***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Rigorous evaluations of food-assisted maternal and child health and nutrition programs are stymied by the ethics of r and omizing recipients to a control treatment . Using nonexperimental matching methods , we evaluated the effect of 2 such programs on  child linear growth in Haiti . The 2 well-implemented programs offered the same services ( food assistance , behavior change communication , and preventive health services ) to pregnant and lactating women and young children . They differed in that one ( the preventive program ) used blanket targeting of all children 6 - 23 mo , whereas the other ( the recuperative program ) targeted underweight ( weight-for-age Z score < -2 ) children 6 - 59 mo , as traditionally done . We estimated program effects on height-for-age Z scores ( HAZ ) and stunting ( HAZ < -2 ) by comparing outcomes of children in program areas with matched children from comparable population s in the Haiti Demographic and Health Survey . Children 12 - 41 mo in the preventive and recuperative program areas had lower prevalence of stunting than those in the matched control group [ 16 percentage points ( pp ) lower in preventive and 11 pp in recuperative ] . Children in the 2 program areas also were more likely than those in the matched control group to be breast-fed up to 24 mo ( 25 pp higher in preventive , 22 in recuperative ) and children 12 mo and older were more likely to have received the recommended full schedule of vaccinations ( 32 pp higher in preventive , 31 in recuperative ) . Both programs improved targeted behaviors and protected child growth in a time of deteriorating economic circumstances Background A central question in the debate about exploitation in international research is whether investigators and sponsors from high-income countries ( HIC ) have obligations to address background conditions of injustice in the communities in which they conduct their research , beyond the healthcare and other research -related needs of participants , to aspects of their basic life circumstances . Discussion In this paper , we describe the Majengo sexually transmitted disease ( STD ) Cohort study , a long-term prospect i ve , observational cohort of sex workers in Nairobi , Kenya . Despite important scientific contributions and a wide range of benefits to the women of the cohort , most of the women have remained in the sex trade during their long-st and ing participation in the cohort , prompting allegations of exploitation . The Majengo STD cohort case extends the debate about justice in international research ethics beyond clinical trials into long-term observational research . We sketch the basic features of a new approach to underst and ing and operationalizing obligations of observational research ers , which we call ' relief of oppression ' . ' Relief of oppression ' is an organizing principle , analogous to the principle of harm reduction that is now widely applied in public health practice . Relief of oppression aims to help observational research ers working in conditions of injustice and deprivation to clarify their ethical obligations to participants . It aims to bridge the gap between a narrow , transaction-oriented account of avoiding exploitation and a broad account emphasizing obligations of reparation for historic injustices . We propose that relief of oppression might focus research ers ' consideration of benefits on those that have some relevance to background conditions of injustice , and so elevate the priority of these benefits , in relation to others that might be considered and negotiated with participants , according to the degree to which the participating communities are constrained in their realization of fundamental freedoms . Summary The over-arching aim of relief of oppression is that , within the range of benefits negotiated over time with the local communities and organizations , an increasing proportion reflects a shared interest in improving participants ' fundamental freedoms . We describe how harm reduction serves as a useful analogy for how we envision relief of oppression functioning in international research Overwhelming evidence shows the quality of reporting of r and omised controlled trials ( RCTs ) is not optimal . Without transparent reporting , readers can not judge the reliability and validity of trial findings nor extract information for systematic review s. Recent method ological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects . Such systematic error is seriously damaging to RCTs , which are considered the gold st and ard for evaluating interventions because of their ability to minimise or avoid bias . A group of scientists and editors developed the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to improve the quality of reporting of RCTs . It was first published in 1996 and up date d in 2001 . The statement consists of a checklist and flow diagram that authors can use for reporting an RCT . Many leading medical journals and major international editorial groups have endorsed the CONSORT statement . The statement facilitates critical appraisal and interpretation of RCTs . During the 2001 CONSORT revision , it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports . A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement . After an expert meeting in January 2007 , the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement . This up date improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition , such as selective outcome reporting bias . This explanatory and elaboration document-intended to enhance the use , underst and ing , and dissemination of the CONSORT statement-has also been extensively revised . It presents the meaning and rationale for each new and up date d checklist item providing examples of good reporting and , where possible , references to relevant empirical studies . Several examples of flow diagrams are included . The CONSORT 2010 Statement , this revised explanatory and elaboration document , and the associated website ( www.consort-statement.org ) should be helpful re sources to improve reporting of r and omised trials This report describes the associations of race/ethnicity and years of education with the validity , reliability , and bias of a self-administered food frequency question naire ( FFQ ) design ed to be sensitive to low-fat , regional , and ethnic dietary patterns . Data were from the Women 's Health Trial Feasibility Study in Minority Population s , a r and omized clinical trial conducted between 1992 and 1994 to test the feasibility of a low-fat dietary intervention that targeted low-income , black , and Hispanic women . Of 1,015 participants eligible for these analyses , 28.1 % were black , 16.2 % were Hispanic , and 12.3 % had not completed high school . The analyses focused on percentage of energy obtained from fat , and used 4-day food records as the criterion instrument . Validity at baseline , defined as the correlation between FFQs and food records , was lower among blacks than among whites ( 0.26 vs. 0.49 ; p < 0.001 ) , did not differ between Hispanics and whites , and was lower among women with fewer years of education ( 0.19 , 0.35 , 0.49 , and 0.42 for < 12 , 12 , 13 - 15 , and > or = 16 years of education , respectively ; for trend , p < 0.05 ) . Six months after r and omization , validity increased in most race/ethnicity and education subgroups , and differences across groups became small and statistically nonsignificant . Validity increased significantly among participants receiving the dietary intervention , while increases among control women were somewhat smaller . Reliability , defined as the correlation between baseline and 6-month measures among controls , was similar across racial/ethnic and educational groups . Bias at baseline , defined as the mean value from the FFQ minus the mean from the food record , was 4.6 percentage points of energy from fat ; it was lowest among blacks ( p < 0.01 ) and did not differ by years of education . These results suggest that special protocol s which address participant training may be necessary when using self-administered FFQs in minority or poorly educated population R and omised controlled trials ( RCTs ) must be internally valid ( i.e. , design and conduct must eliminate the possibility of bias ) , but to be clinical ly useful , the result must also be relevant to a definable group of patients in a particular clinical setting ( i.e. , they must be externally valid ) . Lack of external validity is the most frequent criticism by clinicians of RCTs , systematic review s , and guidelines , and is one explanation for the widespread underuse in routine practice of many treatments that have been shown to be beneficial in trials and are recommended in guidelines [ 1 ] . Yet medical journals , funding agencies , ethics committees , the pharmaceutical industry , and governmental regulators seem to give external validity a low priority . Admittedly , whereas the determinants of internal validity are intuitive and can generally be worked out from first principles , underst and ing of the determinants of the external validity of an RCT requires clinical rather than statistical expertise , and often depends on a detailed underst and ing of the particular clinical condition under study and its management in routine clinical practice . However , reliable judgments about the external validity of RCTs are essential if treatments are to be used correctly in as many patients as possible in routine clinical practice . The results of RCTs or systematic review s will never be relevant to all patients and all setting s , but they should be design ed and reported in a way that allows clinicians to judge to whom the results can reasonably be applied . Table 1 lists some of the important potential determinants of external validity , each of which is review ed briefly below . Many of the considerations will only be relevant in certain types of trials , for certain interventions , or in certain clinical setting s , but they can each sometimes undermine external validity . Moreover , the list is not exhaustive and requires more detailed annotation and explanation than is possible in this short review . Table 1 Main Issues That Can Affect External Validity and Should Be Addressed in Reports of the Results of R and omised Controlled Trials or Systematic Review s and Considered by Clinicians Some of the issues that determine external validity are relevant to the distinction between pragmatic trials and explanatory trials [ 2 ] , but it would be wrong to assume that pragmatic trials necessarily have greater external validity than explanatory trials . For example , broad eligibility criteria , limited collection of baseline data , and inclusion of centres with a range of expertise and differing patient population s have many advantages , but they can also make it very difficult to generalise the overall average effect of treatment to a particular clinical setting Objective To determine whether and how eligibility criteria of participants prespecified in protocol s of r and omised trials are reported in subsequent articles . Design Cohort study . Setting Protocol s su bmi tted to the ethics committee of a German medical faculty . Data sources 52 trial protocol s and 78 subsequent publications published between 2000 and 2006 . Main outcome measure Proportion of matching , missing , modified , or newly added eligibility criteria between trial protocol s and subsequent publications . Results Differences were found between protocol s and subsequent publications for all 52 trials . Information on eligibility criteria was missing in the publications for all 52 trials ( 100 % , 95 % confidence interval 93 % to 100 % ) , modified for 44 ( 85 % , 72 % to 93 % ) , and newly added for 21 ( 41 % , 27 % to 55 % ) . The mean number of eligibility criteria for each trial was 25 ( range 7 - 43 ) and the mean proportion of matching eligibility criteria per trial was 50 % ( 95 % confidence interval 44 % to 55 % , range 13 - 93 ) . Of 1248 eligibility criteria prespecified in the protocol s , 606 ( 49 % , 46 % to 51 % ) were matching in subsequent publications , 479 ( 38 % , 36 % to 41 % ) were missing , and 163 ( 13 % , 11 % to 15 % ) were modified . 51 eligibility criteria were added to publications . Most prespecified eligibility criteria were about comorbidity ( 42 % , 39 % to 45 % ) , treatment ( 20 % , 18 % to 22 % ) , or type or severity of illness ( 17 % , 15 % to 19 % ) . Most of the missing eligibility criteria ( 96 % , 94 % to 97 % ) and modified eligibility criteria ( 54 % , 46 % to 62 % ) suggested broader study population s and most of the added eligibility criteria ( 86 % , 74 % to 94 % ) suggested narrower study population s. Conclusions Many users of trial information rely on published journal articles . These articles generally do not reflect the exact definition of the study population as prespecified in the protocol . Incomplete or inadequate reporting of eligibility criteria hampers a proper assessment of the applicability of trial results In making treatment decisions , doctors and patients must take into account relevant r and omised controlled trials ( RCTs ) and systematic review s. Relevance depends on external validity ( or generalisability)--ie , whether the results can be reasonably applied to a definable group of patients in a particular clinical setting in routine practice . There is concern among clinicians that external validity is often poor , particularly for some pharmaceutical industry trials , a perception that has led to underuse of treatments that are effective . Yet research ers , funding agencies , ethics committees , the pharmaceutical industry , medical journals , and governmental regulators alike all neglect external validity , leaving clinicians to make judgments . However , reporting of the determinants of external validity in trial publications and systematic review s is usually inadequate . This review discusses those determinants , presents a checklist for clinicians , and makes recommendations for greater consideration of external validity in the design and reporting of RCTs Aim Genetic research representative of the population is crucial to underst and ing the underlying causes of many diseases . In a prospect i ve evaluation of informed consent we assessed the willingness of individuals of different ethnicities , gender and drug dependence history to participate in genetic studies in which their genetic sample could be shared with a repository at the National Institutes of Health . Methods Potential subjects were recruited from the general population through the use of flyers  and  referr 
    Output:
    
Results : There is no consistency in the way participants ’ origins ( ancestry , ethnicity , or race ) and ages are described in publications .