***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: OBJECTIVE Effects of pump treatment vs. four times daily injections were explored in children with diabetes with regard to quality of life and impact of disease as well as adverse effects and parameters of metabolic control . METHODS An open , parallel , r and omized controlled prospect i ve comparative study lasting 14 months was completed by 38 type 1 children with diabetes ( age 4 - 16 yr ) following a 3.5-months run-in phase . St and ardized quality -of-life Pediatric Quality of life Inventory ( PedsQL ) and impact of disease scores were obtained every 3.5 months as well as regular medical parameters . Parallel treatment group data and longitudinal within-patient data were analysed for each treatment modality . RESULTS Within-patient comparisons of the two treatment modalities showed significant improvement in PedsQL and impact scores after pump treatment . Treatment group comparisons did not show significant improvement . Pump treatment result ed in decreased symptomatic hypoglycaemia and lowered haemoglobin A1c by 0.22 % after run in . CONCLUSIONS Within-patient comparison suggests that metabolic control , frequency of severe hypoglycaemia ( a threefold decrease ) , quality of life and impact of disease scores are improved by pump treatment in comparison to regular treatment with four daily insulin injections BACKGROUND The management of diabetes in preschool children poses unique difficulties for both the families and the medical team . OBJECTIVE To test the feasibility and safety of insulin pump therapy in the 1 - 6 year age group in order to improve quality of life and metabolic control . METHODS The study group comprised 15 type 1 diabetic children aged 1 - 6 years old ( mean + /- SD , 3.8 + /- 1.2 years ) from three diabetes centers .  Insulin pump therapy was applied for 12 months . Data , including insulin dose , hemoglobin A1c , hypoglycemic events , as well as scores on the Diabetes Quality of Life Measure Question naire and the Diabetes Treatment Satisfaction Question naire , were collected and compared with the multiple daily injection treatment prior to entry into the study , RESULTS HbA1c was measured at the beginning of the study and at 2 , 4 , 8 and 12 months later ; the respective levels ( mean + /- SD ) were 8.82 + /- 0.98 , 8.45 + /- 1.05 , 8.37 + /- 0.85 , 8.32 + /- 0.71 , 8.18 + /- 0.90 % . HbA1c measurements after 12 months were significantly lower than at the beginning of the study ( P < 0.05 ) . There were no significant differences in insulin dose and the total number of hypoglycemic events . In both the DQOL and DTSQ scales there were significant differences in scores in favor of the insulin pump period ( 43.7 + /- 8.0 versus 33.7 + /- 7.9 , P < 0.001 ; and 10.9 + /- 2.3 versus 14.5 + /- 2.3 , P < 0.001 ) , respectively . CONCLUSIONS For very young diabetic children , insulin pump therapy improves quality of life and is feasible and safe . It should be considered as an optional mode of therapy for this age group OBJECTIVE Our goals were to determine if continuous subcutaneous insulin infusion ( CSII ) , compared with those continuing multiple daily injections ( MDIs ) , can be safely used in young children , if those on CSII will have superior glycemic control , if subjects using CSII will have less hypoglycemia for their level of control , and if families using CSII will report an improved quality of life . RESEARCH DESIGN AND METHODS We conducted a r and omized 1-year feasibility trial comparing CSII with continuing MDIs in preschool children with a history of type 1 diabetes for at least 6 months ' duration . Prospect i ve outcomes included measures of overall glycemic control ( HbA1c and continuous glucose monitoring system ) , the incidence of severe hypoglycemia and diabetic ketoacidosis , the percent of glucose values below 3.9 mmol/l , and the parents ' report of quality of life . RESULTS The 19 subjects ' ages ranged from 1.7 to 6.1 ( mean 3.6 ) years , duration of diabetes ranged from 0.6 to 2.6 ( mean 1.4 ) years , and baseline HbA1c ranged from 6.7 to 9.6 % ( mean 7.9 % ) . Seven subjects were male . Nine subjects were r and omized to start CSII and 10 to continue on MDI . All baseline characteristics were well balanced . Overall metabolic control , diabetes quality of life , and the incidence of hypoglycemia were similar in the two groups . No subject had diabetic ketoacidosis , while one subject in each group had an episode of severe hypoglycemia . No CSII subject discontinued using the pump during or after the study . CONCLUSIONS CSII can be a safe and effective method to deliver insulin in young children BACKGROUND The Cochrane Collaboration is strongly encouraging the use of a newly developed tool , the Cochrane Collaboration Risk of Bias Tool ( CCRBT ) , for all review groups . However , the psychometric properties of this tool to date have yet to be described . Thus , the objective of this study was to add information about psychometric properties of the CCRBT including inter-rater reliability and concurrent validity , in comparison with the Effective Public Health Practice Project Quality Assessment Tool ( EPHPP ) . METHODS Both tools were used to assess the method ological quality of 20 r and omized controlled trials included in our systematic review of the effectiveness of knowledge translation interventions  to improve the management of cancer pain . Each study assessment was completed independently by two review ers using each tool . We analysed the inter-rater reliability of each tool 's individual domains , as well as final grade assigned to each study . RESULTS The EPHPP had fair inter-rater agreement for individual domains and excellent agreement for the final grade . In contrast , the CCRBT had slight inter-rater agreement for individual domains and fair inter-rater agreement for final grade . Of interest , no agreement between the two tools was evident in their final grade assigned to each study . Although both tools were developed to assess ' quality of the evidence ' , they appear to measure different constructs . CONCLUSIONS Both tools performed quite differently when evaluating the risk of bias or method ological quality of studies in knowledge translation interventions for cancer pain . The newly introduced CCRBT assigned these studies a higher risk of bias . Its psychometric properties need to be more thoroughly vali date d , in a range of research fields , to underst and fully how to interpret results from its application Intensive therapy for type 1 diabetes mellitus ( DM ) is usually provided by either multiple daily injections of insulin ( MDI ) or by insulin pump ( continuous subcutaneous insulin infusion CSII ) . We design ed an open , r and omized , crossover trial to compare CSII with MDI for glycemic control , dose requirements , weight change , incidence of adverse events , quality of life and satisfaction in adolescents Purpose : To review research design s for rehabilitation . Summary of Key Points : Single-case , observational , and qualitative design s are highlighted in terms of recent advances and ability to answer important scientific questions about rehabilitation . Statement of Conclusions : Single-case , observational , and qualitative design s can be conducted in a systematic and rigorous manner that provides important information that can not be acquired using more common design s , such as r and omized controlled trials . These less commonly used design s may be more feasible and effective in answering many research questions in the field of rehabilitation . Recommendations for Clinical Practice : Research ers should consider these design s when selecting the optimal design to answer their research questions . We should improve education about the advantages and disadvantages of existing research design s to enable more critical analysis of the scientific literature we read and review to avoid undervaluing studies not within more commonly used categories OBJECTIVE To compare the efficacy and feasibility of continuous subcutaneous insulin infusion ( CSII ) with multiple daily insulin injections ( MDI ) in children with type 1 diabetes . METHODS The study sample included 23 children ( 10 males ) aged 9.4 to 13.9 years with type 1 diabetes . An open r and omized crossover design was used to compare 3.5 months of CSII to 3.5 months of MDI therapy for the following variables : diabetic control , incidence of adverse events , daily insulin requirement , body mass index st and ard deviation scores , treatment satisfaction , and quality of life . RESULTS The changes in HbA(1c ) and fructoseamine values were similar in the 2 arms over time . At the end of the study , mean HbA(1c ) level measured 8.05 + /- 0.78 % . There were no differences between the treatment modes in frequency of symptomatic hypoglycemic or hyperglycemic events . There was 1 event of severe hypoglycemia during pump therapy and 3 during MDI , yielding a rate of 0.26 events per patient-year . There were no episodes of diabetic ketoacidosis . Body mass index st and ard deviation scores decreased during CSII and increased during MDI , as did mean insulin dose . Patients expressed a higher treatment satisfaction from CSII than MDI , although there was no difference in quality of life between the 2 modes . CONCLUSIONS Intensive insulin therapy by either insulin pump or MDI is safe in children and young adolescents with type 1 diabetes , with similar diabetes control and a very low rate of adverse events . We suggest that both modes be available to the diabetic team to better tailor therapy BACKGROUND The risk of developing long-term complications of type 1 diabetes ( T1D ) is related to glycaemic control and is reduced by the use of intensive insulin treatment regimens : multiple daily injections ( MDI ) ( ≥ 4 ) and continuous subcutaneous insulin infusion ( CSII ) . Despite a lack of evidence that the more expensive treatment with CSII is superior to MDI , both treatments are used widely within the NHS . OBJECTIVES ( 1 ) To compare glycaemic control during treatment with CSII and MDI and ( 2 ) to determine safety and cost-effectiveness of the treatment , and quality of life ( QoL ) of the patients . DESIGN A pragmatic , open-label r and omised controlled trial with an internal pilot and 12-month follow-up with 1 : 1 web-based block r and omisation stratified by age and centre . SETTING Fifteen diabetes clinics in hospitals in Engl and and Wales . PARTICIPANTS Patients aged 7 months to 15 years . INTERVENTIONS Continuous subsutaneous insulin infusion or MDI initiated within 14 days of diagnosis of T1D . DATA SOURCES Data were collected at baseline and at 3 , 6 , 9 and 12 months using paper forms and were entered central ly . Data from glucometers and CSII were downloaded . The Health Utilities Index Mark 2 was completed at each visit and the Pediatric Quality of Life Inventory ( PedsQL , diabetes module ) was completed at 6 and 12 months . Costs were estimated from hospital patient administration system data . OUTCOMES The primary outcome was glycosylated haemoglobin ( HbA1c ) concentration at 12 months . The secondary outcomes were ( 1 ) HbA1c concentrations of < 48 mmol/mol , ( 2 ) severe hypoglycaemia , ( 3 ) diabetic ketoacidosis ( DKA ) , ( 4 ) T1D- or treatment-related adverse events ( AEs ) , ( 5 ) change in body mass index and height st and ard deviation score , ( 6 ) insulin requirements , ( 7 ) QoL and ( 8) partial remission rate . The economic outcome was the incremental cost per quality -adjusted life-year ( QALY ) gained . RESULTS A total of 293 participants , with a median age of 9.8 years ( minimum 0.7 years , maximum 16 years ) , were r and omised ( CSII , n = 149 ; MDI , n = 144 ) between May 2011 and January 2015 . Primary outcome data were available for 97 % of participants ( CSII , n = 143 ; MDI , n = 142 ) . At 12 months , age-adjusted least mean squares HbA1c concentrations were comparable between groups : CSII , 60.9 mmol/mol [ 95 % confidence interval ( CI ) 58.5 to 63.3 mmol/mol ] ; MDI , 58.5 mmol/mol ( 95 % CI 56.1 to 60.9 mmol/mol ) ; and the difference of CSII - MDI , 2.4 mmol/mol ( 95 % CI -0.4 to 5.3 mmol/mol ) . For HbA1c concentrations of < 48 mmol/mol ( CSII , 22/143 participants ; MDI , 29/142 participants ) , the relative risk was 0.75 ( 95 % CI 0.46 to 1.25 ) , and for partial remission rates ( CSII , 21/86 participants ; MDI , 21/64 ) , the relative risk was 0.74 ( 95 % CI 0.45 to 1.24 ) . The incidences of severe hypoglycaemia ( CSII , 6/144 ; MDI , 2/149 participants ) and DKA ( CSII , 2/144 participants ; MDI , 0/149 participants ) were low . In total , 68 AEs ( 14 serious ) were reported during CSII treatment and 2 
    Output:
    
RESULTS QoL and glycaemic control was significantly better in CSII subjects at baseline and follow-up .
No significant differences in adverse events were found between study groups .
No significant changes over time could be shown for either QoL or glycaemic control .
CONCLUSION CSII proved to provide similar or slightly better outcomes in all analysed fields .
This is consistent with previous research .