Introduction

Informed consent (IC) serves as the ethical foundation for all medical interventions, empowering patients to make informed, autonomous decisions while safeguarding clinicians. Barriers such as limited health literacy and document complexity may hinder comprehension^1,2. This study evaluated the comprehensibility, readability, and effectiveness of the documents provided for IC and instructions for endoscopic procedures.

Aims & Methods

Outpatients undergoing endoscopic procedures completed a questionnaire assessing their understanding of IC, preparation instructions, and adherence to guidelines. Patient confidence and document comprehensibility were assessed through self-reported scales. Readability was assessed using Flesch Reading Ease score adapted for portuguese (FRE-PT)³.

Results

Among 186 participants (mean age: 58.1 ± 16.1 years), 76.9% reported full-extent reading of the provided instructions and IC document. Patients with primary education (≤4th grade) were less likely to read the documents fully (59.2% vs. 83.2%, p < 0.001) and were independently associated with the need for additional assistance (OR 5.65, 95% CI: 1.92 - 16.68, p = 0.002). Full-extent reading was independently associated with greater risk awareness (OR 5.52, 95% CI: 2.37 - 11.55, p < 0.001), reduced need for additional assistance (OR 0.22, 95% CI: 0.09 - 0.51, p < 0.001), and higher compliance with medication guidelines (75.7% vs. 45.8%, OR 3.42, 95% CI: 1.28 - 9.20, p = 0.015). Patients with primary education rated document’s comprehensibility lower (median:8, IQR 7-10) compared to those with higher education (median: 10, IQR 8 - 10, p < 0.001) and reported lower levels of confidence and preparation for the procedure (median: 8, IQR 7 - 10 vs. median: 9, IQR 8 - 10; p = 0.018). Outcomes did not differ significantly between patients aged 65 years or older compared to younger patients. FRE-PT scores classified readability as ‘’very difficult’’ for both upper endoscopy (20.87) and colonoscopy (26.00).

Conclusion

Full-extent reading IC and instruction documents reduces the need for assistance, improves compliance with pre-procedural measures, risk awareness and patient confidence. However, the document’s complexity and difficult readability disproportionately challenge and discourage patients with limited education. Future research should explore strategies to foster more equitable informed decision-making.

References

1. Protheroe J, Rowlands G. Matching clinical information with levels of patient health literacy. Nurs Manag (Harrow). 2013;20(3):20-21. doi:10.7748/nm2013.06.20.3.20.e1095
2. Ley R, Forio T. The use of readability formulas in health care. Psychol Health Med. 1996;1(1):7-28.
3. Martins TBF, Ghiraldelo CM, Nunes MGV, Oliveira Junior ON. Readability formulas applied to textbooks in Brazilian Portuguese. 1996.

Clinical Case Summary

A 66-year-old female patient with a history of duodenal peptic ulcer disease was referred for evaluation of an 8 mm sessile polyp (Paris 0-ls) located in the terminal ileum. The polyp was excised during a colonoscopy with ileoscopy performed at a private facility in the context of colorectal cancer screening. Histological analysis revealed a well-differentiated NET (Grade 1) in the mucosal and submucosal layers of the terminal ileum, measuring 5.6 mm, with an endoscopic resection achieving R0 status (IVL0, 170 µm from the vertical margin). Following multidisciplinary discussion, staging was performed using CT of the abdomen and pelvis, enterography CT, and 68-Ga PET, which showed an ileocolic lymphadenopathy with high expression of somatostatin receptors and elevated serum Chromogranin A (238.7; N<85). A decision was made to reevaluate with 68-Ga PET in four months to determine the course of action regarding surgery versus chemotherapy. Due to the persistence of findings and after further multidisciplinary discussion, a right hemicolectomy with laparoscopic lymphadenectomy was performed. The procedure revealed no mural lesions; however, 5 out of 20 ileocolic lymph nodes were positive for TNE invasion (ypT1N1M0, Ki-67 <1%, mitotic index <1/10 HPF, stage III). The follow-up at five months showed no recurrence.
This case highlights the importance of ileoscopy during colonoscopy, even in the absence of symptoms, in order to exclude lesions of the small intestine. Given their aggressive nature, increasing incidence, and more frequent ileal location, the performance of ileoscopy during total colonoscopy offers significant clinical benefit without a substantial increase in procedure time, even in asymptomatic individuals.This case also highlights the challenge of histopathological criteria in defining curative disease after endoscopic resection and the discrepancy between pre- and post-operative imaging and functional staging, with prognostic and surveillance implications.

References

Joana Carvão, Mário Dinis-Ribeiro, Pedro Pimentel-Nunes, Diogo Libânio; Neuroendocrine Tumors of the Gastrointestinal Tract: A Focused Review and Practical Approach for Gastroenterologists. GE Port J Gastroenterol 1 September 2021; 28 (5): 336–348.

Introduction

Alternate day oral iron therapy is better than daily oral iron therapy in Iron deficiency anemia (IDA) as it increases the fractional absorption of iron. In Ulcerative colitis (UC) with IDA increased fractional absorption of iron with alternate day iron may not only be better in improvement of anemia but also results in reduced unabsorbed iron delivery to distal bowel and may hence reduce adverse effects.

Aims & Methods

In a randomized, open label trial, from February 2023 to December 2024 patients of UC in remission (Mayo ≤2 OR partial Mayo ≤1 with fecal calprotectin <150mcg/gm for last 3 months) with IDA (ferritin <30mcg/l, transferrin saturation <20%, Hb 8-12 gm/dl) were randomized to every other day 132mg (EOD group) or daily 66mg (OD group) elemental oral iron given as ferrous fumarate for 8 weeks. Primary outcome was the difference in mean change in Hemoglobin (Hb) at 8 weeks. Secondary outcomes were the difference in mean change in RBC indices, iron indices and adverse events at 8 weeks.

Results

54 patients were randomized between both groups. One patient in EOD and 2 in OD group withdrew before treatment initiation. Eleven patients had disease flare on oral iron therapy (5 in EOD and 6 in OD group) p= 0.62 and two patients in EOD group had intolerance requiring oral iron stoppage. Thirty-eight patients completed treatment. The mean change in Hb at 8 weeks in EOD and OD groups was 2.08±1.0gm/dl and 2.09±1.11gm/dl respectively in per protocol analysis (p=0.797). The mean change in serum ferritin, serum iron, transferrin saturation and total iron binding capacity in both the groups is not significant. Disease flare within 6 months prior to oral iron therapy correlated with increased incidence of flare on oral iron therapy. (P=0.04)

Conclusion

Alternate day oral iron is not better than daily oral iron in improving Hb levels, iron indices and with similar incidence of adverse events in patients of UC in remission. A recent flare has increased chances of disease flare with oral iron therapy