***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: Background The COSMIN checklist is a tool for evaluating the method ological quality of studies on measurement properties of health-related patient-reported outcomes . The aim of this study is to determine the inter-rater agreement and reliability of each item score of the COSMIN checklist ( n = 114 ) . Methods 75 articles evaluating measurement properties were r and omly selected from the bibliographic data base compiled by the Patient-Reported Outcome Measurement Group , Oxford , UK . Raters were asked to assess the method ological quality of three articles , using the COSMIN checklist . In a one-way design , percentage agreement and intraclass kappa coefficients or quadratic-weighted kappa coefficients were calculated for each item . Results 88 raters participated . Of the 75 selected articles , 26 articles were rated by four to six participants , and 49 by two or three participants . Overall , percentage agreement was appropriate ( 68 % was above 80 % agreement ) , and the kappa coefficients for the COSMIN items were low ( 61 % was below 0.40 , 6 % was above 0.75 ) . Reasons for low inter-rater agreement were need for subjective judgement , and accustom to different st and ards , terminology and definitions . Conclusions Results indicated that raters often choose the same response option , but that it is difficult on item level to distinguish between articles . When using the COSMIN checklist in a systematic review , we recommend getting some training and experience , completing it by two independent raters , and reaching consensus on one final rating . Instructions for using the checklist are improved BACKGROUND The Patient Assessment of Constipation- Quality of Life ( PAC-QOL ) is a self-reported question naire measuring health-related quality of life ( HRQL ) of constipated patients and was used as secondary endpoint in three identical double-blind , r and omized , placebo-controlled Phase III clinical trials . These 12-week trials in subjects with severe chronic constipation evaluated the effects of prucalopride , a selective 5-HT(4 ) agonist given orally once daily . METHODS To consoli date the main treatment effect results observed in the prucalopride trial population s , analyses were undertaken on the pooled data of the three trials to confirm the psychometric properties of the PAC-QOL and to provide guidance for the interpretation of the clinical significance of its scores . KEY RESULTS The evaluation of the psychometric properties confirmed the PAC-QOL reliability , validity and responsiveness to measure the impact of chronic constipation symptoms on HRQL in the prucalopride trials . The 1-point improvement in PAC-QOL scores used as target response level for the main treatment effect analyses was vali date d as a relevant definition of response for treatment group comparisons . Cumulative distribution curves , drawn for each treatment group to provide more complete information on treatment effects than single minimal important difference point estimates , demonstrated consistent superior effects of prucalopride over placebo on all PAC-QOL scores . CONCLUSIONS & INFERENCES The PAC-QOL question naire is a useful measurement tool to assess , from a patient perspective , the potential therapeutic value of chronic constipation treatments in clinical trials and , by directly reflecting the patient 's own perspective on constipation and its treatment , eventually also for informing daily medical practice The Memorial Symptom Assessment Scale ( MSAS ) is a new patient-rated instrument that was developed to provide multidimensional information about a diverse group of common symptoms . This study evaluated the reliability and validity of the MSAS in the cancer population . R and omly selected in patients and out patients ( n = 246 ) with prostate , colon , breast or ovarian cancer were assessed using the MSAS and a battery of measures that independently evaluate phenomena related to quality of life . Symptom prevalence in the 218 evaluable patients ranged from 73.9 % for lack of energy to 10.6 % for difficulty swallowing . Based on a content analysis , three symptoms were deleted and two were added ; the revised scale evaluates 32 physical and psychological symptoms . A factor analysis of variance yielded two factors that distinguished three major symptom groups and several subgroups . The major groups comprised psychological symptoms ( PSYCH ) , high prevalence physical symptoms ( PHYS H ) , and low prevalence physical symptoms ( PHYS L ) . Internal consistency was high in the PHYS H and PSYCH groups ( Cronback alpha coefficients of 0.88 and 0.83 , respectively ) , and moderate in the PHYS L group ( alpha = 0.58 ) . Although the severity , frequency and distress dimensions were highly intercorrelated , canonical correlations and other analyses demonstrated that multidimensional assessment ( frequency and distress ) augments information about the impact of symptoms . High correlations with clinical status and quality of life measures support the validity of the MSAS and indicate the utility of several subscale scores , including PSYCH , PHYS , and a brief Global Distress Index . The MSAS is a reliable and valid instrument for the assessment of symptom prevalence , characteristics and distress . It provides a method for comprehensive symptom assessment that may be useful when information about symptoms is desirable , such as clinical trials that incorporate quality of life measures or studies of symptom epidemiology Background / Aim : A large number of diseases are ascribed to Helicobacter pylori ( H. pylori ) , particularly chronic active gastritis , peptic ulcer disease and gastric cancer . Successful treatment of H. pylori infection with antimicrobial agents can lead to regression of H. pylori – associated disorders . Antibiotic resistance against H. pylori is increasing , and it is necessary to find new effective agents . Nigella sativa seed ( NS ) , a commonly used herb , possesses in vitro anti-helicobacter activity . The present study was undertaken to evaluate the efficacy of NS in eradication of H. pylori infection in non-ulcer dyspeptic patients . Material s and Methods : The study was conducted on 88 adult patients attending King Fahd Hospital of the University , Al-Khobar , Saudi Arabia , from 2007 to 2008 , with dyspeptic symptoms and found positive for H. pylori infection by histopathology and urease test . Patients were r and omly assigned to four groups , receiving i ) triple therapy ( TT ) comprising of clarithromycin , amoxicillin , omeprazole [ n= 23 ] , ii ) 1 g NS + 40 mg omeprazole ( OM ) [ n= 21 ] , iii ) 2 g NS + OM [ n= 21 ] or iv ) 3 g NS + OM [ n= 23 ] . Negative H. pylori stool antigen test four weeks after end of treatment was considered as eradication . Results : H. pylori eradication was 82.6 , 47.6 , 66.7 and 47.8 % with TT , 1 g NS , 2 g NS and 3 g NS , respectively . Eradication rates with 2 g NS and TT were statistically not different from each other , whereas H. pylori eradication with other doses was significantly less than that with TT ( P < 0.05 ) . Dyspepsia symptoms improved in all groups to a similar extent . Conclusions : N. sativa seeds possess clinical ly useful anti-H. pylori activity , comparable to triple therapy . Further clinical studies combining N. sativa with antibiotics are suggested Laryngopharyngeal reflux ( LPR ) is present in up to 50 % of patients with voice disorders . Currently , there is no vali date d instrument that documents symptom severity in LPR . We developed the reflux symptom index ( RSI ) , a self-administered nine-item outcomes instrument for LPR . The purpose of this investigation was to evaluate the psychometric properties of the RSI . For validity assessment , 25 patients with LPR were evaluated prospect ively before and six months after b.i.d . treatment with proton pump inhibitors ( PPI ) .  Each patient completed the RSI as well as the 30-item voice h and icap index ( VHI ) . For reliability assessment , the study patients were given the RSI on two separate occasions before the initiation of treatment . Normative RSI data were derived from 25 age-matched and gender-matched controls taken from an existing data base of asymptomatic individuals without any evidence of LPR . The mean RSI ( + /- st and ard deviation ) of patients with LPR improved from 21.2 ( + /- 10.7 ) to 12.8 ( + /- 10.0 ) , and the mean VHI improved from 52.2 ( + /- 24.7 ) to 41.5 ( + /- 25.0 ) after 6 months of therapy ( p = 0.001 and 0.065 , respectively ) . Of the three VHI subscales ( emotional , physical , functional ) , only the functional subscale improved significantly ( p = 0.037 ) . Patients who experienced a five point or better improvement in RSI were 11 times more likely to experience a five-point improvement in VHI ( 95 % confidence interval = 1.7 , 76.8 ) . For reliability assessment , the first and second pretreatment RSIs were 19.9 ( + /- 11.1 ) and 20.9 ( + /- 9.6 ) , respectively ( correlation coefficient = 0.81 , p < 0.001 ) . The single-item correlation coefficients ranged from 0.41 to 0.91 ( p < 0.05 for all items ) . The mean pretreatment RSI in patients with LPR was significantly higher than controls ( 21.2 versus 11.6 ; p < 0.001 ) . The mean RSI of patients with LPR after 6 months of PPI therapy approached that of asymptomatic controls ( p > 0.05 ) . The RSI is easily administered , highly reproducible , and exhibits excellent construct and criterion-based validity Background The aim was to evaluate and vali date a bowel disease question naire in patients attending an out-patient gastroenterology clinic in Greece . Methods This was a prospect i ve study . Diagnosis was based on detailed clinical and laboratory evaluation . The question naire was tested on a pilot group of patients . Interviewer-administration technique was used . One-hundred- and -forty consecutive patients attending the out-patient clinic for the first time and fifty healthy controls selected r and omly participated in the study .  Reliability ( kappa statistics ) and validity of the question naire were tested . We used logistic regression models and binary recursive partitioning for assessing distinguishing ability among irritable bowel syndrome ( IBS ) , functional dyspepsia and organic disease patients . Results Mean time for question naire  completion was 18 min . In test-retest procedure a good agreement was obtained ( kappa statistics 0.82 ) . There were 55 patients diagnosed as having IBS , 18 with functional dyspepsia ( Rome I criteria ) , 38 with organic disease .  Location of pain was a significant distinguishing factor , patients with functional dyspepsia having no lower abdominal pain ( p < 0.001 ) . Significant factors distinguishing between IBS and functional dyspepsia were relief of pain by either antacids or defecation ( 19 % vs 71 % and 66 % vs 0 % respectively ) . Awakening from pain at night was also a factor distinguishing between IBS and organic disease groups ( 26 % vs 61 % , p < 0.01 ) . Conclusions This question naire for functional bowel disease is a valid and reliable instrument that can distinguish satisfactorily between organic and functional disease in an out-patient setting Background After colorectal surgery , patients often experience impaired functional outcome . Faecal incontinence grading systems and self- assessment question naires are frequently used to assess these complaints . The available faecal incontinence grading systems have been vali date d , but have a limited focus , while more comprehensive question naires , which have been developed , have not been vali date d. Aims To investigate the reliability and validity of a newly developed , colorectal functional outcome ( COREFO ) question naire and of Dutch translations of the Hallböök question naire and an adapted version of the Vaizey question naire . Patient/ methods Two hundred fifty-seven patients with and without impaired functional outcome after ( colorectal ) surgery received a booklet containing the three question naires in r and om order by mail .  One hundred seventy-nine ( 70 % ) completed them , and 160 patients ( 90 % ) completed a retest within , on average , 18 days . Results / findings Reliability and validity were adequate for the COREFO and Hallböök question naire , with slight differences in the psychometric analyses in favour of the COREFO question naire . Significantly more patients found the COREFO question naire to reflect their problems best . The reliability of the Vaizey question naire was not sufficient . Interpretation/ conclusions The newly developed COREFO question naire and the previously unvali date d Hallböök question naire are both suitable instruments to evaluate functional outcome after colorectal surgery . The psychometric analyses showed a slight difference in favour of the COREFO question naire and significantly more patients preferred the COREFO question naire to the other question naires . Therefore , we prefer to use the COREFO question naire in future research Objectives For the measurement of  patient-reported outcomes , such as ( health-related ) quality of life , often many measurement instruments exist that intend to measure the same construct . To facilitate instrument selection , our aim was to develop a highly sensitive search filter for finding studies on measurement properties of measurement instruments in PubMed and a more precise search filter that needs less abstract s to be screened , but at a higher risk of missing relevant studies . Methods A r and om sample of 10,000 PubMed records ( 01 - 01 - 1990 to 31 - 12 - 2006 ) was used as a gold st and ard . Studies on measurement properties were identified using an exclusion filter and h and search ing . Search terms were selected from the relevant records in the 
    Output:
    
: GI PROs cover a wide range of biopsychosocial symptoms .
Although plentiful , GI PROs are limited by low method ological quality .