Acupuncture Case Registry Study: Rationale, Implementations, and Achievements

Table 1

Differences between a acupuncture case registry study and a patient registry.

Topics	Acupuncture case registry study	Patient registry [15]
Definition	Prospective observational studies that use acupuncture as the primary intervention and collect data uniformly to evaluate clinical efficacy and cost-effectiveness, describe the application of acupuncture therapy, monitor the safety of acupuncture therapy, evaluate the quality of acupuncturists, or conduct epidemiological disease investigation.	Organized system that collects uniform data (clinical and other) to identify specified outcomes for a population defined by a particular disease, condition, or exposure.
Objective	Primary purposes include assessing the clinical efficacy and cost-effectiveness of acupuncture, describing the application of acupuncture techniques, monitoring treatment safety, and evaluating the quality of acupuncturists.	Registry purposes can be broadly described in terms of patient outcomes. Major purposes include describing the natural history of disease, determining clinical and/or cost-effectiveness, and assessing safety or harm.
Patient enrollment	As determined by the study objectives, enrolled patients with a disease/certain symptom or a condition who have had acupuncture therapy from an acupuncturist or other acupoint stimulation interventions; generalisability of the acupuncture data and study results to be documented.	Aimed at enrollment of all patients with a disease or condition; generalisability of registry data to be documented.
Follow-up	Timelines are determined by the specific study objectives as well as the collection/extraction and processing of important study data.	Schedules drive timeliness for data collection and any anticipated data analyses which prompted the registry.
Data collection	Data is collected based on the objective of the registry study. A core set of data elements to be collected is agreed upon, and their definitions, coding systems, and data entry procedures are written down. Data collected for the purpose of a registry study can involve the primary collection of data or the secondary use of data.
Data quality management	Study-specific data quality management will be defined in advance and executed using a risk-based approach, with a focus on regular surveillance and inspection of registered data.	Quality management is applied consistently to data and processes, with an emphasis on a core set of data elements; data quality management is specified and documented in advance.
	Data management systems to ensure data integrity, completeness, and security
Analysis plan	Most of the time, detailed statistical considerations are written in a document separate from the study and registry protocols. This document is called a descriptive or hypothesis-driven statistical analysis plan.	Plan for statistical analysis, with analyses often done regularly at regular intervals based on patient accrual or analyses of predefined outcomes at time points described in the registry protocol.