JMIR Research Protocols
Ongoing Trials, Grant Proposals, Formative Research, Methods, Early Results
Journal Description
JMIR Research Protocols (ISSN 1929-0748) publishes peer-reviewed, openly accessible research ideas and grant proposals, study and trial protocols, reports of ongoing research, current methods and approaches, and preliminary results from pilot studies or formative research informing the design of medical and health-related research and technology innovations.
JMIR Res Protoc is a new journal spin-off of JMIR, the worlds' leading medical journal in health sciences / health services research and health informatics (Impact Factor 2016: 5.175)
JMIR Res Protoc publishes protocols and grant proposals in all areas of medicine (and their peer-review reports, if available), as well as feasibility studies, early reports and formative/process evaluations of ongoing studies and descriptions of the development and pilot evaluations of innovations and software applications or other interventions
JMIR Res Protoc is fully open access, with full text articles deposited in PubMed Central
Publishing research protocols, grant proposals, pilot/feasibility studies and early reports of ongoing and planned work encourages collaboration and early feedback, and reduces duplication of effort
JMIR Res Protoc will be a valuable ressource for researchers who want to learn about current research methodologies and how to write a winning grant proposal
JMIR Res Protoc creates an early scientific record for researchers who have developed novel methodologies, software, innovations or elaborate protocols
JMIR Res Protoc faciliates subsequent publication of results demonstrating that the methodology has already been reviewed, and reduces the effort of writing up the results, as the protocol can be easily referenced
JMIR Res Protoc demonstrates to reviewers of subsequent results papers that authors followed and adhered to carefully developed and described a-priori methods
Studies whose protocols or grant proposal have been accepted in JMIR Res Protoc are "in principle accepted" for subsequent publication of results in other JMIR journals as long as authors adhere to their original protocol - regardless of study results (even if they are negative), reducing publication bias in medicine
Authors publishing their protocols in JMIR Res Protoc will receive a 20% discount on the article processing fee if they publish their results in another journal of the JMIR journal family (for example, JMIR for ehealth studies, i-JMR for others)
Recent Articles:
-
Jun 28, 2017
-
Jun 26, 2017
-
Jun 26, 2017
-
Jun 22, 2017
-
Jun 22, 2017
-
Jun 19, 2017
-
Jun 16, 2017
-
Jun 16, 2017
-
Jun 16, 2017
-
Jun 15, 2017
-
Jun 14, 2017
-
Jun 12, 2017
Latest Submissions Open for Peer-Review:
View All Open Peer Review Articles-
Design of a Research- and Practice-Based Nutrition Education and Cooking Workshop Curriculum in Pediatric Oncology
Date Submitted: Jun 26, 2017
Open Peer Review Period: Jun 27, 2017 - Jul 11, 2017
Background: Despite progresses in childhood cancer treatment, diagnosis and management, two-thirds of childhood cancer survivors will be affected by late complications including cardiovascular and met...
Background: Despite progresses in childhood cancer treatment, diagnosis and management, two-thirds of childhood cancer survivors will be affected by late complications including cardiovascular and metabolic diseases. Side effects of cancer treatments can negatively impact children’s nutritional intake and eating behaviors. Adequate nutrition is essential to ensure optimal development and can improve tolerance to treatments. Furthermore, healthy eating can contribute to lower the risk of cardiometabolic diseases. Involving the families of childhood cancer patients in educational workshops could be a promising avenue to promote healthy eating during and after cancer treatment. Objective: To develop and validate a family-based nutrition education and cooking workshop curriculum in a pediatric oncology setting that addresses the nutritional issues encountered during treatments while promoting the adoption of healthy eating habits for the prevention of cardiometabolic late effects. Methods: The workshops were developed and validated following an 8-steps iterative process including a review of the literature and consultations with a steering committee. An evaluation tool was also developed. Results: The themes of the 6 research- and practice-based lessons are: meal fortification during cancer treatments; changes in taste during cancer therapy and their impact on children; adapting diet to eating-related side effects of treatments; Mediterranean diet and health; planning quick and economic meal; nutritional support during cancer treatment. The validation process included consultations with the institution clinical nutrition professionals. Self-administered post questionnaires were developed according to the content of each workshop to measure participants’ perception of knowledge acquisition, behavioral intention and satisfaction. Conclusions: This research- and practice-based nutrition education and cooking demonstration curriculum could consist in a valuable complement to a multidisciplinary lifestyle intervention for prevention of late cardiometabolic complications in childhood cancer.
-
Randomized controlled trial of an 8-week hypnosis-based group intervention for post-treatment cancer patients.
Date Submitted: Jun 26, 2017
Open Peer Review Period: Jun 27, 2017 - Jul 11, 2017
Background: Cancer has a lot of consequences on patients’ quality of life (such as cancer-related fatigue (CRF) and emotional distress) and on patients’ partners and their relationship, such as fa...
Background: Cancer has a lot of consequences on patients’ quality of life (such as cancer-related fatigue (CRF) and emotional distress) and on patients’ partners and their relationship, such as fatigue, distress, and communication difficulties. However, these consequences are still undertreated, and interventions such as hypnosis often focus on breast cancer patients only. Objective: Our longitudinal randomized controlled trial aims to assess the efficacy of an 8-week hypnosis-based intervention to improve cancer patients' CRF and emotional distress and to indirectly improve their partners' distress. Methods: A power analysis required a total sample of 88 patients. Results of the experimental group receiving the intervention will be compared to those of the control group. Data will be collected by questionnaires, relaxation tasks, an attentional bias task, and everyday life assessments measured at four different times: 1.) before inclusion in the study (baseline); 2.) after the intervention; and 3.) at 4- and 12-month follow-up. Partners’ symptoms will also be evaluated with questionnaires at the same measurement times. Conclusion: There is a growing interest in alternative approaches (such as hypnosis) in addition to standard therapies in oncology settings. The results of this study should be useful for improving knowledge about long-term efficacy of hypnosis-based group interventions for CRF and distress among all types of cancer patients and their partners, and to better understand the mechanisms of emotional regulation in cancer patients through the attentional bias task.
-
Web-based intervention to teach developmentally-supportive care to parents of preterm infants: feasibility study
Date Submitted: Jun 23, 2017
Open Peer Review Period: Jun 25, 2017 - Jul 9, 2017
-
This manuscript needs more reviewers
Peer-Review Me -
Background: Preterm birth affects 8-11% of the population and conveys a significant risk of developmental delays. Intervention programs that support child development have been shown to have a positiv...
Background: Preterm birth affects 8-11% of the population and conveys a significant risk of developmental delays. Intervention programs that support child development have been shown to have a positive impact on early motor and cognitive development and on parental well-being. However, these programs are often difficult to implement in a real-life setting due to lack of resources. Hence, our multidisciplinary team developed Mieux Agir au Quotidien (MAQ) to teach developmentally-supportive care to parents of preterm infants with the goal of improving child development and parental outcomes. Our intervention included three in-person workshops that occurred prior to hospital discharge and a web-based platform with written and videotaped materials that addressed five main themes: (1) infant behavioural cues; (2) flexion positioning; (3) oral feeding support; (4) parent-infant interactions; (5) anticipation of developmental milestones. Objective: This study aimed to test the acceptability of the intervention by parents of preterm infants and to assess clinical benefits on child neurodevelopment and parental outcomes during the first year of life. Methods: One hundred seven infants born <30 weeks and admitted to Ste-Justine Hospital neonatal intensive care unit and their parents were enrolled in a nonrandomized controlled before-and-after interventional study (intervention n=55, comparison n=52). Acceptability of the program was assessed with a user satisfaction questionnaire. At 4 months’ corrected age, all parents completed questionnaires on infant temperament, parenting stress, sense of competence and parenting satisfaction. At 12 months’ corrected age, neurodevelopmental testing was performed on infants using the Alberta Infant Motor Scale and the Bayley scales 3rd edition. Comparisons between the two groups were done using independent t-test, Wilcoxon rank-sum test, and Fisher’s exact test. Results: Majority of parents (96%) were satisfied with the intervention program and all would recommend MAQ to others. MAQ responded to their need for evidence-based information that proved useful to support their child development. No difference in parental or child neurodevelopmental outcomes was detected in this pilot study for most outcomes except for higher median scores for parental coercive behaviours in the intervention group although proportions scoring in the coercive range did not differ. Conclusions: Acceptability of the program was high among parents thus supporting the relevance of such intervention. A larger study using a randomized controlled trial design is needed to better document impact on parent and children and to investigate how web-based technologies can efficiently complement individualized intervention to alleviate the burden on health care resources.
-
-
Online communication strategies designed to improve intention to minimize risk for colorectal cancer: a randomized controlled trial to test an FAQ prototype for information targeted by age and gender
Date Submitted: Jun 21, 2017
Open Peer Review Period: Jun 22, 2017 - Jul 6, 2017
Background: Increasingly, people seek information online for managing their health, including colorectal cancer (CRC) risk but retrieve much personally irrelevant material, impacting utility. Targetin...
Background: Increasingly, people seek information online for managing their health, including colorectal cancer (CRC) risk but retrieve much personally irrelevant material, impacting utility. Targeting people with information pertinent to their cohort via a Frequently Asked Questions (FAQ) format might improve commitment to action. Objective: We identified and prioritized CRC information for men and women aged 35−74 years (Study 1), to build a prototype website containing FAQs ordered by age and gender. In Study 2 we conducted a randomized controlled trial (RCT) to test whether information accessed through targeted FAQs was more influential on intention to act on CRC risk than the same information accessed via a generic topic list. Secondary aims compared preference for information via FAQs or LIST, usability, relevance and likelihood of recommendation of FAQ and LIST websites. Methods: Study 1 determined the CRC information needs of Australians (total N = 600) by sex and age group (35-49, 50-59, 60-74) through an online survey. Free text responses were categorized as FAQs with a focus on the “top 5” issues within each of 6 cohorts. Study 2 compared the impact of presentation as targeted FAQ links to information with links presented as a generic list (LIST), and a CONTROL (no information) condition. Participants (N=240) were block randomized by gender and age group to 1 of 3 conditions. We also tested preference for information presentation as FAQ or LIST by adding a CHOICE condition. Dependent measures were willingness to act on CRC risk and ratings of website usability, relevance and intention to recommend. Results: Study 1 showed considerable consistency in information priorities among all six cohorts with two main concerns; treatment of CRC and risk factors. Some differences included a focus on general risk factors, excluding diet and lifestyle, in the younger cohort, and on the existence of a test for CRC in the older cohorts. Study 2 demonstrated that although respondents preferred information ordered by FAQs over a list, presentation in this format had limited impact on readiness to act on CRC risk compared to the list or a no information control (p=.055). Both FAQ and LIST were evaluated as equally useable. Those aged 35–49 rated the information less relevant to them and others in their age group, and information ordered by FAQs was rated, across all age groups and both sexes, as less relevant to people outside the age group targeted within the FAQs. Conclusions: FAQs are preferred over a list as a strategy for presenting information about CRC. They may improve intention to act on risk although further research is required. Future research should aim to identify better the characteristics of information content and presentation that optimize perceived relevance and fully engage the target audience
-
Implementing a Mental Health Care Program and Home-based Training for Mothers of Children with Autism Spectrum Disorder in an urban population in Bangladesh: Protocol for a feasibility assessment study
Date Submitted: Jun 22, 2017
Open Peer Review Period: Jun 22, 2017 - Jul 6, 2017
Background: Mothers of children with Autism Spectrum Disorder (ASD) have reported a higher level of depression than mothers of children with other neurodevelopmental disorders in both developed and de...
Background: Mothers of children with Autism Spectrum Disorder (ASD) have reported a higher level of depression than mothers of children with other neurodevelopmental disorders in both developed and developing countries. Mothers are the lifetime caregivers of children with ASD. A high burden of depression negatively impacts on the ability of the mothers to provide care to children at home. Mental health is not addressed in the primary care setting in Bangladesh, and there is a scarcity of qualified providers for supporting mental health care to mothers for supporting child care and improvement of child performances. We aim to pilot the feasibility of integrating mental health services for the mothers of children with ASD and offer a home-based training program for the mothers to improve skills of child care. We have obtained IRB approval from icddr,b. Objective: The primary objective of the study is to assess the feasibility of the proposed intervention at special schools for children with ASD that would provide mental health services and training to mothers suffering from a concurrent major depressive episode (MDE). The secondary aims of the project are to assess the change in the prevalence of MDE among mothers, as well as the any improvement in the degree of individual performance of the children with ASD. Additional project aims include assessment of incremental institutional costs incurred at schools, and out of pocket costs incurred by the families following the introduction of mental health services in combination with the maternal training program in the schools. The broader goal of the research is to assess the barriers to integrating the pilot intervention package with other types of facility-based services as well as prospect for scaling up of the intervention in other institutional settings in urban Bangladesh. Methods: The study will be conducted in two purposively selected schools in Dhaka city in Bangladesh that have been offering services for ASD for more than ten years. A trained female psychologist will be deployed at each of the two schools to offer non pharmacological interventions for mental health following a structured counseling module under the direct supervision of psychiatrists. About 52 to 78 mothers who would be diagnosed as having a depression will be recruited in the intervention (intervention mother) following a written voluntary informed consent. One educational psychologist with advanced training in ASD care (special educator) will provide training to the intervention mothers for enhancing their skills for child care and follow up at home every month. The proposed packaged intervention will be implemented over 4-6 months period, and feasibility of the intervention will be assessed through a pre-post intervention. The primary outcome will include assessment of acceptability, adaptability, demand, practicality, implementation, and integration of the package intervention in the school settings. The secondary outcomes will include assessment of (i) any change in the prevalence of current depression among the mothers of children with ASD following the intervention; (ii) the degree of individual performance of the children regarding behavioral, social and communication skills; and (iii) the costs incurred to institutions and families due to participation in the intervention. Results: Between January and June, 2017, 175 mothers were recruited for baseline information, and assessment of depression and quality of life. In depth interviews were conducted among 10 mothers and 8 various stakeholders. A psychosocial counseling module has been developed, and two psychologists deployed at the schools offered counseling to 41 mothers who have steeped in to the counseling centre on self will. A training module has been developed for mothers under the guidance of an expert working group and three special educators were trained. Data entry and data management are ongoing. Conclusions: The proposed research will provide essential estimates for designing a randomized control trial in order to evaluate the intervention package in a broader setting. Overall, the study will generate compelling evidence for scaling up of the intervention in other institutional settings in Bangladesh and in other countries with a similar situation of ASD and maternal depression. Clinical Trial: NCT03025646; https://clinicaltrials.gov/ct2/show/NCT03025646
-
Study Protocol of SALT: a retrospective multicenter cohort study for determination of the epidemiology of surgical site infections with Staphylococcus Aureus in Europe
Date Submitted: Jun 16, 2017
Open Peer Review Period: Jun 19, 2017 - Jul 3, 2017
Background: Surgical site infections (SSI) are among the most common hospital acquired infections. The incidence of SSI in certain indicator procedures is the subject of ongoing surveillance efforts i...
Background: Surgical site infections (SSI) are among the most common hospital acquired infections. The incidence of SSI in certain indicator procedures is the subject of ongoing surveillance efforts in hospitals and healthcare systems around the world. However, SSI rates vary markedly within surgical categories and are poorly represented by routinely surveilled indicator procedures, e.g. mastectomy or hernia surgery. Therefore, relying on indicator procedures to estimate the burden of SSI is imprecise and introduces bias as hospitals may take special precautions to achieve lower SSI rates. The most common cause of SSI is Staphylococcus aureus, as recently confirmed by a Europe-wide point-prevalence study conducted by the ECDC. Objective: The primary objective is to determine the overall and the procedure specific incidence of S. aureus surgical SSI in Europe. As secondary objectives the overall and the procedure specific outcomes as well as the economic burden of S. aureus SSI in Europe will be evaluated. Explorative objectives are to characterize the composition of the surgical patient population and to estimate the number of patients at risk for S. aureus SSI. Methods: We will conduct a retrospective multinational, multicenter cohort study with a nested case-control part. The study includes all surgical procedures at a participating center in order to prevent selection bias and strengthen the understanding of SSI risk by determining incidence for all common surgical procedures. Data will be assessed in two populations: the cohort, including 150.000 adult patients who underwent any surgical procedure in 2016, and the case-control population; we will match patients establishing S. aureus SSI 1:1 with controls from the same center. Regarding the cohort, we will export data on demographics, surgery and microbiology from electronic files. More detailed data will be captured from the case-control population. The SALT study will include 16 major or academic surgical centers in Europe: five in France, four in Germany, two in Italy, three in Spain and two in the UK. Sites were selected using a feasibility questionnaire. Results: The overall and the procedure specific incidence and outcome as well as the economic burden of S. aureus SSI in Europe will be determined. Furthermore, the composition of the surgical patient population in Europe will be characterized and the number of patients at risk for S. aureus SSI will be estimated. Conclusions: Results of the SALT study will help to better understand the precise risk of certain procedures. They will allow conclusions on the overall and the procedure specific incidence and outcome as well as the economic burden of S. aureus SSI in Europe. Findings of the study may help designing clinical trials for S. aureus vaccines. Clinical Trial: The study is registered at www.clinicaltrials.gov.
