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JAMA Internal Medicine Nov 2023Cancer screening tests are promoted to save life by increasing longevity, but it is unknown whether people will live longer with commonly used cancer screening tests. (Meta-Analysis)
Meta-Analysis
IMPORTANCE
Cancer screening tests are promoted to save life by increasing longevity, but it is unknown whether people will live longer with commonly used cancer screening tests.
OBJECTIVE
To estimate lifetime gained with cancer screening.
DATA SOURCES
A systematic review and meta-analysis was conducted of randomized clinical trials with more than 9 years of follow-up reporting all-cause mortality and estimated lifetime gained for 6 commonly used cancer screening tests, comparing screening with no screening. The analysis included the general population. MEDLINE and the Cochrane library databases were searched, and the last search was performed October 12, 2022.
STUDY SELECTION
Mammography screening for breast cancer; colonoscopy, sigmoidoscopy, or fecal occult blood testing (FOBT) for colorectal cancer; computed tomography screening for lung cancer in smokers and former smokers; or prostate-specific antigen testing for prostate cancer.
DATA EXTRACTION AND SYNTHESIS
Searches and selection criteria followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guideline. Data were independently extracted by a single observer, and pooled analysis of clinical trials was used for analyses.
MAIN OUTCOMES AND MEASURES
Life-years gained by screening was calculated as the difference in observed lifetime in the screening vs the no screening groups and computed absolute lifetime gained in days with 95% CIs for each screening test from meta-analyses or single randomized clinical trials.
RESULTS
In total, 2 111 958 individuals enrolled in randomized clinical trials comparing screening with no screening using 6 different tests were eligible. Median follow-up was 10 years for computed tomography, prostate-specific antigen testing, and colonoscopy; 13 years for mammography; and 15 years for sigmoidoscopy and FOBT. The only screening test with a significant lifetime gain was sigmoidoscopy (110 days; 95% CI, 0-274 days). There was no significant difference following mammography (0 days: 95% CI, -190 to 237 days), prostate cancer screening (37 days; 95% CI, -37 to 73 days), colonoscopy (37 days; 95% CI, -146 to 146 days), FOBT screening every year or every other year (0 days; 95% CI, -70.7 to 70.7 days), and lung cancer screening (107 days; 95% CI, -286 days to 430 days).
CONCLUSIONS AND RELEVANCE
The findings of this meta-analysis suggest that current evidence does not substantiate the claim that common cancer screening tests save lives by extending lifetime, except possibly for colorectal cancer screening with sigmoidoscopy.
Topics: Male; Humans; Early Detection of Cancer; Prostate-Specific Antigen; Mass Screening; Prostatic Neoplasms; Lung Neoplasms; Randomized Controlled Trials as Topic; Colorectal Neoplasms; Colonoscopy; Occult Blood
PubMed: 37639247
DOI: 10.1001/jamainternmed.2023.3798 -
JAMA May 2021Colorectal cancer (CRC) remains a significant cause of morbidity and mortality in the US.
IMPORTANCE
Colorectal cancer (CRC) remains a significant cause of morbidity and mortality in the US.
OBJECTIVE
To systematically review the effectiveness, test accuracy, and harms of screening for CRC to inform the US Preventive Services Task Force.
DATA SOURCES
MEDLINE, PubMed, and the Cochrane Central Register of Controlled Trials for relevant studies published from January 1, 2015, to December 4, 2019; surveillance through March 26, 2021.
STUDY SELECTION
English-language studies conducted in asymptomatic populations at general risk of CRC.
DATA EXTRACTION AND SYNTHESIS
Two reviewers independently appraised the articles and extracted relevant study data from fair- or good-quality studies. Random-effects meta-analyses were conducted.
MAIN OUTCOMES AND MEASURES
Colorectal cancer incidence and mortality, test accuracy in detecting cancers or adenomas, and serious adverse events.
RESULTS
The review included 33 studies (n = 10 776 276) on the effectiveness of screening, 59 (n = 3 491 045) on the test performance of screening tests, and 131 (n = 26 987 366) on the harms of screening. In randomized clinical trials (4 trials, n = 458 002), intention to screen with 1- or 2-time flexible sigmoidoscopy vs no screening was associated with a decrease in CRC-specific mortality (incidence rate ratio, 0.74 [95% CI, 0.68-0.80]). Annual or biennial guaiac fecal occult blood test (gFOBT) vs no screening (5 trials, n = 419 966) was associated with a reduction of CRC-specific mortality after 2 to 9 rounds of screening (relative risk at 19.5 years, 0.91 [95% CI, 0.84-0.98]; relative risk at 30 years, 0.78 [95% CI, 0.65-0.93]). In observational studies, receipt of screening colonoscopy (2 studies, n = 436 927) or fecal immunochemical test (FIT) (1 study, n = 5.4 million) vs no screening was associated with lower risk of CRC incidence or mortality. Nine studies (n = 6497) evaluated the test accuracy of screening computed tomography (CT) colonography, 4 of which also reported the test accuracy of colonoscopy; pooled sensitivity to detect adenomas 6 mm or larger was similar between CT colonography with bowel prep (0.86) and colonoscopy (0.89). In pooled values, commonly evaluated FITs (14 studies, n = 45 403) (sensitivity, 0.74; specificity, 0.94) and stool DNA with FIT (4 studies, n = 12 424) (sensitivity, 0.93; specificity, 0.85) performed better than high-sensitivity gFOBT (2 studies, n = 3503) (sensitivity, 0.50-0.75; specificity, 0.96-0.98) to detect cancers. Serious harms of screening colonoscopy included perforations (3.1/10 000 procedures) and major bleeding (14.6/10 000 procedures). CT colonography may have harms resulting from low-dose ionizing radiation. It is unclear if detection of extracolonic findings on CT colonography is a net benefit or harm.
CONCLUSIONS AND RELEVANCE
There are several options to screen for colorectal cancer, each with a different level of evidence demonstrating its ability to reduce cancer mortality, its ability to detect cancer or precursor lesions, and its risk of harms.
Topics: Age Factors; Aged; Aged, 80 and over; Colonoscopy; Colorectal Neoplasms; Early Detection of Cancer; Female; Humans; Male; Middle Aged; Occult Blood; Practice Guidelines as Topic; Risk; Sigmoidoscopy; Tomography, X-Ray Computed
PubMed: 34003220
DOI: 10.1001/jama.2021.4417 -
BMJ Open Oct 2019Evaluate effectiveness, harms and burdens of faecal blood testing, sigmoidoscopy and colonoscopy screening for colorectal cancer over 15 years. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
Evaluate effectiveness, harms and burdens of faecal blood testing, sigmoidoscopy and colonoscopy screening for colorectal cancer over 15 years.
DESIGN
We performed an update of a Cochrane systematic review, and performed network meta-analysis comparing randomised trials evaluating colorectal cancer screening with guaiac faecal occult blood test (gFOBT) (annual, biennial), faecal immunochemical test (FIT) (annual, biennial), sigmoidoscopy (once-only) or colonoscopy (once-only) in a healthy population, aged 50-79 years. We conducted subgroup analysis on sex. Follow-up >5 years was required for analysis of colorectal cancer incidence and mortality.
RESULTS
12 randomised trials proved eligible. Compared with no-screening, we found high certainty evidence for sigmoidoscopy screening slightly reducing colorectal cancer incidence (relative risk (RR) 0.76; 95% confidence interval (CI 0.70 to 0.83) and mortality (RR 0.74; 95% CI 0.69 to 0.80), while gFOBT screening had little or no difference on colorectal cancer incidence, but slightly reduced colorectal cancer mortality (annual: RR 0.69; 95% CI 0.56 to 0.86, biennial: RR 0.88; 95% CI 0.82 to 0.93). No screening test reduced mortality nor incidence by more than six per 1000 screened over 15 years. Sigmoidoscopy had a greater effect in men, for both colorectal cancer incidence (women: RR 0.86; 95% CI 0.81 to 0.92, men: RR 0.75, 95% CI 0.71 to 0.79), and mortality (women: RR 0.85; 95% CI 0.71 to 0.96, men: RR 0.67; 95% CI 0.61 to 0.75) (moderate certainty).
CONCLUSIONS
In a 15-year perspective, sigmoidoscopy reduces colorectal cancer incidence, while sigmoidoscopy, annual and biennial gFOBT all reduce colorectal cancer mortality. Sigmoidoscopy may reduce colorectal cancer incidence and mortality more in men than in women.
PROSPERO REGISTRATION NUMBER
CRD42018093401.
Topics: Adenoma; Aged; Carcinoma; Colonoscopy; Colorectal Neoplasms; Early Detection of Cancer; Humans; Middle Aged; Occult Blood; Sigmoidoscopy
PubMed: 31578199
DOI: 10.1136/bmjopen-2019-032773 -
The Cochrane Database of Systematic... Jun 2015This is a second update of a Cochrane Review originally published in Issue 2, 2009. Transcutaneous Electrical Nerve Stimulation (TENS) is a non-pharmacological agent,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
This is a second update of a Cochrane Review originally published in Issue 2, 2009. Transcutaneous Electrical Nerve Stimulation (TENS) is a non-pharmacological agent, based on delivering low voltage electrical currents to the skin. TENS is used by people to treat a variety of pain conditions.
OBJECTIVES
To assess the analgesic effectiveness of TENS, as a sole treatment, for acute pain in adults.
SEARCH METHODS
We searched the following databases up to 3 December 2014: the Cochrane Central Register of Controlled Trials (CENTRAL), in the Cochrane Library; MEDLINE; EMBASE; CINAHL; and AMED. We also checked the reference lists of included trials.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) of adults with acute pain (< 12 weeks) if they examined TENS given as a sole treatment and assessed pain with subjective pain scales. Trials were eligible if they compared TENS to placebo TENS, no treatment controls, pharmacological interventions or non-pharmacological interventions. We excluded trials on experimental pain, case reports, clinical observations, letters, abstracts or reviews. Also we excluded trials investigating the effect of TENS on pain during childbirth (labour), primary dysmenorrhoea or dental procedures. Studies where TENS was given with another treatment as part of the formal trial design were excluded. We did not restrict any articles based on language of publication.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed study eligibility and carried out study selection, data extraction, 'Risk of bias' assessment and analyses of data. We extracted data on the following: types of participants and pain condition, trial design and methods, treatment parameters, adverse effects, and outcome measures. We contacted trial authors for additional information if necessary.
MAIN RESULTS
We included 12 trials in the original review (2009) and included no further trials in the first update (2011). An additional seven new trials met the inclusion criteria in this second update. In total, we included 19 RCTs involving 1346 participants at entry, with 11 trials awaiting classification either because the full text was unavailable or information in the full text failed to clarify eligibility. We excluded most trials because TENS was given in combination with another treatment as part of the formal study design or TENS was not delivered using appropriate TENS technique. The types of acute pain included in this Cochrane Review were procedural pain, e.g. cervical laser treatment, venepuncture, screening flexible sigmoidoscopy and non-procedural pain, e.g. postpartum uterine contractions and rib fractures. We pooled data for pain intensity for six trials (seven comparisons) comparing TENS with placebo but the I(2) statistic suggested substantial heterogeneity. Mean difference (MD) with 95% confidence intervals (CIs) on a visual analogue scale (VAS, 100 mm) was -24.62 mm (95% CI -31.79 to -17.46) in favour of TENS. Data for the proportion of participants achieving ≥ 50% reduction in pain was pooled for four trials (seven comparisons) and relative risk was 3.91 (95% CI 2.42 to 6.32) in favour of TENS over placebo. We pooled data for pain intensity from five trials (seven comparisons) but the I(2) statistic suggested considerable heterogeneity. MD was -19.05 mm (95% CI -27.30 to -10.79) in favour of TENS using a random-effects model. It was not possible to pool other data. There was a high risk of bias associated with inadequate sample sizes in treatment arms and unsuccessful blinding of treatment interventions. Seven trials reported minor adverse effects, such as mild erythema and itching underneath the electrodes and participants disliking TENS sensation.
AUTHORS' CONCLUSIONS
This Cochrane Review update includes seven new trials, in addition to the 12 trials reviewed in the first update in 2011. The analysis provides tentative evidence that TENS reduces pain intensity over and above that seen with placebo (no current) TENS when administered as a stand-alone treatment for acute pain in adults. The high risk of bias associated with inadequate sample sizes in treatment arms and unsuccessful blinding of treatment interventions makes definitive conclusions impossible. There was incomplete reporting of treatment in many reports making replication of trials impossible.
Topics: Acute Pain; Adult; Humans; Pain Measurement; Randomized Controlled Trials as Topic; Transcutaneous Electric Nerve Stimulation
PubMed: 26075732
DOI: 10.1002/14651858.CD006142.pub3 -
The Cochrane Database of Systematic... Jan 2018Endoscopic assessment of mucosal disease activity is routinely used to determine eligibility and response to therapy in clinical trials of ulcerative colitis. The... (Review)
Review
BACKGROUND
Endoscopic assessment of mucosal disease activity is routinely used to determine eligibility and response to therapy in clinical trials of ulcerative colitis. The operating properties of the existing endoscopic scoring indices are unclear.
OBJECTIVES
A systematic review was undertaken to evaluate the development and operating characteristics of endoscopic scoring indices for the evaluation of ulcerative colitis.
SEARCH METHODS
We searched MEDLINE, Embase and CENTRAL from inception to 5 July 2016. We also searched references and conference proceedings (Digestive Disease Week, United European Gastroenterology Week, European Crohn's and Colitis Organization).
SELECTION CRITERIA
Any study design (e.g. randomized controlled trials, cohort studies, case series) that evaluated endoscopic indices for evaluation of ulcerative colitis disease activity were considered for inclusion. Eligible participants were adult patients (> 16 years), diagnosed with ulcerative colitis using conventional clinical, radiologic and endoscopic criteria.
DATA COLLECTION AND ANALYSIS
Two authors independently reviewed the studies identified from the literature search. These authors also independently extracted and recorded data on the number of patients enrolled; number of patients per treatment arm; patient characteristics including age and gender distribution; endoscopic index; and outcomes such as reliability (intra-rater and inter-rater), validity (content, construct, criterion), responsiveness and feasibility. Any disagreements regarding study inclusion or data extraction were resolved by discussion and consensus with a third author. Risk of bias was assessed by determining whether assessors were blinded to clinical information and whether assessors scored the endoscopic index independently. We also assessed the methodological quality of the validation studies using the COSMIN checklist MAIN RESULTS: A total of 23 reports of 20 studies met the pre-defined inclusion criteria and were included in the review. Of the 20 included validation studies, 19 endoscopic scoring indices were assessed, including the Azzolini Classification, Baron Score, Blackstone Endoscopic Interpretation, Chinese Grading System of Ulcerative Colitis, Endoscopic Activty Index, Jeroen Score, Magnifying Colonoscopy Grade, Matts Score, Mayo Clinic Endoscopic Subscore, Modified Baron Score, Modified Mayo Clinic Endoscopic Subscore, Osada Score, Rachmilewtiz Endoscopic Score, St. Mark's Index, Ulcerative Colitis Colonoscopic Index of Serverity (UCCIS), endoscopic component of the Ulcerative Colitis Disease Activity Index (UCDAI), Ulcerative Colitis Endoscopic Index of Severity (UCEIS), Witts Sigmoidoscopic Score and Watson Grade. The individuals who performed the endoscopic scoring were blinded to clinical and/or histologic information in ten of the included studies, not blinded to clinical and/or histologic information in one of the included studies, and it was unclear whether blinding occurred in the remaining nine included studies. Independent observation was confirmed in four of the included studies, unclear in five of the included studies, and non-applicable (since inter-rater reliability was not assessed) in the remaining eleven included studies. The methodological quality (COSMIN checklist) of most of the included studies was rated as 'good' or 'excellent'. One study that assessed responsiveness was rated as 'fair'. The inter-rater reliability of nine endoscopic scoring indices including the Baron Score, Blackstone Endoscopic Interpretation, Endoscopic Activity Index, Matts Score, Mayo Clinic Endoscopic Subscore, Osada Score, UCCIS, UCEIS, Watson Grade was assessed in seven studies, with estimates of correlation, ƙ, ranging from 0.44 to 0.97. The iIntra-rater reliability of seven endoscopic scoring indices including the Baron Score, Blackstone Endoscopic Interpretation, Matts Score, Mayo Clinic Endoscopic Subscore, Osada Score, UCCIS and UCEIS was assessed in three studies, with estimates of correlation, ƙ, ranging from 0.41 to 0.86. No studies assessed content validity. Three studies evaluated the criterion validity of three endoscopic scoring indices including the Rachmilewitz Endoscopic Score, Magnifying Colonoscopy Grade and the UCCIS. These indices were correlated with objective markers of disease activity including albumin, blood leukocytes, C-reactive protein, fecal calprotectin, hemoglobin, mucosal interleukin-8 concentration and platelet count. Correlation estimates ranged from r = -0.19 to 0.83. Thirteen endoscopic scoring indices were tested for construct validity in 13 studies. Estimates of correlation between the endoscopic scoring indices and other measures of disease activity ranged from r = 0.27 to 0.93. Two studies explored the responsiveness of four endoscopic scoring indices including the Mayo Endoscopic Subscore, Modified Baron Score, Modified Mayo Endoscopic Subscore and UCEIS. One study concluded that the Modified Baron Score, Modified Mayo Endoscopic Subscore and UCEIS had similar responsiveness for detecting disease change in ulcerative colitis. The other included study concluded that the UCEIS may be the most accurate endoscopic scoring tool. None of the included studies formally assessed feasibility.
AUTHORS' CONCLUSIONS
While the UCEIS, UCCIS and Mayo Clinic Endoscopic Subscore have undergone extensive validation, none of these instruments have been fully validated and only two studies assessed responsiveness. Further research on the operating properties of these indices is needed given the lack of a fully-validated endoscopic scoring instrument for the evaluation of disease activity in ulcerative colitis.
Topics: Colitis, Ulcerative; Colonoscopy; Humans; Reproducibility of Results; Severity of Illness Index; Sigmoidoscopy
PubMed: 29338066
DOI: 10.1002/14651858.CD011450.pub2 -
Preventive Medicine Oct 2017Screening for colorectal cancer (CRC) by colonoscopy and sigmoidoscopy has been demonstrated to be effective in reducing CRC incidence and mortality, and they are... (Review)
Review
Screening for colorectal cancer (CRC) by colonoscopy and sigmoidoscopy has been demonstrated to be effective in reducing CRC incidence and mortality, and they are increasingly employed as screening tests and for diagnostic purposes in many countries. We conducted a systematic review to provide up-to-date estimates on the utilization of lower gastrointestinal endoscopy (colonoscopy and sigmoidoscopy) in the general average-risk population in different countries. PubMed and Web of Science were searched for relevant articles published between 1 September 2008 and 31 October 2016. A total of 23 studies from the US and 20 studies from other countries were included in this review. Estimates from the US were highest, continued to increase over the past decade and reached 62% for colonoscopy use within 10years in people aged 50-75years in 2012. Endoscopy use in other countries was substantially lower (12-44% for lifetime colonoscopy use and 13-30% for recent colonoscopy use), except for Germany, where 55% of the screening-eligible population reported colonoscopy utilization within the previous 10years in 2008-2011. Both lifetime and recent endoscopy use increased with age and peaked at approximately 70-75years. Although several European and Asian countries have started to collect endoscopy utilization data through periodic national health surveys, more data are still much needed from non-US countries. With the implementation of CRC screening programs in an increasing number of countries, especially European countries, an increase in endoscopy use and subsequent reduction in CRC incidence and mortality in the years to come might be expected in those countries.
Topics: Aged; Colonoscopy; Colorectal Neoplasms; Early Detection of Cancer; Europe; Health Surveys; Humans; Incidence; Mass Screening; Risk Factors; Sigmoidoscopy
PubMed: 28739489
DOI: 10.1016/j.ypmed.2017.07.021 -
Clinical Colorectal Cancer Dec 2016To evaluate the effectiveness of colorectal cancer (CRC) screening in asymptomatic adults. A search was conducted of the Medline, Embase, and the Cochrane Library... (Meta-Analysis)
Meta-Analysis Review
To evaluate the effectiveness of colorectal cancer (CRC) screening in asymptomatic adults. A search was conducted of the Medline, Embase, and the Cochrane Library databases. A targeted search of PubMed was conducted for on-topic randomized controlled trials (RCTs). Meta-analysis across 4 RCTs for guaiac fecal occult blood testing (gFOBT) and flexible sigmoidoscopy (FS) screening showed a reduction of 18% (risk ratio [RR], 0.82; 95% CI [CI], 0.73-0.92) and 26% (RR, 0.74; 95% CI, 0.67-0.83) in CRC mortality for the screening group compared to controls, respectively. The number needed to screen (NNS) were 377 (95% CI, 249-887) and 864 (95% CI, 672-1266) for gFOBT and FS screening, respectively. A reduction of 8% and 27% in incidence of late-stage CRC was also observed for gFOBT and FS screening, respectively, but both had no significant effect on all-cause mortality. A single RCT found that screening with immunochemical fecal occult blood test (iFOBT) had no significant impact on CRC mortality (RR, 0.88; 95% CI, 0.72-1.07). Screening with FS has potential harms such as perforation, major and minor bleeding, and death from the procedure or from follow-up colonoscopy. gFOBT and FS screening reduce CRC mortality and incidence of late-stage disease. The absolute effect and NNS were much more favorable for older adults (≥ 60 years), suggesting that a targeted screening approach may avoid exposing younger adults to the harms of CRC screening, from which they are unlikely to derive any significant benefit. Although there is insufficient RCT evidence on the impact of iFOBT on mortality outcomes. compared to gFOBT, this test showed higher sensitivity and comparable specificity, indicating the need to update and reevaluate the evidence in light of future high-quality research. The protocol for this systematic review have been published with PROSPERO 2014: CRD42014009777.
Topics: Colorectal Neoplasms; Early Detection of Cancer; Humans; Mass Screening; Occult Blood; Sigmoidoscopy
PubMed: 27133893
DOI: 10.1016/j.clcc.2016.03.003 -
Cancers Mar 2023(1) Background: The aim of this study was to pool and compare all-cause and colorectal cancer (CRC) specific mortality reduction of CRC screening in randomized control... (Review)
Review
(1) Background: The aim of this study was to pool and compare all-cause and colorectal cancer (CRC) specific mortality reduction of CRC screening in randomized control trials (RCTs) and simulation models, and to determine factors that influence screening effectiveness. (2) Methods: PubMed, Embase, Web of Science and Cochrane library were searched for eligible studies. Multi-use simulation models or RCTs that compared the mortality of CRC screening with no screening in general population were included. CRC-specific and all-cause mortality rate ratios and 95% confidence intervals were calculated by a bivariate random model. (3) Results: 10 RCTs and 47 model studies were retrieved. The pooled CRC-specific mortality rate ratios in RCTs were 0.88 (0.80, 0.96) and 0.76 (0.68, 0.84) for guaiac-based fecal occult blood tests (gFOBT) and single flexible sigmoidoscopy (FS) screening, respectively. For the model studies, the rate ratios were 0.45 (0.39, 0.51) for biennial fecal immunochemical tests (FIT), 0.31 (0.28, 0.34) for biennial gFOBT, 0.61 (0.53, 0.72) for single FS, 0.27 (0.21, 0.35) for 10-yearly colonoscopy, and 0.35 (0.29, 0.42) for 5-yearly FS. The CRC-specific mortality reduction of gFOBT increased with higher adherence in both studies (RCT: 0.78 (0.68, 0.89) vs. 0.92 (0.87, 0.98), model: 0.30 (0.28, 0.33) vs. 0.92 (0.51, 1.63)). Model studies showed a 0.62-1.1% all-cause mortality reduction with single FS screening. (4) Conclusions: Based on RCTs and model studies, biennial FIT/gFOBT, single and 5-yearly FS, and 10-yearly colonoscopy screening significantly reduces CRC-specific mortality. The model estimates are much higher than in RCTs, because the simulated biennial gFOBT assumes higher adherence. The effectiveness of screening increases at younger screening initiation ages and higher adherences.
PubMed: 37046609
DOI: 10.3390/cancers15071948 -
PloS One 2023Physical harm from Colorectal Cancer Screening tends to be inadequately measured and reported in clinical trials. Also, studies of ongoing Colorectal Cancer Screening... (Meta-Analysis)
Meta-Analysis
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.
Topics: Humans; Sigmoidoscopy; Early Detection of Cancer; Colorectal Neoplasms; Colonoscopy; Mass Screening; Hemorrhage; Occult Blood
PubMed: 37906565
DOI: 10.1371/journal.pone.0292797 -
World Journal of Gastroenterology Apr 2015To examine the available evidence on safety, competency and cost-effectiveness of nursing staff providing gastrointestinal (GI) endoscopy services. (Review)
Review
AIM
To examine the available evidence on safety, competency and cost-effectiveness of nursing staff providing gastrointestinal (GI) endoscopy services.
METHODS
The literature was searched for publications reporting nurse endoscopy using several databases and specific search terms. Studies were screened against eligibility criteria and for relevance. Initial searches yielded 74 eligible and relevant articles; 26 of these studies were primary research articles using original datasets relating to the ability of non-physician endoscopists. These publications included a total of 28883 procedures performed by non-physician endoscopists.
RESULTS
The number of publications in the field of non-specialist gastrointestinal endoscopy reached a peak between 1999 and 2001 and has decreased thereafter. 17/26 studies related to flexible sigmoidoscopies, 5 to upper GI endoscopy and 6 to colonoscopy. All studies were from metropolitan centres with nurses working under strict supervision and guidance by specialist gastroenterologists. Geographic distribution of publications showed the majority of research was conducted in the United States (43%), the United Kingdom (39%) and the Netherlands (7%). Most studies conclude that after appropriate training nurse endoscopists safely perform procedures. However, in relation to endoscopic competency, safety or patient satisfaction, all studies had major methodological limitations. Patients were often not randomized (21/26 studies) and not appropriately controlled. In relation to cost-efficiency, nurse endoscopists were less cost-effective per procedure at year 1 when compared to services provided by physicians, due largely to the increased need for subsequent endoscopies, specialist follow-up and primary care consultations.
CONCLUSION
Contrary to general beliefs, endoscopic services provided by nurse endoscopists are not more cost effective compared to standard service models and evidence suggests the opposite. Overall significant shortcomings and biases limit the validity and generalizability of studies that have explored safety and quality of services delivered by non-medical endoscopists.
Topics: Clinical Competence; Cost Savings; Cost-Benefit Analysis; Education, Nursing; Endoscopy, Gastrointestinal; Health Care Costs; Humans; Nurse Practitioners; Nursing Staff
PubMed: 25945022
DOI: 10.3748/wjg.v21.i16.5056