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Journal Description

 

JMIR Research Protocols (ISSN 1929-0748) is a unique Pubmed- and (new!) Scopus-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.

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 (preliminary results from pilot studies, early results, and formative research should now be published in JMIR Formative Research).

While the original focus was on the design of medical and health-related research and technology innovations, JRP publishes research protocols, proposals, feasibility studies, methods and early results in all areas of medical and health research.

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.

JMIR Res Protoc 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 proposals 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: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2020/1/e16332/; License: Creative Commons Attribution (CC-BY).

    Prospective Evaluation of HIV Testing Technologies in a Clinical Setting: Protocol for Project DETECT

    Abstract:

    Background: HIV testing guidelines provided by the Centers for Disease Control and Prevention (CDC) are continually changing to reflect advancements in new testing technology. Evaluation of existing and new point-of-care (POC) HIV tests is crucial to inform testing guidelines and provide information to clinicians and other HIV test providers. Characterizing the performance of POC HIV tests using unprocessed specimens can provide estimates for the window period of detection, or the time from HIV acquisition to test positivity, which allows clinicians and other HIV providers to select the appropriate POC HIV tests for persons who may be recently infected with HIV. Objective: This paper describes the protocols and procedures used to evaluate the performance of the newest POC tests and determine their sensitivity during early HIV infection. Methods: Project DETECT is a CDC-funded study that is evaluating POC HIV test performance. Part 1 is a cross-sectional, retrospective study comparing behavioral characteristics and HIV prevalence of the overall population of the Public Health–Seattle & King County (PHSKC) Sexually Transmitted Disease (STD) Clinic to Project DETECT participants enrolled in part 2. Part 2 is a cross-sectional, prospective study evaluating POC HIV tests in real time using unprocessed whole blood and oral fluid specimens. A POC nucleic acid test (NAT) was added to the panel of HIV tests in June 2018. Part 3 is a longitudinal, prospective study evaluating seroconversion sensitivity of POC HIV tests through serial follow-up testing. For comparison, HIV-1 RNA and HIV-1/HIV-2 antigen/antibody tests are also performed for participants enrolled in part 2 or 3. A behavioral survey that collects information about demographics, history of HIV testing, STD history, symptoms of acute HIV infection, substance use, sexual behaviors in the aggregate and with recent partners, and use of pre-exposure prophylaxis and antiretroviral therapy is completed at each part 2 or 3 visit. Results: Between September 2015 and March 2019, there were 14,990 Project DETECT–eligible visits (part 1) to the PHSKC STD Clinic resulting in 1819 part 2 Project DETECT study visits. The longitudinal study within Project DETECT (part 3) enrolled 27 participants with discordant POC test results from their part 2 visit, and 10 (37%) were followed until they had fully seroconverted with concordant positive POC test results. Behavioral survey data and HIV test results, sensitivity, and specificity will be presented elsewhere. Conclusions: Studies such as Project DETECT are critical for evaluating POC HIV test devices as well as describing characteristics of persons at risk for HIV acquisition in the United States. HIV tests in development, including POC NATs, will provide new opportunities for HIV testing programs.

  • Source: Image created by Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2020/1/e15883/; License: Creative Commons Attribution (CC-BY).

    Relationship Education and HIV Prevention for Young Male Couples Administered Online via Videoconference: Protocol for a National Randomized Controlled Trial...

    Abstract:

    Background: Young men who have sex with men have a high HIV incidence, and a substantial proportion of incident infections occur in the context of main partnerships. However, romantic relationships also provide numerous benefits to individual health and wellbeing. 2GETHER is a relationship education and HIV prevention program for young male couples, and the 2GETHER USA randomized controlled trial (RCT) was launched to establish the efficacy of an online version of 2GETHER. Objective: The objective of 2GETHER is to optimize relationship functioning in young male couples as a method to improve communication about sexual risk behaviors and reduce HIV transmission. In the 2GETHER USA study, 2GETHER was adapted for online administration to couples across the United States via videoconferencing. The intervention in question aims to address the unique needs of couples from varied racial/ethnic backgrounds and geographic regions. Methods: This is a comparative effectiveness RCT of 2GETHER USA relative to existing public health practice (control). 2GETHER USA is a hybrid group- and individual-level intervention that delivers three weekly online group discussion sessions for skills delivery, followed by two individualized couple sessions that focus on skills implementation in each couple. The control condition differs by participant HIV status: (1) the Testing Together protocol for concordant HIV-negative couples; (2) medication adherence and risk reduction counseling for concordant HIV-positive couples; or (3) both protocols for serodiscordant couples. Follow-up assessments are delivered at 3-, 6-, 9-, and 12-months post-intervention in both conditions. Testing for rectal and urethral Chlamydia and Gonorrhea occurs at baseline and 12-month follow-up. The primary behavioral outcome is condomless anal sex with serodiscordant serious partners or any casual partners. The primary biomedical outcome is sexually transmitted infection incidence at a 12-month follow-up. Results: As of October 11, 2019, the trial has enrolled and randomized 140 dyads (Individual N=280). Enrollment will continue until we randomize 200 dyads (N=400). Assessment of intervention outcomes at 3-, 6-, 9-, and 12-months is ongoing. Conclusions: 2GETHER is innovative in that it integrates relationship education and HIV prevention for optimizing the health and wellbeing of young male couples. The 2GETHER USA online adaptation has the potential to reach couples across the United States and reduce barriers to accessing health care services that are affirming of sexual minority identities for those who live in rural or under-resourced areas. Trial Registration: ClinicalTrials.gov NCT03284541; https://clinicaltrials.gov/ct2/show/NCT03284541

  • Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2020/1/e15354; License: Licensed by JMIR.

    Testing the Effectiveness and Cost-Effectiveness of a Combination HIV Prevention Intervention Among Young Cisgender Men Who Have Sex With Men and Transgender...

    Abstract:

    Background: Pre-exposure prophylaxis (PrEP) is highly effective in the prevention of HIV acquisition, particularly for men who have sex with men (MSM). Questions remain on the benefits of PrEP and implementation strategies for those at occupational risk of HIV acquisition in sex work, as well as on methods to support adherence among young people who initiate PrEP. Objective: The Combination Prevention Effectiveness study for young cisgender MSM and transgender women (TGW) aims to assess the effectiveness and cost-effectiveness of a combination intervention among HIV-uninfected young MSM and TGW engaged in sex work in Thailand. Methods: This open-label, nonrandomized assessment compares the relative effectiveness of a combination prevention intervention with and without daily oral emtricitabine and tenofovir disoproxil fumarate (Truvada) PrEP with SMS-based adherence support. HIV-uninfected young MSM and TGW aged 18 to 26 years in Bangkok and Pattaya who self-report selling/exchanging sex at least once in the previous 12 months are recruited by convenience sampling and peer referral and are eligible regardless of their intent to initiate PrEP. At baseline, participants complete a standard assessment for PrEP eligibility and may initiate PrEP then or at any time during study participation. All participants complete a survey and HIV testing at baseline and every 3 months. Participants who initiate PrEP complete monthly pill pickups and may opt-in to SMS reminders. All participants are sent brief weekly SMS surveys to assess behavior with additional adherence questions for those who initiated PrEP. Adherence is defined as use of 4 or more pills within the last 7 days. The analytic plan uses a person-time approach to assess HIV incidence, comparing participant time on oral PrEP to participant time off oral PrEP for 12 to 24 months of follow-up, using a propensity score to control for confounders. Enrollment is based on the goal of observing 620 person-years (PY) on PrEP and 620 PY off PrEP. Results: As of February 2019, 445 participants (417 MSM and 28 TGW) have contributed approximately 168 PY with 95% (73/77) retention at 12 months. 74.2% (330/445) of enrolled participants initiated PrEP at baseline, contributing to 134 PY of PrEP adherence, 1 PY nonadherence, and 33 PY PrEP nonuse/noninitiation. Some social harms, predominantly related to unintentional participant disclosure of PrEP use and peer stigmatization of PrEP and HIV, have been identified. Conclusions: The majority of cisgender MSM and TGW who exchange sex and participate in this study are interested in PrEP, report taking sufficient PrEP, and stay on PrEP, though additional efforts are needed to address community misinformation and stigma. This novel multilevel, open-label study design and person-time approach will allow evaluation of the effectiveness and cost-effectiveness of combination prevention intervention in the contexts of both organized sex work and exchanged sex.

  • Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2020/1/e15022; License: Creative Commons Attribution + Noncommercial + NoDerivatives (CC-BY-NC-ND).

    Smartphone Cardiac Rehabilitation, Assisted Self-Management Versus Usual Care: Protocol for a Multicenter Randomized Controlled Trial to Compare Effects and...

    Abstract:

    Background: Alternative evidence-based cardiac rehabilitation (CR) delivery models that overcome significant barriers to access and delivery are needed to address persistent low utilization. Models utilizing contemporary digital technologies could significantly improve reach and fidelity as complementary alternatives to traditional center-based programs. Objective: The aim of this study is to compare the effects and costs of the innovative Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) intervention with usual care CR. Methods: In this investigator-, assessor-, and statistician-blinded parallel 2-arm randomized controlled trial, 220 adults (18+ years) with coronary heart disease are being recruited from 3 hospitals in metropolitan and regional Victoria, Australia. Participants are randomized (1:1) to receive advice to engage with usual care CR or the SCRAM intervention. SCRAM is a 24-week dual-phase intervention that includes 12 weeks of real-time remote exercise supervision and coaching from exercise physiologists, which is followed by 12 weeks of data-driven nonreal-time remote coaching via telephone. Both intervention phases include evidence- and theory-based multifactorial behavior change support delivered via smartphone push notifications. Outcomes assessed at baseline, 12 weeks, and 24 weeks include maximal aerobic exercise capacity (primary outcome at 24 weeks), modifiable cardiovascular risk factors, exercise adherence, secondary prevention self-management behaviors, health-related quality of life, and adverse events. Economic and process evaluations will determine cost-effectiveness and participant perceptions of the treatment arms, respectively. Results: The trial was funded in November 2017 and received ethical approval in June 2018. Recruitment began in November 2018. As of September 2019, 54 participants have been randomized into the trial. Conclusions: The innovative multiphase SCRAM intervention delivers real-time remote exercise supervision and evidence-based self-management behavioral support to participants, regardless of their geographic proximity to traditional center-based CR facilities. Our trial will provide unique and valuable information about effects of SCRAM on outcomes associated with cardiac and all-cause mortality, as well as acceptability and cost-effectiveness. These findings will be important to inform health care providers about the potential for innovative program delivery models, such as SCRAM, to be implemented at scale, as a complement to existing CR programs. The inclusion of a cohort comprising metropolitan-, regional-, and rural-dwelling participants will help to understand the role of this delivery model across health care contexts with diverse needs. Trial Registration: Australian New Zealand Clinical Trials Registry (ACTRN): 12618001458224; anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374508.

  • Source: flickr; Copyright: Mr Thinktank; URL: https://www.flickr.com/photos/34621580@N00/4102308307; License: Creative Commons Attribution (CC-BY).

    A Context-Specific Digital Alcohol Brief Intervention in Symptomatic Breast Clinics (Abreast of Health): Development and Usability Study

    Abstract:

    Background: Potentially modifiable risk factors account for approximately 23% of breast cancer cases. In the United Kingdom, alcohol consumption alone is held responsible for 8% to 10% of cases diagnosed every year. Symptomatic breast clinics focus on early detection and treatment, but they also offer scope for delivery of low-cost lifestyle interventions to encourage a cancer prevention culture within the cancer care system. Careful development work is required to effectively translate such interventions to novel settings. Objective: The aim of this study was to develop a theory of change and delivery mechanism for a context-specific alcohol and lifestyle brief intervention aimed at women attending screening and symptomatic breast clinics. Methods: A formative study combined evidence reviews, analysis of mixed method data, and user experience research to develop an intervention model, following the 6 Steps in Quality Intervention Development (6SQuID) framework. Results: A Web app focused on improving awareness, encouraging self-monitoring, and reframing alcohol reduction as a positive choice to improve health was found to be acceptable to women. Accessing this in the clinic waiting area on a tablet computer was shown to be feasible. An important facilitator for change may be the heightened readiness to learn associated with a salient health visit (a teachable moment). Women may have increased motivation to change if they can develop a belief in their capability to monitor and, if necessary, reduce their alcohol consumption. Conclusions: Using the 6SQuID framework supported the prototyping and maximized acceptability and feasibility of an alcohol brief intervention for women attending symptomatic breast clinics, regardless of their level of alcohol consumption.

  • Source: Unsplash; Copyright: Annie Spratt; URL: https://unsplash.com/photos/biVuafyC8oI; License: Licensed by JMIR.

    Evaluation of Patterns of Presentation, Practice, and Outcomes of Upper Tract Urothelial Cancer: Protocol for an Observational, International, Multicenter,...

    Abstract:

    Background: Available guidelines on the management of upper tract urothelial carcinoma (UTUC) are restricted due to the lack of strong evidence–based recommendations. Adequate, well-powered randomized trials are missing due to the rarity of the disease. To overcome this problem, we need alternative study designs to provide generalizable data. Objective: The primary aim of this registry is to provide a real-world overview on patterns of presentation and management of UTUC. Secondary objectives include comparison of outcomes of different treatments and tumor stages and evaluation of compliance with the current European Association of Urology recommendations for UTUC. Methods: For this observational, international, multicenter, cohort study, clinical data of consecutive patients suspected of having UTUC, irrespective of type of management, will be prospectively collected up to 5 years after inclusion. Data on the patterns of presentation, diagnostics, and treatment as well as short-, mid-, and long-term oncological and functional outcomes will be analyzed. Possible associations between variables, basal characteristics, and outcomes will be tested by multivariable analyses. The methodology will address potential sources of bias and confounders. Results: The registry was initiated in November 2014 after obtaining institutional review board approval. Data collection started in December 2014. At the time of submission of this manuscript, 2451 patients from 125 centers from 37 countries were included. Inclusion of patients will be closed 5 years after initiation of the registry. Quality checks will be performed centrally with continuous communication and feedback with the centers to ensure accuracy. The first results are expected in the first trimester of 2020. Conclusions: This large observational prospective cohort will generate landmark “real-world” data and hypotheses for further studies. We expect these data to optimize the management of UTUC, provide insights on harms and benefits of treatment, and serve as quality control. Trial Registration: ClinicalTrials.gov NCT02281188; https://clinicaltrials.gov/ct2/show/NCT02281188.

  • Childhood self-management. Source: Flickr; Copyright: Juhan Sonin; URL: https://www.flickr.com/photos/juhansonin/24760053753/; License: Creative Commons Attribution (CC-BY).

    Self-Management Characterization for Families of Children With Medical Complexity and Their Social Networks: Protocol for a Qualitative Assessment

    Abstract:

    Background: Children with medical complexity (CMC) present rewarding but complex challenges for the health care system. Transforming high-quality care practices for this population requires multiple stakeholders and development of innovative models of care. Importantly, care coordination requires significant self-management by families in home- and community-based settings. Self-management often requires that families of CMC rely on vast and diverse social networks, encompassing both online and offline social relationships with individuals and groups. The result is a support network surrounding the family to help accomplish self-management of medical tasks and care coordination. Objective: The goal of this study is to use a theoretically driven perspective to systematically elucidate the range of self-management experiences across families of CMC embedded in diverse social networks and contextual environments. This approach will allow for characterization of the structure and process of self-management of CMC with respect to social networks, both in person and digitally. This research proposal aims to address the significant gaps in the self-management literature surrounding CMC, including the following: (1) how self-management responsibilities are distributed and negotiated among the social network and (2) how individual-, family-, and system-level factors influence self-management approaches for CMC from a theoretically driven perspective. Methods: This study will encompass a qualitative descriptive approach to understand self-management practices among CMC and their social networks. Data collection and analysis will be guided by a theoretical and methodological framework, which synthesizes perspectives from nursing, human factors engineering, public health, and family counseling. Data collection will consist of semistructured interviews with children, parents, and social network members, inclusive of individuals such as friends, neighbors, and community members, as well as online communities and individuals. Data analysis will consist of a combination of inductive and deductive methods of qualitative content analysis, which will be analyzed at both individual and multiadic levels, where interview data from two or more individuals, focused on the same experience, will be comparatively analyzed. Results: This study will take approximately 18 months to complete. Our long-term goals are to translate the qualitative analysis into (1) health IT design guidance for innovative approaches to self-management and (2) direct policy guidance for families of CMC enrolled in Medicaid and private insurance. Conclusions: Multiple innovative components of this study will enable us to gain a comprehensive and nuanced understanding of the lived experience of self-management of CMC. In particular, by synthesizing and applying theoretical and methodological approaches from multiple disciplines, we plan to create novel informatics and policy solutions to support their care within home and community settings.

  • Medly. Source: Image created by the Authors; Copyright: The Authors; URL: https://www.researchprotocols.org/2020/1/e15753; License: Creative Commons Attribution (CC-BY).

    A Mobile Phone–Based Telemonitoring Program for Heart Failure Patients After an Incidence of Acute Decompensation (Medly-AID): Protocol for a Randomized...

    Abstract:

    Background: Patients with heart failure (HF) are at the highest risk for hospital readmissions during the first few weeks after discharge when patients are transitioning from hospital to home. Telemonitoring (TM) for HF management has been found to reduce mortality risk and hospital readmissions if implemented appropriately; however, the impact of TM targeted for patients recently discharged from hospital, for whom TM might have the biggest benefit, is still unknown. Medly, a mobile phone–based TM system that is currently being used as a standard of care for HF at a large Canadian hospital, may be an effective tool for the management of HF in patients recently discharged from hospital. Objective: The objective of the Medly-After an Incidence of acute Decompensation (Medly-AID) trial is to determine the effect of Medly on the self-care and quality of life of patients with HF who have been recently discharged from hospital after an HF-related decompensation. Methods: A multisite multimethod randomized controlled trial (RCT) will be conducted at 2 academic hospitals and at least one community hospital to evaluate the impact of Medly-enabled HF management on the outcomes of patients with HF who had been hospitalized for HF-related decompensation and discharged during the 2 weeks before recruitment. The trial will include 144 participants with HF (74 in each control and intervention groups). Control patients will receive standard of care, whereas patients in the intervention group will receive standard of care and Medly. Specifically, patients in the intervention group will record daily weight, blood pressure, and heart rate and answer symptom-related questions via the Medly app. Medly will generate automated patient self-care messages such as to adjust diuretic medications, based on the rules-based algorithm personalized to the individual patient, and send real-time alerts to their health care providers as necessary. All patients will be followed for 3 months. Primary outcome measures are self-care and quality of life as measured through the validated questionnaires Self-Care of Heart Failure Index, EQ-5D-5L, and the Kansas City Cardiomyopathy Questionnaire-12. Secondary outcome measures for this study include cost of health care services used and health outcomes. Results: Patient recruitment began in November 2018 at the Sunnybrook Health Sciences Centre, with a total of 35 participants recruited by July 30, 2019 (17 in the intervention group and 18 in the control group). The final analysis is expected to occur in the fall of 2020. Conclusions: This RCT will be the first to assess the effectiveness of the Medly TM system for use following discharge from hospital after a HF-related decompensation. Clinical Trial: ClinicalTrials.gov NCT03358303; https://clinicaltrials.gov/ct2/show/NCT03358303

  • Postoperative pain. Source: Freepik; Copyright: Freepik; URL: https://www.freepik.com/free-photo/mid-section-woman-with-pain-abdomen_3607847.htm#page=1&query=patient%20in%20pain&position=44; License: Licensed by JMIR.

    Movement-Evoked Pain Versus Pain at Rest in Postsurgical Clinical Trials and Meta-Analyses: Protocol for a Follow-Up Systematic Review

    Abstract:

    Background: Postoperative pain is one of the most prevalent and disabling complications of surgery that is associated with personal suffering, delayed functional recovery, prolonged hospital stay, perioperative complications, and chronic postsurgical pain. Accumulating evidence has pointed to the important distinction between pain at rest (PAR) and movement-evoked pain (MEP) after surgery. In most studies including both measures, MEP has been shown to be substantially more severe than PAR. Furthermore, as MEP is commonly experienced during normal activities (eg, breathing, coughing, and walking), it has a greater adverse functional impact than PAR. In a previous systematic review conducted in 2011, only 39% of reviewed trials included MEP as a trial outcome and 52% failed to identify the pain outcome as either PAR or MEP. Given the recent observations of postsurgical pain trials that continue to neglect the distinction between PAR and MEP, this updated review seeks to evaluate the degree of progress in this area. Objective: This updated review will include postsurgical clinical trials and meta-analyses in which the primary outcome was early postoperative pain intensity. The primary outcome for this review is the reporting of MEP (vs PAR) as an outcome measure for each trial and meta-analysis. Secondary outcomes include whether trials and meta-analyses distinguished between PAR and MEP. Methods: To be consistent with the 2011 review that we are updating, this review will again focus on randomized controlled trials and meta-analyses, from Medical Literature Analysis and Retrieval System Online and EMBASE databases, focusing on pain treatment after thoracotomy, knee arthroplasty, and hysterectomy in humans. Trials and meta-analyses will be characterized as to whether or not they assessed PAR and MEP; whether their pain outcome acknowledged the distinction between PAR and MEP; and, for trials assessing MEP, which pain-evoking maneuver(s) were used. Results: Scoping review and pilot data extraction are under way, and the results are expected by March 2020. Conclusions: It is our belief that every postsurgical analgesic trial should include MEP as an outcome measure. The previous 2011 review was expected to have an impact on more widespread assessment of MEP in subsequent postoperative pain treatment trials. Thus, the purpose of this follow-up review is to reevaluate the frequency of use of MEP as a trial outcome, compared with PAR, in more recently published postoperative pain trials. Clinical Trial: PROSPERO CRD42019125855; https://tinyurl.com/qw9dty8

  • Ethical issues discussed in a PhD dissertation focused on health technologies (montage). Source: JMIR Publications / Placeit; Copyright: JMIR Publications; URL: http://www.researchprotocols.org/2020/1/e14157/; License: Creative Commons Attribution (CC-BY).

    Examining the Ethical Implications of Health Care Technology Described in US and Swedish PhD Dissertations: Protocol for a Scoping Review

    Abstract:

    Background: The development of new biomedical technologies is accelerating at an unprecedented speed. These new technologies will undoubtedly bring solutions to long-standing problems and health conditions. However, they will likely also have unintended effects or ethical implications accompanying them. It may be presumed that the research behind new technologies has been evaluated from an ethical perspective; however, the evidence that this has been done is scant. Objective: This study aims to understand whether and in what manner PhD dissertations focused on health technologies describe actual or possible ethical issues resulting from their research. Methods: The purpose of scoping reviews is to map a topic in the literature comprehensively and systematically to identify gaps in the literature or identify key evidence. The search strategy for this protocol will include electronic databases (eg, ProQuest, PubMed, Diva, SwePub, and LIBRIS). Searches will be limited to PhD dissertations published in the United States and Sweden in the last 10 years. The study will be mapped in 5 stages: (1) identifying the research question, (2) identifying relevant studies, (3) study selection, (4) retrieving and charting the data, and (5) collating, summarizing, and reporting the results. Results: The findings of this study will indicate if and how researchers, PhD students, and their supervisors are considering ethics in their studies, including both research ethics and the ethical implications of their work. The findings can guide researchers in determining gaps and shortcomings in current doctoral education and offer a foundation to adjusting doctoral research education. Conclusions: In a society where technology and research are advancing at speeds unknown to us before, we need to find new and more efficient ways to consider ethical issues and address them in a timely manner. This study will offer an understanding of how ethics is currently being integrated into US and Swedish PhD dissertations and inform the future direction of ethics education at a doctoral level.

  • Source: freepik; Copyright: pressfoto; URL: https://www.freepik.com/free-photo/try-these-pills_5401145.htm#page=2&query=doctor+drug&position=47; License: Licensed by JMIR.

    Awareness and Opinions of Research Professionals on India's New Drug and Clinical Trials Regulations: Protocol for a Cross-Sectional Web-Based Survey Study

    Abstract:

    Background: Although several studies have been conducted and several articles have been published on India's new clinical trial regulations, very few have examined the views of investigators and ethics board members regarding modifications to the previous regulations. Overall, they have neglected to find out the opinions of other relevant professionals, such as research assistants, coordinators, associates, and managers. To our knowledge, no study has yet investigated the awareness and opinions of Indian research professionals on the new 2019 regulations. Objective: This study aims to describe the awareness and opinions of Indian research professionals on the new drug and clinical trial regulations. Methods: In this cross-sectional, Web-based study, we will conduct an open survey for various Indian research professionals. These professionals will be selected randomly using multiple sources. The survey questionnaires, which have already been validated, were developed using the form function in Google docs. A Web link was generated for participants to take the survey. Descriptive statistics will be shown as means and standard deviations for constant variables, whereas certain variables will instead be shown as numbers and percentages. Results: The survey was opened in July 2019. Enrollment has already started and will be completed in three months. The results calculations are expected to begin in October 2019. Conclusions: The results of the survey are expected to represent the views of research professionals on the new regulations that will support the development of clinical research and the pharmaceutical industry in India. These regulations are expected to help advance clinical trials, help with the approval of new drugs, and enhance ethical norms in the country.

  • The EchoLaser system. Source: Image created by the Authors; Copyright: AMC / Elesta; URL: https://www.researchprotocols.org/2020/1/e15687; License: Licensed by JMIR.

    Transperineal Laser Ablation Treatment for Lower Urinary Tract Symptoms Due to Benign Prostatic Obstruction: Protocol for a Prospective In Vivo Pilot Study

    Abstract:

    Background: Standard surgical treatments for lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO) use a transurethral approach. Drawbacks are the need for general or spinal anesthesia and complications such as hematuria, strictures, and cloth retention. Therefore, a minimal invasive technique under local anesthesia is desired to improve patient safety. Recently, SoracteLite transperineal laser ablation (TPLA) has been introduced as a novel minimal invasive treatment for BPO. The system used is unique because 4 laser sources are independently available. This 1064-nm diode laser induces coagulative necrosis. Moreover, TPLA is unique because it has a transperineal approach and can be performed under local anesthesia in an outpatient setting. Objective: The primary objective of this study is to determine the safety and feasibility of TPLA treatment for men, who are fit for standard surgery, with LUTS due to BPO. The secondary objectives are to determine functional outcomes by flowmetry and patient-reported outcome measures (PROMs), side effects, and tissue changes observed on imaging. Methods: This study is a prospective, single center, interventional pilot study IDEAL framework stage 2a and will include 20 patients. Eligible patients are men ≥40 years of age, with a prostate volume of 30 to 120 cc, have urodynamically proven bladder outlet obstruction, and have a peak urinary flow of 5 to 15 mL per second. All patients will undergo TPLA of their prostate under local anesthesia by using the EchoLaser system. Depending on the prostate volume, 2 to 4 laser fibers will be placed bilaterally into the prostate. Patient follow-up consists of uroflowmetry, PROMs, and imaging by using contrast-enhanced ultrasound. Total follow-up is 12 months following treatment. Results: Presently, recruitment of patients is ongoing. Publication of first results is expected by early 2020. Conclusions: TPLA offers the potential to be a novel minimal invasive technique for treatment of LUTS due to BPO in men fit for standard desobstruction. This study will evaluate the safety and feasibility of TPLA and report on functional outcomes and tissue changes observed on imaging following TPLA treatment.

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    Open Peer Review Period: Jan 16, 2020 - Mar 12, 2020

    Background: Cancer patients often suffer from the physical and psychological burden of their disease and its treatment which are frequently not sufficiently identified nor addressed in clinical routin...

    Background: Cancer patients often suffer from the physical and psychological burden of their disease and its treatment which are frequently not sufficiently identified nor addressed in clinical routine. In the context of improving patient-centered care of oncological patients, patient-reported outcomes (PROs) represent an important addition to current routine care. So far, available PRO-measurements for cancer patients are unsuitable for routine procedures due to their length and complexity. Objective: Therefore, it is the aim of this study to develop and psychometrically test a short questionnaire to measure HrQoL in cancer patients for use in routine care. Methods: This observational study consists of two parts: [1] a qualitative study to develop a short questionnaire measuring HrQoL and [2] a quantitative study to psychometrically test this questionnaire at five oncological departments of a comprehensive cancer center. In study part 1, semi-structured interviews with 28 cancer patients as well as five focus groups with 22 clinicians and nurses will be conducted to identify clinically relevant dimensions of HrQoL. The identified dimensions will be complemented with related dimensions of empirical studies and discussed in an expert discussion. On this basis a short instrument will be developed. In study part 2, the developed questionnaire will be tested in cancer in- and out-patients of five participating oncological clinics using additional standardized questionnaires assessing HrQoL and further important PROs. The questionnaire will be presented to 770 patients twice during treatment. Results: x Conclusions: With five to six dimensions of one item each, the developed questionnaire is short enough, to not disrupt routine procedures during treatment and is profound enough, to inform clinicians about the patient’s problems and course concerning HrQoL. Clinical Trial: This study was registered at Open Science Framework (https://osf.io/y7xce/).

  • A Prospective Study Evaluating a Pain Assessment Tool in Postoperative Environment: Protocol for Algorithm Testing and Enhancement

    Date Submitted: Jan 12, 2020

    Open Peer Review Period: Jan 12, 2020 - Mar 8, 2020

    Background: Pain assessment is critical to the optimal treatment of pain. There is a high demand for accurate objective pain assessment for effectively optimizing pain management interventions. Howeve...

    Background: Pain assessment is critical to the optimal treatment of pain. There is a high demand for accurate objective pain assessment for effectively optimizing pain management interventions. However, pain as a multivalent, dynamic, and ambiguous phenomenon is difficult to quantify, particularly when the patient’s ability to communicate is limited. The “gold standard” of pain intensity assessment is self-reporting. However, this unidimensional model is disparaged for its oversimplification and limited applicability in several vulnerable patient populations. Researchers have attempted to develop objective pain assessment tools through analysis of physiological pain indicators, such as Electrocardiography (ECG), Electromyography (EMG), Plethysmography (PPG), and Electrodermal Activity (EDA). However, pain assessment by using only these signals can be unreliable, as there are various other factors that alter these vital signs and the adaptation of vital signs to pain stimulation varies from person to person. Objective pain assessment using behavioral signs such as facial expressions has recently gained attention. Several techniques in this category, such as those using computer vision to extracting features from patients’ head-pose, suffer from feasibility issues in clinical settings due to privacy and practical barriers to deployment. Objective: This paper aims to develop an automatic and versatile pain assessment tool algorithm for detection and assessment of pain in a reliable and objective way in non-communicative patients through observational data collection by wearable technologies, measuring facial EMG, ECG, PPG, and EDA. Methods: This study was planned to be done in three different phases: (1) Evaluation and Test of usability, utility, and accuracy of the new pain assessment tool in 30 healthy working-age volunteers, (2) Further development and research of a pain assessment tool in patients likely experiencing mild to moderate pain, and (3) Conduct a trial to assess the effectiveness of the whole platform in uncommunicative patients at two different sites which serve as the sites of both intervention and control group. Currently available state-of-the-art standard sensors were used to measure bioelectrical EMG signals as well as changes in heart rate, respiratory rate, and oxygen saturation. Based on the results, the pain assessment tool was further developed and reconstituted with modern wearable sensors, devices, and algorithms. In this paper, we focus on the second part of the study. HUMAN RESEARCH PROTECTIONS Application for IRB Review (APP) was approved for this paper. Results: The development of the pain assessment tool is calculated to be ready in early 2020. Preliminary results will be ready for publication from Fall 2019. Conclusions: This paper is about the second phase of research on multimodal signals including facial muscle electrical activity, cardiac electrical activity, and electrodermal activity as indicators of pain. This paper will allow testing the smart pain assessment tool in uncommunicative patients in a multicenter, multinational setting in California/USA and Turku/Finland to promote pain management of patients and enhance the safety and quality of care.

  • Daily electronic self-monitoring of subjective symptoms and skill- learning in borderline personality disorder – the mDIARY1 trial protocol: a pragmatic randomised controlled trial

    Date Submitted: Jan 10, 2020

    Open Peer Review Period: Jan 9, 2020 - Mar 5, 2020

    Background: Patient self-monitoring by mobile phones during psychotherapy can enhance overview of the psychotherapeutic progress by graphically displaying current and previous scores, providing feedba...

    Background: Patient self-monitoring by mobile phones during psychotherapy can enhance overview of the psychotherapeutic progress by graphically displaying current and previous scores, providing feedback to the patient, delivering psychoeducative material, and providing timely data to the therapist or treatment team. Objective: The objective is to assess the effect of registering on a smartphone instead of using pen and paper during psychotherapy. There treatment performed is dialectical behaviour therapy.The psychiatric diagnosis treated is borderline personality disorder (BPD).The primary outcome is mean time needed to assimilate coping skills directed at emotion regualation. Secondary outcome is change in BPD symptom score as measured by Zanarini rating scale for BPD Methods: The study is a pragmatic randomised controlled multicenter trial.Recruiting through 5 Danish public general psychiatric outpatient treatment facilities.PAtients are randomly assigned, on 1:1 basis to til either mobile phone registration condition or pen and paper condition.Patients will conclude several self report questionnaires on symptom severity as well as assessment by trained raters on BPD severity. Survival analysis with shared frailty will be used to assess primary outcomes. Results: Recruitment for the study began june 2017. Inclusion into the study ended february 2019. The study is ongoing and scheduled to complete february 2020. 79 particiåants have been recruited from 5 different sites in Denmark. The alternative hypothesis of the study is that there will be an added affect of mobile phone registration during treatment. Conclusions: The RCT will contribute to the literature on effects of mobilephone self monitoring during psychiatric treatment. Clinical Trial: The Danish Ethics Committee in the Region of Southern Denmark [S-20160085]. The Danish Data protection Agency under the common Danish mental health databases of quality [2008-58-0035].

  • A Multi-Lingual, Culturally-Competent Mobile Health Intervention to Improve Treatment Adherence for Women Living with HIV/AIDS: A Feasibility Study Protocol

    Date Submitted: Jan 2, 2020

    Open Peer Review Period: Dec 31, 2019 - Feb 25, 2020

    Design and Objective: This paper describes a protocol to investigate the feasibility of a mobile health (mHealth) intervention to improve adherence among women living with HIV. This is two-phase, mix...

    Design and Objective: This paper describes a protocol to investigate the feasibility of a mobile health (mHealth) intervention to improve adherence among women living with HIV. This is two-phase, mixed-methods, pilot, randomized controlled trial that begins with patient qualitative interviews to inform the application design. Participants will be randomized to one of two study arms. Study Population: Women (>=18 years of age) followed at an academic medical center women’s HIV clinic, with a recent history of non-adherence to HIV care (missed appointments, unsuppressed viral load, not taking medications as prescribed) will be enrolled. Intervention and Control: The experimental arm will receive the intervention, which includes health reminders and psycho-educational messaging, plus clinic standard of care reminders. The psycho-educational messaging will target patient-level barriers of HIV stigma and medical mistrust, and resiliency as a patient-level strength. The control arm will receive the standard of care reminders only—namely, mailed appointments and automated telephone calls. All aspects of the study and intervention, i.e. data measures, regulatory forms, and messaging, will be offered in participants’ preferred language (English, Spanish, or Haitian Creole). Outcome Measures: Primary outcome is study feasibility/acceptability. Secondary outcomes are changes in self-reported medication adherence, depressive symptoms (PHQ-9), HIV stigma (HSS), medical mistrust (GBMMS), and resiliency (CDRISC-25), and clinic attendance and viral suppression, extracted from participants’ medical records. Data will be assessed at baseline (T0), and two subsequent clinic visits--approximately 3-4 months post-baseline (T1); 6-9 months post-baseline (T2). Analysis: Audio recordings of qualitative data will be transcribed and analyzed iteratively. Bivariate analyses will compare data by study group (chi-square, odds ratios, t-tests). Exploratory analyses using analysis of variance will be constructed for each outcome variable—T1 and T2 values will be compared to T0, by study group. Trial Registration: NCT03738410

  • Development of the Advancing People of Color in Clinical Trials (ACT Now!) Intervention: A Web-based Randomized Controlled Trial

    Date Submitted: Dec 22, 2019

    Open Peer Review Period: Dec 22, 2019 - Feb 16, 2020

    Background: Participation in clinical trials among people of color remains low, compared with whites. This protocol describes the development of Act NOW! (Advancing People of Color in Clinical Trials...

    Background: Participation in clinical trials among people of color remains low, compared with whites. This protocol describes the development of Act NOW! (Advancing People of Color in Clinical Trials NOW!), a culturally tailored website designed to influence clinical trial decision making among people of color. Objective: This cluster randomized study aims to test the efficacy of a culturally tailored website to increase literacy, self-efficacy and willingness to enroll in clinical trials among people of color, compared to the standard NYU clinical trial enrollment website. Methods: Act NOW! is a randomized trial including two groups: (1) intervention group (n=50) with access to the culturally tailored website and (2) control group (n=50) exposed to a standard clinical recruitment website. Clinical trial literacy, self-efficacy and willingness to enroll in a clinical trial will be measured before and after exposure to the website corresponding to their assigned group (intervention or control). Surveys will be conducted at baseline and during the 1-month post-intervention and 3-month follow-up. Website architecture and wire-framing will be informed by the literature and experts in the field. Statistical analysis will be conducted using a two-tailed t-test, with 80% power, at 0.05 alpha level, to increase clinical trial literacy, self-efficacy and willingness to enroll in clinical trials 3-months post-intervention. Results: We will design a culturally tailored website and leverage community stakeholders to influence clinical trial literacy, self-efficacy and willingness to enroll in clinical trials among racial and ethnic groups. ACT Now! applies a community-based participatory research informed approach through the use of a Community Steering Committee (CSC). The CSC provides input during the research study conception, development, implementation and enrollment. CSC relationships help to foster trust among communities of color. ACT Now! has the potential to fill a gap in clinical trial enrollment among people of color, through an accessible, online website. Conclusions: A culturally tailored website may have the potential to increase literacy, self-efficacy and willingness to enroll in a clinical trial among people of color. Clinical Trial: Trial registration number NCT03243071 August 8, 2017.

  • Protocol of the DARIO randomized trial: Effects of alternative offers of screening sigmoidoscopy and colonoscopy on utilization and yield of endoscopic screening for colorectal neoplasms

    Date Submitted: Dec 18, 2019

    Open Peer Review Period: Dec 17, 2019 - Feb 11, 2020

    Background: Flexible sigmoidoscopy and colonoscopy are recommended screening options for colorectal cancer (CRC). Of these options, only colonoscopy which requires complete bowel cleansing and is more...

    Background: Flexible sigmoidoscopy and colonoscopy are recommended screening options for colorectal cancer (CRC). Of these options, only colonoscopy which requires complete bowel cleansing and is more invasive but visualizes the entire colon and rectum is offered for CRC screening, but use of this offer has been very limited. Objective: To assess the potential for increasing use of endoscopic CRC screening and the detection of advanced colorectal neoplasms by offering the choice between use of flexible sigmoidoscopy and colonoscopy. Methods: The DARIO study includes a cross-sectional study (Part I), followed by a prospective two-arm randomized controlled intervention trial (Part II) with an associated biobank study (Part III). Participation is possible in part I only, parts I and II, or all three parts. After obtaining informed consent from the municipalities 12,000 people, aged 50-54 years, from the Rhine-Neckar region in Germany are randomly selected from residential lists of the responsible population registries and are invited to complete a standardized questionnaire to investigate the nature, frequency, timing, and results of previous colorectal cancer screening and eventual diagnostic colonoscopies. In study part II participants from study part I with no colonoscopy in the preceding 5 years are randomized into two arms: arm A offering screening colonoscopy only, and arm B offering both options, either screening colonoscopy or screening sigmoidoscopy, to investigate whether the screening offer for less invasive sigmoidoscopy leads to a higher use of endoscopic screening and a higher number of detected and removed neoplasms > 0.5cm (primary endpoint). Part III of the study will use samples from participants in study part II to construct a liquid and tissue biobank for the evaluation of less invasive methods of early detection of colon cancer and for the more detailed characterization of the detected neoplasms. Blood, urine, stool and saliva samples are taken before the endoscopy. Tissue samples are obtained from the neoplasms removed during endoscopy. Results: 10,568 randomly selected women and men aged 50-54 years living in the Rhine-Neckar-Region of Germany have been invited for participation, 1432 could not be invited because they reached the age of 55 at the time of contact, 2789 women and men participated in study part I. Study parts II and III are ongoing. Conclusions: This study will answer the question if alternative offers of either screening sigmoidoscopy or screening colonoscopy will increase utilization and effectiveness of endoscopic CRC screening compared to an exclusive offer of screening colonoscopy. In addition, alternative non-invasive screening tests will be developed and validated. Clinical Trial: The trial was registered during recruitment of the participants in www.drks.de on September 30, 2019: German Clinical Trials Register DRKS-ID: DRKS0000

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