Result card

  • SAF3: What is the timing of onset of harms to patients: immediate, early or late?
English

What is the timing of onset of harms to patients: immediate, early or late?

Authors: Agnes Männik, Irena Guzina, Petra Jandova, Leonor Varela Lema, Gerardo Atienza Merino

Internal reviewers: Matthias Schwenkglenks, Ingrid Wilbacher

Domain research was used and completed with information from HAS report dated 2008 {2} and recommendation dated 2013{1}. Systematic reviews referenced in HAS report {8} were used as a basis for this result card.

Summary of results:

The screening methods gFOBT and FIT are non-invasive procedures that are therefore not likely to cause any direct harm to the participants. Harms can be observed on a psychological basis or can be due to subsequent colonoscopy examination, with different timing.

Summary table of selected references

Author, year

Type of reference

Title

Outcome

HAS, 2013 {1}

National guideline

HAS recommendation on colorectal screening and prevention

Perforation of colon or haemorrhage can be immediate or delayed (7-21 days after colonoscopy).

Senore, C., et al., 2011 {5}

Article

Acceptability and side-effects of colonoscopy and sigmoidoscopy in a screening setting

Bowel distension and abdominal pain were the most common complaints of late onset.

Parker, M. A. et al., 2002

Article referenced in {8}

Article

Psychiatric morbidity and screening for colorectal cancer

Psychological impact can be observed during the whole period of testing. In patients with false positive results, anxiety scores fell the day after colonoscopy and remained low 1 month later.

 

Results from different trials:1) Physical reactions to colonoscopy

Risks of severe complications such as gut perforation and hemorrhage can be immediate or delayed (7-21 days after colonoscopy). {1}

One study specifically examined the risk of immediate and late reactions other than gut perforation and hemorrhage after colonoscopy and sigmoidoscopy in a screening setting {5}.

Among immediate reactions, patients reported serious reactions following bowel preparation (mainly abdominal pain, bowel distension and anal irritation), severe pain immediately after the exam and embarrassment. {5}

The most common post-procedural complaints were abdominal distension and pain.

2) Psychological impact

Psychological impact can be observed as well during the whole period of testing, including time before testing and time after obtaining the results. In a clinical trial (Parker et al, 2002) a general health questionnaire was sent to 2184 subjects before the offer of screening, and 1541 (70.6%) were returned. Of the 1693 subjects offered the questionnaire 3 months after the offer of screening, 1303 (77%) returned it. Anxiety scores were measured in 100 test positive patients and were highest after notification of a positive test and before investigation by colonoscopy. In patients with false positive results, scores fell the day after colonoscopy and remained low 1 month later. No sustained anxiety has been seen in screening participants.

Harms can be observed on a psychological basis or can be due to subsequent colonoscopy examination, with different timing.

Important
Completely
Männik A et al. Result Card SAF3 In: Männik A et al. Safety In: Jefferson T, Cerbo M, Vicari N [eds.]. Fecal Immunochemical Test (FIT ) versus guaiac-based fecal occult blood test (FOBT) for colorectal cancer screening [Core HTA], Agenas - Agenzia nazionale per i servizi sanitari regionali; 2014. [cited 16 June 2021]. Available from: http://corehta.info/ViewCover.aspx?id=206

References