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Protocol Manuscripts

Prior to actually launching a behavioral intervention, an important and initial manuscript can be generated by providing a description of the study’s protocol. A protocol paper describes in detail the intervention protocol and trial design. These types of papers are gaining recognition and importance as evidenced by the increasing number of outlets for these types of manuscripts as shown in Table 24.1.

To publish a protocol paper requires prior formal approval of the study protocol by a funding source and/or institutional review board. Furthermore, the study should also be registered with at least one clinical trial registry, examples of which

Study flow of a typical randomized trial and opportunities for manuscript development

Figure 24.1 Study flow of a typical randomized trial and opportunities for manuscript development.

TABLE 24.1 Select Potential Outlets for Publishing a Research Protocol

Addiction Science & Clinical Practice (IF = n/a): www.ascpjournal.org/authors/instructions

American Heart Journal (IF = 4.50): www.ahjonline.com/authorinfo

BioMed Central (BMC, including BMC Geriatrics [IF = 1.97]): www.biomedcentral.com/ authors/protocols

BMJ Open (IF = 1.58): bmjopen.bmj.com/site/about/guidelines.xhtml#studyprotocols

Clinical Interventions in Aging (IF = 2.65): www.dovepress.com/ call-for-papers-clinical-interventions-in-aging-d57-j4

Contemporary Clinical Trials (IF = 1.60) (formerly Controlled Clinical Trials): www .journals.elsevier.com/contemporary-clinical-trials/

Implementation Science (IF = 2.37): www.implementationscience.com/authors/ instructions

International Psychogeriatrics (IF = 2.19): assets.cambridge.org/IPG/IPG_ifc.pdf

Injury Prevention (IF = 1.76): injuryprevention.bmj.com/site/about/guidelines.xhtml

JMIR: Journal of Medical Internet Research (IF = 4.66): www.jmir.org/announcement/ view/55

JMIR Research Protocols (IF = n/a): www.researchprotocols.org/about

Journal of Advanced Nursing (IF = 1.57): onlinelibrary.wiley.com/journal/10.1111/ (ISSN)1365-2648/homepage/protocol_for_a_research_study_or_systematic_review.htm

Journal of Clinical Trials (IF = n/a): www.omicsgroup.org/journals/clinical-trials.php

Neurosurgery (IF = 3.01): journals.lww.com/neurosurgery/Pages/InformationforAuthors. aspx

Open Access Journal of Clinical Trials (IF = n/a): www.dovepress.com/ aims-and-scope-open-access-journal-of-clinical-trials-d43-j51

Reproductive Health (IF = 1.31): www.reproductive-health-journal.com/authors/ instructions/studyprotocol

Trials (IF = 2.21): www.trialsjournal.com/authors/instructions/studyprotocol

IF, impact factor.

are provided in Table 24.2. Formal peer-approval mechanisms assure that the protocol has been reviewed and deemed meritorious. It provides a measure of confidence that the study is not a fleeting idea, but a worthy endeavor, with the potential of making a scientific contribution.

The content of a protocol paper will vary depending upon what one seeks to emphasize concerning the novelty and importance of the intervention and trial (see examples such as Gitlin et al., 2012; Gitlin, Winter, Dennis, & Hauck, 2007; Gross et al., 2014; Szanton et al., 2014). On occasion, a protocol paper may include data concerning feasibility of recruitment or some aspect of implementation. However, there is no requirement for inclusion of data in a protocol manuscript.

Table 24.3 provides an outline of common, basic elements of a protocol paper. Sections can be informed by the original grant proposal or institutional review

Name

Description

Website Address

ClinicalTrials

.gov

ClinicalTrials.gov is an international, Web-based registry and results database that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions. The website is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). Information on ClinicalTrials.gov is provided and updated by the sponsor or principal investigator of the clinical study. Studies are generally submitted to the website (i.e., registered) when they begin, and the information on the site is updated throughout the study. In some cases, results of the study are submitted after the study ends.

clinicaltrials.gov/

Alzheimer's Disease Education and Referral (ADEAR) Center— Clinical Trials

ADEAR's purpose is to "compile, archive, and disseminate information concerning Alzheimer's disease" for health professionals, people with Alzheimer's disease and their families, and the public. Information on current clinical trials in the United States is available through the website. Alzheimer's disease and related clinical trials are searchable through the ADEAR Center, a service of the National Institute on Aging (NIA), one of the federal government's NIH and part of the U.S. Department of Health and Human Services. The NIA conducts and supports research about health issues for older people, and is the primary federal agency for Alzheimer's disease research.

ADEAR Center strives to be a current, comprehensive, unbiased source of information about Alzheimer's disease. All information and materials about the search for causes, treatment, cures, and better diagnostic tools are carefully researched and thoroughly reviewed by NIA scientists and health communicators for accuracy and integrity.

www.nia.nih.gov/

alzheimers/clinical-trials

International Clinical Trials Registry Platform (ICTRP)

ICTRP Search Portal aims to provide a single point of access to information about ongoing and completed clinical trials. It provides a searchable database containing the trial registration data sets made available by data providers around the world meeting control. The mission of the WHO ICTRP is to ensure that a complete view of research is accessible to all those involved in health care decision making.

apps.who.int/trialsearch/

Name

Description

Website Address

UK Clinical Trials Gateway (UKCTG)

The UKCTG provides easy-to-understand information about clinical research trials running in the United Kingdom providing access to a large range of information about these trials. The UKCTG is established by the National Institute for Health Research on behalf of all the UK Health Departments and with the assistance of a number of clinical research charities, research professionals, and patient representatives. It fulfills the government's commitment in the "Plan for Growth," published by HM Treasury in March 2011 that the government will open up information about clinical trials to enable the public to get involved so that patients can find out about clinical trials that may be relevant to their condition.

www.ukctg.nihr.ac.uk/

default.aspx

European Union Clinical Trials Register

The European Union Clinical Trials Register contains information on interventional clinical trials on medicines conducted in the European Union, or the European Economic Area (EEA), which started after May 1,2004.

www.clinical

trialsregister.eu

Australian New Zealand Clinical Trials Registry (ANZCTR)

The ANZCTR is an online register of clinical trials being undertaken in Australia, New Zealand, and elsewhere. The ANZCTR includes trials from the full spectrum of therapeutic areas of pharmaceuticals, surgical procedures, preventive measures, lifestyle, devices, treatment and rehabilitation strategies, and complementary therapies.

In 2007, the ANZCTR was one of the first three trial registries to be recognized by the WHO ICTRP as a Primary Registry. WHO recognizes registries as Primary Registries if they fulfill certain criteria with respect to data content, quality and validity, accessibility, unique identification, technical capacity, and administration. The ANZCTR contributes data to the WHO ICTRP, which was developed in 2007.

http://www.anzctr.org

.au/TrialSearch.aspx

International

Standard

Randomized

Controlled

Trial Number

(ISRCTN)

The ISRCTN is a simple numeric system for the unique identification of randomized controlled trials worldwide. The ISRCTN Register also accepts registration of other forms of studies designed to assess the efficacy of health care interventions.

isrctn.org/

Name

Description

Website Address

Japan

Medical Association—Center for Clinical Trials

(JMACCT)

The JMA has been conducting Clinical Trial Promotion Research Project subsidized by the Ministry of Health, Labor, and Welfare since 2003 to facilitate improvement of the clinical trial infrastructure through the model research of investigator-initiated trials and formation of regional clinical trial networks, and various advocacy efforts as well.

dbcentre3.jmacct

.med.or.jp/jmactr/

Default_Eng.aspx

University Hospital Medical Information Network (UMIN)

UMIN was established in 1989 as a cooperative organization for national medical schools in Japan, sponsored by the Ministry of Education, Culture, Science, Sports, and Technology (MEXT), Japan. UMIN's purposes are as follows:

  • ? To provide up-to-date information to health care professionals
  • ? To promote communications between health care professionals
  • ? To support collaborative work among university hospitals
  • ? To support collaborative medical research
  • ? To standardize medical data and collect hospital statistics

UMIN is now the largest and most versatile academic network information center for biomedical sciences in the world, and it is now considered an indispensable information infrastructure for the Japanese medical community.

www.umin.ac.jp/ctr/

new-registration/

Brazilian Clinical Trials Registry (Registro Brasileiro de Ensaios Clini- cos [ReBec])

The ReBEC is an open-access virtual platform for registration of ongoing experimental and nonexperimental studies on humans performed in Brazil. ReBEC is a joint Project of Brazilian Ministry of Health, The Pan American Health Organization (PAHO), and The Oswaldo Cruz Foundation (FIOCRUZ). The Executive Committee of ReBEC is composed of the aforementioned institutions and also The National Health Surveillance Agency (ANVISA).

www.ensaiosclinicos

.gov.br/

Chinese Clinical Trial Register (ChiCTR)

ChiCTR is hosted on Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University. The ChiCTR is a nonprofit organization, is established according to both the WHO International Clinical Trials Register Platform Standard and Ottawa Group Standard. ChiCTR provides the services that include register for trials, consultation for trial design, central randomization for an allocation sequence, peer review for draft articles, and training for peer reviewers.

http://www.chictr

.org.cn

Name

Description

Website Address

Clinical Research Information Service (CRIS)

The CRIS is a nonprofit online registration system for clinical trials (researches) to be conducted in Korea. It has been established at the Korea Centers for Disease Control and Prevention (KCDC) with support from the Ministry of

Health and Welfare (MOHW). It joined the WHO ICTRP as 11th member of Primary Registry. The CRIS includes any clinical trial or research that will be prospectively conducted with human participants aiming to prevent, detect, diagnose, or treat diseases. The clinical trial or research should be approved by the Institutional Review Board (IRB) prior to the registration on the CRIS. For multinational clinical trials or researches, the principal investigator should register the trial or research to prevent inadequate information or double registration. The information registered into the CRIS is open to the public on a real-time basis, domestically and internationally, from the time when the system administrator approves the trial or research.

https://cris.nih.go.kr/

cris/en/use_guide/cris_

introduce.jsp

Clinical Trials Registry—India (CTRI)

The CTRI, hosted at the Indian Council of Medical Research (ICMR) National Institute of Medical Statistics (nims-icmr.nic.in), is a free and online public record system for registration of clinical trials being conducted in India that was launched on July 20, 2007 (www.ctri.nic.in). Initiated as a voluntary measure, since June 15, 2009, trial registration in the CTRI has been made mandatory by the Drugs Controller General of India (DCGI) (www.cdsco.nic.in). Moreover, editors of biomedical journals of 11 major journals of India declared that only registered trials would be considered for publication.

ctri.nic.in/Clinicaltrials/

login.php

Internet

Portal of the

German

Clinical Trials

Register

(Deutsches

Register

Klinischer

Studien

[DRKS])

The DRKS is an open-access online register for clinical trials conducted in Germany that allows all users to search, register, and share information on clinical trials. The DRKS is funded by the Federal Ministry of Education and Research (BMBF) and implemented at the Center for Medical Biometry and Medical Informatics at the University Medical Center Freiburg as a common project of the Clinical Trial Unit of the University Medical Center Freiburg and the German Cochrane Center. The DRKS was implemented and is further developed in collaboration with the WHO, especially with the ICTRP. It is an approved WHO Primary Register since October 2008 and thus meets the requirements of the International Committee of Medical Journal Editors (ICMJE), whose members decided in September 2004 already that the prospective registration of clinical trials was a necessary requirement for later publications in the leading medical journals.

https://drks-neu.uniklinik-

freiburg.de/drks_web/

Name

Description

Website Address

Iranian Registry of Clinical Trials (IRCT)

IRCT is a nonprofit website set up with the help from the Ministry of Health and Medical Education. The three main objectives of this site are the following:

  • ? Informing the public of the ongoing trials
  • ? Increasing public awareness of their importance
  • ? Implementing the ICMJE's initiative for mandatory registration of trials before the enrollment of the first patient

www.irct.ir/

The Thai Clinical Trials Registry (TCTR)

The TCTR is an online register of clinical researches established in Thailand since 2009.

The website has been operated by Clinical Research Collaboration Network (CRCN), an organization under the Medical Research Foundation, which is a nonprofit organization, and financially supported by Thailand Center of Excellence for Life Sciences (TCELS). CRCN has been retitled the Medical Research Network (MedResNet) since June 15, 2012. The mission of the TCTR is to encourage all clinical trials conducted in Thailand to be prospectively registered before the subject recruitment. This is to promote research transparency, to reduce redundancy, and to minimize publication bias or selective reporting. Registrants who wish to register clinical trials in TCTR are obliged to disclose details of the 20 mandatory items of the WHO ICTRP dataset.

TCTR also aims to be a research database for clinical researches in Thailand, thus it welcomes the registration of all kinds of clinical researches including clinical trials and observational studies.

www.clinicaltrials.in.th

Netherlands

Dutch Trial Register is part of the Dutch Cochrane Centre, one of the centers of the

www.trialregister.nl/

Trial Register

international Cochrane Collaboration. This international nonprofit organization of volunteers collects and analyzes mainly all possible information about clinical trials, compiling them into systematic reviews. For now, the Cochrane researchers are dependent on official publications, or manually sleuthing in conference reports. A public prospective trial registry will not only make it easier to review work but also make it more complete. In collaboration with other stakeholders, the Dutch Cochrane Centre was established. This is a prospective Dutch Trial Register in the Netherlands involving research into the effectiveness of interventions in health care. The Central Committee for Research Involving Human Subjects (CCMO) plays the role of advisor.

trialreg/index.asp

TABLE 24.2 Sample of Clinical Trial Registries (Continued)

Name

Description

Website Address

Pan African Clinical Trials Registry (PACTR)

The PACTR is a regional register of clinical trials conducted in Africa. The registry is an African initiative serving the needs of Africans. It provides an open-access platform where clinical trials can be registered free of charge. The PACTR aims to increase clinical trial registration in Africa by developing awareness of the need to register trials and by supporting trialists during registration.

www.pactr.org/

The Sri Lanka Clinical Trials Registry (SLCTR)

The SLCTR is an Internet-based, not-for-profit clinical trials registry providing free access to researchers, clinicians, funding agencies, and the public. It welcomes registration of trials conducted in Sri Lanka and overseas. The SLCTR has been operational from November 2006, and was the first functioning clinical trials registry in South Asia. It was recognized as a Primary Registry of the Registry Network of the WHO ICTRP in March 2008. The SLCTR currently accepts only clinical trials with a health-related intervention and does not register observational studies. It encourages prospective registration of all clinical trials, and does not accept trials for retrospective registration. It meets all the requirements specified by the WHO ICTRP and the ICMJE. The SLCTR is managed by the SLCTR Committee, an advisory group appointed by the Sri Lanka Medical Association (SLMA). The SLMA is the premiere professional medical association in Sri Lanka, and is the oldest medical organization in Australasia with a proud history dating back to 1887.

slctr.lk/

TABLE 24.3 Basic Contents of a Protocol Paper

Front matter

Title page Abstract

Trial registration: ClinicalTrials.gov #NCT00511680 Acknowledgments

Background/significance

Methods/design

Aims and study hypotheses

Recruitment, eligibility, and randomization

Measures

Intervention

Theory base Delivery characteristics Session content

Control group Analytic plan

Sample size and power

Primary analyses

Secondary analyses

Exploratory analyses

Determination of clinical significance

Cost analysis (if relevant)

Evidence of feasibility (if relevant and data available)

Recruitment and enrollment outcomes Baseline characteristics of sample Program costs

Discussion Tables (examples)

Session-by-session content of intervention Recruitment results Baseline characteristics Intervention cost categories Figure of study design

board protocol submission. As a result, there is efficiency in writing a manuscript of this type in that the materials that have been previously prepared can be repurposed and updated. Furthermore, a published protocol can also be referred to in subsequent publications that evaluate outcomes so that readers can refer to a more detailed explication of study design and protocols.

As with any journal submission, it is important to first carefully read author instructions in order to appropriately prepare the manuscript. In addition, it is helpful to read other protocol papers that have been published by the targeted journal, which can serve as a guide for observing conventions and providing the expected range of content included in these types of publications.

Publishing a protocol paper is important for several reasons.

First, reading protocol papers in general is an excellent way of learning about forthcoming intervention studies and study designs that are employed by others. This can help to advance one’s own knowledge base and intervention work.

Second, a protocol paper serves as a foundational publication that provides the details of the intervention and study design, which can then be referred to in future manuscripts about the study. Because most data-driven journals impose word limitations on content, it is often difficult to provide study design and intervention details in manuscripts. Unfortunately, most interventions are not well described in publications. This is particularly the case for complex, multicomponent interventions and those directed at behavior change (Michie, Fixsen, Grimshaw & Eccles, 2009). Hence, referring readers to a protocol or methods paper that goes into depth with the important nuances of the trial design and the intervention delivery characteristics can be invaluable.

Third, it is a way to disseminate information about the ongoing trial. This provides others who are working in the field with an understanding of works-in-progress and forthcoming intervention developments and outcomes. This is helpful to the scientific community and in turn to authors themselves as others working in a similar area may seek out professional exchanges.

Fourth, a protocol paper reflects the established and approved methodologies of a study. As such, it can serve as a reference source for the investigative team concerning study details and key citations for future papers and presentations.

Finally, a published protocol paper reflects productivity of the investigative team and can be cited in progress reports to funders.

 
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