Short and long-term psychosocial consequences of participating in a colorectal cancer screening programme: a matched longitudinal study.

OBJECTIVES: To investigate the psychosocial consequences of receiving a false-positive (no abnormalities) result or being diagnosed with polyps compared with receiving a negative result in a colorectal cancer (CRC) screening programme. DESIGN AND SETTING: This was a longitudinal study nested in the roll-out of the Danish CRC screening programme that targets all individuals aged 50-74 years. PARTICIPANTS: In the inclusion period (April-September 2017), all positive screenees (n=1854) were consecutively enrolled and matched 2:1:1 on sex, age (±2 years), municipality and screening date with negative screenees (n=933) and individuals not yet invited to screening (n=933).Questionnaires were sent by mail to all eligible participants in Region Zealand, Denmark, after the screening result, 2 months and 12 months after the final result.Positive screenees who did not receive the follow-up procedure were excluded. MAIN OUTCOME MEASURES: The primary outcomes were psychosocial consequences. Outcomes were measured with the CRC screening-specific questionnaire Consequences of screening in CRC with 11 outcomes after the screening result and with 21 outcomes at the two later assessments. RESULTS: After receiving the screening result, individuals with no abnormalities, low-risk and medium-risk and high-risk polyps scored significantly worse on 8 of 11 outcomes compared with the negative screenee group. At the 12-month follow-up, the differences were still significant in 8 of 21 outcomes (no abnormalities), 4 of 21 outcomes (low-risk polyps) and 10 of 21 outcomes (medium-risk and high-risk polyps). The negative screenee group and the group not yet invited to screening differed psychosocially on 5 of 11 outcomes after the screening result, but on none of the 21 outcomes at the 2 months and 12 months follow-up. CONCLUSIONS: The study showed that there are both short-term and long-term psychosocial consequences associated with receiving a no abnormalities result or being diagnosed with polyps. The consequences were worst for individuals diagnosed with medium-risk and high-risk polyps.

Psychosocial consequences of invitation to colorectal cancer screening: a matched cohort study.

BACKGROUND: Psychosocial consequences of colorectal cancer (CRC) screening can arise anywhere in the screening cascade. Previous studies have investigated the consequences of participating in CRC screening; however, we have not identified any studies investigating the psychosocial consequences of receiving the invitation. Therefore, the objective of this study was to investigate psychosocial consequences of invitation to CRC screening. METHODS: The study was a longitudinal study performed in Region Zealand, Denmark. Participants included in this study were a random sample of 1000 CRC screening invitees and 1000 control persons, not invited to screening, matched in a 1:1 design on sex, age and municipality. We assessed psychosocial consequences before and after invitation in both study groups concurrently. The primary outcomes were psychosocial consequences measured with the condition-specific questionnaire Consequences of Screening in ColoRectal Cancer. RESULTS: Preinvitation response rates were 575 (57.5%) and 610 (61.0%) for the invitation group and control group, respectively. Postinvitation response rates were 442 (44.2%) for the invitation group and 561 (56.1%) for the control group.No differences in mean change in scale score were seen except for the scale 'Change in body perception'. The invitation group had a 0.39 lower change (99% CI (-0.78 to -0.004), p=0.009) in mean score than the control group in the direction of a less negative body perception after invitation. CONCLUSIONS: This study did not identify an association between invitation to CRC screening and negative psychosocial consequences.

Effects of numerical information on intention to participate in cervical screening among women offered HPV vaccination: a randomised study.

OBJECTIVES: To investigate the effects of different types of information about benefits and harms of cervical screening on intention to participate in screening among women in the first cohorts offered human papilloma virus (HPV) vaccination. DESIGN: Randomised survey study. SETTING: Denmark. SUBJECTS: A random sample of women from the birth cohorts 1993, 1994 and 1995 drawn from the general population. INTERVENTIONS: A web-based questionnaire and information intervention. We randomised potential respondents to one of the following four different information modules about benefits and harms of cervical screening: no information; non-numerical information; and two numerical information modules. Moreover, we provided HPV-vaccinated women in one of the arms with numerical information about benefits and harms in two steps: firstly, information without consideration of HPV vaccination and subsequently information conditional on HPV vaccination. MAIN OUTCOME MEASURE: Self-reported intention to participate in cervical screening. RESULTS: A significantly lower proportion intended to participate in screening in the two groups of women receiving numerical information compared to controls with absolute differences of 10.5 (95% CI: 3.3-17.6) and 7.7 (95% CI: 0.4-14.9) percentage points, respectively. Among HPV-vaccinated women, we found a significantly lower intention to participate in screening after numerical information specific to vaccinated women (OR of 0.38). CONCLUSIONS: Women are sensitive to numerical information about the benefits and harms of cervical screening. Specifically, our results suggest that HPV-vaccinated women are sensitive to information about the expected changes in benefits and harms of cervical screening after implementation of HPV vaccination. KEY POINTS Women were less likely to participate in cervical screening when they received numerical information about benefits and harms compared to non-numerical or no information. Specifically, numerical information about the potential impact of the reduced risk of cervical cancer among HPV-vaccinated women reduced the intention to participate among vaccinated women.

How does HPV vaccination status relate to risk perceptions and intention to participate in cervical screening? a survey study.

BACKGROUND: Women 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. METHODS: A 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. RESULTS: HPV 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. CONCLUSIONS: HPV 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.

Do invitations for cervical screening provide sufficient information to enable informed choice? A cross-sectional study of invitations for publicly funded cervical screening.

OBJECTIVE: 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 false-positive 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.

The impact of HPV vaccination on future cervical screening: a simulation study of two birth cohorts in Denmark.

OBJECTIVES: To 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. DESIGN: Estimation 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. SETTING: Denmark. DATA: The 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 MEASURES: Proportions 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. RESULTS: The 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+). CONCLUSIONS: In 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.

Psychosocial consequences of allocation to lung cancer screening: a randomised controlled trial.

OBJECTIVE: To examine the psychosocial consequences of being allocated to the control group as compared with the screen group in a randomised lung cancer screening trial. METHOD: The 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. RESULTS: There 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. CONCLUSIONS: Participation 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.

Participation bias in a randomised trial of screening for lung cancer.

INTRODUCTION: Participation bias might affect the results and the representability of randomised controlled trials. We investigated the degree of socio-demographic and psychosocial participation bias in the Danish Lung Cancer Screening Trial (DLCST). METHODS: In DLCST the questionnaire COS-LC (Consequences of Screening in Lung Cancer) was used to measure the psychosocial aspects of screening. To investigate a difference with a comparable representative sample from the Danish population, we sent out an inclusion questionnaire to 3999 Danes in the age from 50 to 70 years randomly selected from the Central National Register. Those who completed the inclusion questionnaire and met the inclusion criteria from DLCST received the COS-LC. Those who completed the COS-LC-and thus formed a population sample comparable to DLCST - were compared to the DLCST participants on socio-demographics and psychosocial measures. RESULTS: Participation rates were high among the comparable population sample: 75.3% completed the inclusion questionnaire and 77.4% of those who were eligible completed the COS-LC. The analyses revealed differences between the DLCST participants and the comparable population sample in the following socio-demographic aspects: social group, living alone, gender, age and geographical area. DLCST participants reported less negative psychosocial aspects than the comparable population sample. CONCLUSION: The present study has shown substantial socio-demographic and psychosocial participation bias in DLCST.