JMIR Research Protocols

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

Can internet-based sexual health services increase diagnoses of sexually transmitted infections? Evaluation of an internet-based sexual health service.

Background: Sexually transmitted infections (STIs) are an important cause of morbidity and mortality worldwide, and a key indicator of sexual ill health. In England, 448,422 new STI diagnoses were made in 2012, with higher rates recorded among young heterosexuals, men who have sex with men and some black and ethnic minority groups . Importantly, the patterning of STIs reflects stark health inequalities. Internet based STI testing is considered a promising means for increasing access to sexual health services and reaching at-risk groups . Yet to our knowledge there have been no experimental studies to demonstrate the effectiveness of internet-based testing compared to standard face-to-face clinical pathways. Observational studies have been encouraging, reporting high STI positivity among users of internet based services and reaching populations with a combination of both socio-demographic and behavioural risk factors. Sexual Health 24 (SH:24) is an innovative internet-based sexual health service that aims to improve access to sexual health services in the London boroughs of Southwark and Lambeth. In early 2015, SH:24 will launch its first online product (minimal viable product 1) - an online STI testing service allowing users to order free postal STI kits, receive their results by text message or phone (HIV only), and if positive, be referred on to specialist sexual health clinics for treatment. This study aims to establish whether the MvP1 delivers an effective service compared to face-to-face sexual health services, thus contributing to the international evidence base in this field. Objective: - To report the intervention effects on the proportion of participants diagnosed with at least one STI at 6 weeks from randomisation - To report the intervention effects on uptake of STI testing at 6 weeks from randomisation Methods: A pragmatic randomised controlled trial which will allow us to assess the effectiveness of internet based testing compared to a conventional sexual health information website with signposting to clinic-based services. Participants will be randomly allocated: • either to a sexual health website (SH:24) offering postal STI kits, results via text message or by phone (HIV only), and clinic-based treatment options; • or to a website with information on local clinic-based sexual health services. The main analyses will the compare the proportion of participants diagnosed with at least one STI in each arm on an intention to treat basis. A sample of 3000 participants will have 90% power (two-sided alpha=5%) to detect a relative risk of 3.5, assuming a 2.1% risk of STI diagnosis in the intervention group and a 0.6% risk in the control group, allowing for 10% losses to follow up. Clinical Trial: Current Controlled Trials ISRCTN13354298 (registration date: 21 November 2014)

2014-11-06

The year 2014 comes to an end - have you published enough in 2014 to keep your career moving ahead?

Add another paper to your 2014 publication list by publishing a grant proposal or protocol of your ongoing or planned research in our PubMed-indexed journal JMIR Res Protoc:

  • submit your protocol/proposal of your ongoing study to JMIR Res Protoc before Nov 15th, 2014, and if it is already reviewed/approved by your granting agency (attach review reports), WE GUARANTEE ACCEPTANCE/PUBLICATION BEFORE DEC 31, 2014, with FAST-TRACK FEES WAIVED (APF for already peer-reviewed proposals/protocols is $950)
  • NO SUBMISSION FEES for articles submitted to JMIR Res Protoc between Nov 6th-15th, 2014 (UPDATE: We now decided to permanently suspend submission fees for JMIR Res Protoc!)
  • for all studies published in JMIR Res Protoc, we offer a 20% discount on the APF if the subsequent full study results are published in a JMIR journal (this is a $490 value)
  • while many JMIR Res Protoc papers are from the field of ehealth, we publish protocols from all areas of medicine and health research, including wet lab science, systematic review protocols, clinical randomized trial protocols, qualitative study protocols, formative research such as usability studies etc.

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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: 4.7)
  • 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:

  • Symptoms and activity tracking.

    Improving Outcomes in Cancer Patients on Oral Anti-Cancer Medications Using a Novel Mobile Phone-Based Intervention: Study Design of a Randomized Controlled...

    Abstract:

    Background: The widespread and increasing use of oral anti-cancer medications has been ushered in by a rapidly increasing understanding of cancer pathophysiology. Furthermore, their popular ease of administration and potential cost savings has highlighted their central position in the health care system as a whole. These facts have heightened appreciation of the unique challenges associated with the use of oral anti-cancer medications; especially in the long-term use of these medications and the associated side effects that may impede optimal adherence to their use. Therefore, we developed ChemOtheRapy Assistant, CORA, a personalized mobile phone–based self-management application to help cancer patients on oral anti-cancer medications. Objective: Our objective is to evaluate the effect of CORA on adherence to oral anti-cancer medications and other clinically relevant outcomes in the management of patients with renal and prostate cancer. Methods: The study will be implemented as a 2-parallel group randomized controlled trial in 104 patients with renal or prostate cancer on oral anti-cancer medications over a 3-month study period. The intervention group will use CORA in addition to usual care for self-management while the control group will continue care as usual. Medication adherence will be measured objectively by a Medication Event Monitoring System device and is defined as the percentage of prescribed doses taken. We will also assess the effect of the intervention on cancer-related symptoms measured by the MD Anderson Symptom Inventory and unplanned hospital utilizations. Other outcomes that will be measured at study start, midpoint, and endpoint are health-related quality of life, cancer-related fatigue, and anxiety. Group differences in medication adherence will be examined by t tests or by non-parametric Mann-Whitney tests if the data are not normally distributed. Logistic regression will be used to identify potential predictors of adherence. Results: We expect to have results for this study before the end of 2016. Conclusions: This novel mobile phone–enabled, multimodal self-management and educational intervention could lead to improvements in clinical outcomes and serve as a foundation for future mHealth research in improving outcomes for patients on oral anti-cancer medications.

  • Lupus erythematosus. Image source: Fox, George Henry (1886) Photographic illustrations of skin diseases, E.B. Treat (copyright expired). http://commons.wikimedia.org/wiki/File:Lupus_erythematosus.jpg.

    Toward the Development of a Lupus Interactive Navigator to Facilitate Patients and Their Health Care Providers in the Management of Lupus: Results of...

    Abstract:

    Background: Systemic lupus erythematosus is an inflammatory autoimmune disease associated with high morbidity and unacceptable mortality. Information and management tools are needed to help persons with lupus cope with their illness and facilitate health care providers in the delivery of care. Objective: The objective of the study was to assess the needs and find solutions to support persons with lupus and their health care providers. Methods: Web-based surveys were distributed across Canada to persons with lupus and their relatives (n=3119), rheumatologists (n=517), and arthritis health professionals (AHPs) (n=226) by Lupus Canada, the Canadian Rheumatology Association, and the Arthritis Health Professions Association, respectively. Results: The survey sample comprised 665 (21.3%) persons with lupus, 98 (19.0%) rheumatologists, and 74 (32.7%) AHPs. Among the participants with lupus, 92.4% were female, the average age was 46.8 (SD 12.7) years, 79.2% were Caucasian, and 58.8% were employed. All Canadian provinces and territories were represented. The majority (43.3%) of respondents were from Ontario. Mean disease duration was 10.2 (SD 9.5) years, and 41.9% rated their global assessment as fair or poor. There was high agreement between lupus participants and health care providers regarding disease-specific information topics. All groups rated topics related to lupus, fatigue, medications, and stress as most important. Ratings differed among lupus participants and their health care providers regarding perceived helpfulness of some of the patient tools, such as the option to view test results. Needs differed for persons with lupus based on age, sex, depression, stress, and disease activity. Differences in health care provider needs were based on amount of experience in treating lupus. Conclusions: Information and support tools needed for persons with lupus and their health care providers were identified. These results will help guide us in the development of a Web-based Lupus Interactive Navigator as an intervention tool to help persons with lupus self-manage their disease and to facilitate heath care providers in clinical management.

  • The EU cover of the Wii Fit bundle. (c) Nintendo Assets Library, fair use.

    A Telehealth Intervention Using Nintendo Wii Fit Balance Boards and iPads to Improve Walking in Older Adults With Lower Limb Amputation (Wii.n.Walk): Study...

    Abstract:

    Background: The number of older adults living with lower limb amputation (LLA) who require rehabilitation for improving their walking capacity and mobility is growing. Existing rehabilitation practices frequently fail to meet this demand. Nintendo Wii Fit may be a valuable tool to enable rehabilitation interventions. Based on pilot studies, we have developed “Wii.n.Walk”, an in-home telehealth Wii Fit intervention targeted to improve walking capacity in older adults with LLA. Objective: The objective of this study is to determine whether the Wii.n.Walk intervention enhances walking capacity compared to an attention control group. Methods: This project is a multi-site (Vancouver BC, London ON), parallel, evaluator-blind randomized controlled trial. Participants include community-dwelling older adults over the age of 50 years with unilateral transtibial or transfemoral amputation. Participants will be stratified by site and block randomized in triplets to either the Wii.n.Walk intervention or an attention control group employing the Wii Big Brain cognitive software. This trial will include both supervised and unsupervised phases. During the supervised phase, both groups will receive 40-minute sessions of supervised group training three times per week for a duration of 4 weeks. Participants will complete the first week of the intervention in groups of three at their local rehabilitation center with a trainer. The remaining 3 weeks will take place at participants’ homes using remote supervision by the trainer using Apple iPad technology. At the end of 4 weeks, the supervised period will end and the unsupervised period will begin. Participants will retain the Wii console and be encouraged to continue using the program for an additional 4 weeks’ duration. The primary outcome measure will be the “Two-Minute Walk Test” to measure walking capacity. Outcome measures will be evaluated for all participants at baseline, after the end of both the supervised and unsupervised phases, and after 1-year follow up. Results: Study staff have been hired and trained at both sites and recruitment is currently underway. No participants have been enrolled yet. Conclusions: Wii.n.Walk is a promising in-home telehealth intervention that may have useful applications for older adults with LLA who are discharged from rehabilitation or live in remote areas having limited or no access to existing rehabilitation programs. Trial Registration: Clinicaltrial.gov NCT01942798; http://clinicaltrials.gov/ct2/show/NCT01942798 (Archived by WebCite at http://www.webcitation.org/6V0w8baKP).

  • An example of the current iteration of the Results page (cropped Multimedia Appendix 1).

    Development and Validation of a Personalized, Web-Based Decision Aid for Lung Cancer Screening Using Mixed Methods: A Study Protocol

    Abstract:

    Background: The National Lung Screening Trial demonstrated that low-dose computed tomography (LDCT) screening could be an effective way to reduce lung cancer mortality. Informed decision-making in the context of lung cancer screening requires that potential screening subjects accurately recognize their own lung cancer risk, as well as the harms and benefits associated with screening, while taking into account their personal values and preferences. Objective: Our objective is to develop a Web-based decision aid in accordance with the qualifying and certification criteria in the International Patient Decision Aid Standards instrument version 4.0 that will assist patients in making informed decisions with regard to lung cancer screening. Methods: In “alpha” testing, a prototype of the decision aid was tested for usability with 10 potential screening participants in focus groups. Feedback was also sought from public health and health risk communication experts external to the study. Following that, improvements to the prototype were made accordingly, and “beta” testing was done in the form of a quasi-experimental design—a before-after study—with a group of 60 participants. Outcomes tested were knowledge, risk perception of lung cancer and lung cancer screening, decisional conflict, and acceptability of the decision aid as determined by means of a self-administered electronic survey. Focus groups of a subsample of survey participants will be conducted to gain further insight into usability issues. Results: Alpha testing is completed. Beta testing is currently being carried out. As of 2014 December 7, 60 participants had completed the before-after study. We expect to have results by 2015 January 31. Qualitative data collection and analysis are expected to be completed by 2015 May 31. Conclusions: We hypothesize that this Web-based, interactive decision aid containing personalized, graphical, and contextual information on the benefits and harms of LDCT screening will increase knowledge, reduce decisional conflict, and improve concordance between patient preferences and the current US Preventive Services Task Force’s screening guidelines.

  • Hands-on ultrasound training of Ghanaian midwives by US-based registered diagnostic medical sonographer. Licensed under Creative Commons Attribution, please cite the JMIR article.

    Gestational Age Assessment in the Ghana Randomized Air Pollution and Health Study (GRAPHS): Ultrasound Capacity Building, Fetal Biometry Protocol...

    Abstract:

    Background: Four million premature deaths occur yearly as a result of smoke from cooking fires. The Ghana Randomized Air Pollution and Health Study (GRAPHS) is underway in the Kintampo North municipality and South district of rural Ghana to evaluate the impact of improved cook stoves introduced during pregnancy on birth weight and childhood pneumonia. These hypotheses are being tested in a cluster-randomized intervention trial among 1415 maternal-infant pairs within 35 communities assigned to a control arm (traditional cooking) or one of two intervention arms (cooking with an improved biomass stove; cooking with liquefied petroleum gas stoves). Objective: The trial is designed to ensure delivery of the stove intervention prior to the period of maximal fetal growth. To answer questions about the impact of household air pollution on pregnancy outcome, accurate gestational age assessment is critical. This manuscript describes in detail the development of the gestational dating protocol, intensive ultrasound training involved, ultrasound capacity building, and ultrasound quality control program. Methods: Ultrasound training occurred in several phases over the course of 2 years. Training included a basic obstetric ultrasound course offered to all midwives performing antenatal care at the two study hospitals, followed by a more intense period of hands-on training focused on fetal biometry for a select group of providers demonstrating aptitude in the basic course. A standard operating procedure was developed describing how to obtain all fetal biometric measurements. Consensus was obtained on how biometric images are used in the trial to establish gestational age and estimate the delivery date. An ongoing ultrasound quality control program including the use of an image scorecard was also designed. Results: Publication of trial results is anticipated in late 2016. Conclusions: Use of ultrasound should be strongly considered in field-based trials involving pregnant women to accurately establish gestational age, as menstrual dates may be incorrect or unknown. The inclusion of ultrasound in areas where ultrasound capacity does not previously exist requires a significant investment of time and resources. Such investment ensures appropriate training, high quality images, and accurate dating pregnancies. We outline our ultrasound training, image acquisition, quality control, and dating protocols in detail. Trial Registration: Clinicaltrials.gov NCT01335490; http://clinicaltrials.gov/ct2/show/NCT01335490 (Archived by WebCite at http://www.webcitation.org/6UbERJNO6).

  • Diabetes Connect conceptual model.

    “Real-World” Practical Evaluation Strategies: A Review of Telehealth Evaluation

    Abstract:

    Background: Currently, the increasing interest in telehealth and significant technological breakthroughs of the past decade create favorable conditions for the widespread adoption of telehealth services. Therefore, expectations are high that telehealth can help alleviate prevailing challenges in health care delivery. However, in order to translate current research to policy and facilitate adoption by patients and health care providers, there is need for compelling evidence of the effectiveness of telehealth interventions. Such evidence is gathered from rigorously designed research studies, which may not always be practical in many real-world settings. Objective: Our aim was to summarize current telehealth evaluation strategies and challenges and to outline practical approaches to conduct evaluation in real-world settings using one of our previously reported telehealth initiatives, the Diabetes Connect program, as a case study. Methods: We reviewed commonly used current evaluation frameworks and strategies, as well as best practices based on successful evaluative efforts to date to address commonly encountered challenges in telehealth evaluation. These challenges in telehealth evaluation and commonly used frameworks are described relevant to the evaluation of Diabetes Connect, a 12-month Web-based blood glucose monitoring program. Results: Designers of telehealth evaluation frameworks must give careful consideration to the elements of planning, implementation, and impact assessment of interventions. Evaluating performance at each of these phases is critical to the overall success of an intervention. Although impact assessment occurs at the end of a program, our review shows that it should begin at the point of problem definition. Critical to the success of an evaluative strategy is early planning that involves all stakeholders to identify the overall goals of the program and key measures of success at each phase of the program life cycle. This strategy should enable selection of an appropriate evaluation strategy and measures to aid in the ongoing development and implementation of telehealth and provide better evidence of program impact. Conclusions: We recommend a pragmatic, multi-method, multi-phase approach to telehealth evaluation that is flexible and can be adapted to the characteristics and challenges unique to each telehealth program.

  • Cropped Figure 2. ePAL Mobile Application. Welcome page with educational tip.

    Pain Management in Cancer Patients Using a Mobile App: Study Design of a Randomized Controlled Trial

    Abstract:

    Background: Despite the availability of effective medications and clinical guidelines for pain management, pain control is suboptimal in a sizeable proportion of patients with cancer pain. The National Comprehensive Cancer Network guidelines recommend a comprehensive and multimodal approach for management of cancer pain. We developed a mobile phone application, ePAL, based on clinical guidelines to empower patients for cancer pain management by prompting regular pain assessments and coaching for self-management. Objective: The objective of this study is to evaluate the effect of a multidimensional mobile phone-based pain management application, ePAL, on controlling cancer pain and improving quality of life in patients with cancer pain being treated at an academic palliative care clinic. Methods: The study will be implemented as a 2-arm randomized controlled trial with 110 adult patients with CP who own a mobile phone over a follow-up period of two months. Participants will be randomized to either the intervention group receiving ePAL and usual care or to a control group receiving only usual care. The brief pain inventory will be used to assess our primary outcome which is pain intensity. We will also evaluate the effect of the intervention on secondary outcomes which include the effect of the intervention on hospital utilization for pain crisis, quality of life, adherence to analgesic medications, barriers to pain control, anxiety and patient engagement. Instruments that will be used in evaluating secondary outcomes include the Brief Pain Inventory, Morisky Medication Adherence Scale, Barriers Questionnaire-II, Functional Assessment of Cancer Therapy–General, Edmonton Symptom Assessment System, Generalized Anxiety Disorder 7-item scale, and the Functional Assessment of Chronic Illness Therapy-Fatigue. The intention-to-treat approach will be used to evaluate outcomes. Our primary outcome, pain intensity, measured longitudinally over eight weeks, will be assessed by mixed model repeated analysis. Effect sizes will be calculated as mean group differences with standard deviations. Results: The study is still in progress. We hope to have results by the end of 2015. Conclusions: The multidimensional approach to pain management implemented on a mobile phone application could lead to significant improvements in patient outcomes. Trial Registration: ClinicalTrials.gov NCT02069743; https://clinicaltrials.gov/ct2/show/NCT02069743 (Archived by WebCite at http://www.webcitation.org/6Qb65XGGA).

  • Screenshot of a video provided to the patients (from Multimedia Appendix 2). © 2004-2014 Koninklijke Philips Electronics.

    Design and Usage of the HeartCycle Education and Coaching Program for Patients With Heart Failure

    Abstract:

    Background: Heart failure (HF) is common, and it is associated with high rates of hospital readmission and mortality. It is generally assumed that appropriate self-care can improve outcomes in patients with HF, but patient adherence to many self-care behaviors is poor. Objective: The objective of our study was to develop and test an intervention to increase self-care in patients with HF using a novel, online, automated education and coaching program. Methods: The online automated program was developed using a well-established, face-to-face, home-based cardiac rehabilitation approach. Education is tailored to the behaviors and knowledge of the individual patient, and the system supports patients in adopting self-care behaviors. Patients are guided through a goal-setting process that they conduct at their own pace through the support of the system, and they record their progress in an electronic diary such that the system can provide appropriate feedback. Only in challenging situations do HF nurses intervene to offer help. The program was evaluated in the HeartCycle study, a multicenter, observational trial with randomized components in which researchers investigated the ability of a third-generation telehealth system to enhance the management of patients with HF who had a recent (<60 days) admission to the hospital for symptoms or signs of HF (either new onset or recurrent) or were outpatients with persistent New York Heart Association (NYHA) functional class III/IV symptoms despite treatment with diuretic agents. The patients were enrolled from January 2012 through February 2013 at 3 hospital sites within the United Kingdom, Germany, and Spain. Results: Of 123 patients enrolled (mean age 66 years (SD 12), 66% NYHA III, 79% men), 50 patients (41%) reported that they were not physically active, 56 patients (46%) did not follow a low-salt diet, 6 patients (5%) did not restrict their fluid intake, and 6 patients (5%) did not take their medication as prescribed. About 80% of the patients who started the coaching program for physical activity and low-salt diet became adherent by achieving their personal goals for 2 consecutive weeks. After becoming adherent, 61% continued physical activity coaching, but only 36% continued low-salt diet coaching. Conclusions: The HeartCycle education and coaching program helped most nonadherent patients with HF to adopt recommended self-care behaviors. Automated coaching worked well for most patients who started the coaching program, and many patients who achieved their goals continued to use the program. For many patients who did not engage in the automated coaching program, their choice was appropriate rather than a failure of the program.

  • Reticulated erythematous-violaceous patches on the left foot and an ulcer in the left medial malleolus in a patient diagnosed with Livedoid Vasculopathy. Image from Tubone MQ1, Escobar GF1, Peruzzo J1, Schestatsky P2, Maldonado G1. Livedoid vasculopathy associated with peripheral neuropathy: a report of two cases. An Bras Dermatol. 2013 Nov-Dec;88(6 Suppl 1):227-9. Licensed under Creative Commons NonCommercial Attribution license.

    A Phase II Multicenter Trial With Rivaroxaban in the Treatment of Livedoid Vasculopathy Assessing Pain on a Visual Analog Scale

    Abstract:

    Background: Livedoid vasculopathy is an orphan skin disease characterized by recurrent thrombosis of the cutaneous microcirculation. It manifests itself almost exclusively in the ankles, the back of the feet, and the distal part of the lower legs. Because of the vascular occlusion, patients suffer from intense local ischemic pain. Incidence of livedoid vasculopathy is estimated to be around 1:100,000. There are currently no approved treatments for livedoid vasculopathy, making off-label therapy the only option. In Europe, thromboprophylactic treatment with low-molecular-weight heparins has become widely accepted. Objective: The aim of this trial is the statistical verification of the therapeutic effects of the anticoagulant rivaroxaban in patients suffering from livedoid vasculopathy. Methods: We performed a therapeutic phase IIa trial designed as a prospective, one-armed, multicenter, interventional series of cases with a calculated sample size of 20 patients. The primary outcome is the assessment of local pain on the visual analog scale (VAS) as an intraindividual difference of 2 values between baseline and 12 weeks. Results: Enrollment started in December 2012 and was still open at the date of submission. The study is expected to finish in November 2014. Conclusions: Livedoid vasculopathy is associated with increased thrombophilia in the cutaneous microcirculation and the continuous use of anticoagulants helps improve the symptoms. The causes of cutaneous infarctions are heterogenous, but ultimately follow the known mechanisms of the coagulation cascade. Rivaroxaban affects the coagulation cascade and inhibits the factor Xa–dependent conversion of prothrombin to thrombin, thereby considerably reducing the risk of thrombosis. Trial Registration: Trial Registration EudraCT Number: 2012-000108-13-DE; https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000108-13 (Archived by WebCite at http://www.webcitation.org/6UCktWVCA); German Clinical Trials Register (DRKS): DRKS00004652; https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00004652 (Archived by WebCite at http://www.webcitation.org/6UCIAKyCS).

  • Experimental design data (cropped Figure 2).

    Experimental Design to Evaluate Directed Adaptive Mutation in Mammalian Cells

    Abstract:

    Background: We describe the experimental design for a methodological approach to determine whether directed adaptive mutation occurs in mammalian cells. Identification of directed adaptive mutation would have profound practical significance for a wide variety of biomedical problems, including disease development and resistance to treatment. In adaptive mutation, the genetic or epigenetic change is not random; instead, the presence and type of selection influences the frequency and character of the mutation event. Adaptive mutation can contribute to the evolution of microbial pathogenesis, cancer, and drug resistance, and may become a focus of novel therapeutic interventions. Objective: Our experimental approach was designed to distinguish between 3 types of mutation: (1) random mutations that are independent of selective pressure, (2) undirected adaptive mutations that arise when selective pressure induces a general increase in the mutation rate, and (3) directed adaptive mutations that arise when selective pressure induces targeted mutations that specifically influence the adaptive response. The purpose of this report is to introduce an experimental design and describe limited pilot experiment data (not to describe a complete set of experiments); hence, it is an early report. Methods: An experimental design based on immortalization of mouse embryonic fibroblast cells is presented that links clonal cell growth to reversal of an inactivating polyadenylation site mutation. Thus, cells exhibit growth only in the presence of both the countermutation and an inducing agent (doxycycline). The type and frequency of mutation in the presence or absence of doxycycline will be evaluated. Additional experimental approaches would determine whether the cells exhibit a generalized increase in mutation rate and/or whether the cells show altered expression of error-prone DNA polymerases or of mismatch repair proteins. Results: We performed the initial stages of characterizing our system and have limited preliminary data from several pilot experiments. Cell growth and DNA sequence data indicate that we have identified a cell clone that exhibits several suitable characteristics, although further study is required to identify a more optimal cell clone. Conclusions: The experimental approach is based on a quantum biological model of basis-dependent selection describing a novel mechanism of adaptive mutation. This project is currently inactive due to lack of funding. However, consistent with the objective of early reports, we describe a proposed study that has not produced publishable results, but is worthy of report because of the hypothesis, experimental design, and protocols. We outline the project’s rationale and experimental design, with its strengths and weaknesses, to stimulate discussion and analysis, and lay the foundation for future studies in this field.

  • https://www.youtube.com/watch?v=PZFtQSe5Pd8.

    Development of an Evidence-Based Clinical Algorithm for Practice in Hypotonia Assessment: A Proposal

    Authors List:

    Abstract:

    Background: Assessing muscle tone in children is essential during the neurological assessment and is often essential in ensuring a more accurate diagnosis for appropriate management. While there have been advances in child neurology, there remains much contention around the subjectivity of the clinical assessment of hypotonia, which is often the first step in the diagnostic process. Objective: In response to this challenge, the objective of the study is to develop and validate a prototype of a decision making process in the form of a clinical algorithm that will guide clinicians during this assessment process. Methods: Design research within a pragmatic stance will be employed in this study. Multi-phase stages of assessment, prototyping and evaluation will occur. These will include processes that include a systematic review, processes of reflection and action as well as validation methods. Given the mixed methods nature of this study, use of NVIVO or ATLAS-ti will be used in the analysis of qualitative data and SPSS for quantitative data. Results: Initial results from the systematic review revealed a paucity of scientific literature that documented the objective assessment of hypotonia in children. The review identified the need for more studies with greater methodological rigor in order to determine best practice with respect to the methods used in the assessment of low muscle tone in the paediatric population. Conclusions: It is envisaged that this proposal will contribute to a more accurate clinical diagnosis of children with low muscle tone in the absence of a gold standard. We anticipate that the use of this tool will ultimately assist clinicians towards moving to evidenced based practice whilst upholding best practice in the care of children with hypotonia.

  • (cc) Chetty et al. CC-BY-SA-2.0, please cite as (http://www.researchprotocols.org/article/viewFile/3580/1/49675).

    Development of a Model of Care for Rehabilitation of People Living With HIV in a Semirural Setting in South Africa

    Abstract:

    Background: Human immunodeficiency virus continues to challenge health care professionals even after the rollout of antiretroviral therapy. South Africa, among the worst affected countries in the world by the pandemic, has seen the effect of people living longer but facing disabling effects of both the virus and the associated impairments of the antiretroviral therapy. Rehabilitation within the evolving context of the disease has changed its focus from the impairment of the individual to the participation restriction within a person’s daily life. Offering a continuum of coordinated, multilevel, multidiscipline, evidence-based rehabilitation within health care will promote its prominence in health care structures. Objective: This study aims to develop a model of care within a health care structure using a semi-rural African setting as an example. Methods: The study will employ mixed methods using a Learning in Action Approach into the rehabilitation of people living with HIV (PLHIV) at the study setting. The Delphi technique, a multistage consensus method, will be used to obtain feedback from a number of local experts relevant for the field of rehabilitation of people living with HIV. The study will also involve various stakeholders such as the multidisciplinary health care team (doctors, physiotherapists, occupational therapists, dieticians, speech and language therapists, social workers, midlevel workers, community health care workers); department of health representative(s); site affiliated nongovernmental organization representative(s); and service users at the study setting. Results: Once a proposed model of care is derived, the model will be assessed for rigour and piloted at the study setting. Conclusions: The development of a model of care in rehabilitation for PLHIV in a health care setting is aimed to provide an example of a continuum of coordinated service throughout the disease trajectory. The assumption is that the burden on the health care system will be curbed and the projected benefit for all stakeholders will promote a sort after service delivery in rehabilitation of people living with HIV.

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  • Can internet-based sexual health services increase diagnoses of sexually transmitted infections? Evaluation of an internet-based sexual health service.

    Date Submitted: Dec 24, 2014

    Open Peer Review Period: Dec 24, 2014 - Jan 7, 2015

    Background: Sexually transmitted infections (STIs) are an important cause of morbidity and mortality worldwide, and a key indicator of sexual ill health. In England, 448,422 new STI diagnoses were mad...

    Background: Sexually transmitted infections (STIs) are an important cause of morbidity and mortality worldwide, and a key indicator of sexual ill health. In England, 448,422 new STI diagnoses were made in 2012, with higher rates recorded among young heterosexuals, men who have sex with men and some black and ethnic minority groups . Importantly, the patterning of STIs reflects stark health inequalities. Internet based STI testing is considered a promising means for increasing access to sexual health services and reaching at-risk groups . Yet to our knowledge there have been no experimental studies to demonstrate the effectiveness of internet-based testing compared to standard face-to-face clinical pathways. Observational studies have been encouraging, reporting high STI positivity among users of internet based services and reaching populations with a combination of both socio-demographic and behavioural risk factors. Sexual Health 24 (SH:24) is an innovative internet-based sexual health service that aims to improve access to sexual health services in the London boroughs of Southwark and Lambeth. In early 2015, SH:24 will launch its first online product (minimal viable product 1) - an online STI testing service allowing users to order free postal STI kits, receive their results by text message or phone (HIV only), and if positive, be referred on to specialist sexual health clinics for treatment. This study aims to establish whether the MvP1 delivers an effective service compared to face-to-face sexual health services, thus contributing to the international evidence base in this field. Objective: - To report the intervention effects on the proportion of participants diagnosed with at least one STI at 6 weeks from randomisation - To report the intervention effects on uptake of STI testing at 6 weeks from randomisation Methods: A pragmatic randomised controlled trial which will allow us to assess the effectiveness of internet based testing compared to a conventional sexual health information website with signposting to clinic-based services. Participants will be randomly allocated: • either to a sexual health website (SH:24) offering postal STI kits, results via text message or by phone (HIV only), and clinic-based treatment options; • or to a website with information on local clinic-based sexual health services. The main analyses will the compare the proportion of participants diagnosed with at least one STI in each arm on an intention to treat basis. A sample of 3000 participants will have 90% power (two-sided alpha=5%) to detect a relative risk of 3.5, assuming a 2.1% risk of STI diagnosis in the intervention group and a 0.6% risk in the control group, allowing for 10% losses to follow up. Clinical Trial: Current Controlled Trials ISRCTN13354298 (registration date: 21 November 2014)

  • Efficacy, Working Mechanisms and Cost-Effectiveness of a Multicomponent Positive Psychology Self-help Intervention with Email Support to Promote Well-being and Flourishing: Design of a Randomized Controlled Trial

    Date Submitted: Dec 20, 2014

    Open Peer Review Period: Dec 22, 2014 - Jan 5, 2015

    Background: Positive psychology interventions have been found to enhance well-being and decrease clinical symptomatology. However, effect sizes of these interventions were relatively small and it is y...

    Background: Positive psychology interventions have been found to enhance well-being and decrease clinical symptomatology. However, effect sizes of these interventions were relatively small and it is yet unknown how the amount of flourishing can also be enhanced. Whereas multicomponent interventions seems to be necessary for this purpose, different formats can be used. A cost-effective approach could be to use an accessible positive psychology-based self-help book with inexpensive email support to integrate the main advantages of a face-to-face intervention (i.e. support) and an online intervention (reach large target groups). Objective: The purpose of the present study is to evaluate the (cost-)efficacy of a comprehensive multicomponent self-help intervention with or without email support on well-being and flourishing, and to determine the working mechanisms underlying the intervention. Methods: In this three-armed parallel randomized controlled trial, 396 participants with low or moderate levels of well-being and without clinical symptomatology will be randomly assigned to (1) a self-help book condition with weekly email support, (2) a self-help book condition without email support but with a weekly information email, or (3) a waiting list control condition. Online measurements will be assessed at baseline, at post-test (3-months after baseline), and at 6 and 12 months after baseline. Results: The primary outcomes are well-being and flourishing (i.e. high levels of well-being). Secondary outcomes are the well-being components included in the intervention: positive emotion, use of strengths, optimism, self-compassion, resilience and positive relations. Other measures include depressive and anxiety symptoms, personality traits, direct medical and non-medical costs, life-events and client satisfaction. Conclusions: This study will add knowledge to the efficacy of multicomponent positive psychology interventions and its cost-effectiveness, and will gain insight in the efficacy of each well-being component included in the intervention. We will also explore who will benefit most from the intervention. If proven effective, our results will be especially relevant for public mental health services, governments and primary care. Clinical Trial: The Netherlands Trial Register NTR4297; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4297 (Archived by WebCite at http://webcitation.org/6Uwb5SUUM).

  • Working with Parents to Prevent Childhood Obesity: A Protocol for a Primary Care-based Study

    Date Submitted: Dec 19, 2014

    Open Peer Review Period: Dec 22, 2014 - Jan 5, 2015

    Background: Background: Parents play a central role in preventing childhood obesity. For instance, mothers and fathers can help prevent unhealthy weight gain among children with healthy weights as wel...

    Background: Background: Parents play a central role in preventing childhood obesity. For instance, mothers and fathers can help prevent unhealthy weight gain among children with healthy weights as well as manage excess weight in children classified as overweight or obese. There is a need for innovative, scalable, and evidence-based interventions designed to enhance families’ motivation to initiate and sustain children’s healthy lifestyle behaviors, which can facilitate obesity prevention. Objective: Objectives: (i) Develop an online screening, brief intervention, and referral to treatment (SBIRT) tool to enhance parents’ concern for and motivation to support children’s healthy lifestyle behaviors; (ii) refine the SBIRT tool by assessing end-user acceptability, satisfaction, and usability through focus groups; (iii) determine feasibility and preliminary efficacy of the refined SBIRT using a randomized controlled trial design. Methods: Methods: This is a three-phase, multi-method study that includes SBIRT tool development (phase I), refinement (phase II), and preliminary testing (phase III). Phase I: Theoretical underpinnings of the SBIRT tool will be informed by concepts used in existing interventions and content will be incorporated from current literature on children’s healthy lifestyle behaviors. The SBIRT platform will be developed in partnership between our research team and a third-party intervention development company. Phase II: Focus groups with parents, and pediatric-focused health care professionals, researchers, and trainees (n=30) will explore intervention-related perceptions and preferences. Qualitative data from the focus groups will inform refinements to the SBIRT’s aesthetics, content, structure, and function. Phase III: Parents (n=200) of children (boys and girls; 5–17 years old) will be recruited from a primary care pediatric clinic and randomly assigned (as they complete the SBIRT) to one of five groups (four intervention groups; one control group). Parents will complete the online SBIRT using a tablet that will be connected to the Internet. Subsequently, parents will be contacted via email at one-month follow-up to assess (i) concern for and motivation to support children’s dietary and physical activity behaviors (primary outcome) and (ii) use of online resources and referrals to health services for obesity prevention (secondary outcome). Results: Results: This protocol was accepted for funding. Development of the SBIRT commenced in Summer 2012 and expected date of completion is Fall 2016. Conclusions: Conclusions: The proposed research is timely and applies a novel, technology-based application that is designed to enhance parents concern for and motivation to support children’s healthy lifestyle behaviors and encourage use of online resources and community services for childhood obesity prevention. Our SBIRT addresses oft-cited barriers (e.g., lack of time to treat, low perceived self-efficacy) reported by health care professionals who provide obesity-related health services in primary care. Overall, this research builds on a foundation of evidence supporting the application of SBIRTs to encourage (‘nudge’) individuals to make healthy lifestyle and behavioral choices. Clinical Trial: Trial Registration: Pending at www.clinicaltrials.gov (Protocol ID: RIPPLE-0613)

  • QuickSilver: A Phase II study using MRI criteria to identify “good prognosis” rectal cancer patients eligible for primary surgery

    Date Submitted: Dec 16, 2014

    Open Peer Review Period: Dec 17, 2014 - Jan 3, 2015

    Background: Recently two non-randomized, prospective cohort studies used magnetic resonance imaging (MRI) to assess the circumferential resection margin to identify “good prognosis” rectal tumours...

    Background: Recently two non-randomized, prospective cohort studies used magnetic resonance imaging (MRI) to assess the circumferential resection margin to identify “good prognosis” rectal tumours eligible for primary surgery and have reported favourable outcomes. Objective: The objective of this project is to conduct Phase II trial to assess the safety and feasibility of MRI criteria to identify “good prognosis” rectal tumours eligible for primary surgery in the North American setting. Methods: Patients with newly diagnosed primary rectal cancer attending surgical clinics at participating centres will be invited to participate in the study. The inclusion criteria for study are: (i) diagnosis of rectal cancer (0-15 cm) from the anal verge on endoscopy and proximal extent of tumour at or below the sacral promontory on CT or MRI, (ii) meets all MRI criteria for “good prognosis” rectal tumour as defined by the study protocol, (iii) 18 years or older and (iv) able to provide written consent. The initial assessment will include: (i) clinical and endoscopic examination of the primary tumour, (ii) CT chest, abdomen and pelvis and (iii) pelvic MRI. All potentially eligible cases will be presented at multidisciplinary cancer conference to assess for eligibility based on the MRI criteria for “good prognosis” tumour which include: (i) predicted circumferential resection margin (CRM) > 1mm, (ii) definite T2, T2/early T3 or definite T3 tumour with < 5 mm of extramural depth of invasion (EMD), (iii) any N0, N1 or N2, (iv) absence of extramural venous invasion (EMVI). All patients fulfilling the MRI criteria for “good prognosis” rectal cancer and the inclusion and exclusion criteria will be invited to participate in the study and proceed to primary surgery. The safety of the MRI criteria will be evaluated by assessing the positive CRM rate and is the primary outcome for the study. A positive margin will be defined as any macroscopic or microscopic tumour, discontinuous tumour nodule or positive lymph node located within 1 mm of the CRM on final pathologic assessment. Results: We expect to have a minimum of 300 potentially eligible patients and based on a 30% eligibility rate and 80% participation rate, it is expected that 75 patients will be recruited over the two year study period. A Data Safety Monitoring Committee has been organized and the study will be stopped if a positive CRM of >10% is reported at any interim assessment which will occur after every 25 patients accrued in the study. Conclusions: It is expected that the results of this study will show that use of MRI criteria to identify “good prognosis” rectal cancers eligible for primary surgery will be safe (i.e., positive margin less than 10%). Therefore, these results will have significant potential to change the current management of rectal cancer in North America and result in improved quality of life for rectal cancer patients and survivors while reducing overall health care costs. Clinical Trial: Registered with Current Controlled Trials on July 23, 2014. ISRCTN05107772

  • Neurobiological Aspects of Attention Deficit–Hyperactivity Disorder: Contribution of Transcranial Direct Current Stimulation on Inhibitory Control

    Date Submitted: Dec 13, 2014

    Open Peer Review Period: Dec 16, 2014 - Dec 30, 2014

    This is a single center, parallel, randomized, double-blinded, sham-controlled trial to investigate the efficacy of transcranial direct current stimulation (tDCS) over the prefrontal cortex on the mod...

    This is a single center, parallel, randomized, double-blinded, sham-controlled trial to investigate the efficacy of transcranial direct current stimulation (tDCS) over the prefrontal cortex on the modulation of inhibitory control in adults with attention deficit-hyperactivity disorder. A total of 60 individuals will be divided into two groups by block randomization to receive active or sham stimulation. It will be applied anodal stimulation over the left dorsolateral prefrontal cortex at 1mA, during 20 minutes in a single session. Before and after interventions, subjects will perform two Go/ No go tasks and the brain electrical activity will be recorded by EEG with 32 channels, according to the 10-20 EEG international system. The findings from this trial will provide preliminary results about the role of the prefrontal cortex activation through transcranial direct current stimulation to modulate inhibitory control in ADHD patients.