Deaths and cardiopulmonary events following colorectal cancer screening-A systematic review with meta-analyses.

BACKGROUND: Colorectal cancer screening programmes (CRCSPs) are implemented worldwide despite recent evidence indicating more physical harm occurring during CRCSPs than previously thought. Therefore, we aimed to review the evidence on physical harms associated with endoscopic diagnostic procedures during CRCSPs and, when possible, to quantify the risk of the most serious types of physical harm during CRCSPs, i.e. deaths and cardiopulmonary events (CPEs). METHODS: Systematic review with descriptive statistics and random-effects meta-analyses of studies investigating physical harms following CRCSPs. We conducted a systematic search in the literature and assessed the risk of bias and the certainty of the evidence. RESULTS: We included 134 studies for review, reporting findings from 151 unique populations when accounting for multiple screening interventions per study. Physical harm can be categorized into 17 types of harm. The evidence was very heterogeneous with inadequate measurement and reporting of harms. The risk of bias was serious or critical in 95% of assessments of deaths and CPEs, and the certainty of the evidence was very low in all analyses. The risk of death was assessed for 57 populations with large variation across studies. Meta-analyses indicated that 3 to 23 deaths occur during CRCSPs per 100,000 people screened. Cardiopulmonary events were assessed for 55 populations. Despite our efforts to subcategorize CPEs into 17 distinct subtypes, 41% of CPE assessments were too poorly measured or reported to allow quantification. We found a tendency towards lower estimates of deaths and CPEs in studies with a critical risk of bias. DISCUSSION: Deaths and CPEs during CRCSPs are rare, yet they do occur during CRCSPs. We believe that our findings are conservative due to the heterogeneity and low quality of the evidence. A standardized system for the measurement and reporting of the harms of screening is warranted. TRIAL REGISTRATION: PROSPERO Registration number CRD42017058844.

The risk of bleeding and perforation from sigmoidoscopy or colonoscopy in colorectal cancer screening: A systematic review and meta-analyses.

INTRODUCTION: Physical harm from Colorectal Cancer Screening tends to be inadequately measured and reported in clinical trials. Also, studies of ongoing Colorectal Cancer Screening programs have found more frequent and severe physical harm from screening procedures, e.g., bleeding and perforation, than reported in previous trials. Therefore, the objectives of the study were to systematically review the evidence on the risk of bleeding and perforation in Colorectal Cancer Screening. DESIGN: Systematic review with descriptive statistics and random-effects meta-analyses. METHODS: We systematically searched five databases for studies investigating physical harms related to Colorectal Cancer Screening. We assessed the internal and the external validity using the ROBINS-I tool and the GRADE approach. Harm estimates was calculated using mixed Poisson regression models in random-effect meta-analyses. RESULTS: We included 89 studies. Reporting and measurement of harms was inadequate in most studies. In effect, the risk of bias was critical in 97.3% and serious in 98.3% of studies. All GRADE ratings were very low. Based on severe findings with not-critical risk of bias and 30 days follow-up, the risk of bleedings per 100,000 people screened were 8 [2;24] for sigmoidoscopy, 229 [129;408] for colonoscopy following fecal immunochemical test, 68 [39;118] for once-only colonoscopy, and 698 [443;1045] for colonoscopy following any screening tests. The risk of perforations was 88 [56;138] for colonoscopy following fecal immunochemical test and 53 [25;112] for once-only colonoscopy. There were no findings within the subcategory severe perforation with long-term follow-up for colonoscopy following any screening tests and sigmoidoscopy. DISCUSSION: Harm estimates varied widely across studies, reporting and measurement of harms was mostly inadequate, and the risk of bias and GRADE ratings were very poor, collectively leading to underestimation of harm. In effect, we consider our estimates of perforation and bleeding as conservative, highlighting the need for better reporting and measurement in future studies. TRIAL REGISTRATION: PROSPERO registration number: CRD42017058844.

The impact of influences in a medical screening programme invitation: a randomized controlled trial.

BACKGROUND: Invitations to screening programmes may include influences that are intending to increase the participation rates. This study had two objectives: (i) to assess if different categories of influences had a significant effect on the intention to participate in a screening programme for a fictitious disease and (ii) whether participants were aware of the influences, and if the intention to participate was associated to this awareness. METHODS: A seven-armed randomized controlled trial. Six hundred passers-by were randomly allocated to receive one of seven pamphlets inviting to a fictitious screening programme (neutral, relative risk reductions, misrepresentation of harms, pre-booked appointment, recommendation of participation, fear appeals, all combined). Participants were surveyed to assess (i) intention to participate (ITP) in the screening programme and (ii) awareness of an exerted influence. Chi-squared test was used to calculate the effect of the influences on ITP and the association of ITP with indicating awareness of an exerted influence and correctly locating an influence. RESULTS: Five hundred and eighty-nine participants were included for analysis. ITP was significantly increased (P < 0.05) in three pamphlets (misrepresentation of harms, fear appeals, all combined) [adjusted odds ratio (OR) 4.84, 95% confidence interval (CI): 2.54-9.23; OR 2.45, 95% CI: 1.31-4.59; OR 9.02, 95% CI: 4.44-18.34]. A percentage of 60.0-78.3 participants did not indicate awareness. Awareness was associated with a decreased ITP for those who could locate the influence (OR 0.39, 95% CI: 0.21-0.72) and those who failed to locate the influence (OR 0.47, 95% CI: 0.30-0.74). CONCLUSION: The application of influences should be carefully considered for interventions where an informed choice is desired.

Validity of Current Assessment Tools Aiming to Measure the Affective Component of Pain: A Systematic Review.

The objective of this study was to identify patient-reported outcome measures (PROMs), which aim to measure the affective component of pain and to assess their content validity, unidimensionality, measurement invariance, and Internal consistency in patients with chronic pain. The study was reported according to the PRISMA guidelines. A protocol of the review was submitted to PROSPERO before data extraction. Eligible studies were any type of study that investigated at least one of the domains: PROM development, content validity, dimensionality, internal consistency, or measurement invariance of any type of scale that claimed to measure the affective component of pain among patients with chronic pain. The databases Medline, Embase, PsycINFO, and the Cochrane Library were searched for eligible studies. The database search was supplemented by looking for relevant articles in the reference list of included studies, ie backtracking. All included studies were assessed independently by two authors according to the "COSMIN methodology on Systematic Reviews of Patient-Reported Outcome Measures". Descriptive data synthesis of the identified PROMs was conducted. The search yielded 11,242 titles of which 283 were assessed at the full-text level. Full-text screening led to the inclusion of 11 studies and an additional 28 studies were identified via backtracking, leading to the inclusion of 39 studies in total in the review. Included studies described the development and validity of 10 unique PROMs, all of which we assessed to have potentially inadequate content validity and doubtful psychometric properties. No studies reported whether the PROMs possessed invariant measurement properties. The existing PROMs measuring affective components of chronic pain potentially lack content validity and have inadequate psychometric measurement properties. There is a need for new PROMs measuring the affective component of chronic pain that possess high content validity and adequate psychometric measurement properties.

Categories of systematic influences applied to increase cancer screening participation: a literature review and analysis.

BACKGROUND: Health authorities can influence citizens in subtle ways that render them more likely to participate in cancer screening programmes, and thereby possibly increase the beneficial effects. If the influences become too severe, the citizens' ability to make a personal choice may be lost on the way. The purpose of this analysis was to identify and categorize the influences while questioning whether they still permit the citizens to make their own choices regarding participation. METHODS: A two-stringed approach was used to obtain empirical examples of systematic influences that aim to raise participation rates in cancer screening programmes: First, a systematic literature search was conducted on three databases. Second, relevant experts were contacted via internationally based e-mail lists and asked for examples of systematic influences in cancer screening. The present analysis was based on direct, conventional content analysis to address different categories of systematic influences. RESULTS: The literature search yielded 19 included articles and the expert inquiry yielded 11 empirical examples of which content analysis of the empirical examples generated six major categories of systematic influence: (i) misleading presentation of statistics, (ii) misrepresentation of harms vs. benefits, (iii) opt-out systems, (iv) recommendation of participation, (v) fear appeals and (vi) influencing the general practitioners and other healthcare professionals. CONCLUSION: The six categories of identified influences work through psychological biases and personal costs and are still in widely use. The use of these types of influence remains ethically questionable in cancer screening programmes since they might compromise informed decision making.