Hernar Ingvild, Graue Marit, Richards David A, Strandberg Ragnhild B, Nilsen Roy Miodini, Rekdal Magne, Løvaas Karianne Fjeld, Madsen Tone V, Tell Grethe S, Haugstvedt Anne
Department of Health and Caring Sciences, Western Norway University of Applied Sciences, Bergen, Norway
Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.
BMJ Open. 2021 Apr 14;11(4):e042353. doi: 10.1136/bmjopen-2020-042353.
To 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.
Two-arm pilot RCT.
Adults 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.
All 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 () and referred individuals with scores ≥30 or single item(s) ≥3 to minimum two diabetes nurse consultations where reported problems were reviewed and discussed.
Recruitment and retention rates; participants perceptions about intervention components. Variance and estimated between-group differences in follow-up scores ( (DDS), , and ) and DDS correlation with baseline scores, to assist sample size calculations.
We 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).
The 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.
对拟议的糖尿病患者报告结局测量（DiaPROM）试验的各个组成部分进行预试验，并解决与开展一项全面随机对照试验（RCT）相关的不确定性，以评估这样一项试验是否可行。
双臂预试验RCT。
年龄在≥18至39岁之间、1型糖尿病病程至少1年且正在接受门诊随访的成年人。排除标准为妊娠、严重认知、躯体或精神疾病以及视力受损。
所有参与者在年度糖尿病会诊前完成电子患者报告结局测量（PROMs）。采用计算机生成的非盲法区组随机化，我们按性别分层以1:1的比例将参与者分配接受标准护理或干预。医生查看糖尿病困扰评分（），并将评分≥30或单项≥3的个体转介至至少两次糖尿病护士会诊，在会诊中对报告的问题进行审查和讨论。
招募率和保留率；参与者对干预组成部分的看法。随访评分（糖尿病困扰评分（DDS）、、和）的方差和估计组间差异以及DDS与基线评分的相关性，以辅助样本量计算。
我们将80名参与者随机分配至对照组或干预组（一名参与者后来被排除）。干预组的39名参与者中有23名符合额外会诊条件，其中17名参加了会诊。79名参与者中有67名参加了12个月的随访（失访率为15.2%）；转介至额外会诊的17名参与者中有5名失访（失访率为29.4%）。参与者报告PROMs相关（84.6%）且可接受（97.4%），但对会诊有用性的评价为中等至较低。基线时DDS评分的均值±标准差为2.1±0.69；随访时DDS的标准差为0.71（95%置信区间：0.60至0.86）；基线和随访DDS评分之间的相关性为0.8（95%置信区间：0.7至0.9）。
预试验表明，在开展一项全面试验以评估PROMs在糖尿病会诊中的应用之前，需要对干预措施进行调整。具体而言，参与者的可接受性和干预措施的实施需要进一步研究。
