"Rescue" of Nonparticipants in Colorectal Cancer Screening: A Randomized Controlled Trial of Three Noninvasive Test Options.

Few studies have directly targeted nonparticipants in colorectal cancer screening to identify effective engagement strategies. We undertook a randomized controlled trial that targeted nonparticipants in a previous trial of average-risk subjects which compared participation rates for mailed invitations offering a fecal test, a blood test or a choice of either. Nonparticipants (n = 899) were randomized to be offered a kit containing a fecal immunochemical test (FIT), directions on how to arrange a blood DNA test, or the option of doing either. Screening participation was assessed 12 weeks after the offer. To assess the cognitive and attitudinal variables related to participation and invitee choice, invitees were surveyed after 12 weeks, and associations were investigated using multinomial logistic regression. Participation rates were similar between groups (P = 0.88): 12.0% for FIT (35/292), 13.3% for the blood test (39/293), and 13.4% for choice (39/290). Within the choice group, participation was significantly higher with FIT (9.7%, 28/290) compared with the blood test (3.8%, 11/290, P = 0.005). The only variable significantly associated with participation was socioeconomic status when offered FIT, and age when offered choice but there was none when offered the blood test. Survey respondents indicated that convenience, time-saving, comfort, and familiarity were major influences on participation. There was no clear advantage between a fecal test, blood test, or choice of test although, when given a choice, the fecal test was preferred. Differences in variables associated with participation according to invitation strategy warrant consideration when deciding upon an invitation strategy for screening nonparticipants. PREVENTION RELEVANCE: This trial of screening for those at average risk for colorectal cancer targeted past fecal-test nonparticipants and compared participation rates for mailed invitations offering a fecal test, blood test, or choice of either. Although there was no clear advantage between strategies, factors associated with participation differed between each strategy.

Refusal of viral testing during the SARS-CoV-2 pandemic.

Widespread testing for the respiratory syndrome coronavirus-2 (SARS-CoV-2) will represent an important part of any strategy designed to safely reopen societies from lockdown. Healthcare settings have the potential to become reservoirs of infectivity, and therefore many hospital trusts are beginning to carry out routine screening of staff and patients. This could promote the effective cohorting of patients and reduce the rate of nosocomial infection. However, for various reasons, some individuals may refuse this testing. Here we highlight this as an emergent ethicolegal issue which we expect to become increasingly relevant as testing becomes ubiquitous. We explore this position from an ethical and legal perspective, determining whether refusal of testing is acceptable under UK law. Individual patients refusing testing could undermine a hospital's testing strategy; therefore clinicians and policy makers must prospectively determine the best course of action if this were to occur.

Which orthopaedic trauma patients are likely to refuse to participate in a clinical trial? A latent class analysis.

OBJECTIVE: The study aimed to assess systematic differences in the characteristics of patients that consented for the trial compared with the broader pool of eligible patients in a large, pragmatic orthopaedic trauma trial. DESIGN: A retrospective observational study performed from April 2017 to March 2018. SETTING: Academic trauma centre in Baltimore, USA. PARTICIPANTS: There were 642 eligible adult trial participants with an operative fracture to the appendicular skeleton and were indicated for blood clot prophylaxis. The median age of the sample was 50 years (IQR: 31-63), and 60% were male. PRIMARY OUTCOME MEASURE: The primary outcome was the refusal to enrol in the trial. Demographic and injury covariates were included in iterations of latent class models. The final model was selected based on a minimum Bayesian information criterion. RESULTS: The final model identified three clusters with five covariates predictive of cluster membership (age, neighbourhood-based socioeconomic status, alcohol use, multiple fractures, multiple surgeries). The three clusters were associated with 22% (Cluster 1), 38% (Cluster 2) and 62% (Cluster 3) refusal rates, respectively. Members of Cluster 3 (n=84) were most commonly between 66 and 80 years of age (49% vs 6% (Cluster 1) and 21% (Cluster 2)), of high neighbourhood-based socioeconomic status (85% vs 63% (Cluster 1) and 8% (Cluster 2)), with isolated fractures (100% vs 80% (Cluster 1) and 92% (Cluster 2)), and were less likely to have multiple surgeries compared with the other clusters (28% vs 47% (Cluster 1) and 35% (Cluster 2)). CONCLUSION: In this study, the likelihood of refusing to participate in the trial ranged from 22% to 62% in the three identified clusters. Elderly age, high socioeconomic status, and less severe injuries defined the cluster that was most likely to refuse trial participation. TRIAL REGISTRATION NUMBER: NCT02984384.

Who says "no" to participating in stroke clinical trials and why: an observational study from the Vancouver Stroke Program.

BACKGROUND: Successful stroke trials require adequate recruitment. In this observational study, we assessed reasons for refusal to provide informed consent in eligible patients approached for clinical trial participation at the Vancouver Stroke Program. METHODS: We assessed screening logs from four trials that were actively recruiting at our center: three randomized trials, two of which investigated different antithrombotic strategies for secondary prevention (NAVIGATE-ESUS, NCT02313909 12/2014; DATAS-II, NCT02295826 11/2014) and one that investigated surgery plus medical management versus medical management alone for primary prevention (CREST-2, NCT02089217 03/2014). The fourth study was observational and non-randomized; all participants received an external monitoring device (PROPHECY, NCT03712865 10/2018). Screening logs from June 2015 to April 2017 were reviewed retrospectively. Subsequently, we used a prospective structured case report form for screening (May 2017-March 2018). We assessed and compared refusal rates between trials, demographics of those refusing consent, and their reasons for doing so. We used descriptive statistics, chi-square and Fisher's exact tests as appropriate for non-parametric data, and t-tests for parametric data. We examined likelihood of refusal by sex using multivariable logistic regression models including age and trial intervention as co-variables. RESULTS: A total of 235 patients (43% women) were approached for consent. More patients refused the surgical (59%) and antithrombotic trials (53%) compared with the non-randomized external monitoring device study (13%) (p < 0.001). Surgical trial refusals were primarily due to a desire for certainty in receiving a particular intervention (39%), with the majority of those patients wanting surgery. Refusals for the antithrombotic trials were mainly due to concerns with the potential side effects of the study drug (41%); refusals in the device trial were mainly due to disinterest (46%). Women refused participation more often than men (48% vs 33%). Women remained less likely to consent than men, even after adjustment for age and trial intervention (OR 0.46, 95% CI 0.26-0.82, p = 0.009). CONCLUSIONS: Concern surrounding drug safety, randomization, and disinterest were the chief deterrents to enrolment; there were also differences in rates of consent by gender. A better understanding of why patients refuse participation in stroke trials may help to develop future patient-directed communication strategies to improve enrolment. Further research is required to better understand the reasons underlying gender disparities in consent rates.

Understanding how, why, for whom, and under what circumstances opt-out blood-borne virus testing programmes work to increase test engagement and uptake within prison: a rapid-realist review.

BACKGROUND: Prisons represent a unique opportunity to diagnose blood-borne viruses. Opt-out testing is receiving increasing interest, as a result of mounting evidence to suggest that the manner in which a test offer is delivered, affects test uptake. Although the effectiveness of opt-out testing within the prison setting has been established, robust explanations are required for the variation in outcomes reported. METHODS: Rapid-realist review methodology was used to synthesise the literature on prison-based opt-out testing. The review was carried out in three phases. Phase one: An expert panel provided literature relevant to the implementation of opt-out testing within the English prison estate. Unstructured searches were also conducted to identify other social programmes where "opt-out" had been used to increase uptake. Phase two: a systematic search of six peer-review and five grey literature databases was carried out to identify empirical data on opt-out testing within the prison setting. Phase three: Additional non-exhaustive searches were carried out to identify literature that reinforced emergent concepts. The development of programme theory took place with each iteration and was validated in consultation with stakeholders. RESULTS: Programme theory was constructed for two outcomes: the proportion of intake offered a test and the proportion offered that accepted testing. The proportion of intake offered testing was influenced by the timing of the test offer, which was often delayed due to barriers to prisoner access. The decision to accept testing was influenced by concerns about confidentiality, fear of a positive diagnosis, a prisoner's personal interpretation of risk, discomfort with invasive procedures, trust in healthcare, and the fidelity of the opt-out offer. CONCLUSIONS: This review identified important implementation considerations that moderate the effectiveness of opt-out testing programmes. It also highlighted a lack of appreciation for the theoretical underpinnings of opt-out programmes and tension around how to implement testing in a manner that adheres to both default theory and informed consent. It is anticipated that results will be used to inform the design and implementation of subsequent versions of these programmes, as well as catalyse further in-depth analysis into their operation within the unique context of prison. REVIEW REGISTRATION: CRD42017068342 .

[Discontinuation of Orthodontic Treatment: what are the early predictive factors?] / Abandons de traitement orthodontique : quels sont les facteurs predictifs precoces ?

INTRODUCTION: Discontinuation of orthodontic treatment has iatrogenic, psychological, ergonomic and financial consequences. The objective of this study was to investigate early risk factors (prior to installation) of discontinuation of orthodontic treatment. MATERIALS AND METHODS: We performed a case-control study between a group of patients who dropped their orthodontic treatment ("A") and a randomly selected group of patients who had completed their orthodontic treatment ("NA"). The two groups were compared, with descriptive, uni and multivariate analyzes. The risk factors assessed were age, gender, socioeconomic status, type of treatment, dysmorphism, malocclusion, need for treatment, compliance. RESULTS: In the dropout group 55 patients were included ("A") and 100 in the non-abandoned ("NA") group randomly selected. The subject at risk of abandonment was a girl of less than 11 years of age with a low socio-economic level with antero-posterior and vertical skeletal dysmorphisms, a molar class II, a teeth crowding, a small aesthetic prejudice or, on the contrary, very important, complex treatment (with extractions or with surgery) and having delays or missed appointments before the installation of the orthodontic appliance. CONCLUSION: Patients' motivation needs to be strengthened for both extremes: treatments that appear simple and conversely for complex cases requiring strong cooperation.

A Randomized Controlled Trial of Opt-in Versus Opt-Out Colorectal Cancer Screening Outreach.

OBJECTIVES: METHODS:: RESULTS:: Patients randomized to opt-in agreed to participate 23.1% of the time, and only 2.5% of those in opt-out chose not to participate. FIT kits were mailed to 22.4% and 93% of patients in opt-in and opt-out arms, respectively. In intention-to-screen analysis, patients in the opt-out arm had a higher FIT completion rate (29.1%) than in the opt-in arm (9.6%) (absolute difference 19.5%; 95% confidence interval, 10.9-27.9%; P < .001). Results were similar in subgroup analysis of those sent initial messaging through the EHR portal (9.5% opt-in versus 37.5% in opt-out). CONCLUSIONS: .

Informing future research for carriage of multiresistant Gram-negative bacteria: problems with recruiting to an English stool sample community prevalence study.

OBJECTIVES: This study aims to highlight problems with recruiting to an English stool sample community prevalence study. It was part of a larger cross-sectional research to determine the risk factors for the presence of extended-spectrum beta-lactamase and carbapenemase-producing coliforms in stool samples of the asymptomatic general English population. SETTING: Four National Health Service primary care trusts (PCTs) of England representing a different section of the population of England: Newham PCT; Heart of Birmingham Teaching PCT; Shropshire County PCT; and Southampton City PCT. PARTICIPANTS: Sixteen general practices across the four PCTs were purposefully selected. After stratification of GP lists by age, ethnicity and antibiotic use, 58 337 randomly selected patients were sent a postal invitation.Patients who had died, moved to a different surgery, were deemed too ill by their General Practitioner or hospitalised at the time of mailing were excluded. RESULTS: Stool and questionnaire returns varied by area, age, gender and ethnicity; the highest return rate of 27.3% was in Shropshire in the age group of over 60 years; the lowest, 0.6%, was in Birmingham in the age group of 18-39 years. Whereas only 3.9%(2296) returned a completed questionnaire and stool sample, 94.9% of participants gave permission for their sample and data to be used in future research. CONCLUSION: Researchers should consider the low stool specimen return rate and wide variation by ethnicity and age when planning future studies involving stool specimen collection. This is particularly pertinent if the study has no health benefit to participants. Further research is needed to explore how to improve recruitment in multicultural communities and in younger people.

Characteristics and prognosis of patients with early-stage endometrial cancer who refuse adjuvant radiotherapy.

OBJECTIVE: To investigate the risk factors for refusing adjuvant radiotherapy in patients who have undergone surgery for early-stage endometrial cancer, and to compare their survival rates with patients who have undergone adjuvant radiotherapy. METHODS: Data from the Surveillance, Epidemiology, and End Results database for patients operated on for histologically-proven early-stage endometrioid endometrial cancer, between 1988 and 2012, were screened. Univariate and multivariate logistic regression analyses tested the associations between refusal of adjuvant radiotherapy and demographic, tumoral, and management characteristics. Overall and cancer-related survival rates were compared between 376 patients who refused adjuvant radiotherapy and 752 patients who received adjuvant radiotherapy, matched for demographics (age, race, year of diagnosis, marital status, region), tumoral (grade, FIGO stage, size), and management (lymphadenectomy performed) criteria. RESULTS: 434 of the 16,014 patients (2.7%) who were proposed adjuvant radiotherapy refused this treatment. Older, widowed, divorced, or separated patients, who were recently diagnosed and managed in the Northern plains or Pacific coast (USA), with limited tumoral extension, were more likely to refuse adjuvant radiotherapy. Five-year cancer-related survival was significantly lower in patients who refused adjuvant radiotherapy (88.9% vs. 95.7%, p<0.001) whereas overall survival did not significantly differ between the two groups (76.4% vs. 83.7%, p=0.23). CONCLUSIONS: We have identified the patients' characteristics related to refusal of adjuvant radiotherapy. Refusing adjuvant radiotherapy increased cancer-related death but probably does not reduce overall survival.

Teste do bafômetro: resultados e recusas de motoristas interceptados pela Operação Lei Seca no Rio de Janeiro / Breathalyzer test: results and refusals to take the test of drivers intercepted under the DUI Spot-Check Campaign in Rio de Janeiro

Resumo Estudo transversal que avaliou os resultados e as recusas ao teste do bafômetro entre motoristas interceptados pela Operação Lei Seca na capital do Rio de Janeiro e Baixada Fluminense. Realizado com base em dados cedidos pelo Governo do Estado que foram coletados durante atendimento de motoristas interceptados entre dezembro de 2013 e janeiro de 2014. Procederam-se análises descritivas da amostra e de associação entre as variáveis sexo, faixa etária e local de abordagem com as recusas e os resultados do teste do bafômetro através de um modelo de regressão logística. Dos 4756 (100%) condutores interceptados, 59 (1,2%) apresentaram resultado positivo no teste do bafômetro e 229 (4,8%) recusaram-no. Apenas a variável local de abordagem apresentou significância estatística com maiores chances de resultados positivos (OR = 4,01) e recusas ao teste (OR = 5,14) entre os condutores interceptados na Baixada Fluminense. As ações sistemáticas de fiscalização efetuadas pela Operação Lei Seca que ocorrem há mais tempo na capital parecem influenciar positivamente o comportamento de beber e dirigir dos motoristas.

Abstract Abstract This paper involved a cross-sectional study that evaluated the results and refusals to take the breathalyzer test among drivers intercepted by the Driving Under the Influence (DUI) Spot-Check Campaign (Operação Lei Seca) in the capital of Rio de Janeiro and Baixada Fluminense. It was conducted using data provided by the State Government which were collected from drivers intercepted in the months of December 2013 and January 2014. Descriptive analysis was conducted of the sample and of the association between gender, age and location variables with the result of the breathalyzer test and refusal to take the test using a logistic regression model. Of the 4756 (100%) drivers intercepted, 59 (1.2%) failed the breathalyzer test and 229 (4.8%) refused to take it. Only the location of interception variable was statistically significant with greater chances of failing (OR = 4.01) and refusal to take the test (OR = 5.14) among drivers intercepted in the Baixada Fluminense. Systematic monitoring actions taken by the DUI Spot-Check Campaign that have occurred for longer in the capital appear to have a positive impact on the drinking and driving behavior of drivers.

Comparing socially disadvantaged smokers who agree and decline to participate in a randomised smoking cessation trial.

OBJECTIVES: This study examined sociodemographic, smoking and psychosocial characteristics associated with consent to participate in a smoking cessation trial for socially disadvantaged smokers. DESIGN: Baseline data were collected prior to seeking consent for the Call it Quits, a randomised controlled trial. SETTING: An Australian social and community service organisation. Sociodemographic, smoking and psychosocial characteristics were compared between smokers who agreed or declined to participate. PARTICIPANTS: Of the 584 smokers invited to participate, 431 (74%) consented and 153 (26%) declined. RESULTS: Logistic regression modelling indicates the ORs of participation were twice as high for those reporting 'high' motivation to quit compared to the 'moderate' motivation group, and five times higher than the 'low' motivation group (p=0.007). The ORs of consenting were higher for those with a preference for gradual reduction in cigarettes in quit attempts compared with 'no preference'. The ORs were lower for those reporting 'don't know' regarding their enjoyment of smoking compared to 'not at all' enjoying smoking, and reporting that fewer of their family or friends smoked compared to 'most or all'. CONCLUSIONS: This study is the first to examine the characteristics of socially disadvantaged smokers who consent or decline to participate in a smoking cessation trial. Low-income smokers who are motivated to quit, are not enjoying smoking, had family or friends who smoked, and who are interested in gradual cessation approaches may be more likely to participate in a smoking cessation trial. TRIAL REGISTRATION NUMBER: ISRCTN85202510.

Variation in mortality patterns among the general population, study participants, and different types of nonparticipants: evidence from 25 years of follow-up.

The general willingness to participate in health surveys is decreasing, resulting in increasingly selected study populations. We aimed to examine relative mortality rates by different categories of nonparticipation. We included 14,223 men and women aged 25-74 years who were sampled in the Swiss centers of the international Monitoring of Trends and Determinants in Cardiovascular Disease (MONICA) Study (1983-1992) and followed-up until 2008. Logistic regression was used to describe factors associated with nonparticipation. We compared persons who refused to participate (n = 2,911), persons who did not go to their examination (n = 470), and persons that could not be contacted for inclusion in the MONICA Study (n = 989) with participants (n = 9,853). We used Cox regression to determine mortality hazard ratios for the various categories of nonparticipants versus participants or versus the 1990 Census population average. Persons who refused were more likely to be older and female. Compared with participants, those who refused had a higher risk of death (for men, hazard ratio = 1.34, 95% confidence interval: 1.17, 1.54; for women, hazard ratio = 1.31, 95% confidence interval: 1.12, 1.52), whereas persons who did not go to their examination and those who could not be contacted did not differ. Compared with the general (census) population, participants had a lower risk of all-cause mortality and those who refused had a higher risk of all-cause mortality. These variations were mainly due to cardiovascular disease and not cancer. Variations in relative mortality risks between study participants and the general population could depend on the proportion of subjects who actively refused to participate in the study. Considering the increasing participation reluctance, our findings underline the importance of carefully assessing the reasons for nonparticipation.

[Metaanalysis to estimate the expected drop out-rates reported in clinical trials on cataract surgery]. / Metaanalyse zur Schätzung der in klinischen Studien zur Kataraktchirurgie zu erwartenden drop out-Rate.

BACKGROUND: A realistic sample size calculation is crucial to achieve significant results in clinical trials. As an expected drop out-rate has to be included in the sample size calculation, current practice consists in the presumption of drop out-rates published in previous similar investigations. This approach may, however, result in severely over- or under-estimated sample sizes. Therefore this meta-analysis sought to aggregate the drop out-rates from published clinical trial reports on cataract surgery to derive a quantitative suggestion for the planning of future clinical trials. METHODS: The data collection was a complete review of all prospective and retrospective studies in five journals of the years 2002-2012; trial-wise recall rates of subjects at follow-up 3, 6, 12, and 24 months after recruitment were documented. The primary endpoint of the meta-analysis was the reported drop out-rates after 6 months. 95 % confidence intervals were calculated for each trial, respectively; a median drop out-rate was estimated including its 95 % confidence interval. The drop-out-rate estimates were furthermore stratified by design characteristics of the reported studies. RESULTS: For randomised clinical trials on cataract surgery, the median drop out-rate increased during the follow-up period of 24 months from 4 % at three months to 17 % at 24 months after recruitment; for the six-month drop out-rate a median drop-out rate of 3 % (95 % CI 0 %; 14 %) was estimated. CONCLUSION: Drop out-rates in sample size calculations for clinical trials on cataract surgery were found to be over-estimated in general, ending up in the calculation of overly large patient numbers and thereby in both ethical and economic consequences. For randomised clinical trials on cataract surgery the median drop out-rate can be expected to be 5 % during a six-month follow-up and may rise up to 15 % during a 12-month trial period.

Participant recruitment in sensitive surveys: a comparative trial of 'opt in' versus 'opt out' approaches.

BACKGROUND: Although in health services survey research we strive for a high response rate, this must be balanced against the need to recruit participants ethically and considerately, particularly in surveys with a sensitive nature. In survey research there are no established recommendations to guide recruitment approach and an 'opt-in' system that requires potential participants to request a copy of the questionnaire by returning a reply slip is frequently adopted. However, in observational research the risk to participants is lower than in clinical research and so some surveys have used an 'opt-out' system. The effect of this approach on response and distress is unknown. We sought to investigate this in a survey of end of life care completed by bereaved relatives. METHODS: Out of a sample of 1422 bereaved relatives we assigned potential participants to one of two study groups: an 'opt in' group (n=711) where a letter of invitation was issued with a reply slip to request a copy of the questionnaire; or an 'opt out' group (n=711) where the survey questionnaire was provided alongside the invitation letter. We assessed response and distress between groups. RESULTS: From a sample of 1422, 473 participants returned questionnaires. Response was higher in the 'opt out' group than in the 'opt in' group (40% compared to 26.4%: χ(2) =29.79, p-value<.01), there were no differences in distress or complaints about the survey between groups, and assignment to the 'opt out' group was an independent predictor of response (OR=1.84, 95% CI: 1.45-2.34). Moreover, the 'opt in' group were more likely to decline to participate (χ(2)=28.60, p-value<.01) and there was a difference in the pattern of questionnaire responses between study groups. CONCLUSION: Given that the 'opt out' method of recruitment is associated with a higher response than the 'opt in' method, seems to have no impact on complaints or distress about the survey, and there are differences in the patterns of responses between groups, the 'opt out' method could be recommended as the most efficient way to recruit into surveys, even in those with a sensitive nature.

HIV test avoidance among people who inject drugs in Thailand.

Case identification is a key component of HIV prevention efforts; yet rates of HIV testing remain low in some settings. We explored factors associated with HIV test avoidance among people who inject drugs (IDU) in Thailand. Between July and October 2011, 350 Thai IDU participated in the study. In bivariate analyses, male gender, high intensity drug use, syringe sharing, increased police presence, and being refused healthcare services were positively associated with HIV test avoidance, while ever receiving a hepatitis C test was negatively associated. Our findings highlight the need for interventions to reduce stigma in this setting.

Determinants for refusal of HIV testing among women attending for antenatal care in Gambella Region, Ethiopia.

BACKGROUND: In Gambella region, inhabitants owe socio-cultural factors that might favor refusal for HIV testing service utilization among Antenatal Care attendees. OBJECTIVE: To assess determinants for refusal of HIV testing service utilization among ANC attendees in Gambella Region. METHODS: A comparative cross sectional study was conducted among ANC attendees from March 2008 to May 2008 in four selected health facilities of Gambella region. Sample size of 332 participants (83 who refused HIV testing and 249 who accepted HIV testing) were taken for the study. The study was supplemented with four focus group discussions. Multivariate binary logistic regression was employed to control for confounding factors. RESULTS: When adjusted with other factors pregnant women with 2-3 live births in the past; who claimed divorce as a perceived response of their husband following HIV positive test result; who had not sought agreement from their husband for testing; disclosure of test for husband and being from certain ethnic group (E.g. Mejenger) were independent predictors for refusal of HIV testing among ANC attendees. CONCLUSION AND RECOMMENDATION: Based on the findings, the following recommendations were forwarded: Provision of innovative information and education on the pre-test session for those pregnant women having two or more children; community involvement to tackle stigma; women empowerment; designing couple friendly counseling service; and fighting harmful traditional practices related with decision of HIV testing.

Factors affecting participation in group intervention in patients after adjuvant treatment for early-study breast cancer.

BACKGROUND AND PURPOSE: According to studies of patients with cancer, support groups can help in three areas: 1) improve mood; 2) introduce new, adaptive ways of handling potentially difficult situations; and 3) impart strategies for managing stress. Nevertheless, the decrease in the quality of life of cancer patients or survivors does not always translate into their utilization of available psychosocial services. The aim of the current study was to explore the factors affecting the decision of patients with breast cancer to participate in group intervention based on an enhancing-resilience approach. METHODS: One hundred eighty-nine patients who were diagnosed with early-stage breast cancer at a tertiary hospital and had completed adjuvant therapy at least three months previously were asked to enroll in the study with or without group intervention. One hundred and one (53.4%) completed the battery of psychological questionnaires, of whom 56 agreed to participate in the intervention. Sociodemographic and medical data were collected for all 189 subjects from the medical files. RESULTS: No significant differences in sociodemographic or medical data were found between intervention-group participants (N = 56) and non-participants (N = 133). Group participants reported significantly higher levels of psychological pathology. Subjects who completed the questionnaires but did not participate in the intervention reported significantly higher levels of positive cognitive emotion regulation and flexibility than participants. CONCLUSION: Low participation in group interventions may be more strongly associated with psychological characteristics than sociodemographic and medical factors. It seems that patients know to perceive whether their personal resources are inadequate for facing a life-threatening illness. Like individual therapy, group interventions should be more sensitive to perceived individual needs and to the art of tailoring suitable contents according individual needs.

Participation rates in the selection of population controls in a case-control study of colorectal cancer using two recruitment methods.

OBJECTIVES: Low participation rates in the selection of population controls are an increasing concern for the validity of case-control studies worldwide. METHODS: We conducted a pilot study to assess two approaches to recruiting population controls in a study of colorectal cancer, including a face-to-face interview and blood sample collection. In the first approach, persons identified through a population roster were invited to participate through a telephone call by an interviewer telephoning on behalf of our research center. In the second approach, individuals were identified from the lists of selected family practitioners and were telephoned on behalf of the family practitioner. RESULTS: When the second method was used, participation rates increased from 42% to 57% and the percentage of refusals decreased from 47% to 13%. The reasons for refusing to participate did not differ significantly between the two methods. CONCLUSIONS: Contact through the family practitioner yielded higher response rates in population controls in the study area.

[HPV-Hr detection by home self sampling in women not compliant with pap test for cervical cancer screening. Results of a pilot programme in Bouches-du-Rhône]. / L'auto-prélèvement vaginal à domicile pour recherche de papilloma virus à haut risque. Campagne expérimentale du département des Bouches-du-Rhône.

The non-participation to cervical screening is the major determinant in the risk of mortality due to cervical cancer. In France, around 40% of women do not participate to regular screening. The cultural or economic barriers for performing screening by Pap test are numerous; one of the most frequent is the refusal of gynaecological examination. A persistent HPV(HR) infection is a necessary factor for developing cervical cancer. The HPV(HR) testing has a high sensibility to detect high grade cervical intra-epithelial neoplasia (CIN 2-3) and a satisfactory specificity after 30-35 years old. The principal objective of this study was to compare the participation rates in women 35-69 years old who did not perform a Pap test after a first individual invitation, either when an HPV(HR) auto-test was offered to be performed at home or a second invitation to Pap test was sent. We also evaluated the quality of the two tests, the positive results obtained by age groups and the following histological type of lesions diagnosed in the women with positive results. The study included 9,334 women, 35-69 years old, who did not realized a Pap-test during the 2 previous years and who did not respond at a first individual invitation. These non-responders were randomized into two groups: one group (n=4,934) received a second individual invitation and the other (n=4,400) an offer of receiving and performing an HPV auto-test at home. In women 35-69 years the participation to the second invitation to Pap test was significantly lower (7.2%) than the participation to auto-test (26.4%) with P<0.001. The quality of the two tests was satisfactory; the auto-test was not altered by the postage to laboratory (non interpretable rate=1.4% [CI at 95%=0.65%; 2.15%]. From the 311 Pap tests done, 5.5% (17) were classified "abnormal" (nine ASCUS, one high grade and seven low grades). The follow up of 13 women out of 17 confirmed the diagnosis for 1 case of CIN2 and 2 cases of CIN3, 4 women are lost of follow up after 6 months. From the 939 HPV(HR) tests done, 6.2% (58) were positive. Such positivity rate was not influenced by age. Out of the 58 positive HPV(HR) cases, 27 only were of the 16 genotype (46.5% [CI 95%=33.7%; 59.3%]). This law rate is a consequence of an inversion of the ratio HPV 16 versus other types in women 60 years old and over. In this group, the follow-up of 36 women diagnosed five cases of CIN1, one of CIN2 and four of CIN3; 22 patients are lost of follow up at 6 months. Globally, in the studied population, an individual recall for pap test allowed to diagnose and treat 3 high grade lesions (7‰) and the dispatching of an auto test allowed the diagnosis and treatment of five high grade lesions (1,4‰), this difference is significant (P=0.02; OR=0.25 [0.05; 0.97]). The HPV(HR) auto-test seems to be better accepted than the Pap test in the 35-69 years old women previously non-responders to individual invitation, and the quality of the test is satisfactory. Such a test can be proposed to the 35-69 years old non-participant to Pap test to increase the coverage for cervical screening, if the rates of diagnostic examinations performed in case of an HPV(HR) positive is sufficiently high.

Recruitment of representative samples for low incidence cancer populations: do registries deliver?

BACKGROUND: Recruiting large and representative samples of adolescent and young adult (AYA) cancer survivors is important for gaining accurate data regarding the prevalence of unmet needs in this population. This study aimed to describe recruitment rates for AYAs recruited through a cancer registry with particular focus on: active clinician consent protocols, reasons for clinicians not providing consent and the representativeness of the final sample. METHODS: Adolescents and young adults aged 14 to 19 years inclusive and listed on the cancer registry from January 1 2002 to December 31 2007 were identified. An active clinician consent protocol was used whereby the registry sent a letter to AYAs primary treating clinicians requesting permission to contact the survivors. The registry then sent survivors who received their clinician's consent a letter seeking permission to forward their contact details to the research team. Consenting AYAs were sent a questionnaire which assessed their unmet needs. RESULTS: The overall consent rate for AYAs identified as eligible by the registry was 7.8%. Of the 411 potentially eligible survivors identified, just over half (n = 232, 56%) received their clinician's consent to be contacted. Of those 232 AYAs, 65% were unable to be contacted. Only 18 AYAs (7.8%) refused permission for their contact details to be passed on to the research team. Of the 64 young people who agreed to be contacted, 50% (n = 32) completed the questionnaire. CONCLUSIONS: Cancer registries which employ active clinician consent protocols may not be appropriate for recruiting large, representative samples of AYAs diagnosed with cancer. Given that AYA cancer survivors are highly mobile, alternative methods such as treatment centre and clinic based recruitment may need to be considered.