When is a randomised controlled trial health equity relevant? Development and validation of a conceptual framework.

BACKGROUND: Randomised controlled trials can provide evidence relevant to assessing the equity impact of an intervention, but such information is often poorly reported. We describe a conceptual framework to identify health equity-relevant randomised trials with the aim of improving the design and reporting of such trials. METHODS: An interdisciplinary and international research team engaged in an iterative consensus building process to develop and refine the conceptual framework via face-to-face meetings, teleconferences and email correspondence, including findings from a validation exercise whereby two independent reviewers used the emerging framework to classify a sample of randomised trials. RESULTS: A randomised trial can usefully be classified as 'health equity relevant' if it assesses the effects of an intervention on the health or its determinants of either individuals or a population who experience ill health due to disadvantage defined across one or more social determinants of health. Health equity-relevant randomised trials can either exclusively focus on a single population or collect data potentially useful for assessing differential effects of the intervention across multiple populations experiencing different levels or types of social disadvantage. Trials that are not classified as 'health equity relevant' may nevertheless provide information that is indirectly relevant to assessing equity impact, including information about individual level variation unrelated to social disadvantage and potentially useful in secondary modelling studies. CONCLUSION: The conceptual framework may be used to design and report randomised trials. The framework could also be used for other study designs to contribute to the evidence base for improved health equity.

Protocol for the development of a CONSORT-equity guideline to improve reporting of health equity in randomized trials.

BACKGROUND: Health equity concerns the absence of avoidable and unfair differences in health. Randomized controlled trials (RCTs) can provide evidence about the impact of an intervention on health equity for specific disadvantaged populations or in general populations; this is important for equity-focused decision-making. Previous work has identified a lack of adequate reporting guidelines for assessing health equity in RCTs. The objective of this study is to develop guidelines to improve the reporting of health equity considerations in RCTs, as an extension of the Consolidated Standards of Reporting Trials (CONSORT). METHODS/DESIGN: A six-phase study using integrated knowledge translation governed by a study executive and advisory board will assemble empirical evidence to inform the CONSORT-equity extension. To create the guideline, the following steps are proposed: (1) develop a conceptual framework for identifying "equity-relevant trials," (2) assess empirical evidence regarding reporting of equity-relevant trials, (3) consult with global methods and content experts on how to improve reporting of health equity in RCTs, (4) collect broad feedback and prioritize items needed to improve reporting of health equity in RCTs, (5) establish consensus on the CONSORT-equity extension: the guideline for equity-relevant trials, and (6) broadly disseminate and implement the CONSORT-equity extension. DISCUSSION: This work will be relevant to a broad range of RCTs addressing questions of effectiveness for strategies to improve practice and policy in the areas of social determinants of health, clinical care, health systems, public health, and international development, where health and/or access to health care is a primary outcome. The outcomes include a reporting guideline (CONSORT-equity extension) for equity-relevant RCTs and a knowledge translation strategy to broadly encourage its uptake and use by journal editors, authors, and funding agencies.

Enemas during labour.

BACKGROUND: The use of enemas during labour usually reflects the preference of the attending healthcare provider. However, enemas may cause discomfort for women and increase the costs of delivery. OBJECTIVES: To assess the effects of enemas applied during the first stage of labour on infection rates in mothers and newborns, duration of labour, perineal wound dehiscence in the mother, perineal pain and faecal soiling. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (March 2007), PubMed (1966 to December 2006), the Cochrane Central Register of Controlled Trials and Database of Abstracts of Reviews of Effectiveness (The Cochrane Library 2006, Issue 4), clinical trials registers (December 2006) and reference lists of articles. SELECTION CRITERIA: Randomized controlled trials (RCTs) in which an enema was administered during the first stage of labour and which included assessment of possible neonatal or puerperal morbidity or mortality. DATA COLLECTION AND ANALYSIS: Two review authors assessed studies for inclusion independently. MAIN RESULTS: Three RCTs (1765 women) met the inclusion criteria. Meta-analysis revealed no significant differences for infection rates in puerperal women (2 RCTs; 594 women; relative risk (RR) 0.66, 95% CI 0.42 to 1.04) or newborn children (1 RCT; 370 newborns; RR 1.12, 95% CI 0.76 to 1.67) after one month of follow up. No significant differences were found in the incidence of lower or upper respiratory tract infections. One trial described labour to be significantly shorter with enema versus no enema (1 RCT, 1027 women; 409.4 minutes versus 459.8 minutes; weighted mean difference (WMD) -50,40 CI 95% -75.68 to -25.12; P < 0.001), but another, adjusted for parity, did not confirm this (median 515 minutes with enemas versus 585 minutes without enemas, P = 0.24). Two trials found no significant differences in neonatal umbilical infection (2 RCTs; 592 newborns; RR 3.16 95% CI 0.50 to 19.82). The one trial that researched women's views found no significant differences in satisfaction between groups. AUTHORS' CONCLUSIONS: The evidence provided by the three included RCTs shows that enemas do not have a significant effect on infection rates such as perineal wound infection or other neonatal infections and women's satisfaction. This evidence does not support the routine use of enemas during labour; therefore, such practice should be discouraged.

Treatments for iron-deficiency anaemia in pregnancy.

BACKGROUND: Iron deficiency, the most common cause of anaemia in pregnancy worldwide, can be mild, moderate or severe. Severe anaemia can have very serious consequences for mothers and babies, but there is controversy about whether treating mild or moderate anaemia provides more benefit than harm. OBJECTIVES: To assess the effects of different treatments for iron-deficiency anaemia in pregnancy (defined as haemoglobin less than 11 g/dl) on maternal and neonatal morbidity and mortality. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (January 2007), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2005, Issue 4), MEDLINE (1966 to December 2005), EMBASE (1976 to December 2005), LILACS (1982 to 40 edition), BIOSIS Previews (1980 to June 2002) and ongoing clinical trial registers. SELECTION CRITERIA: Randomised controlled trials comparing treatments for iron-deficiency anaemia in pregnancy. DATA COLLECTION AND ANALYSIS: We identified 17 trials, involving 2578 women. We assessed trial quality. MAIN RESULTS: The trials were small and generally methodologically poor. They covered a very wide range of differing drugs, doses and routes of administration, making it difficult to pool data. Oral iron in pregnancy showed a reduction in the incidence of anaemia (one trial, 125 women; relative risk 0.38; 95% confidence interval 0.26 to 0.55). It was not possible to assess the effects of treatment by severity of anaemia. A trend was found between dose and reported adverse effects. We found that most trials had no assessments on relevant clinical outcomes and a paucity of data on adverse effects, including some that are known to be associated with iron administration. Although the intramuscular and intravenous routes produced better haematological indices in women than the oral route, no clinical outcomes were assessed and there were insufficient data on adverse effects, for example, on venous thrombosis and severe allergic reactions. AUTHORS' CONCLUSIONS: Despite the high incidence and burden of disease associated with this condition, there is a paucity of good quality trials assessing clinical maternal and neonatal effects of iron administration in women with anaemia. Daily oral iron treatment improves haematological indices but causes frequent gastrointestinal adverse effects. Parenteral (intramuscular and intravenous) iron enhances haematological response, compared with oral iron, but there are concerns about possible important adverse effects. Large, good quality trials, assessing clinical outcomes (including adverse effects) are required.

Treatments for iron deficiency anaemia in pregnancy.

BACKGROUND: Iron deficiency is the most common cause of anaemia in pregnancy worldwide. Iron treatment can be given by mouth, intramuscular or intravenous injection. Alternatively, blood transfusions and recombinant erythropoietin are also used. OBJECTIVES: To assess the effectiveness of different treatments for iron deficiency anaemia in pregnancy (defined as haemoglobin less than 11 g/dl) on maternal and neonatal morbidity and mortality. SEARCH STRATEGY: Cochrane Pregnancy and Childbirth Group Specialised Register of Trial was searched. Date of last search: December 2000. SELECTION CRITERIA: Randomised controlled trials comparing treatments for iron deficiency anaemia in pregnancy. DATA COLLECTION AND ANALYSIS: The search identified 54 trials. Five trials, involving approximately 1234 women, met the inclusion criteria. Trial quality was assessed. Study authors were contacted for additional information. MAIN RESULTS: Oral iron treatment in pregnancy was assessed in one small trial (n=125), where it was compared with placebo. This showed a reduction in the number of women with haemoglobins under 11g/dl (odds ratio (OR) 0.12, 95% confidence interval (CI) 0.06 to 0.24) and a greater mean haemoglobin level 11.3g/dl compared to 10.5 g/dl (weighted mean difference 0.80, 95% CI 0.62 to 0.98). However, there were no data on clinically relevant outcomes. When comparing different iron treatments, the intravenous (IV) route of administration was associated with an increased risk of venous thrombosis (1 trial, n=74. Iron dextran intramuscularly (IM) versus IV (n=49) OR 0.13, 95% CI 0.02-1.02. IM iron sorbitol-citric acid versus IV iron dextran, OR 0.12, 95% CI 0.02-0.94). Intravenous iron treatments were compared with placebo in one trial (n=54) but only scarce data on adverse outcomes were suitable for inclusion in this review. REVIEWER'S CONCLUSIONS: This review provides inconclusive evidence on the effects of treating iron deficiency anaemia in pregnancy due to the shortage of good quality trials.

Enemas during labor.

BACKGROUND: The use of enemas during labor usually depends on the preference of the attending physician and available resources. However enemas cause discomfort in women and increase the costs of delivery. OBJECTIVES: The objective of this review was to assess the effects of enemas during the first stage of labor on infection rates in mothers and newborns, duration of labor, perineal wound dehiscence in the mother, perineal pain, faecal soiling and costs. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register, the Cochrane Controlled Trials Register, Database of Abstracts of Reviews of Effectiveness, Medline and reference lists of articles. SELECTION CRITERIA: Randomised trials in which an enema was administered during the first stage of labor and which included assessment of possible neonatal or puerperal morbidity or mortality. DATA COLLECTION AND ANALYSIS: Selected studies were assessed by three reviewers independently. MAIN RESULTS: Two trials involving 665 women were included. These showed no clear difference in infection rates for puerperal mothers (odds ratio 0.61, 95% confidence interval 0.36 to 1.04) or newborn children. REVIEWER'S CONCLUSIONS: There is not enough evidence to evaluate the use of routine enemas during the first stage of labor.

Evaluation of institutional cancer registries in Colombia.

The four primary objectives of this descriptive study were to: 1) design a quality-measurement instrument for institutional cancer registries (ICRs), 2) evaluate the existing ICRs in Colombia with the designed instrument, 3) categorize the different registries according to their quality and prioritize efforts that will efficiently promote better registries with the limited resources available, and 4) determine the institution with the greatest likelihood of successfully establishing Colombia's second population-based cancer registry. In 1990 the National Cancer Institute of Colombia developed 13 institution-based cancer registries in different Colombian cities in order to promote the collection of data from a large group of cancer diagnostic and treatment centers. During the first half of 1997, this evaluation reviewed 12 registries; one of the original 13 no longer existed. All of the Colombian institutions (hospitals) that maintain institution-based cancer registries were included in the study. At each institution, a brief survey was administered to the hospital director, the registry coordinator, and the registrar (data manager). Researchers investigated the institutions by looking at six domains that are in standard use internationally. Within each domain, questions were developed and selected through the Delphi method. Each domain and each question were assigned weights through a consensus process. In most cases, two interviewers went to each site to collect the information. The university hospitals in Cali, Pereira, and Medellín had substantially higher scores, reflecting a good level of performance. Four of the 12 institutions had almost no cancer registry work going on. Five of the 12 hospital directors considered that the information provided by the cancer registries influenced their administrative decisions. Three of the registries had patient survival data. Four of the institutions allocated specific resources to operate their cancer registries; in the other 8 hospitals there was no clear budget allocation. Seven of the hospital directors could not identify five or more objectives of a cancer registry. Data management was usually poor and resources insufficient at most of the institutions. In summary, the cancer registry system in Colombia varies greatly from institution to institution. A few of the hospitals do a good job while others have neglected the registries. The high, identical total scores for Pereira and Medellín suggest they would be good locations to establish new population-based cancer registries similar to the existing one in Cali. However, the overall characteristics in Pereira may provide a more appropriate environment for the second registry, with Medellín as an alternative.