***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: The prevalence of sexual dysfunction in schizophrenia patients was investigated as part of this large ( n = 7655 ) , prospect i ve , international ( 27 countries ) study . Based on patient reports , sexual dysfunction affected approx . 50 % of patients and the prevalence of complaints varied significantly between regions ( p < 0.0001 ) . The prevalence of sexual dysfunction , as perceived by psychiatrists , also varied significantly across regions ( p < 0.0001 ) . Psychiatrists significantly underestimated the presence of impotence/sexual dysfunction ( p < 0.0001 ) and loss of libido ( p < 0.0001 ) , compared to reports from patients . The frequency of sexual dysfunction was significantly higher in patients who had been using prolactin-elevating antipsychotics prior to study entry , compared to those who had been treated with prolactin-sparing antipsychotics ( patient reports , p = 0.002 ; psychiatrist perception , p = 0.0004 ) . This study has shown that the prevalence of sexual dysfunction is high in both male and female patients with schizophrenia and frequently underestimated by psychiatrists . Regional variation is evident in both psychiatrist perceptions and patient reports of sexual dysfunction . Given the importance of sexual function to quality of life and treatment compliance , proactive assessment of sexual function is required to optimize schizophrenia management This study compares two methods for elicitation of  treatment-emergent side effects .  One is the open-ended general inquiry and the other is a specific inquiry that asks about a wide range of events thought to be treatment-related . The study goal was to determine the extent to which the specific inquiry method elicits clinical ly useful information over and above that elicited by the general inquiry method . The assessment instrument we used is SAFTEE , a structured interview schedule developed by the National Institute of Mental Health . We looked for differences between general and specific inquiry formats in terms of number of events elicited , type of event , severity , functional impairment , and clinician action taken . We found that both methods contributed to elicitation of events that , in the clinician 's opinion , required some change in management . However , events reported on the General Inquiry form were significantly more distressing , more often interfered with daily functioning , and elicited more extensive changes in clinical management . No medically serious events were elicited on the specific inquiry form alone . Based on these findings , and in view of the amount of time and effort required to administer and score it , we do not recommend the specific inquiry form of SAFTEE as a st and ard assessment tool for routine use in all clinical trials . We do consider it to be a useful method for comprehensive elicitation about treatment-emergent effects in targeted and specific research context s. We see the schedule as a comprehensive document or library of queries to be tailored to the needs of individual protocol CONTEXT R and omized trials with adequate sample size offer an opportunity to assess the safety of new medications in a controlled setting ; however , generalizable data on drug safety reporting are sparse . OBJECTIVE To scrutinize the completeness of safety reporting in r and omized trials .  DESIGN , SETTING , AND PATIENTS Survey of safety reporting in 192 r and omized drug trials 7 diverse topics with sample sizes of at least 100 patients and at least 50 patients in a study arm ( N = 130074 patients ) . Trial reports were identified from comprehensive meta-analyses in 7 medical areas . MAIN OUTCOME MEASURES Adequate reporting of specific adverse effects and frequency and reasons for withdrawals due to toxic effects ; article space allocated to safety reporting and predictors of such reporting . RESULTS Severity of clinical adverse effects and laboratory-determined toxicity was adequately defined in only 39 % and 29 % of trial reports , respectively . Only 46 % of trials stated the frequency of specific reasons for discontinuation of study treatment due to toxicity . For these 3 parameters , there was significant heterogeneity in rates of adequate reporting across topics ( P = .003 , P<.001 , and P = .02 , respectively ) . Overall , the median space allocated to safety results was 0.3 page . A similar amount of space was devoted to contributor names and affiliations ( P = .16 ) . On average , the percentage of space devoted to safety in the results section was 9.3 % larger in trials involving dose comparisons than in those that did not ( P<.001 ) and 3.8 % smaller in trials reporting statistically significant results for efficacy outcomes ( P = .047 ) . CONCLUSIONS The quality and quantity of safety reporting vary across medical areas , study design s , and setting s but they are largely inadequate . Current st and ards for safety reporting in r and omized trials should be revised to address this inadequacy Background We would expect information on adverse drug reactions in r and omised clinical trials to be easily retrievable from specific search es of electronic data bases . However , complete retrieval of such information may not be straightforward , for two reasons . First , not all clinical drug trials provide data on the frequency of adverse effects . Secondly , not all electronic records of trials include terms in the abstract or indexing fields that enable us to select those with adverse effects data . We have determined how often automated search methods , using indexing terms and /or textwords in the title or abstract , would fail to retrieve trials with adverse effects data . Methods We used a sample set of 107 trials known to report frequencies of adverse drug effects , and measured the proportion that ( i ) were not assigned the appropriate adverse effects indexing terms in the electronic data bases , and ( ii ) did not contain identifiable adverse effects textwords in the title or abstract . Results Of the 81 trials with records on both MEDLINE and EMBASE , 25 were not indexed for adverse effects in either data base . Twenty-six trials were indexed in one data base but not the other . Only 66 of the 107 trials reporting adverse effects data mentioned this in the abstract or title of the paper . Simultaneous use of textword and indexing terms retrieved only 82/107 ( 77 % ) papers . Conclusions Specific search strategies based on adverse effects textwords and indexing terms will fail to identify nearly a quarter of trials that report on the rate of drug adverse effects We sought to identify differences in the description of adverse drug experiences in reports of r and omized clinical trials ( RCTs ) from the United States and Japan , using diclofenac and simvastatin as test drugs . Reports were identified in Medline ( Index Medicus 1966 - 1990 ) , EMBASE ( Excerpta Medica 1974 - 1990 ) , JAPICDOC ( 1979 - 1990 ) , and JOIS-III ( JMEDICINE 1980 - 1990 ) . In each search keywords describing study design were paired with the drugs ' generic names , chemical names , and development numbers . Twenty-seven U.S. reports ( 18 for diclofenac and 9 for simvastatin ) and 22 Japanese reports ( 17 for diclofenac and 5 for simvastatin ) identified in these four data bases were selected for review . For each paper we identified the relation of the article to the data ( preliminary , primary , and secondary reports , review s ) , the means of identifying adverse reactions , the principal outcomes of the trials , and a variety of descriptive measures relating to study design , authors hip , and elements of presentation . With few exceptions , Japanese reports were not indexed in English- language data bases , and studies from the United States were not carried out in the Japanese data bases . The Japanese literature consisted exclusively of primary reports of clinical trials , whereas the U.S. literature was dominated by review articles and secondary reports of data from trials not fully published elsewhere . Japanese reports contained more detail on adverse experiences but reported principally those attributed to the drugs by attending clinicians . U.S. reports by contrast offered little detail but tended to include all adverse experiences , whether or not clinical ly attributed to drugs . A preponderance of U.S. articles reported significant differences between drugs in safety or treatment efficacy , whereas only one third of the Japanese articles did so for the same agents . Reports from both countries offered few details of the methods used to gather information on adverse drug experiences , and as a result the reported absolute frequencies of such events are difficult to compare between trials or to generalize to other setting s. In conclusion , the reporting of adverse reactions in clinical trials is inadequate in both the United States and Japanese literature . The shortcomings are complementary in that reports of U.S. trials contain insufficient detail and Japanese reports do not interpret or synthesize experience . Clinical research into drug safety in both countries could be improved through the adoption of simple st and ards of clarity and consistency in the monitoring and reporting of drug adverse effects BACKGROUND Reports of clinical trials usually emphasize efficacy results , especially when results are statistically significant . Poor safety reporting can lead to misinterpretation and inadequate conclusions about the interventions assessed . Our aim was to describe the reporting of harm-related results from r and omized controlled trials ( RCTs ) . METHODS We search ed the MEDLINE data base for reports of RCTs published from January 1 , 2006 , through January 1 , 2007 , in 6 general medical journals with a high impact factor . Data were extracted by use of a st and ardized form to appraise the presentation of safety results in text and tables . RESULTS Adverse events were mentioned in 88.7 % of the 133 reports . No information on severe adverse events and withdrawal of patients owing to an adverse event was given in 27.1 % and 47.4 % of articles , respectively . Restrictions in the reporting of harm-related data were noted in 43 articles ( 32.3 % ) with a description of the most common adverse events only ( n = 17 ) , severe adverse events only ( n = 16 ) , statistically significant events only ( n = 5 ) , and a combination of restrictions ( n = 5 ) . The population considered for safety analysis was clearly reported in 65.6 % of articles . CONCLUSION Our review reveals important heterogeneity and variability in the reporting of harm-related results in publications of RCTs Objective : This r and omized double‐blind multicenter trial evaluated the effects of  olanzapine vs. clozapine  on subjective well‐being , quality of life ( QOL ) and clinical outcome Background : Despite much being written on the topic , there are few surveys investigating the prevalence of anticholinergic adverse effects of antipsychotic drugs . One study , however , used trial-derived data to calculate estimates . Objectives : To investigate the prevalence/incidence rates of anticholinergic effects as viewed from within relevant r and omized trials . Methods : Data were extracted from each relevant study included in Cochrane review s. Data were checked , extracted , and simple frequencies , and 95 % confidence intervals ( CIs ) were calculated . Results : Many trials in relevant review s reported no data on anticholinergic effects ( estimate 40,000 participants ) . However , data were extracted from 177 studies within 54 review s ( N = 27,328 participants ) . Most data are short-term ( < 12 weeks ) . For blurred vision , the newer generations of drugs have rates of between 10 % and 20 % ( eg , risperidone , n = 1460 , 6 r and omized controlled trials [ RCTs ] , 11.9 % prevalence ; CI , 10 - 14 ; olanzapine , n = 1584 ; 4 RCTs , 12.2 % prevalence ; CI , 11 - 14 ) . These estimates are similar to those of sulpiride ( n = 186 ; 2 RCTs , 12.4 % ; CI , 8 - 18 ) and chlorpromazine ( n = 294 ; 10 RCTs , 11.2 % ; CI , 8 - 15 ) , less than trifluoperazine ( n = 167 ; 8 RCTs , 31.1 % ; CI , 25 - 39 ) , but considerably more than perphenazine ( n = 410 ; 8 RCTs , 3.7 % ; CI , 2 - 6 ) . Data are presented on a range of anticholinergic effects across different periods . Conclusions : Anticholinergic symptoms are common adverse effects associated with the use of all antipsychotic drugs , and newer-generation drugs are not clearly distinguishable from many older compounds . Adverse effect data should be more accessible Recent research indicates that subjective well-being is a major determinant of medication compliance in schizophrenia . However , it is yet unresolved whether atypical neuroleptics differ regarding subjective side-effects . A self-report instrument has been constructed to evaluate ' subjective well-being under neuroleptics  ' ( SWN ) . The primary aims of the present study were to develop a short form of the SWN and to investigate the extent to which the atypical antipsychotic improves the patient 's subjective well-being . The short form of the SWN was constructed following an item analysis based on data from 212 schizophrenic patients medicated with either typical or atypical antipsychotics .  The short form of the SWN showed sufficient internal consistency and good construct validity . The SWN was only moderately correlated with positive and negative syndrome scale ( PANSS ) scores or changes in psychopathology ( r=-0.20 to -0.37 ) . SWN-ratings in patients receiving olanzapine were superior compared to those of patients medicated with either clozapine or risperidone on three of five domains of well-being . Clozapine reduced global psychiatric symptoms significantly more than risperidone . It is concluded that the assessment of subjective well-being under antipsychotic treatment provides an independent outcome measure which is relevant to compliance This study examined the relationship of the therapeutic alliance to the treatment course and outcome of 143 patients with nonchronic schizophrenia . Results showed that patients who formed good alliances with their therapists within the first 6 months of treatment were significantly more likely 
    Output:
    
RESULTS Neurological , metabolic , and sedation-related cognitive effects were reported more systematic ally than affective , anticholinergic , autonomic , cutaneous , hormonal , miscellaneous , and nonsedative cognitive effects .
The global impact of AEs on patient well-being was poorly assessed .