Capsule Colonoscopy Increases Uptake of CRC Screening
Capsule Colonoscopy Increases Uptake of CRC Screening
The study was designed and supervised by the Department of Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf (S.G., TR), and executed by four local gastroenterologists in private practice (R.B., H.H., M.B., M.B.), supported by a hospital-based gastroenterologist (H.K.) with previous experience in capsule colonoscopy, in the area of Rinteln, Hameln and Wunsdorf, Lower Saxony, Germany, in close cooperation with a regional medical insurance company (BKK24). This area south of Hannover has a population of 1 307 568 (source: http://www.meinestadt.de), and BKK 24 has 14 304 insured persons in this area, 3091 of whom were above the age of 55 in 2009. About 75 % of all persons insured with BKK 24 in Lower Saxony were living in the study area (see below). The study was approved by the IMDEC GmbH Ethical Committee, Freiburg (31.3.2009).
In Germany, since the end of 2002, persons above the age of 55 who have not undergone colonoscopy in the preceding 10 years are entitled to a screening colonoscopy (which can be repeated after 10 years if negative), without an existing invitation or reminder programme. The nationwide current annual uptake of screening colonoscopy is around 3 %. According to BKK 24 data for the Rinteln area, the uptake of screening colonoscopy in Lower Saxony among their insured persons above the age of 55 has been 1.02 % for the last 3 years before the start of the study, and was set at 1 % for study purposes. This uptake is lower than on National average in Germany according to data from the National screening colonoscopy registry.
At the beginning of the study an introductory meeting was held to guarantee acceptance by all the medical partners in the area, and for discussion and agreement on similar consultation procedures (a summary of bullet points was provided for the informed consent) for the persons showing an interest who responded to the BKK 24 invitation letters. Balanced informed consent about pros and cons of colonoscopy versus capsule endoscopy was agreed upon. The 4 gastroenterologists underwent special training in performance and reading of capsule colonoscopy. Invitation letters were sent out by the BKK 24 medical insurance company to a total of 2150 eligible persons in the area of Rinteln and surrounding cities, with about 25 % each invited in the spring and summer of 2009 and about 50 % in the autumn, starting in Rinteln (where the participating gastroenterologists were located) and subsequently involving people living but within 50 km.
Persons opting to undergo colonoscopy gave informed consent and underwent standard lavage regimens for colon preparation. Those willing to undergo capsule colonoscopy (Pillcam Colon 1, Given Imaging Corp. Hamburg/Germany) were provided with a detailed information sheet about capsule accuracy and the need for repeat colonoscopy if positive (including preparation) as well as about capsule-specific bowel preparation, as described fully elsewhere. If polyps were found, capsule patients were re-invited for colonoscopy. In case of insufficient bowel preparation for adequate capsule reading or incomplete passage of the large bowel, patients were also offered colonoscopy. Study participants were given questionnaires before and after an initial meeting with the gastroenterologist, with items about their motivation and their decision for either capsule or conventional colonoscopy. The non-responders could not be contacted for their motivation not to participate for data safety reasons.
The main outcome parameter was the potential increase in the rate of persons accepting conventional or capsule colonoscopy among all persons invited compared with the mean annual uptake of colonoscopy in the preceding 3 years (1 %, see above).
Secondary outcome parameters were
No precise case number calculation could be made since this was the first study of its kind focusing on uptake when an alternative to colonoscopy was available. The current annual acceptance rate for screening colonoscopy in Germany is around 3 %, in the Rinteln area it is 2.2 %, and among persons insured with BKK 24 it is around 1 % (see above). Thus, a significant difference in uptake, for a one-sided comparison, would be reached at an increased uptake of 1.6 % versus 1 % (p = 0.045), and for a two-sided comparison at 1.7 % (p = 0.049).
Patients and Methods
Study partners
The study was designed and supervised by the Department of Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf (S.G., TR), and executed by four local gastroenterologists in private practice (R.B., H.H., M.B., M.B.), supported by a hospital-based gastroenterologist (H.K.) with previous experience in capsule colonoscopy, in the area of Rinteln, Hameln and Wunsdorf, Lower Saxony, Germany, in close cooperation with a regional medical insurance company (BKK24). This area south of Hannover has a population of 1 307 568 (source: http://www.meinestadt.de), and BKK 24 has 14 304 insured persons in this area, 3091 of whom were above the age of 55 in 2009. About 75 % of all persons insured with BKK 24 in Lower Saxony were living in the study area (see below). The study was approved by the IMDEC GmbH Ethical Committee, Freiburg (31.3.2009).
CRC Uptake in the Rinteln Area
In Germany, since the end of 2002, persons above the age of 55 who have not undergone colonoscopy in the preceding 10 years are entitled to a screening colonoscopy (which can be repeated after 10 years if negative), without an existing invitation or reminder programme. The nationwide current annual uptake of screening colonoscopy is around 3 %. According to BKK 24 data for the Rinteln area, the uptake of screening colonoscopy in Lower Saxony among their insured persons above the age of 55 has been 1.02 % for the last 3 years before the start of the study, and was set at 1 % for study purposes. This uptake is lower than on National average in Germany according to data from the National screening colonoscopy registry.
Organisation of the Present Study
At the beginning of the study an introductory meeting was held to guarantee acceptance by all the medical partners in the area, and for discussion and agreement on similar consultation procedures (a summary of bullet points was provided for the informed consent) for the persons showing an interest who responded to the BKK 24 invitation letters. Balanced informed consent about pros and cons of colonoscopy versus capsule endoscopy was agreed upon. The 4 gastroenterologists underwent special training in performance and reading of capsule colonoscopy. Invitation letters were sent out by the BKK 24 medical insurance company to a total of 2150 eligible persons in the area of Rinteln and surrounding cities, with about 25 % each invited in the spring and summer of 2009 and about 50 % in the autumn, starting in Rinteln (where the participating gastroenterologists were located) and subsequently involving people living but within 50 km.
Persons opting to undergo colonoscopy gave informed consent and underwent standard lavage regimens for colon preparation. Those willing to undergo capsule colonoscopy (Pillcam Colon 1, Given Imaging Corp. Hamburg/Germany) were provided with a detailed information sheet about capsule accuracy and the need for repeat colonoscopy if positive (including preparation) as well as about capsule-specific bowel preparation, as described fully elsewhere. If polyps were found, capsule patients were re-invited for colonoscopy. In case of insufficient bowel preparation for adequate capsule reading or incomplete passage of the large bowel, patients were also offered colonoscopy. Study participants were given questionnaires before and after an initial meeting with the gastroenterologist, with items about their motivation and their decision for either capsule or conventional colonoscopy. The non-responders could not be contacted for their motivation not to participate for data safety reasons.
Outcome Parameters
The main outcome parameter was the potential increase in the rate of persons accepting conventional or capsule colonoscopy among all persons invited compared with the mean annual uptake of colonoscopy in the preceding 3 years (1 %, see above).
Secondary outcome parameters were
· Adenoma yield in both groups, namely the capsule group including those participants with subsequent colonoscopy, and the group with capsule colonoscopy only
Rate of capsule examinations with sufficient bowel preparation (grading was done on a 4-point scale in accordance with previous studies
Adverse events and complications in both arms of the study
Patient opinion and acceptability according to the questionnaires mentioned above
Statistical Analysis
No precise case number calculation could be made since this was the first study of its kind focusing on uptake when an alternative to colonoscopy was available. The current annual acceptance rate for screening colonoscopy in Germany is around 3 %, in the Rinteln area it is 2.2 %, and among persons insured with BKK 24 it is around 1 % (see above). Thus, a significant difference in uptake, for a one-sided comparison, would be reached at an increased uptake of 1.6 % versus 1 % (p = 0.045), and for a two-sided comparison at 1.7 % (p = 0.049).
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