The Karma system is currently undergoing maintenance (Monday, January 29, 2018).
The maintenance period has been extended to 8PM EST.

Karma Credits will not be available for redeeming during maintenance.
Advertisement

Journal Description

 

JMIR Research Protocols (ISSN 1929-0748) is a unique Pubmed-indexed journal, publishing peer-reviewed, openly accessible research ideas and grant proposals, study and trial protocols, reports of ongoing research, current methods and approaches, and preliminary results from pilot studies or formative research informing the design of medical and health-related research and technology innovations.

JMIR Res Protoc is a journal spin-off of JMIR, the worlds' leading medical journal in health sciences / health services research and health informatics (JMIR Impact Factor 2017: 4.671).

While the original focus was on eHealth studies, JMIR Res Protoc now publishes protocols and grant proposals in all areas of medicine (and their peer-review reports, if available), as well as feasibility studies, early reports and formative/process evaluations of ongoing studies and descriptions of the development and pilot evaluations of innovations and software applications or other interventions.

JMIR Res Protoc is fully open access, with full text articles deposited in PubMed Central.

Publishing research protocols, grant proposals, pilot/feasibility studies and early reports of ongoing and planned work encourages collaboration and early feedback, and reduces duplication of effort.

JRP is compatible with the concept of "Registered Reports" and since May 2018, published protocols receive a Registered Report Identifier (What is a Registered Report Identifier?) and acceptance of the subsequent results paper is "in principle" guaranteed in any JMIR journal and partner journals - see What is a Registered Report?

JMIR Res Protoc will be a valuable ressource for researchers who want to learn about current research methodologies and how to write a winning grant proposal.

JMIR Res Protoc creates an early scientific record for researchers who have developed novel methodologies, software, innovations or elaborate protocols.

JMIR Res Protoc provides a "dry-run" for peer-review of the final results paper, and allows feedback/critique of the methods, often while they still can be fixed.

JMIR Res Protoc faciliates subsequent publication of results demonstrating that the methodology has already been reviewed, and reduces the effort of writing up the results, as the protocol can be easily referenced.

JMIR Res Protoc demonstrates to reviewers of subsequent results papers that authors followed and adhered to carefully developed and described a-priori methods.

Studies whose protocols or grant proposal have been accepted in JMIR Res Protoc are "in principle accepted" for subsequent publication of results in other JMIR journals as long as authors adhere to their original protocol - regardless of study results (even if they are negative), reducing publication bias in medicine.

Authors publishing their protocols in JMIR Res Protoc will receive a 20% discount on the article processing fee if they publish their results in another journal of the JMIR journal family (for example, JMIR for ehealth studies, i-JMR for others).

JMIR Res Protoc is also a unique crowdfunding platform, allowing backers to crowdfund carefully peer-reviewed projects that are not junk-science, and giving researchers additional small funding to conduct and publish their research results. Each article is published with a crowdfunding widget, allowing readers to make nominal donations to the project, which benefit the authors (currently in beta).

Need more reasons? Read the Knowledge Base article on "Why should I publish my protocol/grant proposal"!

 
 

Recent Articles:

  • Source: PanCareLIFE; Copyright: The PanCareLIFE Consortium; URL: http://pancarelife.eu; License: Licensed by JMIR.

    Fertility Among Female Survivors of Childhood, Adolescent, and Young Adult Cancer: Protocol for Two Pan-European Studies (PanCareLIFE)

    Abstract:

    Background: Despite a significant number of studies on female fertility following childhood, adolescent, and young adult (CAYA) cancer, studies establishing precise (dose-related) estimates of treatment-related risks are still scarce. Previous studies have been underpowered, did not include detailed treatment information, or were based on self-report only without any hormonal assessments. More precise assessments of who is at risk for sub- or infertility are needed. Objective: The objective of our study is to describe the design and methods of 2 studies on female fertility (a cohort study and a nested case-control study) among female survivors of CAYA cancer performed within the European PanCareLIFE project. Methods: For the cohort study, which aims to evaluate the overall risk of fertility impairment, as well as the risk for specific subgroups of female CAYA cancer survivors, 13 institutions from 9 countries provide data on fertility impairment. Survivors are defined as being fertility impaired if they meet at least one of 8 different criteria based on self-reported and hormonal data. For the nested case-control study, which aims to identify specific treatment-related risk factors associated with fertility impairment in addition to possible dose-response relationships, cases (fertility impaired survivors) are selected from the cohort study and matched to controls (survivors without fertility impairment) on a 1:2 basis. Results: Of the 10,964 survivors invited for the cohort study, data are available from 6619 survivors, either questionnaire-based only (n=4979), hormonal-based only (n=72), or both (n=1568). For the nested case-control study, a total of 450 cases and 882 controls are identified. Conclusions: Results of both PanCareLIFE fertility studies will provide detailed insight into the risk of fertility impairment following CAYA cancer and diagnostic- or treatment-related factors associated with an increased risk. This will help clinicians to adequately counsel both girls and young women, who are about to start anticancer treatment, as well as adult female CAYA cancer survivors, concerning future parenthood and to timely refer them for fertility preservation. Ultimately, we aim to empower patients and survivors and improve their quality of life. Registered Report Identifier: RR1-10.2196/10824

  • Source: Pexels; Copyright: Pixabay; URL: https://www.pexels.com/photo/medical-tablets-pharmacy-cure-51004/; License: Public Domain (CC0).

    Blockchain Technology for Detecting Falsified and Substandard Drugs in Distribution: Pharmaceutical Supply Chain Intervention

    Abstract:

    Background: Drug counterfeiting is a global problem with significant risks to consumers and the general public. In the Philippines, 30% of inspected drug stores in 2003 were found with substandard/spurious/falsely-labeled/falsified/counterfeit drugs. The economic burden on the population drug expenditures and on governments is high. The Philippine Food and Drug Administration (FDA) encourages the public to check the certificates of product registration and report any instances of counterfeiting. The National Police of Philippines responds to such reports through a special task force. However, no literature on its impact on the distribution of such drugs were found. Blockchain technology is a cryptographic ledger that is allegedly immutable through repeated sequential hashing and fault-tolerant through a consensus algorithm. This project will develop and test a pharmacosurveillance blockchain system that will support information sharing along the official drug distribution network. Objective: This study aims to develop a pharmacosurveillance blockchain system and test its functions in a simulated network. Methods: We are developing a Distributed Application (DApp) that will run on smart contracts, employing Swarm as the Distributed File System (DFS). Two instances will be developed: one for Ethereum and another for Hyperledger Fabric. The proof-of-work (PoW) consensus algorithm of Ethereum will be modified into a delegated proof-of-stake (DPoS) or practical Byzantine fault tolerance (PBFT) consensus algorithm as it is scalable and fits the drug supply chain environment. The system will adopt the GS1 pedigree standard and will satisfy the data points in the data standardization guidelines from the US FDA. Simulations will use the following 5 nodes: for FDA, manufacturer, wholesaler, retailer, and the consumer portal. Results: Development is underway. The design of the system will place FDA in a supervisory data verification role, with each pedigree type–specific data source serving a primary data verification role. The supply chain process will be initiated by the manufacturer, with recursive verification for every transaction. It will allow consumers to scan a code printed on the receipt of their purchases to review the drug distribution history. Conclusions: Development and testing will be conducted in a simulated network, and thus, results may differ from actual practice. The project being proposed is disruptive; once tested, the team intends to engage the Philippine FDA to discuss implementation plans and formulate policies to facilitate adoption and sustainability. Registered Report Identifier: RR1-10.2196/10163

  • Source: Freepik; Copyright: sirinarth; URL: https://www.freepik.com/free-photo/young-woman-using-computer-on-green-glasses-in-the-park_1236208.htm#term=teenager%20laptop&page=9&position=16; License: Licensed by JMIR.

    An e-Prehabilitation System of Care for Teenagers and Young Adults Diagnosed With Cancer: Protocol for a Qualitative Co-Design Study

    Abstract:

    Background: A diagnosis of cancer in young adulthood can pose many different and unique challenges for individuals. The provision of adequate and appropriate information as well as care and support for teenagers and young adults at the time of diagnosis is central to their health care experience going forward. Moreover, appropriate and accessible information provision is critical to ensure that young individuals with cancer feel equipped and empowered to make decisions about, and be involved in, their treatment and recovery throughout their experience; this is a concept known as prehabilitation. As digital interventions and resources that support teenagers and young adults with cancer are an increasingly desirable part of health care provision, this study will focus on the development of an age- and population-appropriate electronic prehabilitation (e-Prehabilitation) system of care. Objective: We will conduct an exploratory, co-design research project that will inform the development of an e-Prehabilitation system of care to support teenagers and young adults diagnosed with cancer. A collaborative approach to data collection and prototype design will ensure that a patient-centered approach is embedded throughout. Methods: A qualitative, co-design study utilizing surveys, interviews, and focus group discussions is being conducted with teenagers and young adults, health care professionals, and technologists. Results: This research study is in progress; recruitment and data collection activities have commenced and findings are expected in early 2019. Conclusions: The findings of this study will have important implications for informing the future development and evaluation of an e-Prehabilitation system of care to support teenagers and young adults diagnosed with cancer. Registered Report Identifier: RR1-10.2196/10287

  • SCIPUD+ care plan model (concept). Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/9/e10871/; License: Creative Commons Attribution (CC-BY).

    Individualized Clinical Practice Guidelines for Pressure Injury Management: Development of an Integrated Multi-Modal Biomedical Information Resource

    Abstract:

    Background: Pressure ulcers (PU) and deep tissue injuries (DTI), collectively known as pressure injuries are serious complications causing staggering costs and human suffering with over 200 reported risk factors from many domains. Primary pressure injury prevention seeks to prevent the first incidence, while secondary PU/DTI prevention aims to decrease chronic recurrence. Clinical practice guidelines (CPG) combine evidence-based practice and expert opinion to aid clinicians in the goal of achieving best practices for primary and secondary prevention. The correction of all risk factors can be both overwhelming and impractical to implement in clinical practice. There is a need to develop practical clinical tools to prioritize the multiple recommendations of CPG, but there is limited guidance on how to prioritize based on individual cases. Bioinformatics platforms enable data management to support clinical decision support and user-interface development for complex clinical challenges such as pressure injury prevention care planning. Objective: The central hypothesis of the study is that the individual’s risk factor profile can provide the basis for adaptive, personalized care planning for PU prevention based on CPG prioritization. The study objective is to develop the Spinal Cord Injury Pressure Ulcer and Deep Tissue Injury (SCIPUD+) Resource to support personalized care planning for primary and secondary PU/DTI prevention. Methods: The study is employing a retrospective electronic health record (EHR) chart review of over 75 factors known to be relevant for pressure injury risk in individuals with a spinal cord injury (SCI) and routinely recorded in the EHR. We also perform tissue health assessments of a selected sub-group. A systems approach is being used to develop and validate the SCIPUD+ Resource incorporating the many risk factor domains associated with PU/DTI primary and secondary prevention, ranging from the individual’s environment to local tissue health. Our multiscale approach will leverage the strength of bioinformatics applied to an established national EHR system. A comprehensive model is being used to relate the primary outcome of interest (PU/DTI development) with over 75 PU/DTI risk factors using a retrospective chart review of 5000 individuals selected from the study cohort of more than 36,000 persons with SCI. A Spinal Cord Injury Pressure Ulcer and Deep Tissue Injury Ontology (SCIPUDO) is being developed to enable robust text-mining for data extraction from free-form notes. Results: The results from this study are pending. Conclusions: PU/DTI remains a highly significant source of morbidity for individuals with SCI. Personalized interactive care plans may decrease both initial PU formation and readmission rates for high-risk individuals. The project is using established EHR data to build a comprehensive, structured model of environmental, social and clinical pressure injury risk factors. The comprehensive SCIPUD+ health care tool will be used to relate the primary outcome of interest (pressure injury development) with covariates including environmental, social, clinical, personal and tissue health profiles as well as possible interactions among some of these covariates. The study will result in a validated tool for personalized implementation of CPG recommendations and has great potential to change the standard of care for PrI clinical practice by enabling clinicians to provide personalized application of CPG priorities tailored to the needs of each at-risk individual with SCI. Registered Report Identifier: RR1-10.2196/10871

  • Source: Association of Optometrists, London, UK; Copyright: Association of Optometrists, London, UK; URL: http://www.researchprotocols.org/2018/9/e173/; License: Licensed by JMIR.

    Effect of Peripheral Defocus on Axial Eye Growth and Modulation of Refractive Error in Hyperopes: Protocol for a Nonrandomized Clinical Trial

    Abstract:

    Background: Hyperopia occurs due to insufficient ocular growth and a failure to emmetropize in childhood. In anisohyperopia, it is unclear why one eye may remain hyperopic while the fellow eye grows toward an emmetropic state. Animal studies have shown that manipulating peripheral defocus through optical means while simultaneously providing correct axial focus can either discourage or encourage axial eye growth to effectively treat myopia or hyperopia, respectively. Myopia progression and axial eye growth can be significantly reduced in children and adolescents through the use of multifocal contact lenses. These contact lenses correct distance central myopia while simultaneously imposing relative peripheral myopic defocus. The effect of correcting distance central hyperopia while simultaneously imposing relative peripheral hyperopic defocus is yet to be elucidated in humans. Objective: The objective of our study is to understand the natural progression of axial eye growth and refractive error in hyperopes and anisohyperopes and to establish whether axial eye growth and refractive error can be modified using multifocal contact lenses in hyperopes and anisohyperopes. Methods: There are 3 elements to the program of research. First, the natural progression of axial eye growth and refractive error will be measured in spectacle-wearing hyperopic and anisohyperopic subjects aged between 5 and <20 years. In other words, the natural growth of the eye will be followed without any intervention. Second, as a paired-eye control study, anisohyperopes aged between 8 and <16 years will be fitted with a center-near multifocal design contact lens in their more hyperopic eye and a single-vision contact lens in the fellow eye if required. The progression of axial eye growth and refractive error will be measured and compared. Third, subjects aged between 8 and <16 years with similar levels of hyperopia in each eye will be fitted with center-near multifocal design contact lenses in each eye; the progression of axial eye growth and refractive error in these subjects will be measured and compared with those of subjects in the natural progression study. Results: Recruitment commenced on 6 June 2016 and was completed on 8 April 2017. We estimate the data collection to be completed by April 2020. Conclusions: This trial will establish whether axial eye growth can be accelerated in children with hyperopia by imposing relative peripheral hyperopic defocus using center-near multifocal contact lenses. Trial Registration: ClinicalTrials.gov NCT02686879; https://clinicaltrials.gov/ct2/show/NCT02686879 (Archived by Webcite at http://www.webcitation.org/71o5p3fD2) Registered Report Identifier: RR1-10.2196/9320

  • Predicting 30-day re-admissions in patients with heart failure. Source: US Air Force; Copyright: US Air Force; URL: https://www.af.mil/News/Article-Display/Article/123772/doctors-break-ground-with-new-voice-recognition-medical-capabilities-in-iraq/; License: Public Domain (CC0).

    Validating a Machine Learning Algorithm to Predict 30-Day Re-Admissions in Patients With Heart Failure: Protocol for a Prospective Cohort Study

    Abstract:

    Background: Big data solutions, particularly machine learning predictive algorithms, have demonstrated the ability to unlock value from data in real time in many settings outside of health care. Rapid growth in electronic medical record adoption and the shift from a volume-based to a value-based reimbursement structure in the US health care system has spurred investments in machine learning solutions. Machine learning methods can be used to build flexible, customized, and automated predictive models to optimize resource allocation and improve the efficiency and quality of health care. However, these models are prone to the problems of overfitting, confounding, and decay in predictive performance over time. It is, therefore, necessary to evaluate machine learning–based predictive models in an independent dataset before they can be adopted in the clinical practice. In this paper, we describe the protocol for independent, prospective validation of a machine learning–based model trained to predict the risk of 30-day re-admission in patients with heart failure. Objective: This study aims to prospectively validate a machine learning–based predictive model for inpatient admissions in patients with heart failure by comparing its predictions of risk for 30-day re-admissions against outcomes observed prospectively in an independent patient cohort. Methods: All adult patients with heart failure who are discharged alive from an inpatient admission will be prospectively monitored for 30-day re-admissions through reports generated by the electronic medical record system. Of these, patients who are part of the training dataset will be excluded to avoid information leakage to the algorithm. An expected sample size of 1228 index admissions will be required to observe a minimum of 100 30-day re-admission events. Deidentified structured and unstructured data will be fed to the algorithm, and its prediction will be recorded. The overall model performance will be assessed using the concordance statistic. Furthermore, multiple discrimination thresholds for screening high-risk patients will be evaluated according to the sensitivity, specificity, predictive values, and estimated cost savings to our health care system. Results: The project received funding in April 2017 and data collection began in June 2017. Enrollment was completed in July 2017. Data analysis is currently underway, and the first results are expected to be submitted for publication in October 2018. Conclusions: To the best of our knowledge, this is one of the first studies to prospectively evaluate a predictive machine learning algorithm in a real-world setting. Findings from this study will help to measure the robustness of predictions made by machine learning algorithms and set a realistic benchmark for expectations of gains that can be made through its application to health care. Registered Report Identifier: RR1-10.2196/9466

  • Advanced stage Breast cancer Lifestyle and Exercise (ABLE) study. Source: The Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/8/e10487; License: Creative Commons Attribution + Noncommercial (CC-BY-NC).

    A Personalized Physical Activity Program With Activity Trackers and a Mobile Phone App for Patients With Metastatic Breast Cancer: Protocol for a Single-Arm...

    Abstract:

    Background: About 5% of breast cancer cases are metastatic at diagnosis, and 20%-30% of localized breast cancer cases become secondarily metastatic. Patients frequently report many detrimental symptoms related to metastasis and treatments. The physical, biological, psychological, and clinical benefits of physical activity during treatment in patients with localized breast cancer have been demonstrated; however, limited literature exists regarding physical activity and physical activity behavior change in patients with metastatic breast cancer. Objective: The primary objective of this study is to assess the feasibility of a 6-month physical activity intervention with activity trackers in patients with metastatic breast cancer (the Advanced stage Breast cancer and Lifestyle Exercise, ABLE Trial). Secondary objectives are to examine the effects of physical activity on physical, psychological, anthropometrics, clinical, and biological parameters. Methods: We plan to conduct a single-center, single-arm trial with 60 patients who are newly diagnosed with metastatic breast cancer. Patients will receive an unsupervised and personalized 6-month physical activity program that includes an activity tracker Nokia Go and is based on the physical activity recommendation. Patients will be encouraged to accumulate at least 150 minutes per week of moderate-to-vigorous intensity physical activity. Baseline and 6-month assessments will include anthropometric measures, functional tests (eg, 6-minute walk test and upper and lower limb strength), blood draws, patient-reported surveys (eg, quality of life and fatigue), and clinical markers of tumor progression (eg, Response Evaluation Criteria In Solid Tumors criteria). Results: Data collection occurred between October 2016 and January 2018, and the results are expected in August 2018. Conclusions: The ABLE Trial will be the first study to assess the feasibility and effectiveness of an unsupervised and personalized physical activity intervention performed under real-life conditions with activity trackers in patients with metastatic breast cancer. Trial Registration: ClinicalTrials.gov NCT03148886; https://clinicaltrials.gov/ct2/show/NCT03148886 (Accessed by WebCite at http://www.webcitation.org/71yabi0la) Registered Report Identifier: RR1-10.2196/10487

  • Telehealth consultations. Source: Air Force Medical Service (Stacey Geiger); Copyright: US Air Force Stacey; URL: https://www.airforcemedicine.af.mil/News/Photos/igphoto/2001900164/; License: Public Domain (CC0).

    Psychosocial Assessment Using Telehealth in Adolescents and Young Adults With Cancer: A Partially Randomized Patient Preference Pilot Study

    Abstract:

    Background: Adolescent and young adults with cancer are at increased risk of psychosocial difficulties relative to their healthy peers. Current models of inpatient face-to-face psychosocial care might limit the capacity for clinicians to provide timely and personalized assessment and intervention for this group. Telehealth offers a promising alternative toward increasing access to the provision of evidence-based psychosocial assessment and treatment for adolescent and young adults with cancer. Objective: This pilot study aimed to assess the feasibility and acceptability for both patients and clinicians of providing a psychosocial assessment via telehealth to adolescents and young adults currently receiving treatment for cancer, relative to face-to-face delivery. Methods: We included patients who were aged 15-25 years, currently receiving treatment, could speak English well, and medically stable. Patients were recruited from oncology clinics or wards from 5 hospitals located across Sydney and Canberra, Australia, and allocated them to receive psychosocial assessment (Adolescent and Young Adult Oncology Psychosocial Assessment Measure) with a clinical psychologist or social worker through face-to-face or telehealth modalities using a partially randomized patient preference model. Patients completed a pre- and postassessment questionnaire comprising validated and purposely designed feasibility and acceptability indices, including the impact of technical difficulties, if patients had their own devices; number of patients who were content with their group allocation; self-reported preference of modality; Treatment Credibility and Expectations Questionnaire; and Working Alliance Inventory. Clinicians also completed a postassessment questionnaire rating their impressions of the acceptability and feasibility of intervention delivery by each modality. Results: Of 29 patients approached, 23 consented to participate (response rate: 79%). Participants were partially randomized to either telehealth (8/23, 35%; mean age 16.50 years, range 15-23 years; females: 4/8, 50%) or face-to-face (11/23, 62%; mean age 17 years, range 15-22 years; females: 8/11, 72%) conditions. Four participants withdrew consent because of logistical or medical complications (attrition rate: 17.4%). Most participants (6/8, 75%) in the telehealth group used their computer or iPad (2 were provided with an iPad), with minor technical difficulties occurring in 3 of 8 (37.5%) assessments. Participants in both groups rated high working alliance (Working Alliance Inventory; median patient response in the telehealth group, 74, range 59-84 and face-to-face group, 63, range 51-84) and reported positive beliefs regarding the credibility and expectations of their treatment group. Postassessment preferences between face-to-face or telehealth modalities varied. Most patients in the telehealth group (5/8, 63%) reported no preference, whereas 6 of 11 (55%) in the face-to-face group reported a preference for the face-to-face modality. Conclusions: Telehealth is acceptable as patient comfort was comparable across modalities, with no significant technological barriers experienced. However, patients varied in their preferred interview modality, highlighting the need to tailor the treatment to patient preference and circumstances. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12614001142628; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366609 (Archived by WebCite at http://www.webcitation.org/721889HpE)

  • Empowering with PrEP. Source: Adobe Stock; Copyright: Daniel Ernst; URL: https://stock.adobe.com/images/two-latin-american-guys-playing-a-game-with-phone/175694368; License: Licensed by the authors.

    Empowering With PrEP (E-PrEP), a Peer-Led Social Media–Based Intervention to Facilitate HIV Preexposure Prophylaxis Adoption Among Young Black and Latinx...

    Abstract:

    Background: Young black and Latinx, gay, bisexual, and other men who have sex with men (YBLGBM, aged 18-29 years) have among the highest rates of new HIV infections in the United States and are not consistently reached by existing prevention interventions. Preexposure prophylaxis (PrEP), an oral antiretroviral regimen taken daily by HIV-uninfected individuals to prevent HIV acquisition, is highly efficacious in reducing HIV acquisition and could help stop the HIV epidemic in YBLGBM. Use of social media (eg, Facebook, Twitter, online dating sites) is ubiquitous among young people, providing an efficient avenue to engage YBLGBM to facilitate PrEP adoption. Objective: Our overall goal was to develop and pilot test a theoretically grounded, social media–based, peer-led intervention to increase PrEP uptake in YBLGBM. We used diffusion of innovation and information-motivation-behavioral skills frameworks to (1) identify potential factors associated with interest in and adoption of PrEP among YBLGBM; (2) develop Empowering with PrEP (E-PrEP), a social media–based, peer-led intervention to increase PrEP uptake in YBLGBM; and (3) pilot test the feasibility and acceptability of E-PrEP, and determine its preliminary efficacy for increasing adoption of PrEP by YBLGBM. We describe the development and protocol for E-PrEP. Methods: Using a participatory research approach, we partnered with YBLGBM intervention development partners to develop a social media–based behavioral intervention to facilitate PrEP uptake, which involved an online messaging campaign disseminated by YBLGBM peer leaders to their existing online networks. We designed the 6-week campaign to provide education about PrEP, increase motivation to use PrEP, and facilitate access to PrEP. We then conducted a cluster-randomized trial of E-PrEP compared with an attention-matched general health control condition (E-Health) among YBLGBM aged 18 to 29 years to assess E-PrEP’s feasibility, acceptability, preliminary efficacy for increasing self-reported intention to use PrEP, PrEP uptake, and impact on knowledge and attitudes about PrEP at 12-week follow-up (6 weeks after the end of the online campaign). Results: From October 2016 to March 2017, we developed, pretested, and refined E-PrEP with 6 YBLGBM intervention development partners. From May to June 2017, we recruited, enrolled, and randomly assigned 10 peer leaders (n=5 for each condition). The 10 peer leaders then recruited and enrolled 152 participants from their existing online networks (range 3-33 per peer leader), during June and July 2017. Intervention follow-up was completed after 12 weeks, in November 2017, with analyses underway. Conclusions: We hypothesize that, compared with E-Health, participants randomly assigned to E-PrEP will be more likely to express intention to use PrEP and greater PrEP uptake, and will also show changes in potential mediators of PrEP uptake (knowledge, attitudes, stigma, and access). A Web-based biobehavioral intervention model such as E-PrEP could be rapidly scaled even with limited resources and have significant population-level impact. Trial Registration: ClinicalTrials.gov NCT03213366; https://clinicaltrials.gov/ct2/show/NCT03213366 (Archived by WebCite at http://www.webcitation.org/71onSdcXY) Registered Report Identifier: RR1-10.2196/11375

  • Philip Morris International's analytical chemistry laboratory. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/8/e11294/; License: Licensed by JMIR.

    Evaluation of Biological and Functional Changes in Healthy Smokers Switching to the Tobacco Heating System 2.2 Versus Continued Tobacco Smoking: Protocol for...

    Abstract:

    Background: Tobacco harm reduction, substituting less harmful tobacco products for combustible cigarettes, is a complementary approach for smokers who would otherwise continue to smoke. The Philip Morris International (PMI) Tobacco Heating System (THS) 2.2 is a novel tobacco product with the potential to reduce the risk of harm in smokers compared to continued smoking of combustible cigarettes. It heats tobacco electrically in a controlled manner, never allowing the temperature to exceed 350°C, thereby preventing the combustion process from taking place and producing substantially lower levels of toxicants while providing nicotine, taste, ritual, and a sensory experience that closely parallels combustible cigarettes. Previous clinical studies have demonstrated reduced exposure to the toxicants (approaching the levels observed after quitting) for smokers who switched to THS 2.2, for three months. For adult smokers who would otherwise continue smoking combustible cigarettes, switching to THS 2.2 may represent an alternative way to reduce the risk of tobacco-related diseases. Objective: This study aimed to further substantiate the harm reduction potential of THS 2.2 by demonstrating favorable changes in a set of 8 coprimary endpoints, representative of pathomechanistic pathways (ie, inflammation, oxidative stress, lipid metabolism, respiratory function, and genotoxicity), linked to smoking-related diseases, in smokers switching from combustible cigarettes to THS 2.2. Methods: This study was a randomized, controlled, two-arm parallel group, multicenter ambulatory US study conducted in healthy adult smokers switching from combustible cigarettes to THS 2.2 compared with smokers continuing to smoke combustible cigarettes for six months. Subjects had a smoking history of at least ten years and did not intend to quit within the next six months. Results: Enrollment started in March 2015 and the trial was completed in September 2016. In total, 984 subjects were randomized (combustible cigarettes, n=483; THS 2.2, n=477), and 803 completed the study. The results are expected to be available in a subsequent publication in 2019. Conclusions: In this paper, we describe the rationale and design for this clinical study that focused on the evaluation of THS 2.2’s potential to reduce the risk of smoking-related diseases compared with that of combustible cigarettes. This study will provide insights regarding favorable changes in biological and functional endpoints informed by effects known to be seen upon smoking cessation. Trial Registration: ClinicalTrials.gov NCT02396381; http://clinicaltrials.gov/ct2/show/NCT02396381 (Archived by WebCite at http://www.webcitation.org/71PCRdagP) Registered Report Identifier: RR1-10.2196/11294

  • A 33-week pregnant Ghanaian woman carrying a 51 kg load on her head (left) and a 36-week pregnant Ghanaian woman lifting a 34.5 kg load (right). Source: The Author(s) 2017 Published by Oxford University Press on behalf of the Society of Occupational Medicine; Copyright: The Authors; URL: https://academic.oup.com/occmed/article-abstract/68/1/11/4641817?redirectedFrom=fulltext; License: Creative Commons Attribution (CC-BY).

    A Liftless Intervention to Prevent Preterm Birth and Low Birthweight Among Pregnant Ghanaian Women: Protocol of a Stepped-Wedge Cluster Randomized Controlled...

    Abstract:

    Background: Preterm birth (PTB) is a leading cause of infant morbidity and mortality worldwide. Every year, 20 million babies are born with low birthweight (LBW), about 96% of which occur in low-income countries. Despite the associated dangers, in about 40%-50% of PTB and LBW cases, the causes remain unexplained. Existing evidence is inconclusive as to whether occupational physical activities such as heavy lifting are implicated. African women bear the transport burden of accessing basic needs for their families. Ghana’s PTB rate is 14.5%, whereas the global average is 9.6%. The proposed liftless intervention aims to decrease lifting exposure during pregnancy among Ghanaian women. We hypothesize that a reduction in heavy lifting among pregnant women in Ghana will increase gestational age and birthweight. Objective: To investigate the effects of the liftless intervention on the incidence of PTB and LBW among pregnant Ghanaian women. Methods: A cohort stepped-wedge cluster randomized controlled trial in 10 antenatal clinics will be carried out in Ghana. A total of 1000 pregnant participants will be recruited for a 60-week period. To be eligible, the participant should have a singleton pregnancy between 12 and 16 weeks gestation, be attending any of the 10 antenatal clinics, and be exposed to heavy lifting. All participants will receive standard antenatal care within the control phase; by random allocation, two clusters will transit into the intervention phase. The midwife-led 3-component liftless intervention consists of health education, a take-home reminder card mimicking the colors of a traffic light, and a shopping voucher. The primary outcome are gestational ages of <28, 28-32, and 33-37 weeks. The secondary outcomes are LBW (preterm LBW, term but LBW, and postterm), compliance, prevalence of low back and pelvic pain, and premature uterine contractions. Study midwives and participants will not be blinded to the treatment allocation. Results: Permission to conduct the study at all 10 antenatal clinics has been granted by the Ghana Health Service. Application for funding to begin the trial is ongoing. Findings from the main trial are expected to be published by the end of 2019. Conclusions: To the best of our knowledge, there has been no randomized trial of this nature in Ghana. Minimizing heavy lifting among pregnant African women can reduce the soaring rates of PTB and LBW. The findings will increase the knowledge of the prevention of PTB and LBW worldwide. Trial Registration: Pan African Clinical Trial Register (PACTR201602001301205); http://apps.who.int/trialsearch/ Trial2.aspx?TrialID=PACTR201602001301205 (Archived by WebCite at http://www.webcitation.org/71TCYkHzu) Registered Report Identifier: RR1-10.2196/10095

  • Source: Flickr.com; Copyright: kbrookes; URL: https://www.flickr.com/photos/kbrookes/6739641349/in/photostream/; License: Creative Commons Attribution + Noncommercial + NoDerivatives (CC-BY-NC-ND).

    Postoperative Bio-Chemoradiotherapy Using Cetuximab and Docetaxel in Patients With Cis-Platinum–Intolerant Core High-Risk Head and Neck Cancer: Protocol of...

    Abstract:

    Background: We confirmed the safety of postoperative bio-chemoradiotherapy using cetuximab and docetaxel in a small number of patients with cis-platinum–intolerant core high-risk head and neck cancer. Objective: To assess treatment efficacy, we planned a phase 2 study of postoperative bio-chemoradiotherapy for patients with cis-platinum–intolerant core high-risk head and neck cancer and will compare the results to those of previously collected radiotherapy data. Methods: Patients who underwent definitive surgery for oral cavity, laryngeal, oropharyngeal, or hypopharyngeal advanced cancer, whose postoperative pathological results indicated core high risk for recurrence (eg, positive margin in the primary site or extranodal extension) and who were cis-platinum–intolerant, will undergo postoperative bio-chemoradiotherapy. The primary end point is 2-year disease-free survival. Results: The expected 2-year disease-free survival is set at 55%, and the calculated sample size is 35 patients, according to a statistical analysis based on previous reports. Conclusions: This treatment method is expected to improve the survival rate of patients with severe head and neck cancer. Trial Registration: UMIN Clinical Trials Registry UMIN000031835; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ ctr_view.cgi?recptno=R000036355 (Archived by WebCite at http://www.webcitation.org/71fejVjMr)

Citing this Article

Right click to copy or hit: ctrl+c (cmd+c on mac)

Latest Submissions Open for Peer-Review:

View All Open Peer Review Articles
  • Simultaneous Digital Tracking of Physical Activity, Heart Rate, and Iloprost Inhalation in Patients with Pulmonary Arterial Hypertension: Design of the Observational VENTASTEP Study

    Date Submitted: Sep 10, 2018

    Open Peer Review Period: Sep 15, 2018 - Sep 29, 2018

    Background: Patients with pulmonary arterial hypertension (PAH) – a progressive, ultimately fatal disease – often experience dyspnea which can limit their ability to perform everyday activities. I...

    Background: Patients with pulmonary arterial hypertension (PAH) – a progressive, ultimately fatal disease – often experience dyspnea which can limit their ability to perform everyday activities. Iloprost is an inhaled therapy for PAH that has shown efficacy as monotherapy and when added to other PAH pharmacotherapies. However, clinical trials in PAH have provided only limited data on parameters reflecting the impact of the disease on daily life. Digital monitoring of daily physical activity in PAH is therefore attracting growing interest. To fully understand a patient’s response to treatment, monitoring of treatment adherence is also required. The recently approved Breelib™ nebulizer for administration of iloprost saves inhalation data, thus allowing digital monitoring of adherence. Objective: We aim to perform parallel digital tracking of physical activity parameters, heart rate, and iloprost inhalation data in patients with PAH before and after starting treatment with inhaled iloprost, to investigate the association between changes in digital measures and traditional clinical measures. Methods: VENTASTEP is a digital, prospective, observational, multicenter, single-arm cohort study of adult patients with PAH in Germany starting treatment with inhaled iloprost via the Breelib™ nebulizer on top of existing PAH therapy. The study comprises a baseline period without iloprost treatment (usually ≤ 1 week depending on factors such as nebulizer availability) and an observation period with iloprost treatment (3 months ± 2 weeks). The Apple Watch 2 and iPhone 6S are used with a dedicated study app to measure a range of digital physical activity parameters and heart rate continuously during the baseline and observation periods; the watch is also used with a 6-minute walking distance (6MWD) app to measure digital 6MWD at baseline and the end-of-observation visit. Inhalation frequency, completeness, and duration are monitored digitally via the nebulizer and the BreeConnect™ app. Changes in traditional outcome measures (6MWD, Borg dyspnea scale, EuroQol 5-dimensions questionnaire, functional class, and brain natriuretic peptide [BNP]/N-terminal pro-BNP) between baseline and the end-of-observation visit will be compared with changes in digital daily physical activity parameters and digital 6MWD as the primary analysis. Secondary endpoints include activity status (active, inactive and watch not worn), inhalation behavior, association of physical activity level with time since last inhalation, Pittsburgh Sleep Quality Index, heart rate, association of heart rate with device-based outcomes, and adverse events. Results: The first participant was enrolled in February 2018 (estimated study completion: July 2019; planned sample size: 80 patients). Conclusions: The VENTASTEP study will provide a wealth of data to inform future research on the utility of digital parameters as outcome assessment tools for disease monitoring and guidance of treatment in PAH. The study will also provide insight into clinical outcomes, physical activity, and quality of life in patients starting inhaled iloprost on top of existing PAH therapy. Clinical Trial: ClinicalTrials.gov NCT03293407; https://clinicaltrials.gov/ct2/show/NCT03293407 (Archived by WebCite at http://www.webcitation.org/6ywPGcn4I)

  • Obesity and type 2 diabetes - Raising the issue of weight management in primary care (Small Talk Big Difference): protocol for a randomised controlled trial

    Date Submitted: Sep 10, 2018

    Open Peer Review Period: Sep 15, 2018 - Sep 29, 2018

    Background: Guidelines for the management of type 2 diabetes universally recommends that adults with type 2 diabetes and obesity should be offered individualised interventions to encourage weight loss...

    Background: Guidelines for the management of type 2 diabetes universally recommends that adults with type 2 diabetes and obesity should be offered individualised interventions to encourage weight loss. Yet despite the existing recommendations, provision of weight management services is currently patchy around the UK and where services are available, high attrition rates are often reported. In addition, individuals often fail to take-up services, that is, after discussion with a GP or practice nurse, individuals are referred to the service but do not attend for an appointment. Qualitative research has identified that the initial discussion raising the issue of weight, motivating the patient and referring to services is crucial to a successful outcome from weight management. Objective: To evaluate the effectiveness of an online training programme and practice implementation toolkit +/- face-to-face training for primary care staff. The primary outcome is the change in referral rate of patients with type 2 diabetes to NHS adult weight management programmes, 3 months prior to and post the intervention. Methods: We have used the Behaviour Change Wheel to develop an intervention for staff in primary care consisting of a 1-hour online eLearning package covering the links between obesity, T2DM and the benefits of weight loss, the treatment of diabetes in patients with obesity, specific training in raising the issue of weight, local services and referral pathways, overview of weight management components/ evidence base, and the role of the referrer; a patient leaflet; a discussion tool; a practice implementation checklist; and an optional 2.5-hour face-to-face training session. A total of 100 practices have been randomly assigned in a 1:1 ratio to either have immediate access to all the resources, or have access delayed for 4 months. An intention to treat statistical analysis will be performed. Results: Having fully recruited, this study will finalise follow-up in 2018 and publish in early 2019. Conclusions: This protocol describes the development, and randomised evaluation of the effectiveness, of an intervention to improve referral and uptake rates of weight management programmes for adults with type 2 diabetes. At a time when many new dietary and pharmacological weight loss interventions are showing large clinical benefits for people with type 2 diabetes, it is vital that primary care practitioners are willing, skilled and able to discuss weight and make appropriate referrals to services. Clinical Trial: ClinicalTrials.gov NCT03360058, https://clinicaltrials.gov/ct2/show/NCT03360058

  • SOVA: a social media website to support treatment uptake for adolescents with depression and/or anxiety and their parents: Protocol for a Pilot Randomized Controlled Trial

    Date Submitted: Sep 7, 2018

    Open Peer Review Period: Sep 12, 2018 - Sep 26, 2018

    Background: Few adolescents who experience depression or anxiety connect to mental health treatment. SOVA (Supporting Our Valued Adolescents) is a stakeholder-informed technology intervention which co...

    Background: Few adolescents who experience depression or anxiety connect to mental health treatment. SOVA (Supporting Our Valued Adolescents) is a stakeholder-informed technology intervention which consists of two interactive websites, one for adolescents and one for parents. SOVA is designed to intervene on targets which may increase mental health treatment uptake when adolescents with depression or anxiety are identified in primary care settings. Objective: To describe the protocol for a pilot randomized controlled trial designed to refine recruitment and retention strategies, document intervention fidelity and implementation outcomes, and assess changes in health beliefs and knowledge, emotional/informational support, and parent-adolescent communication quality in adolescents and their parents. Methods: Adolescents identified with symptoms of depression or anxiety for which a healthcare provider recommends treatment and their parents will be recruited from an adolescent and young adult medicine clinic which provides primary and consultative care. Adolescent-parent dyads will be randomized 1:1 to both receive the SOVA websites and enhanced usual care or to enhanced usual care alone. Baseline measures and 6-week and 3-month outcomes will be collected by online self-report surveys and electronic health record review. The main outcome is 6-week study retention rate. Analyses will also assess changes in health beliefs and knowledge, emotional support, and parent-adolescent communication in both adolescents and their parents. Results: Recruitment commenced in April 2018. Conclusions: The findings of this research will inform design of a multi-site hybrid effectiveness-implementation RCT examining the effectiveness and optimal implementation strategies for use of SOVA in community primary care settings. Clinical Trial: ClinicalTrials.gov NCT03318666 ; https://clinicaltrials.gov/ct2/show/NCT03318666

  • Design and rationale of a prospective, observational, multicenter cohort study on biological and functional changes in adult healthy smokers who are continuously abstinent from smoking for one year

    Date Submitted: Sep 7, 2018

    Open Peer Review Period: Sep 12, 2018 - Sep 26, 2018

    Background: The harm of cigarette smoking results mainly from long-term exposure to harmful and potentially harmful constituents (HPHC) generated by the combustion of tobacco. Smoking cessation (SC) e...

    Background: The harm of cigarette smoking results mainly from long-term exposure to harmful and potentially harmful constituents (HPHC) generated by the combustion of tobacco. Smoking cessation (SC) engenders favorable changes of clinical signs, pathomechanisms, and metabolic processes that together could reduce the harm and risk of smoking-related diseases to a relative risk level approximating that of never-smokers over time. In most SC studies, the main focus is on the successful quitting rate of the SC program being tested. As limited information on short- to multiple long-term functional/biological changes following SC is available in the literature, more data on short to mid-term favorable impacts of SC are needed. Objective: The overall study aim was to assess the reversibility of the harm related to smoking over one year of continuous smoking abstinence (SA). This has been verified by assessing a set of biomarkers of exposure (BoExp) to HPHCs and a set of clinical risk endpoints (CRE) indicative of multiple pathophysiological pathways underlying the development of smoking-related diseases. Methods: This multiregional (United States, Japan, Europe), multicenter (42 sites) cohort study consisting of a one-year SA period in an ambulatory setting and a 28-day safety follow-up period was conducted from May 2015 to May 2017. A total of 1,184 male and female adult healthy smokers, willing to quit smoking, were enrolled in the study. Nicotine replacement therapy (NRT) was provided for up to three months upon subject’s request, and SC counseling and behavioral support were continuously provided. BoExp to HPHCs and CREs were assessed in urine and blood at baseline, Month 3, Month 6, and Month 12. Cardiovascular CREs included parameters reflecting inflammation (white blood cell), lipid metabolism (high-density lipoprotein cholesterol), endothelial function (soluble intercellular adhesion molecule-1), platelet function (11-dehydrothromboxane B2), oxidative stress (8-epi-prostaglandin F2 alpha) and carbon monoxide exposure (carboxyhemoglobin). Respiratory CREs included lung function parameters and cough symptoms. The CREs to evaluate genotoxicity (total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) and xenobiotic metabolism (cytochrome P450 2A6 activity) were also assessed. Continuous SA was verified at each visit following the actual quit date using cigarette self-reporting and chemical verification. Safety assessments included adverse events/serious adverse events, body weight, vital signs, spirometry, electrocardiogram, clinical chemistry, hematology and urine analysis safety panel, physical examination, and concomitant medications. Results: In total, 1,184 subjects (50.1% male) were enrolled; 30% of them quit smoking successfully for one year. Data analyses of the study results (including safety data) are ongoing and will be published after study completion. Conclusions: The current study provides insights into biological and functional changes, and health effects, after continuous SA over one year. Study results will be instrumental in assessing novel alternative products to cigarettes considered for tobacco harm reduction strategies. Clinical Trial: ClinicalTrials.gov identifier: NCT02432729

  • Transforming mental health delivery through behavioral economics and implementation science: A project protocol

    Date Submitted: Sep 5, 2018

    Open Peer Review Period: Sep 10, 2018 - Sep 24, 2018

    Background: Efficacious psychiatric treatments are not consistently deployed in community practice and clinical outcomes are attenuated compared with those achieved in clinical trials. A major focus f...

    Background: Efficacious psychiatric treatments are not consistently deployed in community practice and clinical outcomes are attenuated compared with those achieved in clinical trials. A major focus for mental health services research is to develop effective and cost-effective strategies that increase the use of evidence-based assessment, prevention, and treatment approaches in community settings Objective: The goal of this program of research is to apply insights from behavioral economics and participatory design to advance the science and practice of implementing evidence-based practice for individuals with psychiatric disorders across the lifespan. Methods: Project 1 (Assisting Depressed Adults in Primary care Treatment; ADAPT) is patient-focused and leverages decision-making heuristics to compare ways to incentivize adherence to anti-depressant medications in the first six weeks of treatment among adults newly diagnosed with depression. Project 2 (App for Strengthening Services In Specialized Therapeutic Support; ASSISTS) is provider-focused and utilizes normative pressure and social status to increase data collection among community mental health workers treating children with autism. Project 3 (Motivating Outpatient Therapists to Implement: Valuing a Team Effort; MOTIVATE) explores how participatory design can be used to design organizational-level implementation strategies to increase clinician use of evidence-base practices. The projects are supported by a Methods Core that provides expertise in implementation science, behavioral economics, participatory design, measurement, and associated statistical approaches. Discussion: This research will advance the science of implementation through efforts to improve implementation strategy design, measurement, and statistical methods. First, we will test and refine approaches to collaboratively designing implementation strategies with stakeholders (e.g., discrete choice experiments; innovation tournaments). Second, we will refine measurement of mechanisms related to heuristics used in decision-making. Third, we will develop new ways to test mechanisms in multilevel implementation trials. This trifecta, coupled with findings from our three exploratory projects, will lead to improvements in our knowledge of what causes successful implementation, what variables moderate and mediate the effects of those causal factors, and how best to leverage this knowledge to increase the quality of care for people with psychiatric disorders. Trial registration: Clinicaltrials.gov NCT03441399. Registered 15 February 2018. https://www.clinicaltrials.gov/ct2/show/NCT03441399?term=marcus%2C+steven&rank=2.

  • Safety of Intranasal Ketamine for Reducing Uncontrolled Cancer Related Pain

    Date Submitted: Sep 5, 2018

    Open Peer Review Period: Sep 10, 2018 - Sep 24, 2018

    Background: There are about 11.9 million Americans affected with cancer; of these, 53% of patients with cancer experience pain at all stages of cancer. Patients with cancer pain often require high dos...

    Background: There are about 11.9 million Americans affected with cancer; of these, 53% of patients with cancer experience pain at all stages of cancer. Patients with cancer pain often require high dosages of opioids that can cause significant sedation. Occasionally, even after high dose opioid therapy, their pain remains uncontrolled in the setting of opioid tolerance or opioid unresponsive pain. Ketamine is an FDA approved anesthetic with amnesic, analgesic, dissociative, and sedative properties. Subanesthestic doses of ketamine have minimal adverse impact upon cardiovascular or respiratory function, but produce analgesia and modulate central sensitization, hyperalgesia, and opioid tolerance. Ketamine is typically administered intravenously (IV), but the IV route is not convenient for use in an ambulatory setting. Ketamine oral bioavailability is low due to hepatic first pass effect, limiting the application of this route for chronic use. The intranasal (NAS) route has several advantages, such as avoidance of first-pass hepatic metabolism, no need for venous access, ability to repeat doses quickly, and rapid absorption. There are limited data regarding the use of ketamine as an adjuvant to opioids for the management of cancer pain. Objective: We seek to obtain preliminary data on safety, feasibility, and utility of this novel technique for the treatment of uncontrolled cancer pain. Methods: A total of 10 adults with uncontrolled cancer related pain from the supportive oncology clinic, oncology clinics, the pain clinic, and the acute pain service at Emory University Hospital in Atlanta, GA will be enrolled in the study. All patients will be assigned to the same and only investigational treatment arm. Escalating doses of NAS ketamine will be given over 4 study visits (10mg, 30mg, 50mg). Patients will receive 10mg IV ketamine on visit 2 to serve as a control. They will be monitored for 240min after treatment. Pain, side effects, and related symptoms will be assessed using standardized assessment scales throughout each visit. Pharmacokinetics will be determined by drawing serial blood samples at each visit. Results: This trial has been funded by the Emory University Department of Anesthesiology, and is supported in part by the National Center for Advancing Translational Sciences of the National Institutes of Health under Award Number ULTR002378 and KL2TR002381. IND receipt obtained 12/21/16 (IND133570). Approval by the Emory University institutional review board obtained 4/2/2017 (IRB 00086610). The study start date is 7/25/17 and estimated completion date is 7/1/19. Recruitment started in July 2017. Conclusions: This is a Phase I/II clinical trial meant to obtain preliminary data on the safety, feasibility, and utility of intranasal ketamine for the treatment of uncontrolled cancer related pain. Clinical Trial: ClinicalTrials.gov ID: NCT03146806

Advertisement