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Challenges of one-year longitudinal follow-up of a prospective, observational cohort study using an anonymised database: recommendations for trainee research collaboratives.
BMC Medical Research Methodology ( IF 3.9 ) Pub Date : 2019-12-12 , DOI: 10.1186/s12874-019-0857-y
, Dmitri Nepogodiev 1
Affiliation  

BACKGROUND Trainee research collaboratives (TRCs) have pioneered high quality, prospective 'snap-shot' surgical cohort studies in the UK. Outcomes After Kidney injury in Surgery (OAKS) was the first TRC cohort study to attempt to collect one-year follow-up data. The aims of this study were to evaluate one-year follow-up and data completion rates, and to identify factors associated with improved follow-up rates. METHODS In this multicentre study, patients undergoing major gastrointestinal surgery were prospectively identified and followed up at one-year following surgery for six clinical outcomes. The primary outcome for this report was the follow-up rate for mortality at 1 year. The secondary outcome was the data completeness rate in those patients who were followed-up. An electronic survey was disseminated to investigators to identify strategies associated with improved follow-up. RESULTS Of the 173 centres that collected baseline data, 126 centres registered to participate in one-year follow-up. Overall 62.3% (3482/5585) of patients were followed-up at 1 year; in centres registered to collect one-year outcomes, the follow-up rate was 82.6% (3482/4213). There were no differences in sex, comorbidity, operative urgency, or 7-day postoperative AKI rate between patients who were lost to follow-up and those who were successfully followed-up. In centres registered to collect one-year follow-up outcomes, overall data completeness was 83.1%, with 57.9% (73/126) of centres having ≥95% data completeness. Factors associated with increased likelihood of achieving ≥95% data completeness were total number of patients to be followed-up (77.4% in centres with < 15 patients, 59.0% with 15-29 patients, 51.4% with 30-59 patients, and 36.8% with > 60 patients, p = 0.030), and central versus local storage of patient identifiers (72.5% vs 48.0%, respectively, p = 0.006). CONCLUSIONS TRC methodology can be used to follow-up patients identified in prospective cohort studies at one-year. Follow-up rates are maximized by central storage of patient identifiers.

中文翻译:


使用匿名数据库进行前瞻性观察队列研究的一年纵向随访的挑战:对实习研究合作的建议。



背景 实习研究合作组织 (TRC) 在英国率先开展了高质量、前瞻性“快照”手术队列研究。手术肾损伤后的结果 (OAKS) 是第一个尝试收集一年随访数据的 TRC 队列研究。本研究的目的是评估一年随访率和数据完成率,并确定与改善随访率相关的因素。方法 在这项多中心研究中,前瞻性地识别接受重大胃肠道手术的患者,并在手术后一年随访六种临床结果。本报告的主要结果是 1 年死亡率的随访率。次要结果是随访患者的数据完整性率。向调查人员分发了一项电子调查,以确定与改善随访相关的策略。结果 在收集基线数据的 173 个中心中,有 126 个中心注册参加一年随访。总体而言,62.3% (3482/5585) 的患者在 1 年时进行了随访;在登记收集一年结果的中心,随访率为 82.6% (3482/4213)。失访患者和成功随访患者之间的性别、合并症、手术紧迫性或术后 7 天 AKI 率没有差异。在登记收集一年随访结果的中心中,总体数据完整性为 83.1%,其中 57.9% (73/126) 的中心数据完整性≥95%。与实现 ≥95% 数据完整性的可能性增加相关的因素是要随访的患者总数(患者数 < 15 名患者的中心为 77.4%,15-29 名患者为 59.0%,30-59 名患者为 51.4%,36.8 > 60 名患者的百分比,p = 0。030),以及患者标识符的中央存储与本地存储(分别为 72.5% 与 48.0%,p = 0.006)。结论 TRC 方法可用于对前瞻性队列研究中确定的患者进行为期一年的随访。通过集中存储患者标识符,可以最大限度地提高随访率。
更新日期:2019-12-12
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