Cluster randomised trials in the medical literature: two bibliometric surveys

Background: Several reviews of published cluster randomised trials have reported that about half did not take clustering into account in the analysis, which was thus incorrect and potentially misleading. In this paper I ask whether cluster randomised trials are increasing in both number and quality of reporting. Methods: Computer search for papers on cluster randomised trials since 1980, hand search of trial reports published in selected volumes of the British Medical Journal over 20 years. Results: There has been a large increase in the numbers of methodological papers and of trial reports using the term 'cluster random' in recent years, with about equal numbers of each type of paper. The British Medical Journal contained more such reports than any other journal. In this journal there was a corresponding increase over time in the number of trials where subjects were randomised in clusters. In 2003 all reports showed awareness of the need to allow for clustering in the analysis. In 1993 and before clustering was ignored in most such trials. Conclusion: Cluster trials are becoming more frequent and reporting is of higher quality. Perhaps statistician pressure works

Decontaminating terrestrial oil spills: A comparative assessment of dog fur, human hair, peat moss and polypropylene sorbents

Terrestrial oil spills have severe and continuing consequences for human communities and the natural environment. Sorbent materials are considered to be a first line of defense method for directly extracting oil from spills and preventing further contaminant spread, but little is known on the performance of sorbent products in terrestrial environments. Dog fur and human hair sorbent products were compared to peat moss and polypropylene sorbent to examine their relative e ectiveness in adsorbing crude oil from di erent terrestrial surfaces. Crude oil spills were simulated using standardized microcosm experiments, and contaminant adsorbency was measured as percentage of crude oil removed from the original spilled quantity. Sustainable-origin absorbents made from dog fur and human hair were equally e ective to polypropylene in extracting crude oil from nonand semi-porous land surfaces, with recycled dog fur products and loose-form hair showing a slight advantage over other sorbent types. In a sandy terrestrial environment, polypropylene sorbent was significantly better at adsorbing spilled crude oil than all other tested products

A priori postulated and real power in cluster randomized trials: mind the gap

BACKGROUND: Cluster randomization design is increasingly used for the evaluation of health-care, screening or educational interventions. The intraclass correlation coefficient (ICC) defines the clustering effect and be specified during planning. The aim of this work is to study the influence of the ICC on power in cluster randomized trials. METHODS: Power contour graphs were drawn to illustrate the loss in power induced by an underestimation of the ICC when planning trials. We also derived the maximum achievable power given a specified ICC. RESULTS: The magnitude of the ICC can have a major impact on power, and with low numbers of clusters, 80% power may not be achievable. CONCLUSION: Underestimating the ICC during planning cluster randomized trials can lead to a seriously underpowered trial. Publication of a priori postulated and a posteriori estimated ICCs is necessary for a more objective reading: negative trial results may be the consequence of a loss of power due to a mis-specification of the ICC

Sample size calculations for cluster randomised controlled trials with a fixed number of clusters

Background\ud Cluster randomised controlled trials (CRCTs) are frequently used in health service evaluation. Assuming an average cluster size, required sample sizes are readily computed for both binary and continuous outcomes, by estimating a design effect or inflation factor. However, where the number of clusters are fixed in advance, but where it is possible to increase the number of individuals within each cluster, as is frequently the case in health service evaluation, sample size formulae have been less well studied. \ud \ud Methods\ud We systematically outline sample size formulae (including required number of randomisation units, detectable difference and power) for CRCTs with a fixed number of clusters, to provide a concise summary for both binary and continuous outcomes. Extensions to the case of unequal cluster sizes are provided. \ud \ud Results\ud For trials with a fixed number of equal sized clusters (k), the trial will be feasible provided the number of clusters is greater than the product of the number of individuals required under individual randomisation ($n_i$) and the estimated intra-cluster correlation ($\rho$). So, a simple rule is that the number of clusters ($\kappa$) will be sufficient provided: \ud \ud $\kappa$ > $n_i$ x $\rho$\ud \ud Where this is not the case, investigators can determine the maximum available power to detect the pre-specified difference, or the minimum detectable difference under the pre-specified value for power. \ud \ud Conclusions\ud Designing a CRCT with a fixed number of clusters might mean that the study will not be feasible, leading to the notion of a minimum detectable difference (or a maximum achievable power), irrespective of how many individuals are included within each cluster. \ud \u

‘Because it’s our culture!’ (Re)negotiating the meaning of lobola in Southern African secondary schools

Payment of bridewealth or lobola is a significant element of marriage among the Basotho of Lesotho and the Shona of Zimbabwe. However, the functions and meanings attached to the practice are constantly changing. In order to gauge the interpretations attached to lobola by young people today, this paper analyses a series of focus group discussions conducted among senior students at two rural secondary schools. It compares the interpretations attached by the students to the practice of lobola with academic interpretations (both historical and contemporary). Among young people the meanings and functions of lobola are hotly contested, but differ markedly from those set out in the academic literature. While many students see lobola as a valued part of ‘African culture’, most also view it as a financial transaction which necessarily disadvantages women. The paper then seeks to explain the young people’s interpretations by reference to discourses of ‘equal rights’ and ‘culture’ prevalent in secondary schools. Young people make use of these discourses in (re)negotiating the meaning of lobola, but the limitations of the discourses restrict the interpretations of lobola available to them

Planning a cluster randomized trial with unequal cluster sizes: practical issues involving continuous outcomes

BACKGROUND: Cluster randomization design is increasingly used for the evaluation of health-care, screeening or educational interventions. At the planning stage, sample size calculations usually consider an average cluster size without taking into account any potential imbalance in cluster size. However, there may exist high discrepancies in cluster sizes. METHODS: We performed simulations to study the impact of an imbalance in cluster size on power. We determined by simulations to which extent four methods proposed to adapt the sample size calculations to a pre-specified imbalance in cluster size could lead to adequately powered trials. RESULTS: We showed that an imbalance in cluster size can be of high influence on the power in the case of severe imbalance, particularly if the number of clusters is low and/or the intraclass correlation coefficient is high. In the case of a severe imbalance, our simulations confirmed that the minimum variance weights correction of the variation inflaction factor (VIF) used in the sample size calculations has the best properties. CONCLUSION: Publication of cluster sizes is important to assess the real power of the trial which was conducted and to help designing future trials. We derived an adaptation of the VIF from the minimum variance weights correction to be used in case the imbalance can be a priori formulated such as "a proportion (γ) of clusters actually recruit a proportion (τ) of subjects to be included (γ ≤ τ)"

Estimation of Age-at-Death for Adult Males Using the Acetabulum, Applied to Four Western European Populations *

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/73732/1/j.1556-4029.2007.00486.x.pd

Superior outcomes of nodal metastases compared to visceral sites in oligometastatic colorectal cancer treated with stereotactic ablative radiotherapy

BACKGROUND: Stereotactic ablative radiotherapy (SBRT) is a radical option for oligometastatic colorectal cancer (CRC) patients, but most data relate to visceral metastases. METHODS: A prospective, multi-centre database of CRC patients treated with SBRT was interrogated. Inclusion criteria were ECOG PS 0-2, ≤ 3 sites of disease, a disease free interval of > 6 months unless synchronous liver metastases. Primary endpoints were local control (LC), progression free survival (PFS) and overall survival (OS). RESULTS: 163 patients (172 metastases) were analysed. The median FU was 16 months (IQR 12.2 - 22.85). The LC at 1 year was 83.8% (CI 76.4% - 91.9%) with a PFS of 55% (CI 47% - 64.7%) respectively. LC at 1 year was 90% (CI 83% - 99%) for nodal metastases (NM), 75% (63% - 90%) for visceral metastases (VM). NM had improved median PFS (9 vs 19 months) [HR 0.6, CI 0.38 - 0.94, p = 0.032] and median OS (32 months vs not reached) [HR 0.28, CI 0.18 - 0.7, p = 0.0062] than VM, regardless of whether the NM were located inside or outside the pelvis. On multivariate analysis, NM and ECOG PS 0 were significant good prognostic factors. An exploratory analysis suggests KRAS WT is also a good prognostic factor. CONCLUSION: Nodal site is an important prognostic determinant of SBRT that should incorporated into patient selection. We hypothesise this may have an immunoediting basis