局部黑色素瘤病史患者常规安排门诊就诊次数假设性减少的可接受性（MEL-SELF）：一项试点随机临床试验

Acceptability of a Hypothetical Reduction in Routinely Scheduled Clinic Visits Among Patients With History of a Localized Melanoma (MEL-SELF): Pilot Randomized Clinical Trial.

作者信息

Drabarek Dorothy, Ackermann Deonna, Medcalf Ellie, Bell Katy J L

机构信息

Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.

出版信息

JMIR Dermatol. 2023 Jun 26;6:e45865. doi: 10.2196/45865.

DOI:10.2196/45865

PMID:37632976

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10335154/

Abstract

BACKGROUND

After treatment for a localized melanoma, patients attend routinely scheduled clinics to monitor for new primary or recurrent melanoma. Patient-led surveillance (skin self-examination with patient-performed teledermoscopy) is an alternative model of follow-up that could replace some routinely scheduled visits.

OBJECTIVE

This study aims to assess the acceptability of a hypothetical reduction in routinely scheduled visits among participants of the Melanoma Self Surveillance (MEL-SELF) pilot randomized clinical trial of patient-led surveillance (intervention) versus usual care (control).

METHODS

Patients previously treated for localized melanoma in New South Wales who were participating in the MEL-SELF pilot randomized clinical trial were asked to respond to a web-based questionnaire at baseline and after 6 months on trial. We used mixed methods to analyze the data. The main outcome of interest was the acceptability of a hypothetical reduction in routinely scheduled visits for melanoma surveillance.

RESULTS

Of 100 randomized participants, 87 answered the questionnaire at baseline, 66 answered the questionnaire at 6 months, and 79 provided a free-text explanation at either time point. At 6 months, 33% (17/51) of the control group and 35% (17/49) of the intervention group indicated that a hypothetical reduction in routinely scheduled visits with all melanoma doctors was at least slightly acceptable (difference in proportions -1%, 95% CI -20% to 17%; P=.89). Participants suggested that prerequisites for a reduction in routinely scheduled visits would include that sufficient time had elapsed since the previous diagnosis without a new primary melanoma or recurrence, an unscheduled appointment could be made at short notice if the patient noticed something concerning, their melanoma doctor had suggested reducing their clinic visit frequency, and patients had confidence that patient-led surveillance was a safe and effective alternative. Participants suggested that a reduction in routinely scheduled visits would not be acceptable where they perceived a very high risk of new or recurrent melanoma, low self-efficacy in skin self-examination and in the use of technologies for the patient-led surveillance intervention, and where they had a preference for clinician-led surveillance. Some patients said that a partial reduction to once a year may be acceptable.

CONCLUSIONS

Some patients may be receptive to a reduction in routinely scheduled visits if they are assured that patient-led surveillance is safe and effective.

TRIAL REGISTRATION

Australian New Zealand Clinical Trials Registry ACTRN12616001716459; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371865&isReview=true; ClinicalTrials.gov NCT03581188; https://clinicaltrials.gov/ct2/show/NCT03581188.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1001/jamadermatol.2021.4704.

摘要

背景

在接受局限性黑色素瘤治疗后，患者需定期前往诊所监测新发原发性或复发性黑色素瘤。患者主导的监测（患者自行进行皮肤自我检查并使用远程皮肤镜检查）是一种替代模式，可取代一些定期安排的就诊。

目的

本研究旨在评估在黑色素瘤自我监测（MEL-SELF）试点随机临床试验的参与者中，假设减少定期安排的就诊的可接受性，该试验比较了患者主导的监测（干预组）与常规护理（对照组）。

方法

曾在新南威尔士州接受局限性黑色素瘤治疗且参与MEL-SELF试点随机临床试验的患者，被要求在基线时以及试验6个月后回复一份基于网络的问卷。我们采用混合方法分析数据。主要关注的结果是假设减少黑色素瘤监测的定期安排就诊的可接受性。

结果

100名随机参与者中，87人在基线时回答了问卷，66人在6个月时回答了问卷，79人在任一时刻提供了自由文本解释。在6个月时，对照组的33%（17/51）和干预组的35%（17/49）表示，假设减少与所有黑色素瘤医生的定期安排就诊至少在一定程度上是可接受的（比例差异为-1%，95%CI为-20%至17%；P = 0.89）。参与者提出，减少定期安排就诊的先决条件包括自上次诊断后已过去足够时间且无新发原发性黑色素瘤或复发、如果患者发现异常情况可在短时间内预约、他们的黑色素瘤医生建议减少门诊就诊频率，以及患者确信患者主导的监测是一种安全有效的替代方法。参与者表示，在他们认为新发或复发性黑色素瘤风险非常高、皮肤自我检查及使用患者主导监测干预技术的自我效能较低，以及他们更倾向于临床医生主导的监测的情况下，减少定期安排就诊是不可接受的。一些患者表示，每年减少至一次可能是可接受的。