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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:

  • Young adult viewing the SOVA website on a smartphone. Source: Image created by Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2019/1/e12117; License: Creative Commons Attribution (CC-BY).

    A Social Media Website (Supporting Our Valued Adolescents) to Support Treatment Uptake for Adolescents With Depression and/or Anxiety and Their Parents:...

    Abstract:

    Background: Few adolescents who experience depression or anxiety connect to mental health treatment. Supporting Our Valued Adolescents (SOVA) is a stakeholder-informed technology intervention that consists of 2 blog-format websites—one for adolescents and another for parents. SOVA is designed to intervene on targets, which may increase the mental health treatment uptake when adolescents with depression or anxiety are identified in primary care settings. Objective: This study aims 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 or informational support, and parent-adolescent communication quality in adolescents and their parents. Methods: Adolescents identified with symptoms of depression or anxiety, for which a health care provider recommends treatment, and their parents will be recruited from clinics where adolescents are seen for primary care. Adolescent-parent dyads will be randomized at 1:1 to both receive the SOVA websites and enhanced usual care or enhanced usual care alone. Baseline measures and 6-week and 3-month outcomes will be collected by Web-based self-report surveys and electronic health record review. The main pilot outcome is the 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: The project was funded in 2017. Recruitment commenced in April 2018 and enrollment is ongoing, with completion anticipated at the end of 2019 with subsequent plans for data analysis and publication submission in early 2020. Conclusions: The findings of this research will inform the design of a multisite hybrid effectiveness-implementation randomized controlled trial examining the effectiveness and optimal implementation strategies for using SOVA in community primary care settings. Trial Registration: ClinicalTrials.gov NCT03318666; https://clinicaltrials.gov/ct2/show/NCT03318666 International Registered Report Identifier (IRRID): PRR1-10.2196/12117

  • User interface of the Knee OsteoArthritis, Linking Activity and Pain (KOALAP) app for the twice-daily “Level of Knee Pain” question. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2019/1/e10238/; License: Creative Commons Attribution (CC-BY).

    Collecting Symptoms and Sensor Data With Consumer Smartwatches (the Knee OsteoArthritis, Linking Activity and Pain Study): Protocol for a Longitudinal,...

    Abstract:

    Background: The Knee OsteoArthritis, Linking Activity and Pain (KOALAP) study is the first to test the feasibility of using consumer-grade cellular smartwatches for health care research. Objective: The overall aim was to investigate the feasibility of using consumer-grade cellular smartwatches as a novel tool to capture data on pain (multiple times a day) and physical activity (continuously) in patients with knee osteoarthritis. Additionally, KOALAP aimed to investigate smartwatch sensor data quality and assess whether engagement, acceptability, and user experience are sufficient for future large-scale observational and interventional studies. Methods: A total of 26 participants with self-diagnosed knee osteoarthritis were recruited in September 2017. All participants were aged 50 years or over and either lived in or were willing to travel to the Greater Manchester area. Participants received a smartwatch (Huawei Watch 2) with a bespoke app that collected patient-reported outcomes via questionnaires and continuous watch sensor data. All data were collected daily for 90 days. Additional data were collected through interviews (at baseline and follow-up) and baseline and end-of-study questionnaires. This study underwent full review by the University of Manchester Research Ethics Committee (#0165) and University Information Governance (#IGRR000060). For qualitative data analysis, a system-level security policy was developed in collaboration with the University Information Governance Office. Additionally, the project underwent an internal review process at Google, including separate reviews of accessibility, product engineering, privacy, security, legal, and protection regulation compliance. Results: Participants were recruited in September 2017. Data collection via the watches was completed in January 2018. Collection of qualitative data through patient interviews is still ongoing. Data analysis will commence when all data are collected; results are expected in 2019. Conclusions: KOALAP is the first health study to use consumer cellular smartwatches to collect self-reported symptoms alongside sensor data for musculoskeletal disorders. The results of this study will be used to inform the design of future mobile health studies. Results for feasibility and participant motivations will inform future researchers whether or under which conditions cellular smartwatches are a useful tool to collect patient-reported outcomes alongside passively measured patient behavior. The exploration of associations between self-reported symptoms at different moments will contribute to our understanding of whether it may be valuable to collect symptom data more frequently. Sensor data–quality measurements will indicate whether cellular smartwatch usage is feasible for obtaining sensor data. Methods for data-quality assessment and data-processing methods may be reusable, although generalizability to other clinical areas should be further investigated. International Registered Report Identifier (IRRID): DERR1-10.2196/10238

  • Source: iStock; Copyright: TatyanaGl; URL: https://www.istockphoto.com/ca/photo/pregnant-woman-with-a-handkerchief-suffering-from-cold-gm105680152-13032552; License: Licensed by the authors.

    Estimating Vaccine Effectiveness Against Hospitalized Influenza During Pregnancy: Multicountry Protocol for a Retrospective Cohort Study

    Abstract:

    Background: Although pregnant women are believed to have elevated risks of severe influenza infection and are targeted for influenza vaccination, no study to date has examined influenza vaccine effectiveness (IVE) against laboratory-confirmed influenza-associated hospitalizations during pregnancy, primarily because this outcome poses many methodological challenges. Objective: The Pregnancy Influenza Vaccine Effectiveness Network (PREVENT) was formed in 2016 as an international collaboration with the Centers for Disease Control and Prevention; Abt Associates; and study sites in Australia, Canada, Israel, and the United States. The primary goal of this collaboration is to estimate IVE in preventing acute respiratory or febrile illness (ARFI) hospitalizations associated with laboratory-confirmed influenza virus infection during pregnancy. Secondary aims include (1) describing the incidence, clinical course, and severity of influenza-associated ARFI hospitalization during pregnancy; (2) comparing the characteristics of ARFI-hospitalized pregnant women who were tested for influenza with those who were not tested; (3) describing influenza vaccination coverage in pregnant women; and (4) comparing birth outcomes among women with laboratory-confirmed influenza-associated hospitalization versus other noninfluenza ARFI hospitalizations. Methods: For an initial assessment of IVE, sites identified a retrospective cohort of pregnant women aged from 18 to 50 years whose pregnancies overlapped with local influenza seasons from 2010 to 2016. Pregnancies were defined as those that ended in a live birth or stillbirth of at least 20 weeks gestation. The analytic sample for the primary IVE analysis was restricted to pregnant women who were hospitalized for ARFI during site-specific influenza seasons and clinically tested for influenza virus infection using real-time reverse transcription polymerase chain reaction. Results: We identified approximately 2 million women whose pregnancies overlapped with influenza seasons; 550,344 had at least one hospitalization during this time. After restricting to women who were hospitalized for ARFI and tested for influenza, the IVE analytic sample included 1005 women. Conclusions: In addition to addressing the primary question about the effectiveness of influenza vaccination, PREVENT data will address other important knowledge gaps including understanding the incidence, clinical course, and severity of influenza-related hospitalizations during pregnancy. The data infrastructure and international partnerships created for these analyses may be useful and informative for future influenza studies. International Registered Report Identifier (IRRID): DERR1-10.2196/11333

  • Source: iStock by Getty Images; Copyright: AleksandarNakic; URL: https://www.istockphoto.com/photo/first-morning-coffee-and-online-daily-news-gm882349640-245550359; License: Licensed by the authors.

    Accelerating Research With Technology: Rapid Recruitment for a Large-Scale Web-Based Sleep Study

    Abstract:

    Background: Participant recruitment can be a significant bottleneck in carrying out research studies. Connected health and mobile health platforms allow for the development of Web-based studies that can offer improvement in this domain. Sleep is of vital importance to the mental and physical health of all individuals, yet is understudied on a large scale or beyond the focus of sleep disorders. For this reason and owing to the availability of digital sleep tracking tools, sleep is well suited to being studied in a Web-based environment. Objective: The aim of this study was to investigate a method for speeding up the recruitment process and maximizing participant engagement using a novel approach, the Achievement Studies platform (Evidation Health, Inc, San Mateo, CA, USA), while carrying out a study that examined the relationship between participant sleep and daytime function. Methods: Participants could access the Web-based study platform at any time from any computer or Web-enabled device to complete study procedures and track study progress. Achievement community members were invited to the study and assessed for eligibility. Eligible participants completed an electronic informed consent process to enroll in the study and were subsequently invited to complete an electronic baseline questionnaire. Then, they were asked to connect a wearable device account through their study dashboard, which shared their device data with the research team. The data were used to provide objective sleep and activity metrics for the study. Participants who completed the baseline questionnaires were subsequently sent a daily single-item Sleepiness Checker activity for 7 consecutive days at baseline and every 3 months thereafter for 1 year. Results: Overall, 1156 participants enrolled in the study within a 5-day recruitment window. In the 1st hour, the enrollment rate was 6.6 participants per minute (394 per hour). In the first 24 hours, the enrollment rate was 0.8 participants per minute (47 participants per hour). Overall, 1132 participants completed the baseline questionnaires (1132/1156, 97.9%) and 1047 participants completed the initial Sleepiness Checker activity (1047/1156, 90.6%). Furthermore, 1000 participants provided activity-specific wearable data (1000/1156, 86.5%) and 982 provided sleep-specific wearable data (982/1156, 84.9%). Conclusions: The Achievement Studies platform allowed for rapid recruitment and high study engagement (survey completion and device data sharing). This approach to carrying out research appears promising. However, conducting research in this way requires that participants have internet access and own and use a wearable device. As such, our sample may not be representative of the general population.

  • ATN CARES logo. Source: ATN website; Copyright: ATN; URL: https://atnweb.org/atnweb/CARES; License: Public Domain (CC0).

    Strategies to Treat and Prevent HIV in the United States for Adolescents and Young Adults: Protocol for a Mixed-Methods Study

    Abstract:

    Background: Over 20% of HIV diagnoses in the United States are among youth aged 12-24 years. Furthermore, youth have the lowest rates of uptake and adherence to antiretroviral (ARV) medications and are least aware of their HIV status. Objective: Our objective was to design a set of interrelated studies to promote completion of each step of the HIV Prevention Continuum by uninfected youth at high risk (YHR), as well as completion of steps in the Treatment Continuum by youth living with HIV (YLH). Methods: Gay, bisexual, and transgender youth; homeless youth; substance-abusing youth; youth with criminal justice contact; and youth with significant mental health challenges, particularly black and Latino individuals, are being recruited from 13 community-based organizations, clinics, drop-in centers, and shelters in Los Angeles and New Orleans. Youth are screened on the basis of self-reports and rapid diagnostic tests for HIV, drug use, and sexually transmitted infections and, then, triaged into one of 3 studies: (1) an observational cohort of YLH who have never received ARV medications and are then treated—half initially are in the acute infection period (n=36) and half with established HIV infection (n=36); (2) a randomized controlled trial (RCT) for YLH (N=220); and (3) an RCT for YHR (N=1340). Each study contrasts efficacy and costs of 3 interventions: an automated messaging and weekly monitoring program delivered via text messages (short message service, SMS); a peer support intervention delivered via social media forums; and coaching, delivered via text message (SMS), phone, and in-person or telehealth contacts. The primary outcomes are assessing youths’ uptake and retention of and adherence to the HIV Prevention or Treatment Continua. Repeat assessments are conducted every 4 months over 24 months to engage and retain youth and to monitor their status. Results: The project is funded from September 2016 through May 2021. Recruitment began in May 2017 and is expected to be completed by June 2019. We expect to submit the first results for publication by fall 2019. Conclusions: Using similar, flexible, and adaptable intervention approaches for YLH and YHR, this set of studies may provide a roadmap for communities to broadly address HIV risk among youth. We will evaluate whether the interventions are cost-efficient strategies that can be leveraged to help youth adhere to the actions in the HIV Prevention and Treatment Continua. International Registered Report Identifier (IRRID): DERR1-10.2196/10759

  • Source: Pxhere; Copyright: Pxhere; URL: https://pxhere.com/en/photo/896038; License: Public Domain (CC0).

    The Integration of Interlinkages Between Nature and Human Health in Primary Health Care: Protocol for a Scoping Review

    Abstract:

    Background: International overview reports and the majority of scientific publications on interlinkages between nature and human health (NHI) do not seem to focus on the role of the health care sector. Primary health care (PHC) is often the first point of contact people have with the health care system and provides comprehensive, accessible, and community-based care that meets the health needs of individuals throughout their life. PHC is a vital backbone for linking knowledge and practice within the organization of health care. This scoping review aims to focus on the potential role of PHC in relation to NHI. Objective: The objective of this protocol is to present the method used to scope international overview reports and scientific publications on what is mentioned on the integration of NHI in PHC. Methods: The international overview reports have been screened for keywords relating to PHC. We developed a specific search strategy to scope scientific literature on NHI in relation to PHC. The scientific literature search ran in Web of Science (WOS) and PubMed from inception to May 2017. The scientific publications are screened by 2 independent reviewers, which will result in a list of relevant publications that meet eligibility and inclusion criteria. Results: On the basis of a first screen on the title of the first 200 results in both search engines, we decided to restrict to WOS. First insights in the international overview reports and the quantitative overview of the results in WOS give a first impression of a missing link between NHI and PHC. The findings are expected to identify knowledge gaps in the translation of evidence on NHI in PHC practices and the role of PHC regarding the application of that evidence in health care practice. Conclusions: This is, to our knowledge, the first study that seeks to relate existing knowledge on NHI to PHC. The presentation of our method through this protocol allows researchers to build upon and improve our work in future research on the practical implementation of NIH. The findings of the scoping review are expected to guide future scientific research, international policy directives, and PHC workers to fill the gaps in the integration of NHI in PHC. International Registered Report Identifier (IRRID): DERR1-10.2196/12510

  • Source: Image created by Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2019/1/e11533/; License: Licensed by JMIR.

    Primary Prevention of Intimate Partner Violence Among Recently Married Dyads Residing in the Slums of Pune, India: Development and Rationale for a Dyadic...

    Abstract:

    Background: Intimate partner violence (IPV) is frequently experienced by women of low socioeconomic status in India. It is a human rights violation and associated with negative effects on physical and mental well-being, underscoring the need for effective prevention strategies. Objective: This study aimed to develop a dyadic intervention for the primary prevention of IPV among newly married couples residing in slum communities in India. Methods: The intervention was developed using a community-based, mixed-methods design rooted in couple-interdependence theory and guided by the intervention mapping (IM) framework. It used the six critical IM steps to inform the content and delivery of the intervention: (1) needs assessment, (2) preparation of matrices of change objectives, (3) selection of theory-based methods and practical applications, (4) production of intervention components and materials, (5) intervention adoption and implementation, and (6) evaluation planning. Results: The resulting Ghya Bharari Ekatra (Take a Flight Together) intervention is intended to be delivered in 6 weekly sessions by a trained pair of male and female lay community educators to groups of 3 to 5 newly married couples in the community in which they reside. It uses games, discussions, self-reflections, and skill-building exercises to cover the following topics: enhancing relationship quality time, self-esteem and resilience, communication and conflict management, goal setting and implementation, sexual communication and sexual health and reproductive health knowledge, and redefining and challenging norms surrounding IPV occurrence. The formative work guided the protocol, including module duration and timing (2-hour sessions of convenience to participants), ordering of modules (based on potential level of interest and sensitivity of the topics), content (ie, informed scripts of role plays and films), intervention delivery methods (ie, interactive activities), and selection of the interventionists (based on capacity to connect with participants) and venue (community-based, convenient, and safe spaces). Ghya Bharari Ekatra was piloted between January and May 2018, and evaluation is presently underway. Conclusions: Ghya Bharari Ekatra is evidence-based, grounded in intervention-mapping, and developed and iteratively refined using a community-based participatory research approach, suggesting it has great potential to be an acceptable and effective solution to preventing IPV among newly married couples. Trial Registration: ClinicalTrials.gov NCT03332134; https://clinicaltrials.gov/ct2/show/NCT03332134

  • The EPOCH study logo. Source: BTG International group companies; Copyright: BTG International group companies; URL: http://www.researchprotocols.org/2019/1/e11545/; License: Licensed by JMIR.

    TheraSphere Yttrium-90 Glass Microspheres Combined With Chemotherapy Versus Chemotherapy Alone in Second-Line Treatment of Patients With Metastatic...

    Abstract:

    Background: Colorectal cancer is one of the most common cancers and causes of cancer-related death. Up to approximately 70% of patients with metastatic colorectal cancer (mCRC) have metastases to the liver at initial diagnosis. Second-line systemic treatment in mCRC can prolong survival after development of disease progression during or after first-line treatment and in those who are intolerant to first-line treatment. Objective: The objective of this study is to evaluate the efficacy and safety of transarterial radioembolization (TARE) with TheraSphere yttrium-90 (90Y) glass microspheres combined with second-line therapy in patients with mCRC of the liver who had disease progression during or after first-line chemotherapy. Methods: EPOCH is an open-label, prospective, multicenter, randomized, phase 3 trial being conducted at up to 100 sites in the United States, Canada, Europe, and Asia. Eligible patients have mCRC of the liver and disease progression after first-line chemotherapy with either an oxaliplatin-based or irinotecan-based regimen and are eligible for second-line chemotherapy with the alternate regimen. Patients were randomized 1:1 to the TARE group (chemotherapy with TARE in place of the second chemotherapy infusion and subsequent resumption of chemotherapy) or the control group (chemotherapy alone). The addition of targeted agents is permitted. The primary end points are progression-free survival and hepatic progression-free survival. The study objective will be considered achieved if at least one primary end point is statistically significant. Secondary end points are overall survival, time to symptomatic progression defined as Eastern Cooperative Oncology Group Performance Status score of 2 or higher, objective response rate, disease control rate, quality-of-life assessment by the Functional Assessment of Cancer Therapy-Colorectal Cancer questionnaire, and adverse events. The study is an adaptive trial, comprising a group sequential design with 2 interim analyses with a planned maximum of 420 patients. The study is designed to detect a 2.5-month increase in median progression-free survival, from 6 months in the control group to 8.5 months in the TARE group (hazard ratio [HR] 0.71), and a 3.5-month increase in median hepatic progression-free survival time, from 6.5 months in the control group to 10 months in the TARE group (HR 0.65). On the basis of simulations, the power to detect the target difference in either progression-free survival or hepatic progression-free survival is >90%, and the power to detect the target difference in each end point alone is >80%. Results: Patient enrollment ended in October 2018. The first interim analysis in June 2018 resulted in continuation of the study without any changes. Conclusions: The EPOCH study may contribute toward the establishment of the role of combination therapy with TARE and oxaliplatin- or irinotecan-based chemotherapy in the second-line treatment of mCRC of the liver. Trial Registration: ClinicalTrials.gov NCT01483027; https://clinicaltrials.gov/ct2/show/NCT01483027 (Archived by WebCite at http://www.webcitation.org/734A6PAYW) International Registered Report Identifier (IRRID): RR1-10.2196/11545

  • ICU Together. Source: The Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2019/1/e10935/; License: Creative Commons Attribution (CC-BY).

    A Web-Based Recovery Program (ICUTogether) for Intensive Care Survivors: Protocol for a Randomized Controlled Trial

    Abstract:

    Background: Those who experience a critical illness or condition requiring admission to an intensive care unit (ICU) frequently experience physical and psychological complications as a direct result of their critical illness or condition and ICU experience. Complications, if left untreated, can affect the quality of life of survivors and impact health care resources. Explorations of potential interventions to reduce the negative impact of an ICU experience have failed to establish an evidence-based intervention. Objective: The aim of this study is to evaluate the impact of a Web-based intensive care recovery program on the mental well-being of intensive care survivors and to determine if it is a cost-effective approach. Methods: In total, 162 patients that survived an ICU experience will be recruited and randomized into 1 of 2 groups. The intervention group will receive access to the Web-based intensive care recovery program, ICUTogether, 2 weeks after discharge (n=81), and the control group will receive usual care (n=81). Mental well-being will be measured using the Hospital Anxiety and Depression Scale, The Impact of Events Scale-Revised and the 5-level 5-dimension EuroQoL at 3 time points (2 weeks, 6 months, and 12 months post discharge). Family support will be measured using the Multidimensional Scale of Perceived Social Support at 3 time points. Analysis will be conducted on an intention-to-treat basis using regression modeling. Covariates will include baseline outcome measures, study allocation (intervention or control), age, gender, length of ICU stay, APACHE III score, level of family support, and hospital readmissions. Participants’ evaluation of the mobile website will be sought at 12 months postdischarge. A cost utility analysis conducted at 12 months from a societal perspective will consider costs incurred by individuals as well as health care providers. Results: Participant recruitment is currently underway. Recruitment is anticipated to be completed by December 2020. Conclusions: This study will evaluate a novel intervention in a group of ICU survivors. The findings from this study will inform a larger study and wider debate about an appropriate intervention in this population.

  • eMums Plus logo. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2019/1/e11549/; License: Licensed by JMIR.

    Evaluating the Effectiveness of an App-Based Nurse-Moderated Program for New Mothers With Depression and Parenting Problems (eMums Plus): Protocol for a...

    Abstract:

    Background: Postnatal depression adversely affects many mothers and infants with good evidence that caregiving difficulties associated with depressive symptoms play a key role in later adverse childhood outcomes. In many countries, there is only limited support available for women who experience symptoms of depression during the postnatal period, particularly those experiencing subthreshold symptom levels. Furthermore, mental health services and community family health services in many countries tend to focus primarily on providing help for depressive symptoms or maternal caregiving, respectively, despite these problems commonly being comorbid. Group-based nurse-led interventions delivered over the Web through mobile phone “apps” have the potential to be a cost-effective method of providing a large number of mothers with easy access to integrated support for both maternal depressive symptoms and caregiving difficulties. Objective: This paper describes the protocol for a pragmatic randomized controlled trial of a 4-month group-based nurse-led intervention delivered over the Web when infants were 2-6 months. The primary aims of the trial are to determine whether the intervention (1) reduces levels of maternal depressive symptoms and (2) improves the quality of maternal caregiving when infants are 8-12 months of age. Methods: The trial aimed to recruit and randomize 160 mothers of infants aged 2-8 weeks to either the intervention (eMums plus) or standard care. Assessments were completed when infants were aged 1-2 (preintervention), 8, and 12 months. The primary outcomes were the level of maternal depressive symptoms and the quality of maternal caregiving assessed when infants were aged 12 months. The intervention provided specific support for problems with mood and problems with caregiving. The intervention was delivered by community health nurses as a part of routine service delivery to mothers via a mobile phone app. Results: Participant recruitment was carried out from March to July 2017. Follow-up data collection was completed in mid-2018. Data analysis has commenced. Conclusions: In the past, many mothers participated in nurse-led face-to-face groups postnatally. However, mothers’ groups held in clinics can be difficult for busy mothers to attend. The eMums intervention was delivered over the Web by nurses, allowing easy access by mothers early in an infant’s life. The intervention was evaluated while delivered as part of the routine service practice by community child health nurses. The advantage of evaluating the effectiveness of the intervention in the routine service practice is that if it is found to be effective, it can be more easily adopted by the service provider than if it had been assessed in an efficacy trial. International Registered Report Identifier (IRRID): RR1-10.2196/11549

  • Source: Flickr / The Authors; Copyright: The Authors; URL: https://www.flickr.com/photos/mattradickal/6214764720/in/photostream/; License: Creative Commons Attribution + ShareAlike (CC-BY-SA).

    Human Papillomavirus Infection and Transmission Among Couples Through Heterosexual Activity (HITCH) Cohort Study: Protocol Describing Design, Methods, and...

    Abstract:

    Background: Human papillomavirus (HPV) epidemiological research has generally been individual based, typically focusing on women, with couple-based research mostly consisting of cross-sectional assessment of prevalent HPV infection in both partners. Objective: The HPV Infection and Transmission among Couples through Heterosexual activity (HITCH) study was set up to investigate the transmissibility of HPV among young, recently formed couples in Montreal, Canada. This paper provides an overview of the HITCH cohort study design and procedures as well as a narrative summary of the most important findings. Methods: HITCH is a longitudinal investigation of HPV transmission in recently formed heterosexual partnerships initiated within 6-month pre-enrollment, a time at which considerable transmission is believed to occur. A total of 549 newly formed dyads were recruited (2005-2011) from postsecondary institutions, including 502 young women and their male partners. An additional 46 males were enrolled at follow-up, as some women enrolled a subsequent partner at follow-up. Women aged 18-24 years were followed for 24 months for acquisition of HPV types not present at enrollment, whereas men returned for a single follow-up visit at month 4, for a sum total of 3361 clinic visits. The last follow-up visit occurred in January 2014. Extensive sociodemographic, sexual behavioral, and medical history data were collected every 2-4 months using computer-assisted, self-administered questionnaires. Furthermore, participants provided genital, blood, oral, and hand specimens for HPV assessment. Results: Although in its early analysis stage, HITCH has produced important publications. Findings from HITCH have increased the available knowledge about the natural history of HPV transmission and its determinants, provided further evidence regarding oral-oral and oral-genital routes of HPV transmission, and supplied empirically valid epidemiological parameters of HPV transmission to assist mathematical modelers in health economic assessments. In addition, HITCH data were made available to several multistudy collaborations evaluating new HPV detection assays and evidence for-or-against HPV type replacement following the introduction of HPV vaccination. Conclusions: HITCH will continue to offer a unique resource for research on HPV transmission. International Registered Report Identifier (IRRID): RR1-10.2196/11284

  • Listeo+ app. Source: Image created by the authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2019/1/e10938/; License: Creative Commons Attribution + Noncommercial + ShareAlike (CC-BY-NC-SA).

    Effect of a Mobile App on Preoperative Patient Preparation for Major Ambulatory Surgery: Protocol for a Randomized Controlled Trial

    Abstract:

    Background: Inadequate preoperative patient preparation causes organizational, economic, and emotional problems to patients and professionals. In Spain, no current evidence is available on either the rate of compliance or the impact of good compliance with preoperative recommendations by patients in the ambulatory setting. However, it is known that around 25% of surgical cancellations in the major ambulatory surgery (MAS) are due to poor compliance with these recommendations and, therefore, avoidable. Introducing innovative tools based on mobile health (mHealth) apps may help patients meet the preoperative recommendations and, consequently, reduce the rate of cancellations in the ambulatory setting. Objective: The objective of this study was to evaluate the effectiveness of the Listeo+ mHealth app as a tool for improving compliance with preoperative recommendations in MAS versus standard of care (SOC). Methods: A multicenter, randomized, open-label clinical trial that compares SOC with the additional use of Listeo+, a specific mHealth app for MAS preoperative patient monitoring, is being conducted. The study will include patients aged ≥18 years with surgical indication for MAS who meet the necessary technological and connectivity requirements. Patients in the control group will receive written preoperative recommendations, while those in the intervention group will additionally use the Listeo+ mHealth app. There will be a competitive recruitment of 790 patients during 6 months in 4 hospitals in Andalusia (Spain) that belong to the National Health System. The primary efficacy outcome is the level of compliance with preoperative recommendations. Secondary outcomes include the rate of cancellations, associated resource consumption, and perceived usability and utility with Listeo+ by participants of the intervention group. Simple randomization 1:1 procedure will be used to allocate patients to each study group. Results: The technological development of Listeo+ and the integration and interoperability of information systems was completed in September 2017. Subsequently, simulation tests were performed with Listeo+, and a pilot study was initiated with real patients that concluded successfully in October 2017. Patient recruitment began in December 2017 in the 4 participating centers. After an intermediate analysis performed 10 months after the start of the recruitment phase, the data collection and cleaning phases are estimated to be completed in April 2019, and the analysis with the final results will be conducted in July 2019. Conclusions: Progress in the integration and interoperability of information systems represents a major step forward in the field of mHealth. The app will allow health professionals to monitor in real-time patients’ preparation and critical preoperative recommendations fulfillment. We expect a reduction in avoidable preoperative cancellations due to a lack of or a poor patient preparation. Self-assessed Web-based questionnaires and focus group will provide important information about the perceived usability and utility of Listeo+ app among patients and health care professionals. International Registered Report Identifier (IRRID): DERR1-10.2196/10938

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  • Health Research using Facebook to Identify and Recruit Pregnant Women who Use E-cigarettes: Protocol for a Non-Randomized Pilot Study

    Date Submitted: Jan 23, 2019

    Open Peer Review Period: Jan 24, 2019 - Feb 7, 2019

    Background: Participant recruitment is often a challenge, particularly enrolling individuals with relatively rare characteristics. The wide reach of social media may provide a mechanism to overcome th...

    Background: Participant recruitment is often a challenge, particularly enrolling individuals with relatively rare characteristics. The wide reach of social media may provide a mechanism to overcome these challenges. Objective: The primary aim of the paper is to provide information to researchers who seek to recruit participants from rare populations using social media for studies with rather demanding protocols. We describe a pilot study protocol that identified and enrolled currently pregnant women (second or third trimester) who were exclusive electronic cigarette (e-cigarette) users. We describe the recruitment methods, time, and cost; examine advertisement types that were more or less successful; discuss participant retention and relationship management; and describe the process of collecting biological data. Methods: We placed Facebook advertisements selectively targeting women who were likely to be pregnant and interested in e-cigarettes or vaping. The advertisements invited individuals to complete an eligibility screener. Eligible participants were asked to (1) complete an online survey that collected detailed information on the use of e-cigarettes, including the exact type of device and e-liquid, (2) report frequency and intensity of e-cigarette use for the 3 months before pregnancy and during each trimester, and (3) provide a saliva specimen for nicotine biomarker assay. Eight weeks after the mother’s due date, we collected a photograph of each participant’s e-cigarette device to allow corroboration of self-report and the baby’s birth weight and gestational age from the participant’s physician. Results: We enrolled 20 participants in two months at a cost of $3421.28 USD. Baseline data was collected for all 20 participants. Of the 20 women enrolled, 16 provided a saliva sample, 4 provided a photo of the e-cigarette device, and 10 provided physician contact information. Of the 10 physicians contacted by mail, 6 responded with information on the participants and their babies. Conclusions: Study findings suggest that Facebook’s targeting criteria should focus on “e-cigarette users” to maximize advertisement exposure of potentially eligible women. In addition, saliva sample collection was feasible among pregnant women (second or third trimester) who are exclusive e-cigarette users, but obtaining photographs and physician reports was problematic and calls for further refinement. These lessons should be generalizable to others who are seeking to use social media to recruit participants from rare populations into studies with rather demanding protocols. Clinical Trial: n/a

  • New possibilities for exercise in type 2 diabetics with coronary artery disease - aerobic exercise in the fasted state

    Date Submitted: Jan 19, 2019

    Open Peer Review Period: Jan 22, 2019 - Feb 5, 2019

    Background: Exercise is beneficial for health and, when practiced while fasting, can have additional gains (increased consumption of lipids, aerobic capacity and glucose tolerance), being safe in heal...

    Background: Exercise is beneficial for health and, when practiced while fasting, can have additional gains (increased consumption of lipids, aerobic capacity and glucose tolerance), being safe in healthy subjects. In diabetics not on insulin, it seems to have a significantly inferior glucose lowering effect and to attenuate the postprandial glycaemic increase, but there are concerns about its safety. Objective: To present our exercise protocol and to evaluate the effect of fasting in the glycemic profile, cardiovascular safety and ketonemia during exercise in patients with type 2 diabetes (T2DM) and coronary artery disease (CAD). Methods: Patients with T2DM and CAD were invited to perform 6 trials of continuous moderate intensity aerobic exercise, 3 of which in the fasted state (FS). We monitored glucose and ketone levels, signs and symptoms and electrocardiographic changes. Results: A 63-year-old man being treated with metformin completed the protocol. No relevant clinical or electrocardiographic changes were found. Postprandial exercise showed a greater glucose lowering effect than FS. No hypoglycaemia was detected. The difference between interstitial glucose and capillary glycaemia increased when glycaemia was changing fast. All ketonemia tests were negative. Conclusions: FS exercise was safe in this high-risk patient, with an inferior glucose lowering effect. This protocol could be applied in further studies to better understand the effect of FS exercise in patients with T2DM and CAD.

  • Testing the therapeutic effects of transcranial direct current stimulation (tDCS) in semantic dementia: A double blind, sham controlled, randomized clinical trial

    Date Submitted: Jan 18, 2019

    Open Peer Review Period: Jan 21, 2019 - Feb 4, 2019

    Background: Semantic dementia is a neurodegenerative disease that primarily affects the left anterior temporal lobe. It results in a gradual loss of conceptual knowledge resulting in anomia and impair...

    Background: Semantic dementia is a neurodegenerative disease that primarily affects the left anterior temporal lobe. It results in a gradual loss of conceptual knowledge resulting in anomia and impaired word comprehension which severely impact on communications abilities. There is currently no validated treatment. Transcranial stimulation has provided evidence for long-lasting language effects presumably linked to stimulation-induced neuroplasticity in post-stroke aphasia. However, studies evaluating its effects in neurodegenerative diseases as semantic dementia are still rare and evidence from double blind prospective therapeutic trials is required. Objective: The primary objective of the present clinical trial (STIM-SD) is to evaluate the therapeutic efficacy of a multiday transcranial direct current stimulation (tDCS) regime on language/semantic impairment in patients with semantic dementia. The study also explores the time course of potential tDCS-driven improvements and uses imaging biomarkers which could reflect stimulation-induced neuroplasticity. Methods: Double-blind sham-controlled randomized study using tDCS which will be applied daily during 10 days, and language/semantic and imaging assessments at 4 time-points: base-line, 3 days, 2 weeks and 4 months after the 10 stimulation sessions. Language/semantic assessments will be applied at the 4 time-points. Fluorodeoxyglucose Positron Emission tomography (FDG-PET), resting-state functional Magnetic Resonance Imaging (rs-fMRI), T1-weighted images for cortical thickness measures and white matter diffusion tensor imaging (DTI) will be applied at base-line and the two-weeks’ time-point. According to the principle of inter-hemispheric inhibition between left (language-related) and right homotopic regions we will use two potentially efficient stimulation modalities: left-anodal and right-cathodal tDCS over the anterior temporal lobes. This approach allows for comparing two stimulation strategies and aims at revealing the most beneficial strategy. Accordingly, the patient population (n=60) will be subdivided into 3 subgroups: left-anodal tDCS (n=20), right-cathodal tDCS (n=20) and sham tDCS (n=20). The stimulation duration will be sustained for 20 minutes at an intensity of 1.59 mA. It will be delivered through 25cm2 round stimulation electrodes (current density of 0.06 mA/cm2) placed over the left and right anterior temporal lobes for anodal and cathodal stimulation, respectively. A group of age, gender and education-matched healthy participants (n=20) will also be recruited and tested to provide normative values for the language/semantic tasks and imaging measures. Results: Ten patients have been screened for participation between June 2018 and December 2018, and 7 patients have been included in the study and randomized. Three patients have already completed the 4-month follow-up. Data analysis will begin once all study data are collected. Conclusions: The study aims at assessing the efficacy of tDCS as a new therapeutic approach for language/semantic disorders in semantic dementia. A potential treatment would be easily applicable, inexpensive, and renewable when therapeutic effects disappear due to disease progression. Clinical Trial: ClinicalTrials.gov NCT03481933

  • Protocol for an updated meta-analysis and systematic review of radiofrequency-assisted liver resection versus clamp-crush liver resection

    Date Submitted: Jan 17, 2019

    Open Peer Review Period: Jan 21, 2019 - Feb 4, 2019

    Background: Carcinoma of the liver has historically had poor prognosis for patients, and remains the second most common cause of cancer-related deaths globally. Traditionally, clamp-crush technique ha...

    Background: Carcinoma of the liver has historically had poor prognosis for patients, and remains the second most common cause of cancer-related deaths globally. Traditionally, clamp-crush technique has been employed for liver resection, however is associated with high risks of post-operative complications. Many novel techniques have been developed, such as radiofrequency ablation and TACE, however they are not applicable to most cases of liver resection. Clamp-crush liver resection (CCLR) remains gold standard. Radiofrequency-assisted liver resection (RFLR) is one such novel technique which aims to reduce morbidity and mortality through bloodless liver resection. Xiao et al. had previous performed a systematic review in 2014 on RFLR, but results neither agreed nor refuted the use of RFLR due to lack of sufficient evidence from well designed RCTs at the time. Objective: Perform a systematic review and meta-analysis comparing radiofrequency-assisted liver resection against clamp-crush liver resection Methods: Articles comparing RFLR and CCLR that were published from 2014 until 2019 will be reviewed and data extracted. These will be combined with results from the previous meta-analysis by Xiao et al. Data will be statistically analysed and graphically represented through Review Manager 5. Results: Data collection is currently underway, with papers being screened. We hope to publish results in early 2019. Conclusions: Given the poor outcomes currently associated with liver resection, it is imperative that novel surgical techniques are undertaken and investigated so we can develop improved best practice guidance.

  • Effectiveness and cost-effectiveness of blended cognitive behavioral therapy in clinically depressed adolescents: study protocol of a pragmatic quasi-experimental controlled trial

    Date Submitted: Jan 17, 2019

    Open Peer Review Period: Jan 21, 2019 - Feb 4, 2019

    Background: Cognitive Behavioral Therapy (CBT) is an effective intervention to treat depressive disorders in youth. However, 50% of the adolescents still have depressive symptoms after treatment and 5...

    Background: Cognitive Behavioral Therapy (CBT) is an effective intervention to treat depressive disorders in youth. However, 50% of the adolescents still have depressive symptoms after treatment and 57% drops out during treatment. Online preventive CBT interventions have proven to be effective in reducing depressive symptoms and seem promising as treatment for depressed adolescents. However, combining online programs with face-to-face sessions seems necessary to increase the effectiveness and to monitor for suicide risk. Objective: In this study, we examine the effectiveness and cost-effectiveness of a blended CBT treatment protocol, a mixture of online and face-to-face CBT, as a treatment for clinically depressed adolescents. Methods: A pragmatic quasi-experimental controlled trial will be conducted to study the effectiveness of a blended CBT treatment protocol, in which blended CBT is compared to face-to-face CBT (N = 44) and treatment-as-usual (N = 44), the latter both collected in a previous RCT. The same in- and exclusion criteria are used: adolescents between 12 and 21 years old, with a clinical diagnosis of a depressive disorder, and referred to one of the participating mental health institutions. Assessments will be conducted at the same time points, namely before the start of the intervention, during the intervention (after 5 and 10 weeks), post-intervention, 6-month and 12-month follow-up. Results: Primary outcome is the presence of a depression diagnosis at 12-month follow-up. Several secondary outcomes will be measured, such as depressive symptoms, global functioning, and suicide risk. Further, moderating (age, gender, alcohol and drug use, parental depression and other psychopathology) and mediating effects (negative automatic thoughts, cognitive emotion regulation, attributional style) will be tested. Also, treatment characteristics will be studied, such as characteristics of the therapists, treatment expectancy, and therapeutic alliance. Furthermore, the drop-out rate and treatment characteristics will be measured in order to study feasibility of blended CBT. Conclusions: This study examines the effectiveness and cost-effectiveness of a blended CBT program in which depressed adolescents are treated in mental health care. Results of blended CBT will be compared to face-to-face CBT and treatment-as-usual. Further implications for implementation will be reviewed. Clinical Trial: The study is registered in the Dutch Trial Register (NTR6759).

  • Implementation of a Modified Communication and Optimal Resolution (CANDOR) Program for Inter-Facility Medical Error Discovery (IMED): A Study Protocol

    Date Submitted: Jan 14, 2019

    Open Peer Review Period: Jan 17, 2019 - Jan 31, 2019

    Background. Preventable medical errors represent a major public health problem. To prevent future errors, improve disclosure, and mitigate malpractice risks, organizations have adopted strategies for...

    Background. Preventable medical errors represent a major public health problem. To prevent future errors, improve disclosure, and mitigate malpractice risks, organizations have adopted strategies for transparent communication and emphasized quality improvement through peer review. These principles are incorporated into the Agency for Healthcare Research and Quality (AHRQ) Communication and Optimal Resolution (CANDOR) Toolkit, which facilitates 1) transparent communication, 2) error prevention, and 3) achieving optimal resolution with patients and families. How medical errors should be addressed when they are discovered between facilities—inter-facility medical error discovery (IMED)—is less clear. Without mechanisms for disclosure and feedback on the part of the discovering provider, it is uncertain to what extent IMED is communicated with patients or responsible providers. Further, known barriers to disclosure and reporting one’s own error may not be relevant or replaced by other unknown barriers when considering scenarios of IMED. Methods. We plan a series of studies following an implementation framework. First, we plan a participatory, consensus-building stakeholder panel process to modify CANDOR for application to IMED scenarios. We will then conduct a robust pre-implementation analysis to identify determinants of implementation of the modified process. Using the Consolidated Framework for Implementation Framework as a theoretical framework, we will assess organizational readiness by key informant interviews and individual-level behaviors by a survey. Findings from this analysis will inform the implementation Toolkit that will be developed and pilot tested at two sites. We will measure five implementation outcomes (acceptability, appropriateness, reach, adoption and feasibility) using a combination of key informant interviews and surveys over the pre- and post-implementation phases. Discussion. Providing a communication and resolution strategy applicable to IMED scenarios will help address this current blind spot in the patient safety movement. This work will provide important insights into the potential utility of an implementation Toolkit to improve transparent communication and optimal resolution of IMED scenarios. The natural progression of this work will be to test the Toolkit more broadly, understand the feasibility and barriers of implementation on a broader scale and pilot the implementation in new organizations.

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