***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: To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results BACKGROUND Shock-absorbing and biomechanic shoe orthoses are frequently used in the prevention and treatment of back and lower extremity problems . One review concludes that the former is clinical ly effective in relation to prevention , whereas the latter has been tested in only 1 r and omized clinical trial , concluding that stress fractures could be prevented . OBJECTIVES To investigate if biomechanic shoe orthoses can prevent problems in the back and lower extremities and if reducing the number of days off-duty because of back or lower extremity problems is possible . DESIGN Prospect i ve , r and omized , controlled intervention trial . STUDY SUBJECTS One female and 145 male military conscripts ( aged 18 to 24 years ) , representing 25 % of all new conscripts in a Danish regiment . METHOD Health data were collected by question naires at initiation of the study and 3 months later . Custom-made biomechanic shoe orthoses to be worn in military boots were provided to all in the study group during the 3-month intervention period . No intervention was provided for the control group . Differences between the 2 groups were tested with the chi-square test , and statistical significance was accepted at P < .05 . Risk ratio ( RR ) , risk difference ( ARR ) , numbers needed to prevent ( NNP ) , and cost per successfully prevented case were calculated . OUTCOME VARIABLES Outcome variables included self-reported back and /or lower extremity problems ; specific problems in the back or knees or shin splints , Achilles tendonitis , sprained ankle , or other problems in the lower extremity ; number of subjects with at least 1 day off-duty because of back or lower extremity problems and total number of days off-duty within the first 3 months of military service because of back or lower extremity problems . RESULTS Results were significantly better in an actual-use analysis in the intervention group for total number of subjects with back or lower extremity problems ( RR 0.7 , ARR 19 % , NNP 5 , cost 98 US dollars ) ; number of subjects with shin splints ( RR 0.2 , ARR 19 % , NNP 5 , cost 101 US dollars ) ; number of off-duty days because of back or lower extremity problems ( RR 0.6 , ARR < 1 % , NNP 200 , cost 3750 US dollars ) . In an intention-to-treat analysis , a significant difference was found for only number of subjects with shin splints ( RR 0.3 , ARR 18 % , NNP 6 cost 105 US dollars ) , whereas a worst-case analysis revealed no significant differences between the study groups . CONCLUSIONS This study shows that it may be possible to prevent certain musculoskeletal problems in the back or lower extremities among military conscripts by using custom-made biomechanic shoe orthoses . However , because care-seeking for lower extremity problems is rare , using this method of prevention in military conscripts would be too costly . We also noted that the choice of statistical approach determined the outcome Reports of cluster r and omised trials require additional information to allow readers to interpret them accurately The effective reporting of r and omised controlled trials has received useful attention in recent years . Many journals now require that reports conform to the guidelines in the Consoli date d St and ards of Reporting Trials ( CONSORT ) statement , first published in 1996 and revised in 2001 . The statement includes a checklist of items that should be included in the trial report . These items are evidence based whenever possible and are regularly review ed . The statement also recommends including a flow diagram to show the flow of participants from group assignment through to the final analysis . The CONSORT statement focused on reporting parallel group r and omised trials in which individual participants are r and omly assigned to study groups . However , in some situations it is preferable to r and omly assign groups of individuals ( such as families or medical practice s ) rather than individuals . Reasons include the threat of contamination of some interventions ( such as dietary interventions ) if individual r and omisation is used . 5 Also , in certain setting s r and omisation by group may be the only feasible method of conducting a trial . Trials with this design are variously known as field trials , community based trials , place based trials , or ( as in this paper ) cluster r and omised trials . In an earlier discussion paper we considered the implication s of the CONSORT statement for the reporting of cluster r and omised trials . Here we present up date d guidance , based on the 2001 revision of the CONSORT statement Young female players in European h and ball have a very high injury incidence , up to 50 injuries per 1000 hours of game . More than half of these injuries happen without any external cause . The aim of the study was to investigate the effect of an intervention programme design ed to reduce the number of injuries in young female players in European h and ball , with special emphasis on injuries in the lower extremities . The programme was created using elite athlete training programmes and those design ed for rehabilitation of injured athletes with functional instability of their ankles and rupture of the anterior cruciate ligament . It included the use of an ankle disk for 10 - 15 min at all practice sessions , for one 10-month season ( August 1995-May 1996 ) . Twenty-two teams participated in the study , and were r and omly assigned to the intervention or control group . Eleven teams with 111 players were r and omised to the intervention group and 11 teams with 126 players to the control group . Data were analysed using a t-test for continuous variables , chi2- analysis and Fisher 's exact test for dichotomous variables and multivariate methods to determine odds-ratios . The results indicated that using the intervention programme decreased the numbers of both traumatic and overuse injuries significantly . The differences in injuries between the groups were 80 % during games and 71 % during practice . In addition , the players in the control group had a 5.9 times higher risk of acquiring an injury than the players in the intervention group OBJECTIVES The aim of the study was to determine the effectiveness of new , individually fitted sports shoes against overuse injuries to the lower limb among newspaper carriers . METHODS Patients ( N = 176 ) with lower-limb overuse injuries were r and omly assigned to use new , individually adjusted footwear with good shock absorbing properties ( test group = 86 ) or the subjects ' own , used footwear ( control group = 90 ) . The main outcome measurements were lower-limb pain intensity during walking , as rated on a visual analogue scale ( 0 - 100 ) , number of painful days , subjective assessment of global improvement , foot fatigue , number of hyperkeratotic skin lesions and diagnosed overuse injuries , and costs of foot care as compared between the treatment groups . RESULTS At the 6-month follow-up there was a difference in favor of the test group with respect to lower-limb pain intensity and number of painful days , when compared with the control group . At 1 year , 53 % and 33 % of the test and control groups , respectively , thought they were better than at the time of the baseline examination ( number needed to treat being 5 between the test and control groups ) . The test subjects had less foot fatigue and fewer hyperkeratotic skin lesions . There was no difference in the number of diagnosed overuse injuries between the groups . During the year of follow-up , the all-inclusive mean costs of foot care were USD 70 and USD 158 in the test and control groups , respectively . CONCLUSIONS Individually adjusted shock-absorbing shoes offer slight health benefits for lower-limb overuse injuries . Proper shoes may decrease the need to use health care re sources Three hundred fifty male recruits were r and omly allocated to either the st and ard recruit training program ( N = 180 ) or substituted a weighted-march activity for all formal run periods ( N = 170 ) in the physical training program . All injuries were seen at a single medical facility , and the cause , location , and severity of injury were recorded in the medical documents . Lower-limb injuries constituted 79.8 % of all Run injuries and 61.1 % of all Walk injuries . Foot ( 18.9 % ) , knee ( 16.7 % ) , ankle ( 13.3 % ) , and shoulder ( 8.9 % ) were the most common sites of injury in the Walk group . In the Run group , the most common sites were knee ( 32.1 % ) , ankle ( 18.3 % ) , foot ( 11.9 % ) , and shin ( 7.3 % ) . There were two stress fractures ( tibial ) in the Run group and none in the Walk group , giving the Run group an incidence of 1.1 % . There were 10 medical discharges  in the Walk group and 16 in the Run group . Ten ( 62.5 % ) of the Run and 2 ( 20 % ) of the Walk discharges were due to lower-limb causes . Of these , only 1 ( 10 % ) of the Walk and 4 ( 25 % ) of the Run injuries were not considered to be pre-existing conditions . Marching ( 30.0 % ) , physical training ( 25.5 % ) , and the obstacle course ( 11.1 % ) were the most frequent causes of injury in the Walk group . In the Run group , the leading causes were running ( 36.6 % ) , physical training ( 19.2 % ) , and the obstacle course ( 14.6 % ) . Running was the major cause of knee injury in the Run group ( 17/35 ) , whereas physical training was the major cause of knee injury in the Walk group ( 5/15 ) . Running was also the major cause of other lower-limb injuries in the Run group ( 19/58 ) , whereas marching was the major cause in the Walk group ( 19/50 ) . Lower-limb injuries were more frequent in the Run group , with running cited as the major cause of these injuries The effect of low-energy laser therapy on shin splints was examined in a r and omized study with an unblinded design . Constripts from the Jutl and Dragoon regiment with shin splints were given either active laser treatment ( 40 mW in 60 sec per cm tender tibia edge ) or placebo laser .  All patients were exempted from normal duty concerning activities like running and march . Forty-nine patients participated in the study , 23 in the laser group and 26 in the control group . From the start the study was design ed to be double-blind , but by accident the code was broken towards the end of the study . We found no significant differences between the groups regarding pain visual analog score and readiness to return to active duty after 14 days Three hundred fifty male recruits were r and omly allocated to either the st and ard recruit training program ( N = 180 ) or substituted a weighted march activity for all running periods in the physical training program ( N = 170 ) . There were no other differences in the formal training program . The incidence of injury was 37.6 and 46.6 % in the walk and run groups , respectively . The rate of injury was 52.9/100 recruits in the walk group and 61.7/100 in the run group . The exposure incidence was 12.8/1,000 hours of physical training in the walk group and 14.9/1,000 hours in the run group . There was no statistically significantly difference in the total number of injured recruits in the two groups ( 64 vs. 85 , chi(2 ) = 2.90 , p = 0.09 , relative risk [ RR ] = 1.24 ) . There were , however , significantly more lower-limb ( 43 vs. 75 , chi(2 ) = 9.77 , p = 0.0018 , RR = 1.65 ) and knee injuries ( 15 vs. 35 , chi(2 ) = 6.54 , p = 0.011 , RR = 2.14 ) in the Run group . Lower-limb injuries constituted 79.8 % of all Run injuries and 61.1 % of all Walk injuries . Injuries in the Run group produced more morbidity , with nearly double the number of days of restriction , hospitalization , and not fit for duty . St and ardized morbidity rates showed an average of 5.4 days of restriction per injury in the Run group and 3.96 days of restriction per injury in the Walk group . Reduction of running distance in the physical training program result ed in significant reductions in both the incidence of lower-limb injury and the overall severity of injury To determine whether use of viscoelastic insoles would significantly decrease the frequency of musculoskeletal overuse injury in aerobic dancers , 139 
    Output:
    
The use of shock absorbing inserts in footwear probably reduces the incidence of stress fractures in military personnel .