Diagnostic spectrum and time intervals in Sweden’s first diagnostic center for patients with nonspecific symptoms of cancer

<b>Background:</b> Fast-track referral is an increasingly used method for diagnostic evaluation of patients suspected of having cancer. This approach is challenging and not used as often for patients with only nonspecific symptoms. In order to expedite the diagnostics for these patients, we established Sweden’s first Diagnostic Center (DC) focusing on outcomes related to diagnoses and diagnostic time intervals. <b>Material and Methods:</b> The study was designed as a prospective cohort study. Patients aged ≥18 years who presented in primary care with nonspecific symptoms of a serious disease were eligible for referral to the DC after having completed an initial investigation. Acceptable diagnostic time intervals were defined to be a maximum of 15 days in primary care and 22 days at the DC. Diagnostic outcome, length of diagnostic time intervals and patient satisfaction were evaluated. <b>Results:</b> A total of 290 patients were included in the study. Cancer was diagnosed in 22.1%, other diseases in 64.1%, and no diagnosis was identified in 13.8% of these patients. Patients diagnosed with cancer were older, had shorter patient interval (time from first symptom to help-seeking), shorter DC-interval (time from referral decision in primary care to diagnosis) and showed a greater number of symptoms compared to patients with no diagnosis. The median primary care interval was 21 days and the median DC interval was 11 days. Few symptoms, no diagnosis, female sex, longer patient interval, and incomplete investigations were associated with prolonged diagnostic time intervals. Patient satisfaction was high; 86% of patients reported a positive degree of satisfaction with the diagnostic procedures. <b>Conclusions:</b> We demonstrated that the DC concept is feasible with a diagnosis reached in 86.2% of the patients in addition to favorable diagnostic time intervals at the DC and a high degree of patient satisfaction. <b>Trial registration:</b>ClinicalTrials.gov identifier: NCT01709539.

<b>研究背景：</b>快速转诊是疑似癌症患者诊断评估中日益常用的手段，但针对仅表现为非特异性症状的患者，该策略实施难度较大且应用频次偏低。为加快此类患者的诊断流程，我们建立了瑞典首个以诊断结局与诊断时长为核心关注指标的诊断中心（Diagnostic Center，DC）。
<b>材料与方法：</b>本研究为前瞻性队列研究。纳入在基层医疗就诊、表现为重症非特异性症状且年满18周岁的患者，此类患者在完成初始检查后，符合转诊至本DC的入选标准。本研究将可接受的诊断时长定义为：基层医疗阶段最长15天，DC阶段最长22天。本研究评估了诊断结局、诊断时长及患者满意度。
<b>研究结果：</b>本研究共纳入290例患者。其中22.1%确诊为癌症，64.1%确诊为其他疾病，13.8%未明确诊断。与未明确诊断的患者相比，癌症确诊患者年龄更大、患者间隔时长（从首次出现症状至就医的时间）更短、DC间隔时长（从基层医疗作出转诊决定至确诊的时间）更短，且症状数量更多。基层医疗阶段的中位诊断时长为21天，DC阶段的中位诊断时长为11天。症状较少、未明确诊断、女性、更长的患者间隔时长以及初始检查不完整，均与诊断时长延长显著相关。患者整体满意度较高，86%的患者对诊断流程表示满意。
<b>研究结论：</b>本研究证实，DC模式具备临床可行性：86.2%的患者可明确诊断，DC阶段诊断时长符合预设标准，且患者满意度较高。
<b>试验注册：</b>ClinicalTrials.gov 标识符：NCT01709539。