***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 In the HPV FOCAL trial , we will establish the efficacy of hr-HPV DNA testing as a st and -alone screening test followed by liquid based cytology ( LBC ) triage of hr-HPV-positive women compared to LBC followed by hr-HPV triage with ≥ CIN3 as the outcome . Methods / Design HPV-FOCAL is a r and omized , controlled , three-armed study over a four year period conducted in British Columbia . It will recruit 33,000 women aged 25 - 65 through the province 's population based cervical cancer screening program . Control arm : LBC at entry and two years , and combined LBC and hr-HPV at four years among those with initial negative results and hr-HPV triage of ASCUS cases ; Two Year Safety Check arm : hr-HPV at entry and LBC at two years in those with initial negative results with LBC triage of hr-HPV positives ; Four Year Intervention Arm : hr-HPV at entry and combined hr-HPV and LBC at four years among those with initial negative results with LBC triage of hr-HPV positive cases Discussion To date , 6150 participants have a completed sample and epidemiologic question naire . Of the 2019 women enrolled in the control arm , 1908 ( 94.5 % ) were cytology negative . Women aged 25 - 29 had the highest rates of HSIL ( 1.4 % ) . In the safety arm 92.2 % of women were hr-HPV negative , with the highest rate of hr-HPV positivity found in 25 - 29 year old women ( 23.5 % ) . Similar results were obtained in the intervention arm HPV FOCAL is the first r and omized trial in North America to examine hr-HPV testing as the primary screen for cervical cancer within a population -based cervical cancer screening program . Trial Registration International St and ard R and omised Controlled Trial Number Register , IS RCT BACKGROUND To determine whether testing for DNA of oncogenic human papillomaviruses ( HPV ) is superior to the Papanicolaou ( Pap ) test for cervical-cancer screening , we conducted a r and omized trial comparing the two methods . METHODS We compared HPV testing , using an assay approved by the Food and Drug Administration , with conventional Pap testing as a screening method to identify high- grade cervical intraepithelial neoplasia in women ages 30 to 69 years in Montreal and St. John 's , Canada . Women with abnormal Pap test results or a positive HPV test ( at least 1 pg of high-risk HPV DNA per milliliter ) underwent colposcopy and biopsy , as did a r and om sample of women with negative tests . Sensitivity and specificity estimates were corrected for verification bias . RESULTS A total of 10,154 women were r and omly assigned to testing . Both tests were performed on all women in a r and omly assigned sequence at the same session . The sensitivity of HPV testing for cervical intraepithelial neoplasia of grade 2 or 3 was 94.6 % ( 95 % confidence interval [ CI ] , 84.2 to 100 ) , whereas the sensitivity of Pap testing was 55.4 % ( 95 % CI , 33.6 to 77.2 ; P=0.01 ) . The specificity was 94.1 % ( 95 % CI , 93.4 to 94.8 ) for HPV testing and 96.8 % ( 95 % CI , 96.3 to 97.3 ; P<0.001 ) for Pap testing . Performance was unaffected by the sequence of the tests . The sensitivity of both tests used together was 100 % , and the specificity was 92.5 % . Triage procedures for Pap or HPV testing result ed in fewer referrals for colposcopy than did either test alone but were less sensitive . No adverse events were reported . CONCLUSIONS As compared with Pap testing , HPV testing has greater sensitivity for the detection of cervical intraepithelial neoplasia . ( Current Controlled Trials number , IS RCT N57612064 [ controlled-trials.com ] . ) BACKGROUND Although testing for human papillomavirus ( HPV ) has higher sensitivity and lower specificity than cytology alone for detecting cervical intraepithelial neoplasia ( CIN ) , studies comparing conventional and liquid-based cytology have had conflicting results . METHODS In the first phase of a two-phase multicenter r and omized controlled trial , women aged 35 - 60 years in the conventional arm ( n = 16,658 ) were screened using conventional cytology , and women in the experimental arm ( n = 16,706 ) had liquid-based cytology  and were tested for high-risk HPV types using the Hybrid Capture 2 assay . Women in the conventional arm were referred to colposcopy with atypical cells of undetermined significance ( ASCUS ) or higher and those in the experimental arm were referred with ASCUS or higher cytology or with a positive ( > or = 1 pg/mL ) HPV test . Sensitivity and positive predictive value ( PPV ) for detection of cervical intraepithelial neoplasia grade 2 or higher ( CIN2 + ) were calculated . RESULTS The screening methods and referral criterion applied in the experimental arm had higher sensitivity than that in the conventional arm ( relative sensitivity = 1.47 ; 95 % confidence interval [ CI ] = 1.03 to 2.09 ) but a lower PPV ( relative PPV = 0.40 ; 95 % CI = 0.23 to 0.66 ) . With HPV testing alone at > or = 1 pg/mL and at > or = 2 pg/mL , the gain in sensitivity compared with the conventional arm remained similar ( relative sensitivity = 1.43 , 95 % CI = 1.00 to 2.04 and relative sensitivity = 1.41 , 95 % CI = 0.98 to 2.01 , respectively ) but PPV progressively improved ( relative PPV = 0.58 , 95 % CI = 0.33 to 0.98 and relative PPV = 0.75 , 95 % CI = 0.45 and 1.27 , respectively ) . Referral based on liquid-based cytology alone did not increase sensitivity compared with conventional cytology ( relative sensitivity = 1.06 ; 95 % CI = 0.72 to 1.55 ) but reduced PPV ( relative PPV = 0.57 ; 95 % CI = 0.39 to 0.82 ) . CONCLUSIONS HPV testing alone was more sensitive than conventional cytology among women 35 - 60 years old . Adding liquid-based cytology improved sensitivity only marginally but increased false-positives . HPV testing using Hybrid Capture 2 with a 2 pg/mL cutoff may be more appropriate than a 1 pg/mL cutoff for primary cervical cancer screening BACKGROUND Primary cervical screening with both human papillomavirus ( HPV ) DNA testing and cytological examination of cervical cells with a Pap test ( cytology ) has been evaluated in r and omized clinical trials . Because the vast majority of women with positive cytology are also HPV DNA positive , screening strategies that use HPV DNA testing as the primary screening test may be more effective . METHODS We used the data base from the intervention arm ( n = 6,257 women ) of a population -based r and omized trial of  double screening with cytology and HPV DNA testing to evaluate the efficacy of 11 possible cervical screening strategies that are based on HPV DNA testing alone , cytology alone , and HPV DNA testing combined with cytology  among women aged 32 - 38 years . The main outcome measures were sensitivity for detection of cervical intraepithelial neoplasia grade 3 or worse ( CIN3 + ) within 6 months of enrollment or at colposcopy for women with a persistent type-specific HPV infection and the number of screening tests and positive predictive value ( PPV ) for each screening strategy . All statistical tests were two-sided . RESULTS Compared with screening by cytology alone , double testing with cytology and for type-specific HPV persistence result ed in a 35 % ( 95 % confidence interval [ CI ] = 15 % to 60 % ) increase in sensitivity to detect CIN3 + , without a statistically significant reduction in the PPV ( relative PPV = 0.76 , 95 % CI = 0.52 to 1.10 ) , but with more than twice as many screening tests needed . Several strategies that incorporated screening for high-risk HPV subtypes were explored , but they result ed in reduced PPV compared with cytology . Compared with cytology , primary screening with HPV DNA testing followed by cytological triage and repeat HPV DNA testing of HPV DNA-positive women with normal cytology increased the CIN3 + sensitivity by 30 % ( 95 % CI = 9 % to 54 % ) , maintained a high PPV ( relative PPV = 0.87 , 95 % CI = 0.60 to 1.26 ) , and result ed in a mere 12 % increase in the number of screening tests ( from 6,257 to 7,019 tests ) . CONCLUSIONS Primary HPV DNA-based screening with cytology triage and repeat HPV DNA testing of cytology-negative women appears to be the most feasible cervical screening strategy Objective To assess which of three triage strategies for women with borderline abnormal cervical smear results in the best psychosocial outcomes . Design Pragmatic , non-blinded , multicentre , r and omised controlled trial . Setting 18 family planning clinics across Australia , covering both urban and rural areas , between January 2004 and October 2006 . Participants Women aged 16 - 70 years ( n=314 ) who attended routine cervical screening and received a borderline cervical smear . Interventions Patients were r and omly assigned to human papillomavirus ( HPV ) DNA testing ( n=104 ) , a repeat smear test at six months ( n=106 ) , or the patient ’s informed choice of either test supported by a decision aid ( n=104 ) . Psychosocial outcomes were assessed at multiple time points over 12 months by postal question naire . Main outcome measures We assessed health related quality of life ( SF36 mental health subscale ) , cognitive effects ( such as perceived risk of cervical cancer , intrusive thoughts ) , affective outcomes ( general anxiety [ state-trait anxiety inventory ] ) , specific anxiety about an abnormal smear ( cervical screening question naire ) , and behavioural outcomes ( sexual health behaviour and visits to the doctor ) over 12 months of follow-up . Results At two weeks , some psychosocial outcomes were worse for women allocated to HPV testing compared with those in the smear testing group ( SF36 vitality subscale : t=−1.63 , df=131 , P=0.10 ; intrusive thoughts χ2=8.14 , df=1 , P<0.01 ) . Over 12 months , distress about the abnormal smear was lowest in women allocated to HPV testing and highest in the repeat smear testing group ( t=−2.89 , df=135 , P<0.01 ) . Intrusive thoughts were highest in patients allocated to HPV testing ( 25 % , compared with 13 % in the informed choice group ; difference=12 % , 95 % CI −1.1 % to 25.1 % ) . Women in the HPV DNA group and the informed choice group were more satisfied with their care than women allocated to repeat smear testing . Conclusions Although the psychosocial effect was initially worse for women allocated to HPV triage , over the full year of follow-up this intervention was better for women ’s psychosocial health than repeat smear testing . Offering informed choice could have a small advantage for cognitive outcomes , but in view of the additional effort and logistical complexity that this intervention requires , HPV testing alone can be justified for most women . Trial Registration actr.org.au Identifier : BACKGROUND Testing for human papillomavirus ( HPV ) DNA is reportedly more sensitive than cytology for the detection of high- grade cervical intraepithelial neoplasia ( CIN ) . The effectiveness of HPV testing in primary cervical screening was assessed in the ARTISTIC trial , which was done over two screening rounds approximately 3 years apart ( 2001 - 03 and 2004 - 07 ) by comparing liquid-based cytology ( LBC ) combined with HPV testing against LBC alone . METHODS Women aged 20 - 64 years who were undergoing routine screening as part of the English National Health Service Cervical Screening Programme in Greater Manchester were r and omly assigned ( between July , 2001 , and September , 2003 ) in a ratio of 3:1 to either combined LBC and HPV testing in which the results were revealed and acted on , or to combined LBC and HPV testing where the HPV result was concealed from the patient and investigator . The primary outcome was the detection rate of cervical intraepithelial neoplasia grade 3 or worse ( CIN3 + ) in the second screening round , analysed by intention to treat . This trial is registered with the International St and ard R and omised Controlled Trial Number IS RCT N25417821 . FINDINGS There were 24 510 eligible women at entry ( 18 386 in the revealed group , 6124 in the concealed group ) . In the first round of screening 233 women ( 1.27 % ) in the revealed 
    Output:
    
Four fair- to good- quality diagnostic accuracy studies and 4 fair- to good- quality RCTs showed mixed results of cotesting ( HPV plus cytology )  in women aged 30 years or older compared with cytology alone , with no clear advantage over primary HPV screening .