■关于藏毛病的最佳管理尚无共识。手术实践多种多样,现有文献主要是不同疾病严重程度的单中心队列研究,干预措施和结果评估。
一项前瞻性队列研究,以确定:•疾病严重程度和干预关系•患者最有价值的结果和治疗偏好•政策和未来研究建议。
■采用嵌套混合方法的观察性队列研究案例研究。离散选择实验。临床医生调查。针对患者和临床医生的三阶段德尔菲调查。分类系统的评分者间可靠性。
■31个国家卫生服务信托基金。
■年龄>16岁的患者转诊为择期手术治疗的藏毛疾病。
■手术。
■术后第1天和第7天疼痛,愈合和恢复正常活动的时间,并发症,复发。使用回归模型比较主要程序和次要程序之间的结果,基于倾向得分的方法和增强的逆概率加权,以考虑测量的潜在混杂特征。
■临床医生调查:外科医生的实践偏好存在显著的异质性。有限的培训机会可能会阻碍改进实践的努力。队列研究:超过一半的患者(60%;N=667)进行了主要手术。对于这些程序,第1天和第7天疼痛更大(第1天疼痛平均差异1.58分,95%置信区间1.14至2.01点,n=536;平均差异第7天疼痛1.53分,95%置信区间1.12至1.95点,n=512)。并发症发生率较高(调整后的风险差异17.5%,95%置信区间9.1至25.9%,n=579),较低的复发率(调整后的风险差异-10.1%,95%置信区间-18.1至-2.1%,n=575),愈合时间更长(估计差异>34天)和恢复正常活动的时间(差异25.9天,95%置信区间18.4至33.4天)。混合方法分析:患者的决策受先前的疾病经验和预期的恢复时间的影响。伤口护理的负担以及恢复的预期时间与实际时间之间的差距是造成决策遗憾的主要原因。离散选择实验:患者治疗选择的最强预测因素是感染/持续风险(属性重要性70%),和更短的恢复时间(属性重要性30%)。患者愿意权衡这些属性。30岁以上的人如果能够快速康复,对治疗失败的风险承受能力更高(22.35-34.67%)。没有强有力的证据表明年轻患者愿意接受更高的治疗失败风险,以换取更快的康复。由于需要长期的护理,患者在拒绝切除和开放方面表现均匀。Wysocki分类分析:评分者之间存在可接受的一致性(κ=0.52,95%置信区间0.42至0.61)。共识活动:确定了五个研究和实践优先事项。最优先的研究是比较试验应该广泛地分组干预。最重要的做法是,任何干预措施都应该比疾病本身更具破坏性。
■不完整的招聘和后续数据是一个问题,特别是考虑到多种干预措施。对风险调整进行了假设。
■结果表明,藏毛手术的负担比以前报道的要大。这可以通过根据疾病类型和患者期望的目标更好地选择干预来减轻。结果为未来更高质量的试验提供了一个框架,可以对疾病进行分层,并利用广泛的常见干预措施,并开发以患者为中心的核心结果集。
■本试验注册为ISRCTN95551898。
■该奖项由美国国家卫生与护理研究所(NIHR)健康技术评估计划(NIHR奖项编号:17/17/02)资助,并在《健康技术评估》中全文发布。28号33.有关更多奖项信息,请参阅NIHR资助和奖励网站。
人皮病是由臀部之间的毛发生长引起的。它可能会引起疼痛和感染,可能需要手术。我们不知道哪种操作能带来最好的结果,或谁的操作帮助。PITSTOP旨在找出哪种手术是最好的,以及在决定手术时对患者重要的是什么,并提出更好的治疗和未来研究的想法。我们查看了所做的操作及其结果。我们采访了患者的经历。一些人完成了一项调查,以帮助我们了解他们基于风险和结果可能更喜欢哪些操作。外科医生完成了一项关于他们经历的调查,我们探索了一种新工具是否可以帮助我们区分“轻度”和“不良”疾病。我们使用这些研究的结果来帮助患者和外科医生为未来的实践和研究提供优先考虑。六百六十七名患者加入了PITSTOP。进行大手术的人疼痛更大,需要更长的时间才能恢复正常活动。有些人在手术后6个月仍受到影响。然而,疾病复发率低于小手术后。患者根据成功的可能性和恢复的时间来决定治疗。这项研究和外科医生的调查都显示出在实践中的明显差异。外科医生倾向于提供训练期间学到的一两个操作。分类工具将案例分为相似的组,但这并不影响治疗选择。共识工作确定了五个研究重点,最重要的是将手术类型分为两组。在五个实践优先事项中,最重要的是手术不应该让病人比疾病更糟糕。藏毛疾病的治疗存在差异。应避免伤口问题和对日常生活的影响。应解决突出的研究问题以改善护理。
UNASSIGNED: There is no consensus on optimal management of pilonidal disease. Surgical practice is varied, and existing literature is mainly single-centre cohort studies of varied disease severity, interventions and outcome assessments.
UNASSIGNED: A prospective cohort study to determine: • disease severity and intervention relationship • most valued outcomes and treatment preference by patients • recommendations for policy and future research.
UNASSIGNED: Observational cohort study with nested mixed-methods case study. Discrete choice experiment. Clinician survey. Three-stage Delphi survey for patients and clinicians. Inter-rater reliability of classification system.
UNASSIGNED: Thirty-one National Health Service trusts.
UNASSIGNED: Patients aged > 16 years referred for elective surgical treatment of pilonidal disease.
UNASSIGNED: Surgery.
UNASSIGNED: Pain postoperative days 1 and 7, time to healing and return to normal activities, complications, recurrence. Outcomes compared between major and minor procedures using regression modelling, propensity score-based approaches and augmented inverse probability weighting to account for measured potential confounding features.
UNASSIGNED: Clinician survey: There was significant heterogeneity in surgeon practice preference. Limited training opportunities may impede efforts to improve practice. Cohort study: Over half of patients (60%; N = 667) had a major procedure. For these procedures, pain was greater on day 1 and day 7 (mean difference day 1 pain 1.58 points, 95% confidence interval 1.14 to 2.01 points, n = 536; mean difference day 7 pain 1.53 points, 95% confidence interval 1.12 to 1.95 points, n = 512). There were higher complication rates (adjusted risk difference 17.5%, 95% confidence interval 9.1 to 25.9%, n = 579), lower recurrence (adjusted risk difference -10.1%, 95% confidence interval -18.1 to -2.1%, n = 575), and longer time to healing (>34 days estimated difference) and time to return to normal activities (difference 25.9 days, 95% confidence interval 18.4 to 33.4 days). Mixed-methods analysis: Patient decision-making was influenced by prior experience of disease and anticipated recovery time. The burden involved in wound care and the gap between expected and actual time for recovery were the principal reasons given for decision regret. Discrete choice experiment: The strongest predictors of patient treatment choice were risk of infection/persistence (attribute importance 70%), and shorter recovery time (attribute importance 30%). Patients were willing to trade off these attributes. Those aged over 30 years had a higher risk tolerance (22.35-34.67%) for treatment failure if they could experience rapid recovery. There was no strong evidence that younger patients were willing to accept higher risk of treatment failure in exchange for a faster recovery. Patients were uniform in rejecting excision-and-leave-open because of the protracted nursing care it entailed. Wysocki classification analysis: There was acceptable inter-rater agreement (κ = 0.52, 95% confidence interval 0.42 to 0.61). Consensus exercise: Five research and practice priorities were identified. The top research priority was that a comparative trial should broadly group interventions. The top practice priority was that any interventions should be less disruptive than the disease itself.
UNASSIGNED: Incomplete recruitment and follow-up data were an issue, particularly given the multiple interventions. Assumptions were made regarding risk adjustment.
UNASSIGNED: Results suggest the burden of pilonidal surgery is greater than reported previously. This can be mitigated with better selection of intervention according to disease type and patient desired goals. Results indicate a framework for future higher-quality trials that stratify disease and utilise broad groupings of common interventions with development of a patient-centred core outcome set.
UNASSIGNED: This trial is registered as ISRCTN95551898.
UNASSIGNED: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 17/17/02) and is published in full in Health Technology Assessment; Vol. 28, No. 33. See the NIHR Funding and Awards website for further award information.
Pilonidal disease is caused by ingrowing hairs between the buttocks. It can cause pain and infection and may need surgery. We do not know which operation gives the best results, or who operations help. PITSTOP aimed to find out which operation is the best and what is important to patients when deciding on surgery, and to suggest ideas for better treatment and future research. We looked at what operations were done and their outcomes. We interviewed patients about their experiences. Some completed a survey to help us understand what operations they might prefer based on risks and outcomes. Surgeons completed a survey about their experiences, and we explored whether a new tool could help us tell the difference between ‘mild’ and ‘bad’ disease. We used findings from these studies to help patients and surgeons give priorities for future practice and research. Six hundred and sixty-seven patients joined PITSTOP. People who had a major operation had more pain and took longer to return to normal activities. Some were still affected 6 months after surgery. However, disease recurrence was lower than after a minor procedure. Patients based decisions about treatment on the likelihood of success and the time to recover. The study and the surgeons’ survey both showed marked differences in practice. Surgeons tended to offer one or two operations learned during training. A classification tool put cases in similar groups, but this did not influence treatment choices. The consensus exercise identified five research priorities, the top one being to put types of surgery into two groups. Of the five practice priorities, the top one was that surgery should not make the patient worse than the disease. There is variation in the treatment of pilonidal disease. Wound issues and impact on daily living should be avoided. The highlighted research questions should be addressed to improve care.