Tools

STandards for Reporting Interventions in Clinical Trials of Acupuncture

STRICTA:

“STRICTA has been designed to improve the Standards for Reporting Interventions in Clinical Trials of Acupuncture. These guidelines provide authors a way to structure their reports of interventions with a minimum set of items within a checklist. This will facilitate transparency in published reports, enabling a better understanding and interpretation of results, aiding their critical appraisal, and providing detail that is necessary for replication. 

These guidelines are a revised version of what was originally published in 2001. The new version has been developed in conjunction with the CONSORT Group Executive, such that the new version of STRICTA has become an official extension to the CONSORT Statement. Involved in the revision process have been a wide range of acupuncturists, physicians, clinical trialists, methodologists, guideline developers and journals editors from around the world.”

The SAR White Paper Paradoxes in Acupuncture Research: Strategies for Moving Forward

Comparative Effectiveness Research (CER):

Because of the dire need for an increase in funding for acupuncture research, it seems there is a push to make acupuncture research as directly relevant as possible to decision-making bodies. One of the best ways to do this is to use comparative effectiveness research.

According to the Center for Medical Technology Policy (CMTP), Comparative Effectiveness Research is defined as:

“The direct comparison of existing health care interventions to determine which work best for which patients and which pose the greatest benefits and harms. The core question of comparative effectiveness research is which treatment works best, for whom, and under what circumstances.”

In order to effectively use CER, trials must be designed strongly and efficiently. To aid in this structuring, the Pragmatic Explanatory Continuum Indicator Summary (PRECIS) has been developed. From the CMTP website:

“The purpose of the PRECIS tool is to provide a framework for describing and evaluating key features of trial design that researchers should consider when designing trials to meet the need of post-regulatory decision makers (patients, clinicians, payers, and policy makers).”

Here is the complete PRECIS document (html):

A pragmatic–explanatory continuum indicator summary (PRECIS): a tool to help trial designers

CER Guidelines

Checklist for CER relevant aspects for acupuncture clinical studies  (Table 1 from the following article:)

Effectiveness Guidance Document (EGD) for acupuncture research – a consensus document for conducting trials. BMC Complement Altern Med. 2012 Sep 6;12:148. doi: 10.1186/1472-6882-12-148. Authors: Witt CMAickin MBaca TCherkin DHaan MNHammerschlag RHao JJKaplan GALao LMcKay TPierce BRiley DRitenbaugh CThorpe KTunis S,Weissberg JBerman BMEffectiveness Guidance Documents Collaborators.

Outcome Assessment Tools

The Society for Acupuncture Research has a full listing of these, broken down by mechanism and by condition, available for members on their website: http://www.acupunctureresearch.org/membership

Guiding document for selection of Outcome Measures:

Paterson, C. (2006) Measuring changes in self-concept: a qualitative evaluation of outcome questionnaires in people having acupuncture for their chronic health problemsBMC Complementary and Alternative Medicine, Mar 16;6:7.

Attributes of a Good Outcome Measure (IN-CAM)

IN-CAM Outcomes Database

“We have developed a database of outcome measures of particular importance to Complementary and Alternative Medicine (CAM) and Integrative Health Care (IHC) effectiveness and efficacy research in order to facilitate and support the assessment of CAM interventions through high quality research, and thus, to improve clinical practice and inform policy.

…Our goals are to: 1) include practical information on outcome measures within a framework of domains that makes them easily accessible, and 2) assist researchers and practitioners in framing their approach (research or clinical) within a whole person perspective and/or a wellness orientation.”

Outcome Measures- Useful Measures in Acupuncture Research:

PROMIS: 

“Patient Reported Outcomes Measurement Information System (PROMIS) is a system of highly reliable, precise measures of patient–reported health status for physical, mental, and social well–being. PROMIS tools measure what patients are able to do and how they feel by asking questions. PROMIS’ measures can be used as primary or secondary endpoints in clinical studies of the effectiveness of treatment.”

MYMOP:

“MYMOP is a patient-generated, or individualised, outcome questionnaire. It is problem-specific but includes general wellbeing. It is applicable to all patients who present with symptoms, and these can be physical, emotional or social. It is brief and simple to administer.”

Paterson C. Measuring outcome in primary care: a patient-generated measure, MYMOP, compared to the SF-36 health survey. British Medical Journal 1996;312:1016-20. Available online

Medication Change Questionnaire (MCQ):

“This questionnaire can be used alongside MYMOP in evaluations of all kinds. When the two are used together the medication questions on the bottom of MYMOP can be deleted.”

Source: Paterson C, Symons L, Britten N, Bargh J. Medication change as an outcome: developing the Medication Change Questionnaire. FACT.Focus on Alternative and Complementary Therapies. 2003;8:526

PSYCHLOPS:

“[A] short one page mental health outcome measure and can be used during the course of any psychotherapeutic intervention.”

Hedinsson H, Kristjansdottir H, Olason D, Sigurdsson JF. A validation and replication study of the patient-generated measure ‘PSYCHLOPS’ (Psychological Outcome Profiles) on an Icelandic clinical population.European Journal of Psychological Assessment 2013; doi:10.1027/1015-5759/a000136.

Patient Enablement Instrument (PEI):

“[D]esigned to capture the concept of ‘enablement’ which is defined as reflecting patients’ ability to understand the nature of their problems and cope with their illness.  Enablement is conceived as being conceptually distinct from patient-centredness.  The PEI was developed to be used in primary care and is to be completed by the patient after consultation.  That is, enablement is assesd as an outcome measure for the quality of the consultation.”

Howie, J. G., Heaney, D. J., Maxwell, M., Walker, J. J., & Freeman, G. K. (1999). Quality at general practice consultations: Cross sectional survey. British Medical Journal, 319, 738-743

Well-Being Questionnaire (W-BQ12):

“The Well-Being Questionnaire (WBQ) is a 22-item, multi-dimensional measure that assesses depression (6 items), anxiety (6 items), vitality or energy (4 items) and positive well-being (6 items)…The WBQ-22 has been shortened to the WBQ-12, a 12-question form. There are numerous studies on the W-BQ12 validity. The WBQ-22 and the WBQ-12 have been adapted for use outside of diabetes.”

Covert D, Berdeaux G, Mitchell J, Bradley C, Barnes R. (2007). Quality of Life and Health Economic Assessments of Age-Related Macular Degeneration.Survey of Ophthalmology, 52(1), S20-S25.

NCCAM Clinical Research Toolbox:

“The purpose of the NCCAM Clinical Research Toolbox is to provide a Web-based information repository for investigators and staff involved in NCCAM-funded clinical research. The Toolbox contains templates, sample forms, and information materials to assist clinical investigators in the development and conduct of high-quality clinical research studies.”

NIH Toolbox:

“NIH Toolbox is a multidimensional set of brief measures assessing cognitive, emotional, motor and sensory function from ages 3-85, meeting the need for a standard set of measures that can be used as a “common currency” across diverse study designs and settings.

By using multiple constructs of each domain, the NIH Toolbox monitors neurological and behavioral function over time, and measures the domain constructs across developmental stages. This facilitates the study of functional changes across the lifespan, including evaluating intervention and treatment effectiveness. Fees may apply for use of the NIH Toolbox in projects not funded by NIH.”

PDF: NIH Toolbox Brochure

IMMPACT: Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials

“IMMPACT recommendations and systematic reviews have been widely cited and have guided the design of clinical trials, other types of clinical research, and a national survey. Additional consensus meetings are planned, and research initiatives involving the assessment of pain and the design and interpretation of clinical trials are ongoing.”

NeuroNEXT • Network for Excellence in Neuroscience Clinical Trials

“The Network for Excellence in Neuroscience Clinical Trials, or NeuroNEXT, was created to conduct studies of treatments for neurological diseases through partnerships with academia, private foundations, and industry. The network is designed to expand the National Institute of Neurological Disorders and Stroke’s (NINDS) capability to test promising new therapies, increase the efficiency of clinical trials before embarking on larger studies, and respond quickly as new opportunities arise to test promising treatments for people with neurological disorders.”

Clinical Trials Databases

World Health Organization: International Clinical Trials Registry Platform: Search Portal

“The Clinical Trials Search Portal provides access to a central database containing the trial registration data sets provided by the registries listed on the right. It also provides links to the full original records.”

NIH RePORTER: Currently Funded Trials

“The information found in RePORTER is drawn from several extant databases–eRA databases, Medline, PubMed Central, the NIH Intramural Database, and iEdison–using newly-formed linkages among these disparate data sources.”

PubMed:

“PubMed comprises more than 22 million citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.”

AcuTrials:

“[A] comprehensive collection of randomized controlled trials and systematic reviews of acupuncture published in the English language. The database is consistently updated by the Research Department at OCOM, and is compiled primarily from PubMed, the Cochrane Library and the OCOM library. AcuTrials® is a unique resource for practitioners, students, and researchers interested in refining searches for specific acupuncture research.”

Recommended Reading

Suggested by Kristen Huntley, PhD, NCCAM Program Officer, at the Society for Acupuncture Research 2013 Conference.

The SAR White Paper Paradoxes in Acupuncture Research: Strategies for Moving Forward

Effectiveness guidance document (EGD) for acupuncture research – a consensus document for conducting trials

A pragmatic–explanatory continuum indicator summary (PRECIS): a tool to help trial designers

Interpreting the Clinical Importance of Treatment Outcomes in Chronic Pain Clinical Trials: IMMPACT Recommendations

Multi-site effectiveness trials of treatments for substance abuse and co-occurring problems: Have we chosen the best designs?

An Evidence Integration Triangle for Aligning Science with Policy and Practice (full text requires payment)

Also: How to communicate with your biostatistician:

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