Study Planner

研究方案规划器

Plan digital health studies and research protocols without assuming a particular app stack.

无需依赖特定应用技术栈，即可规划数字健康研究及研究方案。

When to Use

适用场景

Use this skill when you need to:

shape a research question into a study plan
define enrollment, consent, and participation requirements
design data collection and assessment schedules
align outcomes, operations, and participant burden

当你需要完成以下工作时，可使用本技能：

将研究问题转化为研究方案
明确受试者招募、知情同意及参与要求
设计数据收集与评估时间表
平衡研究结果、运营安排与受试者负担

Working Style

工作方式

Start by understanding the study, not the interface. Ask questions before proposing structure.

Clarify:

objective or hypothesis
participant population
study type and duration
primary and secondary outcomes
expected study procedures and burden
operational constraints such as staffing, review, and follow-up

首先聚焦研究本身，而非技术界面。在提出结构框架前先厘清相关问题。

需明确以下内容：

研究目标或假设
受试者人群
研究类型与时长
主要及次要研究结果
预期研究流程与受试者负担
运营限制条件，如人员配置、审查流程及随访安排

Planning Framework

规划框架

1. Study Overview

1. 研究概述

Define:

study name
objective or hypothesis
population
study type such as observational, interventional, feasibility, or survey-based
duration and major milestones

需明确：

研究名称
研究目标或假设
受试者人群
研究类型（如观察性研究、干预性研究、可行性研究或基于调查的研究）
研究时长及关键里程碑

2. Enrollment and Consent

2. 受试者招募与知情同意

Work through:

inclusion criteria
exclusion criteria
recruitment channels
screening steps
consent requirements
participant withdrawal process

Do not assume device ownership, app literacy, or language access without checking.

需梳理：

纳入标准
排除标准
招募渠道
筛选流程
知情同意要求
受试者退出流程

未经确认，请勿默认受试者拥有设备、具备应用操作能力或可获取对应语言支持。

3. Data Collection Plan

3. 数据收集方案

Create a table like this:

Data Type	Source	Frequency	Purpose	Notes
Baseline demographics	Intake questionnaire	Once	Eligibility and cohort description	Keep minimal
Symptoms	Participant self-report	Daily or weekly	Outcome tracking	Define burden clearly
Clinical measurements	Device, sensor, chart, or manual entry	As needed	Primary or secondary outcomes	Clarify validation path
Engagement data	Product telemetry	Ongoing	Feasibility and adherence	Avoid collecting unnecessary detail

创建如下格式的表格：

数据类型	数据来源	收集频率	用途	备注
基线人口统计学数据	入组调查问卷	一次	资格判定与队列描述	尽量精简
症状数据	受试者自我报告	每日或每周	结果追踪	明确受试者负担
临床测量数据	设备、传感器、病历或手动录入	按需收集	主要或次要研究结果	明确验证路径
参与度数据	产品遥测数据	持续收集	可行性与依从性评估	避免收集不必要的细节

4. Assessment Schedule

4. 评估时间表

Map the study rhythm:

baseline
recurring assessments
triggered events
follow-up visits
closeout or exit steps

For each step, note:

what happens
expected completion time
whether it is required or optional
what constitutes missingness or protocol deviation

规划研究节奏：

基线评估
定期重复评估
触发式事件评估
随访访问
研究收尾或受试者退出流程

针对每个步骤，需记录：

具体内容
预期完成时间
是否为必填项
缺失数据或方案偏离的判定标准

5. Outcome Measures

5. 结果指标设定

Define:

primary outcomes
secondary outcomes
feasibility or engagement measures
timing of analysis
what success or signal detection means

Push for measurable outcomes, not vague aspirations.

需明确：

主要研究结果
次要研究结果
可行性或参与度指标
分析时间点
成功或信号检测的判定标准

力求设定可量化的结果指标，而非模糊的目标。

Operational Questions

运营相关问题

Ask about:

who monitors study progress
who responds to missed assessments
what happens if participants stop engaging
whether reminders, escalations, or coordinator outreach are planned
what data quality review is needed during the study

需询问以下问题：

谁负责监控研究进度
谁负责处理未完成的评估
若受试者停止参与，应如何处理
是否计划设置提醒、升级流程或协调员跟进
研究期间需要进行哪些数据质量审查

Deliverable Format

交付物格式

Produce a concise study planning brief with:

study summary
enrollment and consent plan
data collection matrix
assessment schedule
outcome measures
operational risks and open questions

Save the brief as

docs/planning/study-brief.md

in the project repository.

生成一份简洁的研究规划简报，包含：

研究摘要
受试者招募与知情同意方案
数据收集矩阵
评估时间表
结果指标
运营风险与待解决问题

将简报保存至项目仓库的

docs/planning/study-brief.md

路径下。

Guardrails

注意事项

Keep the plan platform-agnostic unless the user explicitly wants implementation advice.
Do not assume a particular interoperability standard, sensor integration, or client architecture by default.
Flag where clinical, statistical, or IRB review is still needed.
Highlight participant burden whenever the plan becomes too heavy.

除非用户明确要求实施建议，否则保持方案的平台无关性。
请勿默认采用特定的互操作性标准、传感器集成方式或客户端架构。
标记仍需进行临床、统计或IRB（机构审查委员会）审查的环节。
当方案给受试者带来的负担过重时，需重点指出。

Checklist

检查清单

Objective and population clearly defined
Study type and duration captured
Enrollment and consent plan outlined
Data collection matrix created
Assessment schedule defined
Primary and secondary outcomes specified
Operational responsibilities identified
Key risks and open questions documented

已明确研究目标与受试者人群
已确定研究类型与时长
已梳理受试者招募与知情同意方案
已创建数据收集矩阵
已制定评估时间表
已明确主要及次要研究结果
已确定运营职责
已记录关键风险与待解决问题

digital-health-study-planning

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