ObjectiveTo pilot test the proposed DiaPROM trial components and address uncertainties associated with conducting a full-scale randomised controlled trial (RCT) to evaluate whether such a trial is feasible.DesignTwo-arm pilot RCT.ParticipantsAdults aged ≥18–39 years, with minimum 1 year type 1 diabetes duration, attending outpatient follow-up. Exclusion criteria were pregnancy, severe cognitive, somatic or psychiatric conditions and impaired vision.Randomisation and interventionAll participants completed electronic Patient-Reported Outcome Measures (PROMs) prior to the annual diabetes consultation. Using computer-generated block-randomisation without blinding, we assigned participants in a 1:1 ratio stratified by sex to receive standard care or an intervention. Physicians reviewed diabetes distress scores (Problem Areas In Diabetes scale) and referred individuals with scores ≥30 or single item(s) ≥3 to minimum two diabetes nurse consultations where reported problems were reviewed and discussed.OutcomesRecruitment and retention rates; participants perceptions about intervention components. Variance and estimated between-group differences in follow-up scores (Diabetes Distress Scale (DDS), WHO 5-Well-being Index, Perceived Competence for Diabetes Scale and glycaemic control) and DDS correlation with baseline scores, to assist sample size calculations.ResultsWe randomised 80 participants to the control or intervention arm (one participant was later excluded). 23/39 intervention arm participants qualified for additional consultations and 17 attended. 67/79 attended the 12-month follow-up (15.2% attrition); 5/17 referred to additional consultations were lost to follow-up (29.4% attrition). Participants reported PROMs as relevant (84.6%) and acceptable (97.4%) but rated the usefulness of consultations as moderate to low. Baseline mean±SD DDS score was 2.1±0.69; DDS SD was 0.71 (95% CI: 0.60 to 0.86) at follow-up; correlation between baseline and follow-up DDS scores was 0.8 (95% CI: 0.7 to 0.9).ConclusionsThe pilot trial revealed need for intervention modifications ahead of a full-scale trial to evaluate use of PROMs in diabetes consultations. Specifically, participant acceptability and intervention implementation need further investigation.

The findings illustrate how choices regarding risk estimation highly affect the size of the target population. Modelling studies are important when preparing guidelines, to address implications for resource allocation and risk of medicalization. The population share to be targeted for primary prevention ought to be estimated, including the impact of various cut-off points for risk algorithms on the size of the risk population.

Background/Objectives Gastopexy (G) has been introduced as a surgical technique to reduce gastroesophageal reflux disease (GERD) in patients undergoing sleeve gastrectomy (SG). We aimed to determine whether adding G to SG improves use of acid reducing medication (ARM), second operations for GERD, epigastric pain or heartburn after surgery. Subjects/Methods Patients undergoing SG at two Norwegian hospitals were included consecutively from 2011 to 2015. Data was collected prospectively up to 7 years after surgery. GERD was defined by use of ARM on a regular basis and epigastric pain and heartburn by questions derived from the Rome II classification of functional gastrointestinal disorders. G was defined as suturing the gastrocolic ligament to the staple line. Patients undergoing SG only (NG group) were compared to those with additional G (G group) by mixed effect models. Results Of 376 included patients (75% females, mean age 42.6 years and BMI 42.9 kg/m2), 350 (93%) and 232 (62%) were available for evaluation after one and 7 years, respectively. Baseline patient characteristics in the NG (n=235) and G groups (n=141) were similar. In patients without ARM use before surgery, the use increased equally in the NG and G groups up to 7 years after SG. In patients that used ARM at baseline, the proportion decreased equally in the NG and G groups. With a combined endpoint of ARM use and/or second operation for GERD, there was no difference during follow-up between the NG and G groups. With time, the proportion of patients with epigastric pain did not differ between the groups, whereas heartburn was significantly more prominent in the G group. Conclusion In this population of patients undergoing SG, adding G was not associated with reduced use of ARM and/or second operation for uncontrolled GERD, epigastric pain, or heartburn during the first 7 postoperative years.

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SummaryWe investigated whether adding gastropexy to sleeve gastrectomy (SG) reduced gastroesophageal reflux disease (GERD) in patients operated for severe obesity, assessed mainly by use of anti‐reflux medication (ARM) and second operations due to GERD worsening. In a prospective non‐randomized study, patients undergoing SG at two Norwegian hospitals were included from 2011 to 2015 and followed for 7 years. GERD was defined by regular use of ARM, and epigastric pain and heartburn were measured by the Rome II questionnaire. Gastropexy was done by suturing the gastrocolic ligament to the staple line. Patients undergoing SG only, mainly before gastropexia was introduced in 2013, were compared to those with additional gastropexy from 2013 onwards. Of 376 included patients (75% females, mean age 42.6 years and BMI 42.9 kg/m2), 350 (93%) and 232 (62%) were available for evaluation after 1 and 7 years, respectively. Baseline characteristics in the no‐gastropexy (n = 235) and gastropexy groups (n = 141) were similar. In patients without ARM use before surgery, the use increased and in those that used ARM at baseline, the proportion decreased, with no difference in the no‐gastropexy and gastropexy groups. With a combined endpoint of ARM use and/or second operation for GERD, there was no difference during follow‐up between the two groups. With time, adding gastropexy did not reduce symptoms of GERD significantly. In this population, adding gastropexy to SG did not reduce use of ARM and/or second operation for uncontrolled GERD, epigastric pain or heartburn during the first 7 postoperative years.