JMIR Publications

JMIR Research Protocols

Ongoing Trials, Grant Proposals, Formative Research, Methods, Early Results

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Journal Description

 

JMIR Research Protocols (ISSN 1929-0748) publishes 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 new journal spin-off of JMIR, the worlds' leading medical journal in health sciences / health services research and health informatics (Impact Factor 2016: 5.175)

JMIR Res Protoc 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 

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 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)

 
 

Recent Articles:

  • Repeated chest image. Source: Image created by the Authors; Copyright: Abdullah Almalki; URL: http://www.researchprotocols.org/2017/9/e185/; License: Creative Commons Attribution (CC-BY).

    Educational Module Intervention for Radiographers to Reduce Repetition Rate of Routine Digital Chest Radiography in Makkah Region of Saudi Arabia Tertiary...

    Abstract:

    Background: Repetition of an image is a critical event in any radiology department. When the repetition rate of routine digital chest radiographs is high, radiation exposure of staff and patients is increased. In addition, repetition consumes the equipment’s life span, thus affecting the annual budget of the department. Objective: The aim of this study is to determine the impact of a printed educational module on reducing the repetition rate of routine digital chest radiography among radiographers in Makkah Region tertiary hospitals. Methods: A quasi-experimental time series with a control group will be conducted in Makkah Region tertiary hospitals for 8 months starting in the second quarter of 2017. Four hospitals out of 5 in the region will be selected; 2 of them will be selected as the control group and the other 2 as the intervention group. Stratification and a simple random sampling technique will be used to sample 56 radiographers in each group. Pre- and postintervention assessments will be conducted to determine the radiographer knowledge, motivation, and skills and repetition rate of chest radiographs. Radiographs of the chest performed by sampled radiographers in the selected hospitals will be collected for 2 weeks before and after the intervention. A piloted questionnaire will be distributed and collected by a researcher in both groups. One-way multivariate analysis of variance and 2-way repeated multivariate analysis of variance will be used to analyze the data. Results: It is expected that the repetition rate in the intervention group will decline after implementing the intervention and the change will be statistically significant (P<.05). Furthermore, it is expected that the knowledge, motivation, and skill levels in the intervention group will increase significantly among radiographers after implementation of the intervention (P<.05). Meanwhile, knowledge, motivation, and skills in the control group will not change. Conclusions: A quasi-experimental time series with a control will be conducted to investigate the effect of printed educational material in reducing the repetition rate of routine digital chest radiographs among radiographers in tertiary hospitals in the Makkah Region of Saudi Arabia.

  • Anxious child. Source: Pexels; Copyright: Trinity Kubassek; URL: https://www.pexels.com/photo/adorable-boy-child-face-227609/; License: Public Domain (CC0).

    Protocol for Co-Design, Development, and Open Trial of a Prototype Game-Based eHealth Intervention to Treat Anxiety in Young People With Long-Term Physical...

    Abstract:

    Background: Approximately 10% to 12% of New Zealand young people (and 21% of Maori young people) have long-term physical conditions and are more likely to develop psychological problems, particularly anxiety and depression. Delayed treatment leads to worse management of physical conditions, school absence, and poorer long-term outcomes. Recently, electronic health (eHealth) interventions have been shown to be as good as face-to-face therapy and biofeedback techniques have been shown to enhance relaxation during the treatment of anxiety. In addition, young people with long-term physical conditions have expressed a preference for more technologically based support, including game-based interventions, to deal with psychological issues, particularly anxiety. Objective: The aim of this study is to develop a prototype game-based eHealth intervention to address anxiety in young people with long-term physical conditions. The game will be based on the principles of cognitive behavior therapy (CBT) and will integrate a module of biofeedback-based relaxation. Methods: During the first phase of the study, up to 48 young people with long-term physical conditions aged 13 to 18 years, attending a tertiary pediatric hospital will be invited to participate in a 3-stage series of co-design workshops. Following the design, development, and refinement of a working prototype, during the second phase of the study, a further 20 young people with long-term physical conditions and anxiety will be recruited from the same location to participate in an open pilot trial to evaluate its acceptability, usability, and preliminary efficacy. Results: Changes in anxiety will be measured using the Generalized Anxiety Disorder 7-item scale (GAD-7) and the Spence Child Anxiety Scales (SCAS) at the end of every module (recommended to be completed weekly), post intervention, and 3 months later. Usability of the intervention will be measured using the System Usability Scale (SUS) and by measuring frequency and quantity of use of the intervention. Acceptability of the intervention will be assessed using brief, open-ended questionnaires and semi-structured interviews, the data from which will be analyzed using a general inductive approach. Recruitment to the study commenced in January 2017 and data collection will be completed by the end of December 2017. Conclusions: If acceptable and useful, this game-based eHealth intervention may offer a cost-effective and clinically useful intervention for addressing the psychological needs of over 16,000 young people with long term health conditions in New Zealand. Trial Registration: Australian New Zealand Clinical Trials Network Registry (ANZCTR): ACTRN12616001253493p; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371443 (Archived by WebCite at http://www.webcitation.org/6sYB716lf)

  • The Box. Source: Image created by the Authors; Copyright: Heart Lung Center Leiden; URL: http://www.researchprotocols.org/2017/9/e186/; License: Creative Commons Attribution (CC-BY).

    Using Smart Technology to Improve Outcomes in Myocardial Infarction Patients: Rationale and Design of a Protocol for a Randomized Controlled Trial, The Box

    Abstract:

    Background: Recent evidence suggests that frequent monitoring using smartphone-compatible wearable technologies might improve clinical effectiveness and patient satisfaction of care. Objective: The aim of this study is to investigate the clinical effectiveness and patient satisfaction of a smart technology intervention in patients admitted with a ST elevation myocardial infarction (STEMI) or non-ST acute coronary syndrome (NST-ACS). Methods: In this single center, open, randomized controlled trial patients who suffered from STEMI or NST-ACS will be randomized 1:1 to an intervention group or control group. Both groups will be followed up to one year after the index event. The intervention group will take daily measurements with a smartphone-compatible electrocardiogram device, blood pressure (BP) monitor, weight scale, and activity tracker. Furthermore, two of four outpatient clinic visits will be replaced by electronic visits (1 and 6 months after index event). The control group will receive regular care, consisting of four outpatient clinic visits (1, 3, 6, and 12 months after index event). All patients will be asked to fill in validated questionnaires about patient satisfaction, quality of life, propensity of medication adherence, and physical activity. Results: The primary outcome of this trial will be percentage of patients with controlled BP. Secondary outcomes include patient satisfaction, health care utilization, major adverse cardiac events, medication adherence, physical activity, quality of life, and percentage of patients in which a sustained arrhythmia is detected. Conclusions: Smart technology could potentially improve care in postmyocardial infarction patients. This trial will investigate whether usage of smart technology can improve clinical- and cost-effectiveness of care. Trial Registration: Clinicaltrials.gov NCT02976376; https://clinicaltrials.gov/ct2/show/NCT02976376 (Archived by WebCite at http://www.webcitation.org/6tcvAdbdH)

  • ADR-PRISM project website (montage). Source: Projet ADR-PRISM / Placeit.net; Copyright: JMIR Publications; URL: https://www.damien-leprovost.fr/Project/ADRPrism?userlang=en; License: Creative Commons Attribution (CC-BY).

    The Adverse Drug Reactions from Patient Reports in Social Media Project: Five Major Challenges to Overcome to Operationalize Analysis and Efficiently Support...

    Abstract:

    Background: Adverse drug reactions (ADRs) are an important cause of morbidity and mortality. Classical Pharmacovigilance process is limited by underreporting which justifies the current interest in new knowledge sources such as social media. The Adverse Drug Reactions from Patient Reports in Social Media (ADR-PRISM) project aims to extract ADRs reported by patients in these media. We identified 5 major challenges to overcome to operationalize the analysis of patient posts: (1) variable quality of information on social media, (2) guarantee of data privacy, (3) response to pharmacovigilance expert expectations, (4) identification of relevant information within Web pages, and (5) robust and evolutive architecture. Objective: This article aims to describe the current state of advancement of the ADR-PRISM project by focusing on the solutions we have chosen to address these 5 major challenges. Methods: In this article, we propose methods and describe the advancement of this project on several aspects: (1) a quality driven approach for selecting relevant social media for the extraction of knowledge on potential ADRs, (2) an assessment of ethical issues and French regulation for the analysis of data on social media, (3) an analysis of pharmacovigilance expert requirements when reviewing patient posts on the Internet, (4) an extraction method based on natural language processing, pattern based matching, and selection of relevant medical concepts in reference terminologies, and (5) specifications of a component-based architecture for the monitoring system. Results: Considering the 5 major challenges, we (1) selected a set of 21 validated criteria for selecting social media to support the extraction of potential ADRs, (2) proposed solutions to guarantee data privacy of patients posting on Internet, (3) took into account pharmacovigilance expert requirements with use case diagrams and scenarios, (4) built domain-specific knowledge resources embeding a lexicon, morphological rules, context rules, semantic rules, syntactic rules, and post-analysis processing, and (5) proposed a component-based architecture that allows storage of big data and accessibility to third-party applications through Web services. Conclusions: We demonstrated the feasibility of implementing a component-based architecture that allows collection of patient posts on the Internet, near real-time processing of those posts including annotation, and storage in big data structures. In the next steps, we will evaluate the posts identified by the system in social media to clarify the interest and relevance of such approach to improve conventional pharmacovigilance processes based on spontaneous reporting.

  • Study logo. Source: The Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2017/9/e184/; License: Creative Commons Attribution (CC-BY).

    Cancer Predisposition Cascade Screening for Hereditary Breast/Ovarian Cancer and Lynch Syndromes in Switzerland: Study Protocol

    Abstract:

    Background: Breast, colorectal, ovarian, and endometrial cancers constitute approximately 30% of newly diagnosed cancer cases in Switzerland, affecting more than 12,000 individuals annually. Hundreds of these patients are likely to carry germline pathogenic variants associated with hereditary breast ovarian cancer (HBOC) or Lynch syndrome (LS). Genetic services (counseling and testing) for hereditary susceptibility to cancer can prevent many cancer diagnoses and deaths through early identification and risk management. Objective: Cascade screening is the systematic identification and testing of relatives of a known mutation carrier. It determines whether asymptomatic relatives also carry the known variant, needing management options to reduce future harmful outcomes. Specific aims of the CASCADE study are to (1) survey index cases with HBOC or LS from clinic-based genetic testing records and determine their current cancer status and surveillance practices, needs for coordination of medical care, psychosocial needs, patient-provider and patient-family communication, quality of life, and willingness to serve as advocates for cancer genetic services to blood relatives, (2) survey first- and second-degree relatives and first-cousins identified from pedigrees or family history records of HBOC and LS index cases and determine their current cancer and mutation status, cancer surveillance practices, needs for coordination of medical care, barriers and facilitators to using cancer genetic services, psychosocial needs, patient-provider and patient-family communication, quality of life, and willingness to participate in a study designed to increase use of cancer genetic services, and (3) explore the influence of patient-provider communication about genetic cancer risk on patient-family communication and the acceptability of a family-based communication, coping, and decision support intervention with focus group(s) of mutation carriers and relatives. Methods: CASCADE is a longitudinal study using surveys (online or paper/pencil) and focus groups, designed to elicit factors that enhance cascade genetic testing for HBOC and LS in Switzerland. Repeated observations are the optimal way for assessing these outcomes. Focus groups will examine barriers in patient-provider and patient-family communication, and the acceptability of a family-based communication, coping, and decision-support intervention. The survey will be developed in English, translated into three languages (German, French, and Italian), and back-translated into English, except for scales with validated versions in these languages. Results: Descriptive analyses will include calculating means, standard deviations, frequencies, and percentages of variables and participant descriptors. Bivariate analyses (Pearson correlations, chi-square test for differences in proportions, and t test for differences in means) will assess associations between demographics and clinical characteristics. Regression analyses will incorporate generalized estimating equations for pairing index cases with their relatives and explore whether predictors are in direct, mediating, or moderating relationship to an outcome. Focus group data will be transcribed verbatim and analyzed for common themes. Conclusions: Robust evidence from basic science and descriptive population-based studies in Switzerland support the necessity of cascade screening for genetic predisposition to HBOC and LS. CASCADE is designed to address translation of this knowledge into public health interventions. Clinical Trial: ClinicalTrials.gov NCT03124212; https://clinicaltrials.gov/ct2/show/NCT03124212 (Archived by WebCite at http://www.webcitation.org/6tKZnNDBt)

  • Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2017/9/e181/; License: Creative Commons Attribution (CC-BY).

    Assessing the Efficacy and Safety of an 11β-Hydroxysteroid Dehydrogenase Type 1 Inhibitor (AZD4017) in the Idiopathic Intracranial Hypertension Drug Trial,...

    Abstract:

    Background: Idiopathic intracranial hypertension (IIH) is a condition with few effective management options. So far, there have been no randomized controlled trials evaluating new treatments in IIH. Objectives: The purpose of this paper is to outline the trial design for the Idiopathic Intracranial Hypertension Drug Trial (IIH:DT), assessing an innovative medical treatment in IIH and the rationale for the chosen trial methodology. Methods: IIH:DT is a phase II double-blind randomized placebo-controlled trial recruiting 30 female participants with active IIH (intracranial pressure >25cm H2O and papilledema). Participants are randomized in a 1:1 ratio to 12 weeks of either AZD4017, an 11β-hydroxysteroid dehydrogenase type 1 inhibitor, or a matching placebo. They receive either 400 mg of AZD4017 or placebo twice daily. Participants are followed up at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16 postrandomization. The primary outcome is to examine the effect of AZD4017 on intracranial pressure, measured by lumbar puncture, over 12 weeks. Secondary outcome measures include IIH symptoms, visual function, papilledema, headache measures, safety, and tolerability. Cerebrospinal fluid, serum, plasma, urine, and adipose tissue are also taken for exploratory outcomes. Results: All participants were recruited between April 2014 and August 2016. Conclusions: IIH:DT is the first phase II double-blind randomized placebo-controlled trial assessing the efficacy and safety of the novel pharmacological intervention, AZD4017, for the treatment of IIH. Trial Registration: Clinicaltrials.gov NCT02017444; https://clinicaltrials.gov/ct2/show/NCT02017444 (Archived by WebCite at http://www.webcitation.org/6tVHesN6s)

  • Family with daughter with spina bifida. Source: The Authors; Copyright: Centers for Disease Control and Prevention; URL: https://www.cdc.gov/ncbddd/spinabifida/index.html; License: Public Domain (CC0).

    Understanding the Natural Progression of Spina Bifida: Prospective Study

    Abstract:

    Background: Spina bifida (SB) is monitored through birth defects surveillance across the United States and in most developed countries. Although much is known about the management of SB and its many comorbid conditions in affected individuals, there are few systematic, longitudinal studies on population-based cohorts of children or adults. The natural history of SB across the life course of persons with this condition is not well documented. Earlier identification of comorbidities and secondary conditions could allow for earlier intervention that might enhance the developmental trajectory for children with SB. Objective: The purpose of this project was to assess the development, health, and condition progression by prospectively studying children who were born with SB in Arizona and Utah. In addition, the methodology used to collect the data would be evaluated and revised as appropriate. Methods: Parents of children with SB aged 3-6 years were eligible to participate in the study, in English or Spanish. The actual recruitment process was closely documented. Data on medical history were collected from medical records; family functioning, child behaviors, self-care, mobility and functioning, and health and well-being from parent reports; and neuropsychological data from testing of the child. Results: In total, 152 individuals with SB were identified as eligible and their parents were contacted by site personnel for enrollment in the study. Of those, 45 (29.6%) declined to participate and 6 (3.9%) consented but did not follow through. Among 101 parents willing to participate, 81 (80.2%) completed the full protocol and 20 (19.8%) completed the partial protocol. Utah enrolled 72.3% (73/101) of participants, predominately non-Hispanic (60/73, 82%) and male (47/73, 64%). Arizona enrolled 56% (28/50) of participants they had permission to contact, predominately Hispanic (18/28, 64%) and male (16/28, 57%). Conclusions: We observed variance by site for recruitment, due to differences in identification and ascertainment of eligible cases and the required institutional review board processes. Restriction in recruitment and the proportion of minorities likely impacted participation rates in Arizona more than Utah.

  • Source: Image created by the Authors; Copyright: Poorna Kushalnagar; URL: https://www.researchprotocols.org/2017/9/e172/; License: Creative Commons Attribution (CC-BY).

    Health Information National Trends Survey in American Sign Language (HINTS-ASL): Protocol for the Cultural Adaptation and Linguistic Validation of a National...

    Abstract:

    Background: The Health Information National Trends Survey (HINTS) collects nationally representative data about the American’s public use of health-related information. This survey is available in English and Spanish, but not in American Sign Language (ASL). Thus, the exclusion of ASL users from these national health information survey studies has led to a significant gap in knowledge of Internet usage for health information access in this underserved and understudied population. Objective: The objectives of this study are (1) to culturally adapt and linguistically translate the HINTS items to ASL (HINTS-ASL); and (2) to gather information about deaf people’s health information seeking behaviors across technology-mediated platforms. Methods: We modified the standard procedures developed at the US National Center for Health Statistics Cognitive Survey Laboratory to culturally adapt and translate HINTS items to ASL. Cognitive interviews were conducted to assess clarity and delivery of these HINTS-ASL items. Final ASL video items were uploaded to a protected online survey website. The HINTS-ASL online survey has been administered to over 1350 deaf adults (ages 18 to 90 and up) who use ASL. Data collection is ongoing and includes deaf adult signers across the United States. Results: Some items from HINTS item bank required cultural adaptation for use with deaf people who use accessible services or technology. A separate item bank for deaf-related experiences was created, reflecting deaf-specific technology such as sharing health-related ASL videos through social network sites and using video remote interpreting services in health settings. After data collection is complete, we will conduct a series of analyses on deaf people’s health information seeking behaviors across technology-mediated platforms. Conclusions: HINTS-ASL is an accessible health information national trends survey, which includes a culturally appropriate set of items that are relevant to the experiences of deaf people who use ASL. The final HINTS-ASL product will be available for public use upon completion of this study.

  • Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2017/9/e183/; License: Creative Commons Attribution (CC-BY).

    A Multi-Level, Mobile-Enabled Intervention to Promote Physical Activity in Older Adults in the Primary Care Setting (iCanFit 2.0): Protocol for a Cluster...

    Abstract:

    Background: Most older adults do not adhere to the US Centers for Disease Control physical activity guidelines; their physical inactivity contributes to overweight and multiple chronic conditions. An urgent need exists for effective physical activity-promotion programs for the large number of older adults in the United States. Objective: This study presents the development of the intervention and trial protocol of iCanFit 2.0, a multi-level, mobile-enabled, physical activity-promotion program developed for overweight older adults in primary care settings. Methods: The iCanFit 2.0 program was developed based on our prior mHealth intervention programs, qualitative interviews with older patients in a primary care clinic, and iterative discussions with key stakeholders. We will test the efficacy of iCanFit 2.0 through a cluster randomized controlled trial in six pairs of primary care clinics. Results: The proposed protocol received a high score in a National Institutes of Health review, but was not funded due to limited funding sources. We are seeking other funding sources to conduct the project. Conclusions: The iCanFit 2.0 program is one of the first multi-level, mobile-enabled, physical activity-promotion programs for older adults in a primary care setting. The development process has actively involved older patients and other key stakeholders. The patients, primary care providers, health coaches, and family and friends were engaged in the program using a low-cost, off-the-shelf mobile tool. Such low-cost, multi-level programs can potentially address the high prevalence of physical inactivity in older adults.

  • Transportation through the corridor of the operating theater in virtual reality. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2017/9/e174/; License: Creative Commons Attribution (CC-BY).

    Development of a Virtual Reality Exposure Tool as Psychological Preparation for Elective Pediatric Day Care Surgery: Methodological Approach for a...

    Abstract:

    Background: Preoperative anxiety in children is highly prevalent and is associated with adverse outcomes. Existing psychosocial interventions to reduce preoperative anxiety are often aimed at distraction and are of limited efficacy. Gradual exposure is a far more effective way to reduce anxiety. Virtual reality (VR) provides a unique opportunity to gradually expose children to all aspects of the operating theater. Objective: The aims of our study are (1) to develop a virtual reality exposure (VRE) tool to prepare children psychologically for surgery; and (2) to examine the efficacy of the VRE tool in a randomized controlled trial (RCT), in which VRE will be compared to care as usual (CAU). Methods: The VRE tool is highly realistic and resembles the operating room environment accurately. With this tool, children will not only be able to explore the operating room environment, but also get accustomed to general anesthesia procedures. The PREoperative Virtual reality Intervention to Enhance Wellbeing (PREVIEW) study will be conducted. In this single-blinded RCT, 200 consecutive patients (aged 4 to 12 years) undergoing elective day care surgery for dental, oral, or ear-nose-throat problems, will be randomly allocated to the preoperative VRE intervention or CAU. The primary outcome is change in child state anxiety level between baseline and induction of anesthesia. Secondary outcome measures include child’s postoperative anxiety, emergence delirium, postoperative pain, use of analgesics, health care use, and pre- and postoperative parental anxiety. Results: The VRE tool has been developed. Participant recruitment began March 2017 and is expected to be completed by September 2018. Conclusions: To our knowledge, this is the first RCT evaluating the effect of a VRE tool to prepare children for surgery. The VRE intervention is expected to significantly diminish preoperative anxiety, postoperative pain, and the use of postoperative analgesics in pediatric patients. The tool could create a less stressful experience for both children and their parents, in line with the modern emphasis on patient- and family-centered care. Trial Registration: Netherlands Trial Registry: NTR6116; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6116 (Archived by WebCite at http://www.webcitation.org/6ryke7aep)

  • Source: Pixabay; Copyright: Gerd Altmann; URL: https://pixabay.com/photo-513530/; License: Public Domain (CC0).

    Influence of Fear of Pain and Coping Strategies on Health-Related Quality of Life and Patient-Anticipated Outcomes in Patients With Chronic Pain:...

    Abstract:

    Background: Fear of pain and coping strategies are emotional-behavioral responses to pain and are known to play an important role in the development and maintenance of pain. It is highly likely that fear of pain and coping strategies influence each other, potentially affecting the course of chronic pain. To our knowledge, the relationship between pain, fear of pain and coping strategies, and how they influence patient-anticipated outcomes and health-related quality of life, have not been investigated. Objective: The aims of this study are to test (1) if both fear of pain and/or coping strategies are sufficient causes for maintaining pain; and (2) whether fear of pain influences coping strategies and pain intensity. The study will also examine the impact of fear of pain and coping strategies on health-related quality of life and patient-anticipated outcomes. Methods: The cross-sectional study will be conducted using an online survey. The Fear of Pain Questionnaire-III (FPQ-III), the Brief Coping Inventory (COPE), and EuroQoL-5d (EQ-5D) validated questionnaires will be used to collect data. Information pertaining to demographic factors, pain-related factors, and patient-anticipated outcomes will also be collected. The study has ethics approval from the Human Research Ethics Committee of the University of Adelaide. Study participants will be individuals aged 18 years and above who are experiencing chronic pain (ie, pain lasting more than 6 months). Effect measure modification technique (EMMM) will be used to examine if fear of pain acts as a moderator or mediator between coping strategies and pain. Simple and multinomial logistic regression analysis will be used to examine the effect of fear of pain and coping strategies on health-related quality of life and patient-anticipated outcomes. Results: Recruitment began July 2017 and it is anticipated that data collection will be completed by October 2017. Findings from this study will help to extend our understanding of fear of pain and coping strategies, their interaction, and their impact on health-related quality of life and patient-anticipated outcomes. Conclusions: Fear of pain and coping strategies have significant influence on the experience of chronic pain and its course. This study will help enhance our understanding of the relationship between fear of pain and coping strategies, which may help in developing patient-centered care practices.

  • Source: Flickr; Copyright: Quinn Dombrowski; URL: https://www.flickr.com/photos/53326337@N00/5646117488; License: Creative Commons Attribution + ShareAlike (CC-BY-SA).

    Protocol for Usability Testing and Validation of the ISO Draft International Standard 19223 for Lung Ventilators

    Abstract:

    Background: Clinicians, such as respiratory therapists and physicians, are often required to set up pieces of medical equipment that use inconsistent terminology. Current lung ventilator terminology that is used by different manufacturers contributes to the risk of usage errors, and in turn the risk of ventilator-associated lung injuries and other conditions. Human factors and communication issues are often associated with ventilator-related sentinel events, and inconsistent ventilator terminology compounds these issues. This paper describes our proposed protocol, which will be implemented at the University of Waterloo, Canada when this project is externally funded. Objective: We propose to determine whether a standardized vocabulary improves the ease of use, safety, and utility as it relates to the usability of medical devices, compared to legacy medical devices from multiple manufacturers, which use different terms. Methods: We hypothesize that usage errors by clinicians will be lower when standardization is consistently applied by all manufacturers. The proposed study will experimentally examine the impact of standardized nomenclature on performance declines in the use of an unfamiliar ventilator product in clinically relevant scenarios. Participants will be respiratory therapy practitioners and trainees, and we propose studying approximately 60 participants. Results: The work reported here is in the proposal phase. Once the protocol is implemented, we will report the results in a follow-up paper. Conclusions: The proposed study will help us better understand the effects of standardization on medical device usability. The study will also help identify any terms in the International Organization for Standardization (ISO) Draft International Standard (DIS) 19223 that may be associated with recurrent errors. Amendments to the standard will be proposed if recurrent errors are identified. This report contributes a protocol that can be used to assess the effect of standardization in any given domain that involves equipment, multiple manufacturers, inconsistent vocabulary, symbology, audio tones, or patterns in interface navigation. Second, the protocol can be used to experimentally evaluate the ISO DIS 19223 for its effectiveness, as researchers around the world may wish to conduct such tests and compare results.

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  • Treatment of low back pain with a mobile health app: a digital multidisciplinary pain treatment tool reveals significant pain reduction in a short-term follow-up

    Date Submitted: Sep 25, 2017

    Open Peer Review Period: Sep 25, 2017 - Oct 9, 2017

    Background: Even though modern concepts of disease management of unspecific low back pain (LBP) postulate active participation of patients, this strategy is difficult to adapt unless multidisciplinary...

    Background: Even though modern concepts of disease management of unspecific low back pain (LBP) postulate active participation of patients, this strategy is difficult to adapt unless multidisciplinary pain therapy is applied. Recently, mhealth solutions have proven to be effective aides to foster self-management of many diseases. Objective: Here we report on retrospective short-term results of a digital multidisciplinary pain app for the treatment of low back pain. Methods: Kaia is a mobile app that digitalizes multidisciplinary pain treatment and is in the market as a medical product class I. For the current study, we retrospectively analyzed the data of anonymized Kaia users. User data were evaluated for 12 weeks regarding duration of use and effect on in-app user reported pain levels (NRS) depending on whether LBP was classified as acute, subacute or chronic back pain according to current guidelines. Results: Overall, data of 180 users were available. Mean age of the users was 33.9 years (SD=10.9). Pain levels decreased from baseline (BL) NRS 4.8 to 3.75 for all users at the end of the observation period. Users who completed 4, 8 or 12 weeks respectively showed an even more pronounced decrease in pain level NRS (BL 4.9 ± 1.7 vs 3.6 ± 1,5 at 4 weeks; BL 4.7 ± 1.8 vs 3.2 at 8 weeks; BL 4.6 ± 2.2 vs 2.6 ± 2.0 at 12 weeks). In addition, subgroup analysis of acute, subacute or chronic classification revealed no significant main effect of group (p> .30) on the reduction of pain. Conclusions: The current retrospective analysis shows that in a pre-selected population of app users, an app digitalizing multidisciplinary rehabilitation for the self-management of LBP reduces pain levels significantly. This effect increases if users adhere to the program for longer periods. The results of this retrospective observation of user data are currently validated in a prospective RCT- trial to adjust for potential bias and also address other outcomes like mobility, functionality or psychometric measures.

  • Effects of Drug Interventions with Combined Oral Contraceptives on the hypothalamic–pituitary–gonadal axis in patients with polycystic ovary syndrome: Protocol for systematic review and meta-analysis

    Date Submitted: Sep 22, 2017

    Open Peer Review Period: Sep 23, 2017 - Oct 4, 2017

    Background: Selection of combined oral contraceptives (COCs) with maximum antiandrogenic effects is one the most important issues in treatment of patients with polycystic ovary syndrome (PCOS). Object...

    Background: Selection of combined oral contraceptives (COCs) with maximum antiandrogenic effects is one the most important issues in treatment of patients with polycystic ovary syndrome (PCOS). Objective: This systematic review and meta-analysis protocol aimed to compare the effects of COCs containing progestins with low androgenic and antiandrogenic activities on the hypothalamic–pituitary–gonadal (HPG) axis in patients with PCOS. Methods: We searched PubMed, Scopus, Google Scholar, ScienceDirect, and Web of Science databases (1980–2017) to identify randomized clinical trials (RCTs) or non-randomized studies (NRS) investigating the effect of COCs containing progestins with low androgenic and antiandrogenic activities including products containing desogestrel (DSG), cyproterone acetate (CA) and drospirenone (DRSP) on the HPG axis in patients with PCOS. In this meta-analysis, fixed and random effect models were used. Outcomes interested were follicle stimulating hormone (FSH), luteinizing hormone (LH), LH to FSH ratio, estradiol (E2), total testosterone (TT) and sex hormone-binding globulin (SHBG). Potential sources of heterogeneity were investigated using meta-regression and subgroup analyses. Subgroup analyses were performed based on used progestin compound and treatment duration. We assessed quality of included studies and their risk of bias using Cochrane guidelines. Publication bias were assessed using Egger’s test and Funnel plot. Results: COC use was significantly associated with a decrease in gonadotropin levels including FSH and LH. Use of products containing CA was associated with a decrease in FSH after 3 months (WMD= -0.48; 95% CI: -0.81, -0.15), 6 months (WMD = -2.33; 95% CI: -3.48, -1.18) and 12 months (WMD = -4.70; 95% CI: -4.98, -4.42) and LH levels after 3 months (WMD = -3.57; 95% CI: -5.14, -1.99), after 6 months (WMD = -5.68; 95% CI: -9.57, -1.80), and after 12 months (WMD = -11.60; 95% CI: -17.60, -5.60). COCs containing DRSP for 6 months decreased FSH (WMD = -0.93; 95% CI: -1.79, -0.08) and LH (WMD = -4.59; 95% CI: -7.53, -1.66). Data for products containing desogestrel were few, but this compound generally had no influence on gonadotropin levels similar to that observed with COCs containing CA and DRSP. Use of COCs was not associated with any significant change in LH to FSH ratio. COCs containing CA showed maximum effect on gonadotropin suppression. COCs containing CA significantly decreased E2 concentrations, whereas those containing DRSP exhibited no such effect. All COCs demonstrated improvement in androgenic profile and had the same effects on TT and SHBG concentrations. Progestin compound and treatment duration had no important effects on changing TT and SHBG levels. Conclusions: COCs containing progestins with low androgenic and antiandrogenic activities can suppress gonadotropins, leading to a decrease in androgenic profiles in women with PCOS. All studied COCs showed the same effects on androgenic profile, whereas products containing CA had maximum effects in suppressing gonadotropin and E2 levels.

  • Physical trauma patients with symptoms of an acute and post-traumatic stress disorder: an observational prospective cohort study

    Date Submitted: Sep 20, 2017

    Open Peer Review Period: Sep 23, 2017 - Oct 7, 2017

    Background: Injury, medical treatment and rehabilitation can have a major impact on patients’ wellbeing. About 25-33% of the patients experience an acute (ASD) or post-traumatic stress disorder (PTS...

    Background: Injury, medical treatment and rehabilitation can have a major impact on patients’ wellbeing. About 25-33% of the patients experience an acute (ASD) or post-traumatic stress disorder (PTSD) after injury. ASD is a relatively new diagnosis. Therefore, knowledge about patients’ experiences, the course and who is at risk for developing ASD or PTSD is lacking. Objective: The aims of this multi-method study are to explore patients’ experiences with injury (care) using a focus group study. Then, in the observational study (possible) different courses of ASD, PTSD, and quality of life (QOL) will be examined. In addition, this study will examine if these courses could be characterized by socio-demographic, clinical, and psychological variables. Consequently, a risk profile will be developed to determine which patients are at risk for developing ASD and/or PTSD during 12 months after injury. Methods: Trauma patients treated in the shock room (2015) of the Elisabeth-TweeSteden Hospital will share their experiences with injury in the focus group study. Open, axial, and selective coding will be used to analyze the data. Concerning the observational study, patients treated in the shock room (during 2016 and 2017, Elisabeth-TweeSteden Hospital and Erasmus Medical Centre) will be asked to participate. The inclusion period is 12 months. Participants will complete the Impact of Event Scale-Revised, MINI-plus, the Hospital Anxiety and Depression Scale, and the World Health Organization Quality of Life-BREF after inclusion and at 3, 6, 9, and 12 months after injury. The NEO-Five Factor Inventory and the State-Trait Anxiety Inventory-Trait are completed after inclusion only. Repeated measures latent class analysis and linear mixed models repeated measures will be used to examine the research aims. Results: This project was funded in August 2015 by ZonMW. The results of the focus group study are expected in the first trimester of 2018. With regard to the observational study, recruitment is currently underway. Data collection will be completed in November 2018. Then, the first results will be expected in the first trimester of 2019. Conclusions: This is the first multi-method study in trauma patients that examines patients’ experiences (qualitative design) as well as psychological disorders (observational prospective). This study will contribute to the need for information on psychological consequences after injury. Moreover, it provides knowledge about which patients to include in future psychological intervention research. Finally, awareness in clinicians about the psychological consequences can be created, so they are able to act more effective to provide patient-oriented care. Clinical Trial: NTR6258

  • Protocol for a systematic review of substance use prevention programs for Indigenous adolescents in the United States of America, Canada, Australia and New Zealand

    Date Submitted: Sep 20, 2017

    Open Peer Review Period: Sep 21, 2017 - Oct 5, 2017

    Indigenous adolescents are at higher risk of experiencing harms related to substance use, compared to their non-Indigenous counterparts as a consequence of earlier onset and higher rates of substance...

    Indigenous adolescents are at higher risk of experiencing harms related to substance use, compared to their non-Indigenous counterparts as a consequence of earlier onset and higher rates of substance use. Early onset of substance use has been identified as a risk factor for future substance use problems and other health, social and family outcomes. Therefore, prevention of substance use among adolescents has been identified as a key area to improve Indigenous health. Evidence exists for the effectiveness of substance use prevention approaches for adolescents in mainstream populations and most recently, for the use of computer- and internet-delivered interventions to overcome barriers to implementation. However, there is currently no conclusive evidence about the effectiveness of these approaches for Indigenous adolescents. The purpose of this review is to synthesize the international evidence regarding the effectiveness of substance use prevention programs for Indigenous adolescents in the United States of America, Canada, Australia and New Zealand. Eight peer-reviewed databases will be searched, using search terms in line with the aims of this review and based on previous relevant reviews of substance use prevention. Studies will be included if they evaluate a substance use prevention program with Indigenous adolescents (aged 10 to 19) as the primary participant group and are published between 1 January 1990 and 31 August 2017. A narrative synthesis will be provided about the effectiveness of the programs, the type of program (whether cultural-based, adapted or unadapted), delivery of program (computer- and internet-delivered or traditional) and the setting in which the programs are delivered (community, school, family or a combination). The study will identify core elements of effective substance use prevention programs among Indigenous adolescents and appraise the methodological quality of the studies. This review will provide researchers, policy makers and program developers with evidence about the potential use of prevention approaches for Indigenous adolescents.

  • National Food, Nutrition and Physical Activity Survey of the Portuguese general population, 2015-2016: Design and methods

    Date Submitted: Sep 18, 2017

    Open Peer Review Period: Sep 20, 2017 - Oct 4, 2017

    The National Food, Nutrition and Physical Activity Survey, 2015-2016 aimed to collect national and regional data on dietary habits and physical activity, and to evaluate their relation with health det...

    The National Food, Nutrition and Physical Activity Survey, 2015-2016 aimed to collect national and regional data on dietary habits and physical activity, and to evaluate their relation with health determinants. Data were collected in a representative sample of the Portuguese general population (3 months to 84 years), by multistage sampling, and harmonized according to European guidelines/methodologies. An electronic platform was developed to manage the field work and to assist data collection by using Computer-assisted personal interviewing and includes the ‘eAT24’ module for dietary data collection by 24-hour recalls (two non-consecutive, 8-15 days apart) or food diaries in the case of children <10 years-old, synchronized with nutritional composition data and considering the FoodEx2 classification system; the ‘MOVE’ module for physical activity data (including the International Physical Activity Questionnaire, the Activity Choice Index, and 4-days physical activity diaries); and the ‘You’ module to collect sociodemographic and other health-related data. The results will assist policy planning and management of national health programs on the improvement of nutritional status and risk assessment related with food hazards, and the enhancement of physical activity. The infrastructures and data driven are a solid basis to the development of a future surveillance system reproducible over time.

  • Multicenter Study on the Burden of Illness of Oral Side Effects from Conditioning Therapy Before Stem Cell Transplantation “Ora-Stem Study”

    Date Submitted: Sep 15, 2017

    Open Peer Review Period: Sep 17, 2017 - Oct 1, 2017

    Background: The oral cavity is a common site of complications related to the cytotoxic effect of high-dose chemotherapy and radiation therapy. Considering our limited understanding of the burden of i...

    Background: The oral cavity is a common site of complications related to the cytotoxic effect of high-dose chemotherapy and radiation therapy. Considering our limited understanding of the burden of illness in the oral cavity from various cytotoxic therapies, it is difficult to produce evidence-based, preventive and management protocols. A prospective multicenter study is necessary to collect data on the burden of illness from various cytotoxic regimens. Objective: The objectives of this prospective international observational multicenter study in hematopoi-etic stem cell transplant (HSCT) patients are to establish the nature, incidence and temporal re-lationship of oral complications related to conditioning regimens (chemotherapy with or with-out total body irradiation-TBI), stem cell transplantation and the immunologic reactions (main-ly GVHD) that may follow, and to determine what subjective and objective oral complica-tions related to treatment can predict negative clinical and economic outcomes and reduced quality of life (QoL). Methods: Adult patients at six study sites receiving full intensity conditioning (FIC), reduced intensity conditioning (RIC) or non-myeloablative conditioning (NMA), followed by autologous or al-logeneic hematopoietic stem cell infusion, are included. A pre-treatment assessment includes medical conditions, planned chemo- and radiation therapy regimen, medications, allergies, so-cial history, patient report of oral problems, dental history, subjective oral complaints, objec-tive measures of oral conditions, current laboratory values, dental treatment recommended and untreated dental disease. Starting 1-3 days after hematopoietic stem cell infusion, a bedside assessment is completed 3 days/week until resolution of neutropenia. A patient questionnaire is also completed during hospitalization. Beyond this time, patients with continued oral mu-cositis or other oral problems are followed 1 day/week in an inpatient or outpatient setting. Additional visits for urgent care for acute oral problems after hospitalization are documented. Autologous transplant patients are being followed up at 100 days ±30 days and at 1 year ±30 days post-transplantation to identify any long-term side effects. Patients treated with alloge-neic transplantation are being followed at 100 days ±30 days, 6 months ±30 days, and 12 months ±30 days. The follow-up assessments include cancer response to therapy, current med-ical conditions, medications, subjective and objective oral findings, QoL measures and labora-tory values. Results: A total of 211 participants have been enrolled. We anticipate enrollment of 109 additional par-ticipants to obtain the sample size of 320. Conclusions: The results of the ongoing prospective study will provide a unique dataset to understand the impact of oral complications on patients undergoing HSCT and provide needed information with forming more evidence-based guidelines regarding the management of this patient co-hort.

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