Participation bias in a randomised trial of screening for lung cancer

Hestbech, Mie Sara; Siersma, Volkert; Dirksen, Asger; Pedersen, Jesper Holst; Brodersen, John

doi:10.1016/j.lungcan.2010.12.018

Cited by 79 publications

(73 citation statements)

References 33 publications

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“…Although participants in screening trials experience increased distress as a result of nodule detection, they are unlikely representative of patients in routine care, particularly in terms of sociodemographic and psychosocial characteristics (38,39). In addition, communication processes in trials are different than in routine care.…”

Section: Original Researchmentioning

confidence: 99%

Distress and Patient-Centered Communication among Veterans with Incidental (Not Screen-Detected) Pulmonary Nodules. A Cohort Study

et al. 2015

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Rationale: Incidental pulmonary nodule detection is postulated to cause distress, but the frequency and magnitude of that distress have not been reported. The quality of patient-clinician communication and the perceived risk of lung cancer may influence distress Objectives: To evaluate the association of communication processes with distress and the perceived risk of lung cancer using validated instruments. Methods:We conducted a prospective cohort study of patients with incidentally detected nodules who received care at one Department of Veterans Affairs Medical Center. We measured distress with the Impact of Event Scale and patient-centered communication with the Consultation Care Measure, both validated instruments. Risk of lung cancer was self-reported by participants. We used multivariable adjusted logistic regression to measure the association of communication quality with distress.Measurements and Main Results: Among 122 Veterans with incidental nodules, 23%, 12%, and 4% reported experiencing mild, moderate, and severe distress, respectively, at the time they were informed of the pulmonary nodule. Participant-reported risk of lung cancer was not associated with distress. In the adjusted model, high-quality communication was associated with decreased distress (odds ratio [OR] = 0.28, 95% confidence interval [CI] = 0.08-1.00, P = 0.05). Among participants who reported a risk of malignancy of 30% or less, high-quality communication was associated with decreased distress (OR = 0.15, 95% CI = 0.02-0.92, P = 0.04), but was not associated with distress for those who reported a risk greater than 30% (OR = 0.12 (95% CI = 0.00-3.97, P = 0.24), although the P value for interaction was not significant. Conclusions:Veterans with incidental pulmonary nodules frequently reported inadequate information exchange regarding their nodule. Many patients experience distress after they are informed that they have a pulmonary nodule, and high-quality patient-clinician communication is associated with decreased distress. Communication strategies that only target improved knowledge of the risk of malignancy may not be sufficient to reduce the distress associated with nodule detection.

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Section: Original Researchmentioning

confidence: 99%

Distress and Patient-Centered Communication among Veterans with Incidental (Not Screen-Detected) Pulmonary Nodules. A Cohort Study

et al. 2015

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“…Generally, the DLCST participants had a different socio-demographic make-up, higher socioeconomic status and reported fewer negative psychosocial aspects compared with the ordinary heavy smokers from the general population 35. This might also have biased the results in the present study.…”

Section: Discussionmentioning

confidence: 75%

“…A substantial participation bias was identified in a study where the 4104 participants in the DLCST were comparable with current and former smokers in the general population 35. Generally, the DLCST participants had a different socio-demographic make-up, higher socioeconomic status and reported fewer negative psychosocial aspects compared with the ordinary heavy smokers from the general population 35.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2012

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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.

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“…Percentage of current smokers of all ever smokers among all males, aged 50-74 that were randomised for the NELSON trial (RAND) compared to the selected Statistics Netherlands group (SN selection). explore more detailed to what extent the study results are generalisable to the average target population as well as the general population and whether the study population might affect the outcome measure: lung cancer mortality, especially since the DLSCT reported substantial participation bias [15,20,21]. However, no data is available about mortality rates amongst participants and non-participants, although comparing all-cause and lung cancer specific mortality is considered to give the highest level of evidence about whether self-selection bias affects the internal validity.…”

Section: Discussionmentioning

confidence: 99%

“…The NLST research team stated that the cohort is roughly representative for the target population in the US. In contrast, researchers showed a substantial socio-demographic and psychosocial participation bias in the Danish Lung Cancer Screening Trial (DLSCT), where the recruitment was also by media [15].…”

Section: Introductionmentioning

confidence: 99%

Generalisability of the results of the Dutch–Belgian randomised controlled lung cancer CT screening trial (NELSON): Does self-selection play a role?

Aalst¹,

Iersel²,

Klaveren³

et al. 2012

Lung Cancer

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Participation bias in a randomised trial of screening for lung cancer

Cited by 79 publications

References 33 publications

Distress and Patient-Centered Communication among Veterans with Incidental (Not Screen-Detected) Pulmonary Nodules. A Cohort Study

Distress and Patient-Centered Communication among Veterans with Incidental (Not Screen-Detected) Pulmonary Nodules. A Cohort Study

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

Generalisability of the results of the Dutch–Belgian randomised controlled lung cancer CT screening trial (NELSON): Does self-selection play a role?

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