JMIR Research Protocols

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

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

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

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:

  • 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.

  • Screenshot of OPIS homepage.

    An Interactive Health Communication Application for Supporting Parents Managing Childhood Long-Term Conditions: Outcomes of a Randomized Controlled...

    Abstract:

    Background: Families living with chronic or long-term conditions such as chronic kidney disease (CKD), stages 3-5, face multiple challenges and respond to these challenges in various ways. Some families adapt well while others struggle, and family response to a condition is closely related to outcome. With families and professionals, we developed a novel condition-specific interactive health communication app to improve parents’ management ability—the online parent information and support (OPIS) program. OPIS consists of a comprehensive mix of clinical caregiving and psychosocial information and support. Objective: The purpose of this study was to (1) assess feasibility of a future full-scale randomized controlled trial (RCT) of OPIS in terms of recruitment and retention, data collection procedures, and psychometric performance of the study measures in the target population, and (2) investigate trends in change in outcome measures in a small-scale RCT in parents of children with CKD stages 3-5. Methods: Parents were recruited from a pediatric nephrology clinic and randomly assigned to one of two treatment groups: usual support for home-based clinical caregiving (control) or usual support plus password-protected access to OPIS for 20 weeks (intervention). Both groups completed study measures at study entry and exit. We assessed feasibility descriptively in terms of recruitment and retention rates overall; assessed recruitment, retention, and uptake of the intervention between groups; and compared family condition management, empowerment to deliver care, and fathers’ involvement between groups. Results: We recruited 55 parents of 39 children (42% of eligible families). Of those, about three-quarters of intervention group parents (19/26, 73%) and control group parents (22/29, 76%) were retained through completion of 20-week data collection. The overall retention rate was 41/55 (75%). The 41 parents completing the trial were asked to respond to the same 10 questionnaire scales at both baseline and 20 weeks later; 10 scores were missing at baseline and nine were missing at 20 weeks. Site user statistics provided evidence that all intervention group parents accessed OPIS. Analysis found that intervention group parents showed a greater improvement in perceived competence to manage their child’s condition compared to control group parents: adjusted mean Family Management Measure (FaMM) Condition Management Ability Scale intervention group 44.5 versus control group 41.9, difference 2.6, 95% CI -1.6 to 6.7. Differences between the groups in the FaMM Family Life Difficulty Scale (39.9 vs 36.3, difference 3.7, 95% CI -4.9 to 12.2) appeared to agree with a qualitative observation that OPIS helped parents achieve understanding and maintain awareness of the impact of their child’s condition. Conclusions: A full-scale RCT of the effectiveness of OPIS is feasible. OPIS has the potential to beneficially affect self-reported outcomes, including parents’ perceived competence to manage home-based clinical care for children with CKD stage 3-5. Our design and methodology can be transferred to the management of other childhood conditions. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 84283190; http://www.controlled-trials.com/ISRCTN84283190 (Archived by WebCite at http://www.webcitation.org/6TuPdrXTF).

  • Web-based CBT program screenshot.

    A Web-Based Training Program Using Cognitive Behavioral Therapy to Alleviate Psychological Distress Among Employees: Randomized Controlled Pilot Trial

    Abstract:

    Background: A number of psychoeducational programs based on cognitive behavioral therapy (CBT) to alleviate psychological distress have been developed for implementation in clinical settings. However, while these programs are considered critical components of stress management education in a workplace setting, they are required to be brief and simple to implement, which can hinder development. Objective: The intent of the study was to examine the effects of a brief training program based on CBT in alleviating psychological distress among employees and facilitating self-evaluation of stress management skills, including improving the ability to recognize dysfunctional thinking patterns, transform dysfunctional thoughts to functional ones, cope with stress, and solve problems. Methods: Of the 187 employees at an information technology company in Tokyo, Japan, 168 consented to participate in our non-blinded randomized controlled study. The training group received CBT group education by a qualified CBT expert and 1 month of follow-up Web-based CBT homework. The effects of this educational program on the psychological distress and stress management skills of employees were examined immediately after completion of training and then again after 6 months. Results: Although the training group did exhibit lower mean scores on the Kessler-6 (K6) scale for psychological distress after 6 months, the difference from the control group was not significant. However, the ability of training group participants to recognize dysfunctional thinking was significantly improved both immediately after training completion and after 6 months. While the ability of participants to cope with stress was not significantly improved immediately after training, improvement was noted after 6 months in the training group. No notable improvements were observed in the ability of participants to transform thoughts from dysfunctional to functional or in problem-solving skills. A sub-analysis of participants who initially exhibited clinically significant psychological distress (K6 score ≥5) showed that the mean K6 score was significantly improved immediately after training completion for the training group compared to the control group (−2.50 vs −0.07; mean difference 2.43, 95% CI 0.55-4.31; d=0.61), with this effect remaining even after 6 months (−3.49 vs −0.50; mean difference 2.99, 95% CI 0.70-5.29; d=0.60). Conclusions: Our results suggest that a brief stress management program that combines group CBT education with Web-based CBT homework moderately alleviates the distress of employees with clinically significant psychological distress. In addition, the program might help improve employees’ ability to evaluate their own stress management skills.

  • This is a royalty free image by Praisaeng (http://www.freedigitalphotos.net/images/disabled-woman-using-a-laptop-in-her-wheelchair-photo-p182055).

    Tying eHealth Tools to Patient Needs: Exploring the Use of eHealth for Community-Dwelling Patients With Complex Chronic Disease and Disability

    Abstract:

    Background: Health policy makers have recently shifted attention towards examining high users of health care, in particular patients with complex chronic disease and disability (CCDD) characterized as having multimorbidities and care needs that require ongoing use of services. The adoption of eHealth technologies may be a key strategy in supporting and providing care for these patients; however, these technologies need to address the specific needs of patients with CCDD. This paper describes the first phase of a multiphased patient-centered research project aimed at developing eHealth technology for patients with CCDD. Objective: As part of the development of new eHealth technologies to support patients with CCDD in primary care settings, we sought to determine the perceived needs of these patients with respect to (1) the kinds of health and health service issues that are important to them, (2) the information that should be collected and how it could be collected in order to help meet their needs, and (3) their views on the challenges/barriers to using eHealth mobile apps to collect the information. Methods: Focus groups were conducted with community-dwelling patients with CCDD and caregivers. An interpretive description research design was used to identify the perceived needs of participants and the information sharing and eHealth technologies that could support those needs. Analysis was conducted concurrently with data collection. Coding of transcripts from four focus groups was conducted by 3 authors. QSR NVivo 10 software was used to manage coding. Results: There were 14 total participants in the focus groups. The average age of participants was 64.4 years; 9 participants were female, and 11 were born in Canada. Participants identified a need for open two-way communication and dialogue between themselves and their providers, and better information sharing between providers in order to support continuity and coordination of care. Access issues were mainly around wait times for appointments, challenges with transportation, and costs. A visual depiction of these perceived needs and their relation to each other is included as part of the discussion, which will be used to guide development of our eHealth technologies. Participants recognized the potential for eHealth technologies to support and improve their care but also expressed common concerns regarding their adoption. Specifically, they mentioned privacy and data security, accessibility, the loss of necessary visits, increased social isolation, provider burden, downloading responsibility onto patients for care management, entry errors, training requirements, and potentially confusing interfaces. Conclusions: From the perspective of our participants, there is a significant potential for eHealth tools to support patients with CCDD in community and primary care settings, but we need to be wary of the potential downfalls of adopting eHealth technologies and pay special attention to patient-identified needs and concerns. eHealth tools that support ongoing patient-provider interaction, patient self-management (such as telemonitoring), and provider-provider interactions (through electronic health record integration) could be of most benefit to patients similar to those in our study.

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  • 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.

  • Street Food Environment in Maputo (STOOD MAP): a cross-sectional study in Mozambique

    Date Submitted: Dec 9, 2014

    Open Peer Review Period: Dec 10, 2014 - Dec 24, 2014

    Street food represents a cultural, social and economic phenomenon that is typical of urbanized areas, directly linked with a more sedentary lifestyle and providing a very accessible and inexpensive so...

    Street food represents a cultural, social and economic phenomenon that is typical of urbanized areas, directly linked with a more sedentary lifestyle and providing a very accessible and inexpensive source of nutrition. Food advertising may contribute to shape the consumers’ preferences and has the potential to drive the supply of specific foods. The purpose of this study is to characterize the street food offer available to the urban population of Maputo, the capital city of Mozambique, and the billboard food advertising in the same setting. People selling ready-to-eat food, beverages or snacks, from venues such as carts, trucks, stands, and a variety of improvised informal set-ups (e.g.: shopping carts, trunks of cars, sides of vans, blankets on the sidewalk, etc.) will be identified in the district of KaMpfumu. We will gather information about the actual food being sold, through direct observation and interviews to vendors, and from the billboard advertising in the same areas. A second phase of the research entails collecting food samples to be analyzed in a specialized laboratory. The street food environment will be characterized, overall and according to socio-economic and physical characteristics of the neighborhood, using descriptive statistics and spatial analysis. The study protocol was approved by the National Committee for Bioethics for Health in Mozambique. The district of KaMpfumu is the wealthiest and most urbanized in Maputo, and is considered to represent the area with the highest concentration and variety of street food vendors. The expected results may yield important information to assess the nutrition environment and the characteristics of the foods to which a great majority of the urban population living or working of Maputo is exposed to. Furthermore, this study protocol provides a framework for a stepwise standardized characterization of the street food environment, comprising three steps with increasing complexity and demand for human and technical resources: step 1 consists of the evaluation of food advertising in the streets; step 2 includes the identification of street food vendors and the characterization of the products available; step 3 requires the collection of food samples for bromatological analyses. This structured approach to the assessment of the street food environment may enable within-country and international comparisons as well as monitoring of temporal trends.

  • Cardiovascular Risk and its associated factors in health care workers in Colombia. A Study Protocol

    Date Submitted: Dec 5, 2014

    Open Peer Review Period: Dec 8, 2014 - Dec 22, 2014

    Introduction: Cardiovascular diseases are the leading cause of mortality worldwide, for this reason, they are a public health problem. In Colombia, cardiovascular diseases are the main cause of mortal...

    Introduction: Cardiovascular diseases are the leading cause of mortality worldwide, for this reason, they are a public health problem. In Colombia, cardiovascular diseases are the main cause of mortality having a death rate of 152 deaths per 100,000 population. Eighty percent of these cardiovascular events are considered avoidable.Objective: To determine the prevalence of the cardiovascular risk and its associated factors among the institution’s workers, in order to design and implement interventions in the work environment which may achieve a decrease in this risk. Methods and analysis: An analytical cross-sectional study was designed to determine the cardiovascular risk and its associated factors among workers of a high complexity health care institution, and design and implement interventions in their work environment to decrease that risk. A self-applied survey will be conducted considering sociodemographic aspects, physical activity, diet, alcohol consumption, smoking, level of perceived stress, and personal and family history. In a second appointment, a physical examination will be made, as well as anthropometric measurements and blood pressure determination. Also, blood samples for evaluating total and HDL cholesterol, triglycerides and fasting blood sugar will be taken. Ten-year global risk for cardiovascular disease will be determined using the Framingham score. A descriptive analysis of the population’s characteristics and a stratified analysis by sex, age and profession will be made. Bivariate and multivariate analysis will be made using logistic regression models to evaluate the association between cardiovascular risk and the independent variables. Ethics and dissemination: Research will be conducted in agreement with the 1993 Number 08430 Resolution from the Health Ministry of Colombia. The research protocol was approved by the Scientific and Technical Committee and the Ethics Committee on Research of the Fundación Cardiovascular de Colombia. The findings about this proyect will be disseminated through peer-reviewed publication and conference presentations. Discussion: The results of this study will give the foundation for the design, implementation and evaluation of a program based on promoting healthy lifestyles such as performing regular physical activity and healthy food intake in order to avoid and/or control the cardiovascular risk in the workers in of a high complexity health care institution.