ObjectiveTo examine the psychosocial consequences of being allocated to the control group as compared with the screen group in a randomised lung cancer screening trial.MethodThe Danish Lung Cancer Screening Trial, a randomised controlled trial, ran from 2004 to 2010 with the purpose of investigating the benefits and harms of lung cancer screening. The participants in Danish Lung Cancer Screening Trial were randomised to either the control group or the screen group and were asked to complete the questionnaires Consequences Of Screening and Consequences Of Screening in Lung Cancer (COS-LC). The Consequences Of Screening and the COS-LC were used to examine the psychosocial consequences of participating in the study, by comparing the control and the screen groups' responses at the prevalence and at the incidence round.ResultsThere was no statistically significant difference in socio-demographic characteristics or smoking habits between the two groups. Responses to the COS-LC collected before the incidence round were statistically significantly different on the scales ‘anxiety’, ‘behaviour’, ‘dejection’, ‘self-blame’, ‘focus on airway symptoms’ and ‘introvert’, with the control group reporting higher negative psychosocial consequences. Furthermore, the participants in both the control and the screen groups exhibited a mean increase in negative psychosocial consequences when their responses from the prevalence round were compared with their responses from the first incidence round.ConclusionsParticipation in a randomised controlled trial on lung cancer screening has negative psychosocial consequences for the apparently healthy participants—both the participants in the screen group and the control group. This negative impact was greatest for the control group.
SummaryObjective: To investigate whether invitations for publicly funded cervical screening provide sufficient information to enable an informed choice about participation. Design: Cross-sectional study using a checklist of 23 information items on benefits and harms from cervical screening and the risks related to cervical cancer. Material: Invitations to publicly funded cervical screening in 10 Scandinavian and English-speaking countries. Setting: Ten Scandinavian and English speaking countries. Participants: Sixteen screening units representing 10 Scandinavian and English speaking countries. Main outcome measures: Number of information items presented in invitations for cervical screening. Results: We contacted 21 coordinating units from 11 countries and 20 (95%) responded. Of these, four units did not issue invitations, but the remaining 16 coordinating units in 10 different countries supplied a sample. The invitations for cervical screening were generally information poor and contained a median of only four out of 23 information items possible (17%), ranging from 0 to 12 (0-52%). The most important harms of cancer screening, overdiagnosis and overtreatment, were typically downplayed or unmentioned. The same applied to other important harms, such as falsepositive results and the psychological consequences from an abnormal test result. The majority of invitations took a paternalistic approach. While only two invitations (17%) included a pre-assigned appointment date, eight (70%) of the invitations contained strong appeals for participation. Conclusions: Invitations to cervical cancer screening were information poor and biased in favour of participation. This means that informed choice is not possible, which is in conflict with modern requirements for personal involvement in medical decisions.
ObjectivesTo explore the interplay between primary and secondary prevention of cervical cancer by estimating future screening outcomes in women offered human papillomavirus (HPV) vaccination when they were sexually naïve.DesignEstimation of outcome of liquid-based cytology screening for a post-HPV vaccination cohort using pre-vaccination screening data combined with HPV vaccination efficacy data reported in the literature.SettingDenmark.DataThe number of screening diagnoses at first screen in a pre-vaccination birth cohort was multiplied by reported risk reductions expected for women who were vaccinated for HPV before sexual debut. All identified studies were reviewed by two authors, and weighted pooled estimates of vaccine efficacies were used.Main outcome measuresProportions of positive and false-positive cervical cytologies and positive predictive value (PPV) were calculated using cervical intraepithelial neoplasia (CIN) grade 2+ and 3+ as cut-off values.ResultsThe proportion of positive screening tests was reduced from 8.7% before vaccination to 6.5% after vaccination, and the proportion of false-positive screening tests using CIN2+ as a cut-off was reduced from 5.5% pre-vaccination to 4.3% post-vaccination, and using CIN3+ as a cut-off from 6.2% to 4.7%. PPVs were reduced from 23% to 19% (cut-off CIN2+), and from 14% to 12% (cut-off CIN3+).ConclusionsIn our calculations, the proportion of positive screening results with liquid-based cytology will be reduced as a consequence of HPV vaccination, but the reduction is small, and the expected decline in PPV is very limited. In this situation, the information general practitioners will have to provide to their patients will be largely unchanged.
BackgroundWomen in several countries will soon be covered by two preventive programmes targeting cervical cancer: HPV vaccination and cervical screening. The HPV vaccines are expected to prevent approximately 70 % of cervical cancers. It has been speculated, that HPV vaccinated women will not attend screening because they falsely think that the vaccine has eliminated their cervical cancer risk. The aim of this study was to investigate the association between HPV vaccination status and perceptions of cervical cancer risk; perceptions of vaccine effect; and intention to participate in cervical screening. Furthermore, to investigate associations between perceptions of cervical cancer risk and intention to participate in cervical screening.MethodsA random sample of Danish women from the birth cohorts 1993–1995 was invited to complete a web-based questionnaire concerning risk perceptions and intentions to participate in cervical screening. Main outcomes were: perceived lifetime-risk of cervical cancer; perceived HPV vaccine effect; and intention to participate in cervical screening.ResultsHPV vaccinated women more often than unvaccinated women intended to participate in screening: adjusted odds ratio (OR) for being HPV vaccinated when intending to participate in screening of 3.89 (95 % CI: 2.50–6.06). HPV vaccinated women perceived cervical cancer risk to be higher than unvaccinated women did: adjusted OR of 0.11 (95 % CI: 0.03–0.39) and 0.51 (95 % CI: 0.33–0.78) for being HPV vaccinated while having the lowest perception of risk (in two different pre-specified dichotomisations). HPV vaccinated women perceived the vaccine effect to be larger than unvaccinated women did: adjusted OR of 0.31 (95 % CI: 0.18–0.51) and 0.37 (95 % CI: 0.25–0.53) for being HPV vaccinated while having the lowest perception of vaccine effect (in two different pre-specified dichotomisations). There were no associations between perceived cervical cancer risk and intention to participate in screening.ConclusionsHPV vaccinated women more often than unvaccinated women intended to participate in screening and they perceived cervical cancer risk to be higher and the vaccine effect to be larger than unvaccinated women did. However, in our analyses, risk perceptions could not explain screening intentions neither among vaccinated nor among unvaccinated women.Electronic supplementary materialThe online version of this article (doi:10.1186/s12889-016-3397-y) contains supplementary material, which is available to authorized users.
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