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Randomized controlled comparison of cross-sectional survey approaches to optimize follow-up completeness in clinical studies.
PLOS ONE ( IF 2.9 ) Pub Date : 2019-03-18 , DOI: 10.1371/journal.pone.0213822
Regula S von Allmen 1, 2 , Christian Tinner 2 , Jürg Schmidli 2 , Hendrik T Tevaearai 2 , Florian Dick 1, 2
Affiliation  

INTRODUCTION In outcome research, incomplete follow-up is a major, yet potentially correctable source of bias. Cross-sectional surveys may theoretically increase completeness of follow-up, but low response rates are reported typically. We investigated whether a pre-notification letter improved patient availability for follow-up phone interviews and thereby improved cross-sectional survey yield. METHODS A consecutive series of vascular patients was randomly divided into a trial and a validation population. The trial population was then randomized 1:1 to one of two cross-sectional contact strategies: Strategy 1 consisted of direct contact attempts by up to 12 systematically timed phone calls, whereas Strategy 2 used a personalized pre-notification letter to arrange for scheduled phone call interviews. Response rates, average time and efforts needed per patient and overall survey duration were compared. Subsequently, trial findings were externally validated in the validation population. RESULTS Of 728 consecutive patients, 370 were allocated to the trial population. Trial patients contacted by strategy 1 (n = 183) had a similar profile when compared to trial patients contacted by strategy 2 (n = 187). Follow-up periods following surgery (54.3 versus 53.6 months) and all-cause mortality rates (21.3% versus 18.7%) were comparable between the trial groups. Cross-sectional information on survival outcomes was almost complete after both contact strategies (99.5% versus 98.9%, P = 1.0). In 144/187 strategy 2 patients (77%) interviews were scheduled successfully necessitating significantly less contact attempts (median of 1.3 versus 2.3 per patient, P<0.0001). However, invested time per patient was similar between the groups (median of 10.1 versus 9.6 minutes), and survey strategy 1 completed earlier (median time to contact 4 versus 11 days, P<0.0001). Therefore, strategy 1 was validated in the validation population (n = 358): a low lost to follow-up rate below 1% (P = 1.0) was reconfirmed necessitating an average of 2.3 contact attempts per patient. CONCLUSIONS Both contact strategies were equally successful in contacting almost all patients cross-sectionally. If systematically timed, direct phone calls were less complicated to organize and faster completed. Given the low time and effort per patient, outcome studies should invest in systematic follow-up surveys to minimize attrition bias.

中文翻译:

横断面调查方法的随机对照比较,以优化临床研究中的随访完整性。

引言在结局研究中,不完全的随访是主要的,但有可能纠正的偏见来源。从理论上讲,横断面调查可能会增加随访的完整性,但通常报告的答复率较低。我们调查了预通知信是否改善了患者的随访电话访问率,从而提高了横断面调查的收率。方法将连续的血管病患者随机分为试验人群和验证人群。然后将试验人群1:1随机分配到两个横截面联系策略之一:策略1包括通过最多12个系统定时的电话进行的直接联系尝试,而策略2使用个性化的预通知字母安排预定的电话电话面试。回应率,比较了每位患者平均所需的时间和精力以及总体调查持续时间。随后,试验结果在验证人群中进行了外部验证。结果在728名连续患者中,有370名被分配到试验人群中。与通过策略2接触的试验患者(n = 187)相比,通过策略1接触的试验患者(n = 183)具有相似的特征。两组之间的术后随访时间(54.3对53.6个月)和全因死亡率(21.3%对18.7%)是可比的。两种接触策略后,关于生存结局的横断面信息几乎完整(99.5%对98.9%,P = 1.0)。在144/187策略中,成功安排了2位患者(77%)进行访谈,因此接触尝试明显减少(每位患者的中位数为1.3对2.3),P <0.0001。但是,两组之间每位患者的投入时间相似(中位数为10.1对9.6分钟),调查策略1较早完成(接触中位数的时间为4天对11天,P <0.0001)。因此,策略1在验证人群中得到了验证(n = 358):再次证实失访率低于1%(P = 1.0)低,因此每位患者平均需要进行2.3次接触尝试。结论两种接触策略在横断面接触几乎所有患者方面均同样成功。如果系统地安排时间,直接电话的组织就不会那么复杂,并且可以更快地完成。鉴于每位患者的时间和精力较少,结果研究应投资于系统的后续调查,以最大程度地减少损耗偏倚。调查策略1的完成时间较早(联系4天与11天的中位数时间相比,P <0.0001)。因此,策略1在验证人群中得到了验证(n = 358):再次证实失访率低于1%(P = 1.0)低,因此每位患者平均需要进行2.3次接触尝试。结论两种接触策略在横断面接触几乎所有患者方面均同样成功。如果系统地安排时间,直接电话的组织就不会那么复杂,并且可以更快地完成。鉴于每位患者的时间和精力较少,结果研究应投资于系统的后续调查,以最大程度地减少损耗偏倚。调查策略1的完成时间较早(联系4天与11天的中位数时间相比,P <0.0001)。因此,策略1在验证人群中得到了验证(n = 358):再次证实失访率低于1%(P = 1.0)低,因此每位患者平均需要进行2.3次接触尝试。结论两种接触策略在横断面接触几乎所有患者方面均同样成功。如果系统地安排时间,直接电话的组织就不会那么复杂,并且可以更快地完成。鉴于每位患者的时间和精力较少,结果研究应投资于系统的后续调查,以最大程度地减少损耗偏倚。再次确认为0),平均每位患者需要进行2.3次接触尝试。结论两种接触策略在横断面接触几乎所有患者方面均同样成功。如果系统地安排时间,直接电话的组织就不会那么复杂,并且可以更快地完成。鉴于每位患者的时间和精力较少,结果研究应投资于系统的后续调查,以最大程度地减少损耗偏倚。再次确认为0),平均每位患者需要进行2.3次接触尝试。结论两种接触策略在横断面接触几乎所有患者方面均同样成功。如果系统地安排时间,直接电话的组织就不会那么复杂,并且可以更快地完成。鉴于每位患者的时间和精力较少,结果研究应投资于系统的随访调查,以最大程度地减少损耗偏倚。
更新日期:2019-03-19
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