informants' understanding on the form was checked, informants could correct their forms, and then collectively agreed a consolidated list. MADE-FOR consisted of visits relatives of likely pregnancy related deaths (PRDs) identified from MADE-IN, to confirm the PRD status and gather information about the cause of death. Capture-recapture (CRC) analysis enabled estimation of coverage rates of the two networks, and of total PRDs. RESULTS: The RT network identified a higher proportion of PRDs than the kaders (estimated 0.85 vs. 0.71), but the latter was easier and cheaper to access. Assigned PRD status amongst identified WRA deaths was more accurate for the kader network, and seemingly for more recent deaths, and for deaths from rural areas. Assuming information on live births from an existing source to calculate the MMR, MADE-IN/MADE-FOR cost only $0.1 (US) per women-year risk of exposure, substantially cheaper than alternatives. CONCLUSIONS: This study shows that reliable local, recent estimates of MMR can be obtained relatively cheaply using two independent informant networks to identify cases. Neither network captured all PRDs, but capture-recapture analysis allowed self-calibration. However, it requires careful avoidance of false-positives, and matching of cases identified by both networks, which was achieved by the home visit.

Sample-size calculations for trials that inform individual treatment decisions: a 'true-choice' approach.

BACKGROUND: Sample size decisions for clinical trials should be taken in such a way as to maximize informed choice by reducing scientific uncertainty about the consequences of an intervention. PURPOSE: Recent approaches to trial design have focused on the potential decision impact of the trial when deciding whether the trial should be undertaken, and how large it ought to be. For the most part these approaches are concerned with the impact of trials either on clinical opinion or on collective reimbursement recommendations. Our purpose is to model the contribution of clinical trials to patient-level decision-making and to propose a way of assessing this contribution at the design stage. METHODS: The model is developed within the framework of Bayesian decision theory. It is presumed that some patients make choices that they would not have made in the presence of perfect information about the likely consequences. These 'false' choices would be reversed in response to a fully informative (ie, very large) trial of the competing interventions. By contrast, choices that would not change in response to a fully informative trial are termed 'true' choices since they accurately reflect patient preferences. RESULTS: An impact plot is proposed which maps how the expected numbers of 'true' and 'false' choices change in response to a trial of any given size. The approach is illustrated with reference to the choice of delivery mode for term breech presentation, using data obtained before the recent term breech trial. Applications in other contexts are indicated. LIMITATIONS: No account is taken of the magnitude of expressed patient preferences for one treatment over another. The upside is that the need for detailed utility-elicitation is obviated. CONCLUSIONS: The approach is a pragmatic aid to trial design in settings where patient preference drives the choice between alternative treatments.

Cost-utility analysis when not everyone wants the treatment: modeling split-choice bias.

Not all clinically eligible patients will necessarily accept a new treatment. Cost-utility analysis recognizes this by multiplying the mean incremental expected utility (EU) by the participation rate to obtain the utility gain per head. However, the mean EU gain over all patients in a defined clinical category is traditionally used as a proxy for the mean EU gain over the subpopulation of acceptors. Even for clinically identical patients, this may lead to a biased assessment of total benefit because a patient motivated to accept the new treatment is likely to value its effects more favorably than a patient who declines. An analysis that ignores this tendency will be biased toward an underestimate of true benefits of a health technology (HT). The extent of this bias is described within a quality-adjusted life year-based utility model for a population of clinically indistinguishable patients who differ with respect to the values that they place on the possible health outcomes of an HT. The size of the bias is sensitive to the proportion of patients who accept the treatment, under both deterministic and probabilistic models of individual decision making. In all cases in which decision making is correlated with personal utility gain, the bias rises steeply as the proportion of acceptors declines.

Survey of Australasian clinicians' prior beliefs concerning lipiodol flushing as a treatment for infertility: a Bayesian study.

OBJECTIVE: To evaluate clinicians' beliefs concerning the effectiveness of lipiodol flushing as a treatment for unexplained infertility, and to integrate these prior beliefs with evidence from randomised trials. DESIGN: Survey. SETTING: Specialists in Australasian in vitro fertilisation (IVF) clinics in 2001. METHODS: One of two types of structured survey was used to gather information from fertility specialists in Australasian IVF clinics. Prior beliefs were captured graphically and textually from responses. RESULTS: Nineteen specialists returned questionnaires. Eighteen of the 19 specialists believed that lipiodol flushing was more likely to be beneficial than harmful. The most widely held prior belief, reflected in both textual and numerical responses, was that lipiodol was likely to produce a small beneficial response. The credible limits of this belief were compatible with a reasonable fertility benefit, as more than 50% believed that a 1.5-fold increase in pregnancy rate was plausible. The two surveys found that a 1.2-fold or 1.4-fold increase in pregnancy rate was the median expected level of benefit at which clinicians would have been inclined to recommend lipiodol flushing to their patients (combined range 1.1- to 2.3-fold) - new evidence suggests that for women with endometriosis but otherwise unexplained infertility, these levels of benefit are exceeded. CONCLUSIONS: Among Australasian fertility specialists there is variation in prior beliefs concerning the effectiveness of lipiodol flushing as a treatment for unexplained infertility and in the expected level of benefit at which clinicians are inclined to recommend this treatment. Generalisability of these beliefs remains uncertain owing to a low study response rate.

The ethics of placebo-controlled trials: a comparison of inert and active placebo controls.

Because of the recent and controversial example of sham surgery for the evaluation of fetal tissue transplants for Parkinson's disease, there is renewed interest in the ethics of using "active" placebos in surgical trials, where otherwise there are no inert procedures available, and in pharmacological trials, where there are inert substances, but where patients may guess to which arm they have been allocated. This paper seeks to clarify the ethical arguments surrounding the use of active placebos in trials, and to set up a notation for assessing the ethics of trials more generally. We first establish an framework by which ethics committees can analyze such trials. We examine (1) the scientific value of the research; (2) the expected risks and benefits to individual patients, and (3) the voluntary nature of consent. We then contrast the implications of this framework for inert and active placebo-controlled trials, respectively. In particular, we analyze their relative expected utility using three main utility factors, namely, treatment effects, placebo effects, and altruism. We conclude that, when the intervention is already widely available, active placebo trials rely more heavily on altruism than do inert placebo trials and, when the intervention is restricted, this excess reliance may not be needed. What our analysis provides is the explicit justification for the apparent caution of Institutional Review Boards or ethics committees when reviewing sham operations, especially when the expected harm is not trivial and the risk of exploitation is high.

Measurement of beliefs about effectiveness of laparoscopic uterosacral nerve ablation.

To explore gynaecologists' 'prior' beliefs on effectiveness of laparoscopic uterosacral nerve ablation (LUNA), a structured survey was used to gather information on the distribution of their prior beliefs regarding the effects of LUNA on pelvic pain, both numerically [on a 10-point visual analogue scale] and by responses to a questionnaire. None of the 25 gynaecologists responding to the questionnaire stated that LUNA would increase pain, while two of the 25 gave numerical answers suggesting they believed that the intervention would worsen the pain. The most widely held 'prior belief', reflected in both questionnaire and numerical responses, was that LUNA would have a small beneficial effect on pain.

The impact of describing clinical trial treatments as new or standard.

Concern has been expressed over a possible widespread belief amongst patients in trials, that a new treatment is better than the standard, despite the lack of evidence of such superiority. A sample of the general public (N = 130) read a leaflet describing a hypothetical trial comparing two similar treatments for either arthritis or back-pain. Half read that both treatments were standard and generally available; half that one was new and available only within the trial. Participants rated any preference for one or the other treatment, gave written reasons, and indicated their willingness to enter the randomized trial. Fifteen participants subsequently talked through their answers. Most participants expressed no preference for either treatment when both were described as standard. When one was new more people with the arthritis (but not the back-pain) scenario expressed a preference (chi2 = 5.44, P = 0.031). Importantly, this was not more likely to be for the new treatment. Rationally, those who preferred a freely available treatment were less likely to participate in the trial (chi2 = 23.3, P < 0.001). The mere description of a trial treatment as new was insufficient to engender a preference for it over a standard treatment, although it may contribute to preference under certain additional circumstances.

Lay conceptions of the ethical and scientific justifications for random allocation in clinical trials.

Randomised controlled trials (RCTs) play a central role in modern medical advance, and they require participants who understand and accept the procedures involved. Published evidence suggests that RCT participants often fail to understand that treatments are allocated at random and that clinicians are in equipoise about which treatment is best. We examine background assumptions that members of the public might draw upon if invited to take part in a RCT. Four studies (N=82; 67; 67; 128), in the UK, identified whether members of the public (i). accept that an individual clinician might be genuinely unsure which of two treatments was better; (ii). judge that when there is uncertainty it is acceptable to suggest deciding at random; (iii). recognise scientific benefits of random allocation to treatment conditions in a trial. Around half the participants were loathe to accept that a clinician could be completely uncertain, and this was no different whether the context was one of individual treatment or research. Most participants found it unacceptable to suggest allocating treatment at random, though there was weak evidence that a research context may reduce the unacceptability. Participants did not judge that more certain knowledge would be gained about which treatment was best when treatments were allocated at random rather than by patient/doctor choice: scientific benefits of randomisation were apparently not recognised. Judgements were no different in non-medical contexts. Results suggest a large mismatch between the assumptions underlying the trial design, and the assumptions that lay participants can bring to bear when they try to make sense of descriptive information about randomisation and equipoise. Previous attempts to improve understanding by improving the clarity or salience of trial information, or of making explicit the research context, while helpful, may need to be supplemented with accessible explanations for random allocation.

Action research: a way of researching or a way of managing?

Scrutinising recent systematic reviews both on action research and on the management of change in organisations, we have made two observations which, we believe, clarify a rather amorphous literature. First, by comparing formal descriptions of each, action research cannot be clearly distinguished from many other change methodologies. This applies particularly to total quality management (TQM). Both action research and TQM are cyclical activities involving examination of existing processes, change, monitoring the apparent effects of the change and further change. Both emphasise active participation of stakeholders. The examples used to illustrate action research would serve equally well as examples of TQM and vice versa. Second, the methods used in action research are neither specific to action research nor are they of any particular kind. It therefore follows that action research, in so far as it purports to describe a unique or discrete form of research rather than a change process, is a misnomer. Based on these observations, we make two suggestions. Organisational change should be described in terms of the steps actually taken to effect change rather than in 'terms of art' which, like the various brands of post-Freudian psychotherapy, obscure what they have in common rather than illuminate substantive differences. And the research embedded in any cyclical managerial process can have two broad (non-exclusive) aims: to help local service managers to take the next step or to assist managers in other places and in future years to make decisions. These can be described as limited (formative) and general (summative) aims. Whether, or to what extent, a research finding is generalisable across place and time is a matter of judgement and turns on the form of the research and on its context; it is completely independent of whether or not the research was carried out within a cycle of managerial action currently described by terms such as action research or TQM.

Relation of adult lifestyle and socioeconomic factors to the prevalence of Helicobacter pylori infection.

INTRODUCTION: The influence of adult socioeconomic status, co-habitation, gender, smoking, coffee and alcohol intake on risk of Helicobacter pylori infection is uncertain. METHODS: Subjects between aged 40-49 years were randomly invited to attend their local primary care centre. Participants were interviewed by a researcher on smoking, coffee and alcohol intake, history of living with a partner, present and childhood socioeconomic conditions. Helicobacter pylori status was determined by 13C-urea breath test. RESULTS: In all, 32 929 subjects were invited, 8429 (26%) were eligible and 2327 (27.6%) were H. pylori positive. Helicobacter pylori infection was more common in men and this association remained after controlling for childhood and adult risk factors in a logistic regression model (odds ratio [OR] = 1.15; 95% CI: 1.03-1.29). Living with a partner was also an independent risk factor for infection (OR = 1.30; 95% CI: 1.01-1.67), particularly in partners of lower social class (social class IV and V-OR = 1.47; 95% CI: 1.19-1.81, compared with social class I and II). Helicobacter pylori infection was more common in lower social class groups (I and II-22% infected, III-29% infected, IV and V-38% infected) and there was a significant increase in risk of infection in manual workers compared with non-manual workers after controlling for other risk factors (OR = 1.18; 95% CI: 1.03-1.34). Alcohol and coffee intake were not independent risk factors for infection and smoking was only a risk factor in those smoking >35 cigarettes a day. CONCLUSIONS: Male gender, living with a partner and poor adult socioeconomic conditions are associated with increased risk of H. pylori infection.