Gastroenterology · Medical Literature
Effect of physician prescribed information to the inflammatory bowel disease patients on quality of life and disease relapse: a randomised control trial.
Abstract
Inflammatory Bowel Diseases (IBD), including Ulcerative Colitis and Crohn&s Disease, are chronic and recurrent conditions that severely impact patients' quality of life and increase the risk of complications. Providing accurate and evidence-based health information is a non-pharmacological strategy that may improve disease outcomes. This study aimed to evaluate the effect of physician-prescribed information on patients' quality of life and disease Relapse. In this randomized controlled trial, 160 patients with IBD were randomly assigned to two groups. The intervention group received a structured information prescription (IP) developed by a trained medical librarian and approved by a physician, while the control group received routine oral explanations. The World Health Organization Quality of Life Questionnaire (WHOQOL) and Time to Relapse Questionnaire (TRQ) were used to assess quality of life and Relapse, respectively. Statistical analyses included t-tests, Chi-square, and Mann-Whitney tests using Stata17 software. The Relapse rate in the intervention group was significantly lower than in the control group at both two months (12.5% vs. 87.5%, p=0.004) and four months (15% vs. 42.5%, P<0.001). The risk of Relapse in the control group was more than twice as high compared to the intervention group (Hazard ratio: 2.1; 95% CI: 1.6-2.8). The mean overall quality of life scores showed an improvement in the intervention group, while a decline was observed in the control group. A significant improvement was also indicated in all quality-of-life domains in the intervention group when compared to the control group (P < 0.001). Physician-prescribed information interventions significantly enhance quality of life and reduce disease Relapse in IBD patients, offering a promising complementary approach in clinical care.
Clinical relevance
Does a structured physician-prescribed information prescription (IP), developed by a trained medical librarian, reduce disease relapse and improve quality of life in patients with inflammatory bowel disease (IBD) compared with routine oral explanations alone? __SNAPSHOT__ {"studyDesign":"Randomized controlled trial (RCT)","setting":"Iran (Tabriz University of Medical Sciences affiliated clinical setting, based on author institutional affiliation); specific institution type not explicitly reported in abstract","sampleSize":"n = 160 (intervention: 80, control: 80; allocation assumed equal-arm — not explicitly stated in abstract)","population":"Adult patients with a confirmed diagnosis of IBD (Ulcerative Colitis or Crohn's Disease); additional inclusion/exclusion criteria not reported in abstract","intervention":"Structured Information Prescription (IP) developed by a trained medical librarian and approved by a physician, provided in addition to (or in lieu of) routine oral explanations","comparator":"Routine oral explanations (standard-of-care informational practice)","primaryOutcome":"Disease relapse rate (assessed via Time to Relapse Questionnaire [TRQ]) and health-related quality of life (assessed via WHO Quality of Life Questionnaire [WHOQOL]); co-primary or hierarchical ordering not specified in abstract","followUp":"4 months (interim assessment at 2 months)","fundingSource":"Not reported"}
Key findings
At 2 months, the relapse rate in the intervention group was 12.5% compared with 87.5% in the control group (absolute risk reduction [ARR] = 75.0% [calculated]; relative risk reduction [RRR] = 85.7% [calculated]; NNT = 1.3 [calculated]; p = 0.004). At 4 months, the relapse rate was 15% in the intervention group versus 42% in the control group — however, the abstract is truncated and the 4-month comparator figure and its p-value are incomplete; the full magnitude of the 4-month effect size, confidence intervals for either time point, and WHOQOL domain-level scores with their between-group differences are not reported in the available abstract. Statistical methods included t-tests, Chi-square, and Mann-Whitney tests. No data on adverse events are reported, as the intervention is non-pharmacological. Note: the 2-month absolute difference (12.5% vs. 87.5%) is unusually large and warrants scrutiny regarding randomization fidelity, baseline disease severity balance, and relapse definition operationalization.
Practice implications
This RCT suggests that a librarian-curated, physician-approved structured information prescription may substantially reduce short-term IBD relapse rates and potentially improve quality of life compared with routine verbal education. However, several critical cautions apply. First, only the abstract is available; full methods, randomization concealment details, blinding procedures, baseline characteristic tables, and complete outcome data cannot be evaluated. Second, the 2-month relapse disparity (12.5% vs. 87.5%) is exceptionally large for a non-pharmacological educational intervention and raises concern about baseline imbalance, differential co-interventions, or a narrow/non-standard relapse definition. Third, the abstract is truncated, meaning the 4-month WHOQOL results and inferential statistics are unreportable here. Fourth, the study appears to have been conducted in an Iranian academic center, limiting direct generalizability to health systems with different baseline patient education practices or literacy contexts. The findings do not establish which IBD subtypes (UC vs. CD) benefited most, nor whether effects persist beyond 4 months. Practice should not change on the basis of this single trial alone; replication with rigorous methods, longer follow-up, and clinically validated relapse definitions is needed. __LIMITATIONS__ Only the abstract is available; full methodological details (randomization sequence generation, allocation concealment, blinding, baseline covariate balance) cannot be assessed.,Abstract is truncated: 4-month relapse comparator value and all quality-of-life outcome data with statistics are incomplete and unreportable.,The 2-month relapse difference (12.5% vs. 87.5%) is implausibly large for an informational intervention and may reflect methodological concerns including imbalanced randomization, co-intervention contamination, or non-standard relapse ascertainment.,Confidence intervals are not reported for any outcome, precluding assessment of precision.,No blinding of participants or outcome assessors is described; patient-reported outcomes (WHOQOL, TRQ) are particularly susceptible to performance and detection bias in open-label designs.,Relatively small sample (n = 160) with only 4 months of follow-up; IBD is a chronic relapsing-remitting condition requiring long-term evaluation.,Generalizability is uncertain: single-country academic setting; patient health literacy, baseline education practices, and IBD phenotype mix may differ from other populations.,UC and Crohn's disease are not analyzed separately; differential responses across disease subtypes are unknown.,Funding source is not reported, precluding assessment of sponsorship bias.,The Time to Relapse Questionnaire (TRQ) is not a widely validated, universally recognized instrument; its measurement properties are not described in the abstract. __BOTTOM_LINE_CATEGORY__ promising_but_preliminary __BOTTOM_LINE__ This RCT reports a striking reduction in IBD relapse rates at 2 and 4 months with a structured, physician-approved information prescription versus routine oral education, but the findings must be interpreted with extreme caution given an implausibly large effect size, a truncated and incomplete abstract, absence of confidence intervals, and inability to evaluate key methodological safeguards. The concept of information prescribing as an adjunct to IBD management is clinically plausible and worth further rigorous investigation, but current evidence is insufficient to justify changing practice. Replication in larger, methodologically transparent trials with validated disease-specific outcomes and longer follow-up is required before clinical adoption.