An observational study investigating the safety, tolerability and health outcomes of cannabinoid therapy prescribed to eligible patients for management of recognized chronic conditions

Interventions: This is an observational, single center investigator driven study conducted in Australia with patients who are about to start cannabinoid therapy for management of recognized chronic
conditions. Patients are to be enrolled into the study no earlier than their Physician’s decision to initiate treatment with a cannabinoid therapy. It is mandatory that the prescriber’s decision to start treatment with cannabinoid therapy was taken independently and before presenting the patient the option to participate in the study. Participants will be followed monthly for a maximum of 12 months from the signing of the informed consent forms (PISCF) or until death, withdrawal of consent, loss of follow-up/record, whichever comes first. During the follow-up visits, assessments will be performed according to routine local clinical practice. Data collected at each visit for the study may include:
- Change in concomitant medications and rationale
- Kessler Psychological Distress Scale (K10) score
- Insomnia Severity Index score
- Simple Pain Index score
- Kemp Quality of Life Scale score
- Rationale for change in cannabinoid therapy and/or dose if applicable
- Participant withdrawal from the study and/or reason for discontinuation of cannabinoid therapy
- Adverse Events/Serious Adverse Events/Adverse Drug reaction that may have occurred while on the study
Follow-up patient reports detailing the required information will be completed for a maximum of 12 months (Reports to coincide with patient visit for follow-up consultation and/or new cannabinoid therapy prescription).
Primary outcome(s): The primary scientific objective of this project is to investigate the safety and tolerability characteristics of cannabinoid therapy prescribed to eligible patients for management of recognized chronic conditions. Safety and tolerability are measured through collection and reporting of adverse events. Information on severity, seriousness and relationship to medical cannabinoid treatment will be used to measure the tolerability and safety of any given dose. Like all prescription medicines, medicinal cannabis products can have side effects. These may include:
- Fatigue and sedation
- Vertigo
- Nausea and vomiting
- Fever
- Appetite increase or decrease
- Dry mouth
- Diarrhoea
- Convulsions
- Feelings of euphoria (intense happiness) or depression confusion
- Hallucinations or paranoid delusions
- Psychosis or cognitive distortion (having untrue thoughts)
Adverse event / serious adverse event data is collected at each visit through subject reporting of symptoms, collection of any relevant medical records / GP letters, and laboratory/pathology results. Adverse event information is documented via the observational trial specific adverse event log that is maintained by the treating physician. [Once a month for twelve months.];Participant withdrawal from the study and/or reason for discontinuation of cannabinoid therapy. This is assessed and reported by the treating physician at each visit via completion of observational trial worksheets and patient medical records. [Once a month for twelve months.];Number of doses consumed since previous visit (tolerability). This is assessed and reported by the treating physician at each visit via completion of observational trial worksheets and patient medical records [Once a month for twelve months.]
Study Design: Purpose: Natural history;Duration: Longitudinal;Selection: Defined population;Timing: Prospective

研究干预：本研究为在澳大利亚开展的单中心研究者发起的观察性研究，纳入即将启动大麻素疗法以治疗已确诊慢性疾病的患者。入组时间不得早于主治医师决定启动大麻素治疗的节点，且必须满足：处方医师决定启用大麻素疗法的行为需独立于向患者提供本研究参与选项的环节。受试者将自签署知情同意书（PISCF）之日起，接受为期最长12个月的每月随访，直至受试者死亡、撤回知情同意、失访或失去研究记录，以先发生者为准。随访期间的评估将遵循当地常规临床实践流程开展。每次访视收集的研究数据可包括：
- 合并用药变化及相关依据
- 凯斯勒心理困扰量表（Kessler Psychological Distress Scale, K10）得分
- 失眠严重指数量表得分
- 简易疼痛指数量表得分
- 坎普生活质量量表（Kemp Quality of Life Scale）得分
- 大麻素疗法或剂量调整的依据（如适用）
- 受试者退出研究的情况及/或停止大麻素疗法的原因
- 研究期间可能发生的不良事件/严重不良事件/药物不良反应

患者需填写包含研究所需信息的随访报告，报告周期最长为12个月（报告需与患者随访咨询就诊及/或新开具大麻素疗法处方的时间同步）。

主要结局指标：本项目的核心科学目标为评估为符合入组标准的已确诊慢性疾病患者开具大麻素疗法的安全性与耐受性特征。安全性与耐受性通过不良事件的收集与报告进行评估。将通过不良事件的严重程度、严重性以及与医用大麻素治疗的相关性，来衡量特定剂量下的耐受性与安全性。与所有处方药物一样，医用大麻产品可能出现不良反应，包括：
- 疲劳与镇静作用
- 眩晕
- 恶心与呕吐
- 发热
- 食欲增减
- 口干
- 腹泻
- 惊厥
- 欣快感（强烈愉悦感）或抑郁、意识模糊
- 幻觉或偏执性妄想
- 精神病性障碍或认知扭曲（出现不实想法）

不良事件/严重不良事件数据将通过以下方式在每次访视时收集：受试者症状报告、相关医疗记录/全科医生信函的收集，以及实验室/病理检查结果。不良事件信息将由主治医师通过维护观察性试验专用不良事件日志进行记录。【每月1次，持续12个月】；受试者退出研究的情况及/或停止大麻素疗法的原因：将由主治医师在每次访视时通过填写观察性试验工作表及查阅患者病历进行评估并报告。【每月1次，持续12个月】；上次访视以来的用药剂量数（用于评估耐受性）：将由主治医师在每次访视时通过填写观察性试验工作表及查阅患者病历进行评估并报告。【每月1次，持续12个月】

研究设计：研究目的：自然病史研究；研究时长：纵向研究；入组人群：特定人群；研究时序：前瞻性研究