Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): Extending the CONSORT Statement

MacPherson, Hugh; Altman, Douglas G.; Hammerschlag, Richard; Li, Youping; Wu, Taixiang; White, Adrian; Moher, David

doi:10.1089/acm.2010.1610

Cited by 290 publications

(283 citation statements)

References 55 publications

Supporting

Mentioning

280

Contrasting

Unclassified

Order By: Relevance

“…As technology is changing constantly and rapidly, and reporting of eHealth and mHealth interventions is determined by what is technologically possible, the checklist will need to be updated much more frequently than other guidelines dealing with more “static” interventions, such as acupuncture (STRICTA) [21]. …”

Section: Discussionmentioning

confidence: 99%

CONSORT-EHEALTH: Improving and Standardizing Evaluation Reports of Web-based and Mobile Health Interventions

2011

View full text Add to dashboard Cite

BackgroundWeb-based and mobile health interventions (also called “Internet interventions” or "eHealth/mHealth interventions") are tools or treatments, typically behaviorally based, that are operationalized and transformed for delivery via the Internet or mobile platforms. These include electronic tools for patients, informal caregivers, healthy consumers, and health care providers. The Consolidated Standards of Reporting Trials (CONSORT) statement was developed to improve the suboptimal reporting of randomized controlled trials (RCTs). While the CONSORT statement can be applied to provide broad guidance on how eHealth and mHealth trials should be reported, RCTs of web-based interventions pose very specific issues and challenges, in particular related to reporting sufficient details of the intervention to allow replication and theory-building.ObjectiveTo develop a checklist, dubbed CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth), as an extension of the CONSORT statement that provides guidance for authors of eHealth and mHealth interventions.MethodsA literature review was conducted, followed by a survey among eHealth experts and a workshop.ResultsA checklist instrument was constructed as an extension of the CONSORT statement. The instrument has been adopted by the Journal of Medical Internet Research (JMIR) and authors of eHealth RCTs are required to submit an electronic checklist explaining how they addressed each subitem.ConclusionsCONSORT-EHEALTH has the potential to improve reporting and provides a basis for evaluating the validity and applicability of eHealth trials. Subitems describing how the intervention should be reported can also be used for non-RCT evaluation reports. As part of the development process, an evaluation component is essential; therefore, feedback from authors will be solicited, and a before-after study will evaluate whether reporting has been improved.

show abstract

Section: Discussionmentioning

confidence: 99%

CONSORT-EHEALTH: Improving and Standardizing Evaluation Reports of Web-based and Mobile Health Interventions

2011

View full text Add to dashboard Cite

show abstract

“…This is a single-center, patient-assessor-blinded, parallel-group RCT that conforms to the Consolidated Standards of Reporting Trials [14] and Standards for Reporting Interventions in Clinical Trials of Acupuncture [15] guidelines for acupuncture studies. Eligible patients will be randomly divided into the intervention group and the control group in a 1:1 allocation ratio.…”

Section: Methodsmentioning

confidence: 99%

Effect of acupuncture on insomnia following stroke: study protocol for a randomized controlled trial

Cao

Yin

Soto-Aguilar

et al. 2016

Trials

View full text Add to dashboard Cite

BackgroundThe incidence, mortality, and prevalence of stroke are high in China. Stroke is commonly associated with insomnia; both insomnia and stroke have been effectively treated with acupuncture for a long time. The aim of this proposed trial is to assess the therapeutic effect of acupuncture on insomnia following stroke.MethodsThis proposed study is a single-center, single-blinded (patient-assessor-blinded), parallel-group randomized controlled trial. We will randomly assign 60 participants with insomnia following stroke into two groups in a 1:1 ratio. The intervention group will undergo traditional acupuncture that achieves the De-qi sensation, and the control group will receive sham acupuncture without needle insertion. The same acupoints (DU20, DU24, EX-HN3, EX-HN22, HT7, and SP6) will be used in both groups. Treatments will be given to all participants three times a week for the subsequent 4 weeks. The primary outcome will be the Pittsburgh Sleep Quality Index. The secondary outcomes will be: the Insomnia Severity Index; sleep efficacy, sleep awakenings, and total sleep time recorded via actigraphy; the National Institutes of Health Stroke Scale; the Stroke-Specific Quality of Life score; the Hospital Anxiety and Depression Scale. The use of estazolam will be permitted and regulated under certain conditions. Outcomes will be assessed at baseline, 2 weeks after treatment commencement, 4 weeks after treatment commencement, and at the 8-week follow-up.DiscussionThis proposed study will contribute to expanding knowledge about acupuncture treatment for insomnia following stroke. This will be a high-quality randomized controlled trial with strict methodology and few design deficits. It will investigate the effectiveness of acupuncture as an alternative treatment for insomnia following stroke.Trial registrationChinese Clinical Trial Registry identifier: ChiCTR-IIC-16008382. Registered on 28 April 2016.

show abstract

“…This study protocol followed the guidelines for clinical research on acupuncture (WHO Regional Publication, Western Pacific Series No.15, 1995) and both the recommendations of Consolidated Standard of Reporting Trials [16] and Standards for Reporting Interventions in Clinical Trials of Acupuncture [17]. The protocol was approved by the Sichuan Regional Ethics Review Committee on Traditional Chinese Medicine, and the ethics approval number of 2012KL-002.…”

Section: Methodsmentioning

confidence: 99%

Effect of catgut implantation at acupoints for the treatment of allergic rhinitis: a randomized, sham-controlled trial

Liu

Zhang

et al. 2016

BMC Complement Altern Med

View full text Add to dashboard Cite

BackgroundThe effect and safety of catgut implantation at acupoints o treat allergic rhinitis (ICD-10 code J30.4) remain controversial. Here, we used a sham catgut implantation group to determine whether catgut implantation at acupoints is an effective and safe treatment for allergic rhinitis.MethodsA randomized double-blind clinical trial, with parallel groups was conducted. Skin prick and puncture test (SPT) was performed to confirm the diagnosis before enrollment. The participants received two sessions of treatments of active or sham catgut implantation at acupoints (once every two weeks) with a follow-up phase of 8 weeks. The visual analogue scale (VAS) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) were used to determine the severity of allergic rhinitis. The use of anti-allergic medication was used as a secondary indicator. The incidence of adverse events was also recorded and analyzed.ResultsAn improvement of the VAS and RQLQ scores was observed in both the active and sham-controlled group sat four and eight weeks after the treatment in the self-control analysis. Comparison revealed no significant difference between the treatment and sham-controlled groups until 8 weeks after the 2-week treatment regimen (t = −2.424, P = 0.017). However, the RQLQ scores significantly differed between the two groups after 4 weeks of treatment completion (t = −2.045, P = 0.05) and this difference lasted until the end of 8-week follow-up (t = −2.246, P = 0.033). Throughout the treatment regimen, none of the participants took any relief medication, and no severe adverse events occurred.ConclusionOur findings suggest that catgut implantation at acupoints is an effective and safe method for symptomatic treatment of allergic rhinitis.Trial registrationChinese Clinical Trial Registry ChiCTR-TRC-12002191 (Date of Registration: 2012-05-09)

show abstract

Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): Extending the CONSORT Statement

Cited by 290 publications

References 55 publications

CONSORT-EHEALTH: Improving and Standardizing Evaluation Reports of Web-based and Mobile Health Interventions

CONSORT-EHEALTH: Improving and Standardizing Evaluation Reports of Web-based and Mobile Health Interventions

Effect of acupuncture on insomnia following stroke: study protocol for a randomized controlled trial

Effect of catgut implantation at acupoints for the treatment of allergic rhinitis: a randomized, sham-controlled trial

Contact Info

Product

Resources

About