Evidera, Bethesda, MD, USA.
Eli Lilly and Company, Indianapolis, IN, USA.
J Patient Rep Outcomes. 2023 Jan 31;7(1):8. doi: 10.1186/s41687-022-00535-x.
Patient-reported outcome measures are needed to assess the impact of treatments for COVID-19 on symptoms. The ACTIV-2 COVID-19 Symptom Diary (ACSD) is being used in the ongoing Accelerating COVID-19 Therapeutic Interventions and Vaccines-2 (ACTIV-2) platform clinical trial. The purpose of the current study was to conduct qualitative interviews to assess content validity of the ACSD.
Interviews were conducted with adults who had tested positive for SARS-CoV-2. The ACSD begins with global items, followed by a symptom checklist. Each interview began with concept elicitation focusing on participant experiences with COVID-19. Then, participants completed the ACSD, and cognitive interviews were conducted to evaluate the questionnaire. Interviews were recorded, transcribed, and coded following a qualitative content analysis. For the qualitative analysis, a coding dictionary was developed with a list of all potential codes and instructions for how the codes should be applied and combined.
Interviews were conducted with 30 participants (mean age = 39 years; 57% female; 17% Latinx; 17% Black/African American; 40% meeting at least one criterion for classification as high risk of progression to severe COVID-19). Commonly reported symptoms included fatigue (reported by 100% of the sample), body pain/muscle pain/aches (87%), headaches (87%), cough (83%), loss of smell (73%), shortness of breath/difficulty breathing (70%), and chills (70%). The 13 symptoms most commonly reported in this study are included in the ACSD. After completing the ACSD, participants consistently reported that it was clear and easy to complete, and all items were generally interpreted as intended. Based on participants' input, the ACSD was edited slightly after the first 13 interviews, and the revised version was used for the final 17 interviews. Two additional items assessing "brain fog" and dizziness were recommended for addition to the ACSD in future research.
This qualitative study supports the content validity of the ACSD for assessment of COVID-19 symptoms. Quantitative research with larger samples will be needed to examine the questionnaire's measurement properties.
需要患者报告的结局测量来评估 COVID-19 治疗对症状的影响。正在进行的加速 COVID-19 治疗干预和疫苗-2（ACTIV-2）平台临床试验中使用了 ACTIV-2 COVID-19 症状日记（ACSD）。本研究的目的是进行定性访谈，以评估 ACSD 的内容效度。
对 SARS-CoV-2 检测呈阳性的成年人进行了访谈。ACSD 首先包含整体项目，然后是症状清单。每次访谈都从关注参与者 COVID-19 经历的概念启发开始。然后，参与者完成 ACSD，并进行认知访谈以评估问卷。访谈记录、转录并按照定性内容分析进行编码。对于定性分析，开发了一个编码字典，其中包含所有潜在代码的列表以及如何应用和组合代码的说明。
对 30 名参与者进行了访谈（平均年龄 39 岁；57%为女性；17%为拉丁裔；17%为黑人和/或非裔美国人；40%符合至少一项标准，被归类为 COVID-19 进展为严重疾病的高风险人群）。常见的报告症状包括疲劳（100%的样本报告）、身体疼痛/肌肉疼痛/疼痛（87%）、头痛（87%）、咳嗽（83%）、嗅觉丧失（73%）、呼吸急促/呼吸困难（70%）和发冷（70%）。本研究中最常报告的 13 种症状包括在 ACSD 中。完成 ACSD 后，参与者一致报告说它清晰易懂，易于完成，并且所有项目通常都按预期解释。根据参与者的反馈，在完成前 13 次访谈后，对 ACSD 进行了细微编辑，并用修订后的版本进行了最后 17 次访谈。建议在未来的研究中向 ACSD 添加评估“脑雾”和头晕的两个附加项目。
这项定性研究支持 ACSD 用于评估 COVID-19 症状的内容效度。需要更大样本量的定量研究来检验问卷的测量特性。
