ICR-Clinical Trials and Statistics Unit (ICR-CTSU), Division of Clinical Studies, The Institute of Cancer Research, London UK.
ICR-Clinical Trials and Statistics Unit (ICR-CTSU), Division of Clinical Studies, The Institute of Cancer Research, London UK.
Clin Oncol (R Coll Radiol). 2018 Jul;30(7):433-441. doi: 10.1016/j.clon.2018.03.007. Epub 2018 Apr 10.
Exploratory analysis of patients' unsolicited written comments in the first 2 years of the Standardisation of Breast Radiotherapy (START) trial quality of life study highlighted a potential effect of non-treatment-related problems on the ratings and interpretation of patient self-reported questionnaires. At 5 years of follow-up all eligible subjects were invited to write comments to further explore these findings.
Using inductive qualitative methods informed by the exploratory analysis, comments were allocated to relevant themes. Key patient-reported outcome measures (PROMs), clinical and demographic factors were collated for patients who did and did not comment at 5 years and comparisons between the groups explored.
Of 2208 women completing baseline PROMs, 482 proffered comments from 0 to 24 months, forming nine distinct themes, including chronic conditions, life events and psychosocial concerns. At 5 years, 1041/1727 (60.3%) women contributed comments, of whom 500 randomly selected participants formed the sample for analysis. Findings revealed comorbidity, impaired physical functioning and psychosocial problems as key themes, with prevalent adverse effects from local and systemic treatments. Eight new themes emerged at 5 years, including ageing, concerns about future cancer and positive aspects of care. Women commenting were better educated, slightly older and more likely to have had chemotherapy compared with non-commenters. They had significantly worse PROM scores for global health and key quality of life domains relevant to the difficulties they revealed.
Difficult personal circumstances and other health concerns affected many women's PROM ratings at 5 years of follow-up, in addition to ongoing cancer treatment effects. Greater attention to multiple sources of distress and adversity could facilitate personalised care and aid interpretation of PROMs.
对标准化乳腺癌放射治疗（START）试验质量研究中前 2 年患者非预期书面意见的探索性分析表明，非治疗相关问题可能会影响患者自我报告问卷的评分和解释。在 5 年随访时，邀请所有符合条件的受试者发表意见，以进一步探讨这些发现。
采用探索性分析中提供的归纳定性方法，将意见分配到相关主题中。对于在 5 年时发表意见和未发表意见的患者，收集了关键患者报告结局测量（PROM）、临床和人口统计学因素，并对两组进行了比较。
在完成基线 PROM 的 2208 名女性中，有 482 名在 0 至 24 个月期间提出了意见，形成了九个不同的主题，包括慢性疾病、生活事件和心理社会问题。在 5 年时，有 1727 名女性中的 1041 名发表了意见，其中 500 名随机选择的参与者构成了分析样本。研究结果显示，合并症、身体功能受损和心理社会问题是关键主题，局部和全身治疗的常见不良反应。5 年后出现了 8 个新主题，包括衰老、对未来癌症的担忧以及对护理的积极看法。发表意见的女性受教育程度更高、年龄稍大，且与未发表意见的女性相比，更有可能接受过化疗。与她们所揭示的困难相关的全球健康和关键生活质量领域的 PROM 评分显著更差。
除了持续的癌症治疗效果外，个人困难情况和其他健康问题还影响了许多女性在 5 年随访时的 PROM 评分。更多地关注多种困扰和逆境的来源，可以促进个性化护理，并有助于解释 PROM。
