title: Quality of randomized controlled trials reporting in the primary treatment of brain tumors. [Effect of zinc oxide tape on plantar ulcers in leprosy patients in Indonesia]. Topical phenytoin suspension and normal saline in the treatment of leprosy trophic ulcers: a randomized, double‐blind, comparative study Use of topical ketanserin for the treatment of ulcers in leprosy patients. Better reporting of randomised controlled trials: the CONSORT statement Comparison of topical phenytoin with normal saline in the treatment of chronic trophic ulcers in leprosy. A randomised controlled trial comparing Drawtex with standard dressings for exuding wounds.
abstract: PURPOSE To assess the reporting quality of r and omized controlled trials ( RCTs  ) in the primary treatment of brain tumors and to identify significant predictors of quality . PATIENTS AND METHODS Two investigators search ed MEDLINE , EMBASE , and bibliographies of retrieved articles for RCTs in the primary treatment of brain tumors published between January 1990 and December 2004 . We assessed the quality of overall reporting and key method ologic factors reporting ( allocation concealment , blinding , and intention to treat [ ITT ] ) .  Two investigators also rated articles independently using items from the revised Consoli date d St and ards of Reporting Trials statement . A generalized estimated equation was used to generate regression models that identified significant factors associated with quality of reporting . RESULTS We retrieved 74 relevant RCTs that r and omly assigned 14,498 brain tumor patients . The quality of overall reporting has improved during the last 15 years , but eight of the 15 method ologic items were reported in less than 50 % of trials . In the appraisal of the reporting quality of key method ologies , allocation concealment , blinding , and adherence to the ITT principle were reported in less than 30 % of articles . Multivariable regression models revealed that an impact factor more than 1.66 , publication after 1995 , and sample size more than 280 were significant factors associated with better overall reporting , whereas complete industrial funding , impact factors more than 2.64 , and positive primary outcomes were predictors of higher ratings of the three most important method ologic qualities . CONCLUSION Despite improvement in general reporting quality , key method ologies that safeguard against biases may still benefit from better description . Significant factors associated with better reporting may act as surrogates for other characteristics In this investigation the effectiveness was studied of adhesive zinc oxide tape , as additional therapy to the usual application of povidone iodine ( 10 % ) , for leprosy patients with plantar ulcers in Sulawesi Tengah , Indonesia . The effectiveness ( degree of wound healing measured as surface reduction ) of this experimental therapy was compared with that of the usual therapy alone . At the same time the influence of the physical activity level on the effectiveness of both therapies was studied . During six weeks 38 leprosy patients with simple ulcers were treated with either one of the therapies . The average wound healing of the experimental group and the control group was 388 mm2 ( SD 498 ) and 260 mm2 ( SD 260 ) respectively . Using the t-test , there was no statistically significant difference in wound healing between the two therapies ( p = 1.7 ) . The average wound healing of the experimental group with a high and a low activity level was 342 mm2 ( SD 226 ) and 405 mm2 ( SD 571 ) respectively . The average wound healing of the control group with a high and low activity level was 246 mm2 ( SD 289 ) and 275 mm2 ( SD 232 ) respectively . Using analyses of variance , there was no statistically significant influence on the effectiveness of the therapies ( p greater than 0.1 ) . Method ological problems possibly influenced on the results . Different problems which may be encountered during research in third world countries are mentioned OBJECTIVE : To evaluate and compare two strengths of topical phenytoin sodium suspension ( 2 % and 4 % ) with normal saline in the healing of acute trophic ulcers in leprosy patients . METHODS : A prospect i ve , parallel , double‐blind , r and omized study was conducted in 45 leprosy in patients with acute trophic ulcers . Patients were r and omized to receive 2 % , 4 % or normal saline dressing on their ulcers once daily for 4 weeks . Efficacy parameters such as a reduction in the surface area of the ulcer , bacterial culture of the ulcer swab , appearance of healthy granulation tissue , cessation of ulcer discharge and overall gradation of clinical healing and safety were assessed at weekly intervals . RESULTS : The ulcer area reduction was greater in the 2 % and 4 % phenytoin groups compared with the normal saline group ( p<0.001 ) . Appearance of healthy granulation tissue and cessation of ulcer discharge was also observed earlier in the two phenytoin groups . At the end of 4 weeks , 11 ulcers each had healed completely in both the 2 % and 4 % phenytoin groups compared with none in the control group . There were no statistical differences between the 2 % and 4 % phenytoin groups . No side effects were reported by any patient . CONCLUSION : Topical phenytoin appears to be an effective , safe and cheap therapeutic option for the healing of trophic ulcers in leprosy patients A comparative study was carried out in which 66 leprosy patients with ulcers were r and omly divided in two groups of 33 patients each : Group A ( experimental group ) was treated with ketanserin gel ( 2 % ) and group B with clioquinol cream and /or Lassar paste during a three month period . At the end of the study , when ulcer sizes in the two groups were compared , the group treated with topical  ketanserin  showed superior results ( p < 0.001 using Kolmogorov-Smirnov 's test ) . We conclude that the drug is useful as coadjuavant treatment for healing ulcers in these patients R and omised controlled trials are the best way to compare the effectiveness of different interventions . Only r and omised trials allow valid inferences of cause and effect . Only r and omised trials have the potential directly to affect patient care — occasionally as single trials but more often as the body of evidence from several trials , whether or not combined formally by meta- analysis . It is thus entirely reasonable to require higher st and ards for papers reporting r and omised trials than those describing other types of study . Like all studies , r and omised trials are open to bias if done badly.1 It is thus essential that r and omised trials are done well and reported adequately . Readers should not have to infer what was probably done , they should be told explicitly . Proper methodology should be used and be seen to have been used . Yet review s of published trials have consistently found major deficiencies in reporting,2 3 4 making the task BACKGROUND Trophic ulceration , one of the most common complications of leprosy , is disabling , distressing , and demoralizing for the patient . METHODS The wound healing effects of topical phenytoin powder were compared with those of normal saline in a controlled in-patient study of 100 patients with 110 trophic leprosy ulcers of varying chronicity , over a 4-week study period . Fifty patients were assigned to the topical phenytoin group and 50 to saline therapy group . Ten patients had two ulcers each , and , in these cases , one ulcer was treated with phenytoin and the other with saline . RESULTS Over the 4-week treatment period healthy granulation tissue appeared earlier , and mean percentage of ulcer volume reduction was greater , in the phenytoin group ( 72.1 + /- 19.9 % versus 55.5 + /- 21.6 % ) compared with the control group . CONCLUSIONS This difference was statistically significant at the level of P < 0.001 . Phenytoin appears to be a useful agent for the promotion of healing of trophic leprosy ulcers OBJECTIVE This r and omised controlled clinical trial compared a capillary dressing ( Drawtex , now rebr and ed as Vibriant RCD [ Vibriant Technology Services ] ) with routine practice for exuding wounds greater than 2.5 x 2.5 cm . METHOD The target population was 300 control and 300 test subjects across three sites in the UK , but recruitment difficulties result ed in only 125 patients being evaluable .  Wound progress was recorded by nurses ' perception of the progress of wound healing and by objective digital imaging . In the final analysis digital images were r and omised ( in time order ) and a panel of nurses who were not otherwise involved in the research project grade d the wound 's progress . RESULTS After deconvolution of the data , the subjective ( nurse perception ) method of evaluation determined that the new dressing result ed in wound improvement in 12.7 % more patients than did routine practice , but the blinded assessment method ( based on the digital images ) showed that routine practice was better by 6.6 % . CONCLUSION Evaluation of wound progress is clearly difficult . Human nature makes us favour novelty if we believe it is going to be better . Making interpretation more objective removed that bias and did not demonstrate a significant advantage for the test dressing . The findings suggest that unblinded assessment by trial nurses is unacceptable on its own . Blinded assessment s may miss finer nuances of wound progression , but are likely to be more accurate . The authors suggest that the true result lies somewhere in the middle , with the trial dressing likely to be as effective as , but not more effective than , a st and ard dressing
target: The most under-reported items were concealment of allocation , blinding of patients and outcome assessors , intention to treat and validation of outcomes .
background: BACKGROUND In the process of conducting a systematic review on interventions for skin lesions due to neuritis in leprosy , we assessed several primary papers with respect to the quality of reporting and methods used in the studies .
  Awareness of what constitutes weak points in previously conducted studies may be used to improve the planning , conducting and reporting of future clinical trials .
  AIMS To assess the quality of reporting and of methodology  in studies of interventions for skin lesions due to neuritis in leprosy .