JMIR Research Protocols

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

DPVD (Diabetes Prevention with active Vitamin D) trial: A randomized controlled trial of the effect of eldecalcitol on the incidence of type 2 diabetes among pre-diabetic individuals

Type 2 diabetes is an important risk factor for cardiovascular disease and for a variety of complications. Moreover, the incidence of type 2 diabetes is currently increasing and has become a major burden to healthcare systems and societies worldwide.1 In Japan, there are approximately 7.1 million persons with diabetes and 109,000 persons per year are diagnosed with diabetes.2 Additionally, 552 million people worldwide will have type 2 diabetes by the year 2030.3 The incidence of type 2 diabetes from pre-diabetes (impaired fasting glucose [IFG] and/or impaired glucose tolerance [IGT]) is about 10% (5.8–13.2%).4-7 While diabetes is an irreversible state, pre-diabetes can be reverted to a normal glucose state. Therefore, many clinical trials have aimed to evaluate the reduction of the incidence of type 2 diabetes by targeting individuals with pre-diabetes. Active vitamin D is currently prescribed as the drug of choice for osteoporosis and hypocalcemia, but it was reported that vitamin D and active vitamin D have additional metabolic effects aside from that on bone and calcium metabolism.8,9 One of the additional effects of vitamin D is that exerted on the glucose metabolism. Many studies reported that the serum 25(OH)D3 level is inversely associated with the incidence of type 2 diabetes.10-14 Thus, some small clinical trials have evaluated whether vitamin D and active vitamin D have an effect to improve insulin resistance and glucose metabolism, but the results are still controversial.15-22 None of the studies reported so far tested whether active vitamin D could prevent diabetes. Thus, we plan to conduct a randomized controlled trial to evaluate whether active vitamin D can prevent the incidence of type 2 diabetes among pre-diabetic individuals, and whether it can normalize blood glucose levels. In 2011, a new active vitamin D (eldecalcitol) became a prescription drug for osteoporosis and hypocalcemia in Japan. It showed superior efficacy in preventing bone fracture to existing active vitamin D drugs. Active vitamin D is inexpensive and has no intake restrictions. Additionally, the drug compliance of eldecalcitol should be better than that of vitamin D-containing dietary supplements. Although hypercalcemia could be a side effect, if patients have normal renal function, the excess serum calcium would be excreted through the urine. Furthermore, this side effect is very rare. Clinical Trials Registry Number: UMIN 000010758 https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000012436&type=summary&language=E

2015-07-01

Thomson Reuters, producer of the Journal Citation Reports and Web of Science and other database products, is creating a new edition of Web of Science; and we are proud to report that JMIR journals have been selected for the content expansion. 

The new Thomson Reuters Web of Science edition, which launches later in 2015, will include influential journals covering a variety of disciplines. "The journals selected have been identified as important to key opinion leaders, funders, and evaluators worldwide.", say a Thomson Reuters communication about the database. "We are proud that the Thomson Reuters team recognizes the influence of the JMIR journals", says Gunther Eysenbach, publisher at JMIR Publications.

The following journals are confirmed to be part of the initial release:

JMIR Publications is working on getting its newer journals such as JMIR Mental Health into the collection as well. JMIR Publications is now publishing over a dozen journals with topics covering innovation in health and technology.

Read Post

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:

  • MenSS homepage with carousel of personalised tailored content.

    Defining the Content of an Online Sexual Health Intervention: The MenSS Website

    Abstract:

    Background: Health promotion and risk reduction are essential components of sexual health care. However, it can be difficult to prioritize these within busy clinical services. Digital interventions may provide a new method for supporting these. Objective: The MenSS (Men’s Safer Sex) website is an interactive digital intervention developed by a multidisciplinary team, which aims to improve condom use in men who have sex with women (MSW). This paper describes the content of this intervention, and the rationale for it. Methods: Content was informed by a literature review regarding men’s barriers to condom use, workshops with experts in sexual health and technology (N=16) and interviews with men in sexual health clinics (N=20). Data from these sources were analyzed thematically, and synthesized using the Behavior Change Wheel framework. Results: The MenSS intervention is a website optimized for delivery via tablet computer within a clinic waiting room setting. Key targets identified were condom use skills, beliefs about pleasure and knowledge about risk. Content was developed using behavior change techniques, and interactive website features provided feedback tailored for individual users. Conclusions: This paper provides a detailed description of an evidence-based interactive digital intervention for sexual health, including how behavior change techniques were translated into practice within the design of the MenSS website. Triangulation between a targeted literature review, expert workshops, and interviews with men ensured that a range of potential influences on condom use were captured.

  • Untitled.

    Collecting and Analyzing Patient Experiences of Health Care From Social Media

    Abstract:

    Background: Social Media, such as Yelp, provides rich information of consumer experience. Previous studies suggest that Yelp can serve as a new source to study patient experience. However, the lack of a corpus of patient reviews causes a major bottleneck for applying computational techniques. Objective: The objective of this study is to create a corpus of patient experience (COPE) and report descriptive statistics to characterize COPE. Methods: Yelp reviews about health care-related businesses were extracted from the Yelp Academic Dataset. Natural language processing (NLP) tools were used to split reviews into sentences, extract noun phrases and adjectives from each sentence, and generate parse trees and dependency trees for each sentence. Sentiment analysis techniques and Hadoop were used to calculate a sentiment score of each sentence and for parallel processing, respectively. Results: COPE contains 79,173 sentences from 6914 patient reviews of 985 health care facilities near 30 universities in the United States. We found that patients wrote longer reviews when they rated the facility poorly (1 or 2 stars). We demonstrated that the computed sentiment scores correlated well with consumer-generated ratings. A consumer vocabulary to describe their health care experience was constructed by a statistical analysis of word counts and co-occurrences in COPE. Conclusions: A corpus called COPE was built as an initial step to utilize social media to understand patient experiences at health care facilities. The corpus is available to download and COPE can be used in future studies to extract knowledge of patients’ experiences from their perspectives. Such information can subsequently inform and provide opportunity to improve the quality of health care.

  • (cc) Barley et al, CC-BY-SA-2.0, please cite as (http://www.researchprotocols.org/article/viewFile/4280/1/61301).

    The Space From Heart Disease Intervention for People With Cardiovascular Disease and Distress: A Mixed-Methods Study

    Abstract:

    Background: Poor self-management of symptoms and psychological distress leads to worse outcomes and excess health service use in cardiovascular disease (CVD). Online-delivered therapy is effective, but generic interventions lack relevance for people with specific long-term conditions, such as cardiovascular disease. Objective: To develop a comprehensive online CVD-specific intervention to improve both self-management and well-being, and to test acceptability and feasibility. Methods: Informed by the Medical Research Council (MRC) guidance for the development of complex interventions, we adapted an existing evidence-based generic intervention for depression and anxiety for people with CVD. Content was informed by a literature review of existing resources and trial evidence, and the findings of a focus group study. Think-aloud usability testing was conducted to identify improvements to design and content. Acceptability and feasibility were tested in a cross-sectional study. Results: Focus group participants (n=10) agreed that no existing resource met all their needs. Improvements such as "collapse and expand" features were added based on findings that participants’ information needs varied, and specific information, such as detecting heart attacks and when to seek help, was added. Think-aloud testing (n=2) led to changes in font size and design changes around navigation. All participants of the cross-sectional study (10/10, 100%) were able to access and use the intervention. Reported satisfaction was good, although the intervention was perceived to lack relevance for people without comorbid psychological distress. Conclusions: We have developed an evidence-based, theory-informed, user-led online intervention for improving self-management and well-being in CVD. The use of multiple evaluation tests informed improvements to content and usability. Preliminary acceptability and feasibility has been demonstrated. The Space from Heart Disease intervention is now ready to be tested for effectiveness. This work has also identified that people with CVD symptoms and comorbid distress would be the most appropriate sample for a future randomized controlled trial to evaluate its effectiveness.

  • preSANO trial logo.

    Accuracy of Detecting Residual Disease After Cross Neoadjuvant Chemoradiotherapy for Esophageal Cancer (preSANO Trial): Rationale and Protocol

    Abstract:

    Background: Results from the recent CROSS trial showed that neoadjuvant chemoradiotherapy (nCRT) significantly increased survival as compared to surgery alone in patients with potentially curable esophageal cancer. Furthermore, in the nCRT arm 49% of patients with a squamous cell carcinoma (SCC) and 23% of patients with an adenocarcinoma (AC) had a pathologically complete response in the resection specimen. These results provide a rationale to reconsider and study the timing and necessity of esophagectomy in (all) patients after application of the CROSS regimen. Objective: We propose a “surgery as needed” approach after completion of nCRT. In this approach, patients will undergo active surveillance after completion of nCRT. Surgical resection would be offered only to those patients in whom residual disease or a locoregional recurrence is highly suspected or proven. However, before a surgery as needed approach in oesophageal cancer patients (SANO) can be tested in a randomized controlled trial, we aim to determine the accuracy of detecting the presence or absence of residual disease after nCRT (preSANO trial). Methods: This study is set up as a prospective, single arm, multicenter, diagnostic trial. Operable patients with potentially curable SCC or AC of the esophagus or esophagogastric junction will be included. Approximately 4-6 weeks after completion of nCRT all included patients will undergo a first clinical response evaluation (CRE-I) including endoscopy with (random) conventional mucosal biopsies of the primary tumor site and of any other suspected lesions in the esophagus and radial endo-ultrasonography (EUS) for measurement of tumor thickness and area. Patients in whom no locoregional or disseminated disease can be proven by cytohistology will be offered a postponed surgical resection 6-8 weeks after CRE-I (ie, approximately 12-14 weeks after completion of nCRT). In the week preceding the postponed surgical resection, a second clinical response evaluation (CRE-II) will be planned that will include a whole body PET-CT, followed again by endoscopy with (random) conventional mucosal biopsies of the primary tumor site and any other suspected lesions in the esophagus, radial EUS for measurement of tumor thickness and area, and linear EUS plus fine needle aspiration of PET-positive lesions and/or suspected lymph nodes. The main study parameter is the correlation between the clinical response assessment during CRE-I and CRE-II and the final pathological response in the resection specimen. Results: The first patient was enrolled on July 23, 2013, and results are expected in January 2016. Conclusions: If this preSANO trial shows that the presence or absence of residual tumor can be predicted reliably 6 or 12 weeks after completion of nCRT, a randomized trial comparing nCRT plus standard surgery versus chemoradiotherapy plus “surgery as needed” will be conducted (SANO trial). Trial Registration: Netherlands Trial Register: NTR4834; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4834 (archived by Webcite at http://www.webcitation.org/6Ze7mn67B).

  • (cc) Sooong et al, please cite as (http://www.researchprotocols.org/article/viewFile/4408/1/60745). JMIR EMA methods - mobile phone.

    Using Ecological Momentary Assessment to Study Tobacco Behavior in Urban India: There’s an App for That

    Abstract:

    Background: Ecological momentary assessment (EMA) uses real-time data collection to assess participants’ behaviors and environments. This paper explores the strengths and limitations of using EMA to examine social and environmental exposure to tobacco in urban India among older adolescents and adults. Objective: Objectives of this study were (1) to describe the methods used in an EMA study of tobacco use in urban India using a mobile phone app for data collection, (2) to determine the feasibility of using EMA in the chosen setting by drawing on participant completion and compliance rates with the study protocol, and (3) to provide recommendations on implementing mobile phone EMA research in India and other low- and middle-income countries. Methods: Via mobile phones and the Internet, this study used two EMA surveys: (1) a momentary survey, sent multiple times per day at random to participants, which asked about their real-time tobacco use (smoked and smokeless) and exposure to pro- and antitobacco messaging in their location, and 2) an end-of-day survey sent at the end of each study day. Trained participants, from Hyderabad and Kolkata, India, reported on their social and environmental exposure to tobacco over 10 consecutive days. This feasibility study examined participant compliance, exploring factors related to the successful completion of surveys and the validity of EMA data. Results: The sample included 205 participants, the majority of whom were male (135/205, 65.9%). Almost half smoked less than daily (56/205, 27.3%) or daily (43/205, 21.0%), and 4.4% (9/205) used smokeless tobacco products. Participants completed and returned 46.87% and 73.02% of momentary and end-of-day surveys, respectively. Significant predictors of momentary survey completion included employment and completion of end-of-day surveys. End-of-day survey completion was only significantly predicted by momentary survey completion. Conclusions: This first study of EMA in India offers promising results, although more research is needed on how to increase compliance. End-of-day survey completion, which has a lower research burden, may be the more appropriate approach to understanding behaviors such as tobacco use within vulnerable populations in challenging locations. Compliance may also be improved by increasing the number of study visits, compliance checks, or opportunities for retraining participants before and during data collection.

  • Picture of the ProMove accelerometer and mobile phone app with feedback.

    Effectiveness, Mediators, and Effect Predictors of Internet Interventions for Chronic Cancer-Related Fatigue: The Design and an Analysis Plan of a 3-Armed...

    Abstract:

    Background: Internet interventions offer advantages that especially cancer survivors who suffer from fatigue could benefit from. Given the growing number of such patients, Internet interventions could supplement and strengthen currently available health care. Objective: This paper describes the design and analysis plan that will be used to study 2 Internet interventions aimed at reducing severe fatigue in cancer survivors: a mobile ambulant activity feedback therapy supported through a weekly email by a physiotherapist and a weekly Web- and mindfulness-based cognitive therapy supported online by a psychologist. The data resulting from this trial will be used to (1) investigate the effectiveness, (2) investigate potential mediators of these interventions, and (3) explore participant characteristics that can predict the effect of these interventions. Methods: A 3-armed randomized controlled trial is proposed that compares both Internet interventions with an active control condition that solely consists of receiving psycho-educational emails. The intervention period is 9 weeks for all 3 conditions. Six months after baseline, participants in the control condition can choose to follow 1 of the 2 experimental Internet interventions. Outcomes are measured in terms of fatigue severity, mental health, and self-perceived work ability. All are Web-assessed at baseline, 2 weeks after the intervention period, and at 6 and 12 months after baseline. Fatigue severity, mindfulness, physical activity, expectations and credibility of the intervention, therapeutic working alliance, sleep quality, and sense of control over fatigue are assessed 3 times during the intervention period for identifying mediators of the interventions. Recruitment is performed nationally throughout the Netherlands through patient organizations and their websites, newspapers, and by informing various types of health professionals. All participants register at an open-access website. We aim at including 330 cancer survivors who have finished curative-intent cancer treatment at least 3 months previously, and have been suffering from severe fatigue ever since. All cancer types are included. A detailed analysis plan is described to address the research questions, which allows for individual variation, and fully exploits the longitudinal design. Results: Recruitment started in April 2013 and will proceed until April 2015. Conclusions: This paper describes a systematic trial design for studying 2 different interventions for chronic cancer-related fatigue in order to gain insight into the effectiveness and mediators of the interventions. This design will also be used to identify predictors for the interventions’ effect on fatigue. By publishing our hypotheses and analysis plan before completion of data collection, this paper is a first step in reporting on this trial comprehensively. Clinical Trial: The Netherlands National Trial Register (NTR3483). (Archived by WebCite at http://www.webcitation.org/6NWZqon3o).

  • Photo taken by one of authors.

    Household Transmission of Zoonotic Influenza Viruses in a Cohort of Egyptian Poultry Growers

    Abstract:

    Background: The highly pathogenic avian influenza H5N1 viruses and the low pathogenic H9N2 viruses are enzootic in Egyptian poultry. Several cases of human infection with H5N1 were reported in Egypt. We previously determined that the seroprevalence of H5N1 antibodies in Egyptians exposed to poultry is 2.1% (15/708), suggesting that mild or subclinical infections with this virus occur. We aim to measure the incidence of avian influenza infection in Egyptians exposed to poultry, study risk factors of infection, study the resulting immune response, study household transmission rates, and characterize the viruses causing infections. Objective: The objective of the study is to design a 7-year, prospective, household-based cohort investigation to determine incidence and household transmission of avian influenza viruses in humans exposed to poultry. Methods: At baseline, we will collect sera to measure antibodies against influenza A. Field nurses will visit enrolled subjects at least weekly to check for influenza-like illness symptoms and verify influenza infection by a point of care rapid test. From subjects with influenza infection and their household contacts, we will collect nasal swabs, throat swabs, and nasal washes to characterize the antigenic and genetic makeup of influenza viruses infecting humans. The nurse will also obtain 2x 3-ml blood samples, one for serology, and another for isolating peripheral blood mononuclear cells. Results: Results from this cohort will enhance our understanding of the transmission of avian influenza viruses to humans in a country where such viruses are enzootic. Conclusions: This may enhance public health efforts aimed at reducing this burden.

  • TOC Suriname Health Study.

Interviewer and respondent from the Suriname Health study.
Picture from the

    A National Surveillance Survey on Noncommunicable Disease Risk Factors: Suriname Health Study Protocol

    Abstract:

    Background: Noncommunicable diseases (NCDs) are the leading cause of death in low- and middle-income countries. Therefore, the surveillance of risk factors has become an issue of major importance for planning and implementation of preventive measures. Unfortunately, in these countries data on NCDs and their risk factors are limited. This also prevails in Suriname, a middle-income country of the Caribbean, with a multiethnic/multicultural population living in diverse residential areas. For these reasons, “The Suriname Health Study” was designed. Objective: The main objective of this study is to estimate the prevalence of NCD risk factors, including metabolic syndrome, hypertension, and diabetes in Suriname. Differences between specific age groups, sexes, ethnic groups, and geographical areas will be emphasized. In addition, risk groups will be identified and targeted actions will be designed and evaluated. Methods: In this study, several methodologies were combined. A stratified multistage cluster sample was used to select the participants of 6 ethnic groups (Hindustani, Creole, Javanese, Maroon, Chinese, Amerindians, and mixed) divided into 5 age groups (between 15 and 65 years) who live in urban/rural areas or the hinterland. A standardized World Health Organization STEPwise approach to surveillance questionnaire was adapted and used to obtain information about demographic characteristics, lifestyle, and risk factors. Physical examinations were performed to measure blood pressure, height, weight, and waist circumference. Biochemical analysis of collected blood samples evaluated the levels of glucose, high-density-lipoprotein cholesterol, total cholesterol, and triglycerides. Statistical analysis will be used to identify the burden of modifiable and unmodifiable risk factors in the aforementioned subgroups. Subsequently, tailor-made interventions will be prepared and their effects will be evaluated. Results: The data as collected allow for national inference and valid analysis of the age, sex, and ethnicity subgroups in the Surinamese population. A publication of the basic survey results is anticipated in mid-2015. Secondary results on the effect of targeted lifestyle interventions are anticipated in late 2017. Conclusions: Using the data collected in this study, the national prevalence of NCD risk factors will be approximated and described in a diverse population. This study is an entry point for formulating the structure of NCD prevention and surveillance.

  • © LilliDay, purchased from iStock (http://www.istockphoto.com/photo/pen-with-blood-test-results-8302229).

    Rural Versus Urban Health Service Utilization and Outcomes for Renal Patients in New South Wales: Protocol for a Data Linkage Study

    Abstract:

    Background: Kidney disease is a significant burden on health systems globally, with the rising prevalence of end stage kidney disease in Australia mirrored in many other countries. Approximately 25% of the Australian population lives in regional and rural areas and accessing complex tertiary services is challenging. Objective: We aim to compare the burden and outcomes of chronic kidney disease and end stage kidney disease in rural and urban regions of New South Wales (Australia’s most populous state) using linked health data. Methods: This is a retrospective cohort study and we have defined two cohorts: one with end stage kidney disease and one with chronic kidney disease. The end stage kidney disease cohort was defined using the Australia and New Zealand Dialysis and Transplant Registry, identifying all patients living in NSW receiving renal replacement therapy at any time between 01/07/2000 and 31/07/2010. The chronic kidney disease cohort used the NSW Admitted Patient Data Collection (APDC) to identify patients with a diagnostic code relating to chronic renal failure during any admission between 01/07/2000 and 31/07/2010. Both cohorts were linked to the NSW APDC, the Registry of Births, Deaths and Marriages, and the Central Cancer Registry allowing derivation of outcomes by categories of geographical remoteness. Results: To date, we have identified 10,505 patients with 2,384,218 records in the end stage kidney disease cohort and 159,033 patients with 1,599,770 records in the chronic kidney disease cohort. Conclusions: This study will define the geographical distribution of end stage and chronic kidney disease and compare the health service utilization between rural and urban renal populations.

  • This is a royalty free image by David Castillo Dominici (http://www.freedigitalphotos.net/images/Family_g212-Young_Mother_And_Daughter_p65236.html).

    Internet-Based Birth-Cohort Studies: Is This the Future for Epidemiology?

    Abstract:

    Background: International collaborative cohorts the NINFEA and the ELF studies are mother-child cohorts that use the internet for recruitment and follow-up of their members. The cohorts investigated the association of early life exposures and a wide range of non-communicable diseases. Objective: The objective is to report the research methodology, with emphasis on the advantages and limitations offered by an Internet-based design. These studies were conducted in Turin, Italy and Wellington, New Zealand. Methods: The cohorts utilized various online/offline methods to recruit participants. Pregnant women who became aware volunteered, completed an online questionnaire, thus obtaining baseline information. Results: The NINFEA study has recruited 7003 pregnant women, while the ELF study has recruited 2197 women. The cohorts targeted the whole country, utilizing a range of support processes to reduce the attrition rate of the participants. For the NINFEA and ELF cohorts, online participants were predominantly older (35% and 28.9%, respectively), highly educated (55.6% and 84.9%, respectively), and were in their final trimester of pregnancy (48.5% and 53.6%, respectively). Conclusions: Internet-based cohort epidemiological studies are feasible, however, it is clear that participants are self-selective samples, as is the case for many birth cohorts. Internet-based cohort studies are potentially cost-effective and novel methodology for conducting long-term epidemiology research. However, from our experience, participants tend to be self-selective. In marked time, if the cohorts are to form part of a larger research program they require further use and exploration to address biases and overcome limitations.

  • From the University of Michigan Health System (UMHS) media bank: http://mediabank.med.umich.edu/category/General/19671691
All rights to all images in this database belong to UMHS or one of its units. All available images may be used for any official UMHS or U-M purpose. Images may be shared with the news media and external organizations.

    The Effect of Health Information Technology on Health Care Provider Communication: A Mixed-Method Protocol

    Abstract:

    Background: Communication failures between physicians and nurses are one of the most common causes of adverse events for hospitalized patients, as well as a major root cause of all sentinel events. Communication technology (ie, the electronic medical record, computerized provider order entry, email, and pagers), which is a component of health information technology (HIT), may help reduce some communication failures but increase others because of an inadequate understanding of how communication technology is used. Increasing use of health information and communication technologies is likely to affect communication between nurses and physicians. Objective: The purpose of this study is to describe, in detail, how health information and communication technologies facilitate or hinder communication between nurses and physicians with the ultimate goal of identifying how we can optimize the use of these technologies to support effective communication. Effective communication is the process of developing shared understanding between communicators by establishing, testing, and maintaining relationships. Our theoretical model, based in communication and sociology theories, describes how health information and communication technologies affect communication through communication practices (ie, use of rich media; the location and availability of computers) and work relationships (ie, hierarchies and team stability). Therefore we seek to (1) identify the range of health information and communication technologies used in a national sample of medical-surgical acute care units, (2) describe communication practices and work relationships that may be influenced by health information and communication technologies in these same settings, and (3) explore how differences in health information and communication technologies, communication practices, and work relationships between physicians and nurses influence communication. Methods: This 4-year study uses a sequential mixed-methods design, beginning with a quantitative survey followed by a two-part qualitative phase. Survey results from aim 1 will provide a detailed assessment of health information and communication technologies in use and help identify sites with variation in health information and communication technologies for the qualitative phase of the study. In aim 2, we will conduct telephone interviews with hospital personnel in up to 8 hospitals to gather in-depth information about communication practices and work relationships on medical-surgical units. In aim 3, we will collect data in 4 hospitals (selected from telephone interview results) via observation, shadowing, focus groups, and artifacts to learn how health information and communication technologies, communication practices, and work relationships affect communication. Results: Results from aim 1 will be published in 2016. Results from aims 2 and 3 will be published in subsequent years. Conclusions: As the majority of US hospitals do not yet have HIT fully implemented, results from our study will inform future development and implementation of health information and communication technologies to support effective communication between nurses and physicians.

  • Hep B screenshot.

    Development of a Culturally Appropriate Bilingual Electronic App About Hepatitis B for Indigenous Australians: Towards Shared Understandings

    Abstract:

    Background: Hepatitis B is endemic in Indigenous communities in Northern Australia; however, there is a lack of culturally appropriate educational tools. Health care workers and educators in this setting have voiced a desire for visual, interactive tools in local languages. Mobile phones are increasingly used and available in remote Indigenous communities. In this context, we identified the need for a tablet-based health education app about hepatitis B, developed in partnership with an Australian remote Indigenous community. Objective: To develop a culturally appropriate bilingual app about hepatitis B for Indigenous Australians in Arnhem Land using a participatory action research (PAR) framework. Methods: This project was a partnership between the Menzies School of Health Research, Miwatj Aboriginal Health Corporation, Royal Darwin Hospital Liver Clinic, and Dreamedia Darwin. We have previously published a qualitative study that identified major knowledge gaps about hepatitis B in this community, and suggested that a tablet-based app would be an appropriate and popular tool to improve this knowledge. The process of developing the app was based on PAR principles, particularly ongoing consultation, evaluation, and discussion with the community throughout each iterative cycle. Stages included development of the storyboard, the translation process (forward translation and backtranslation), prelaunch community review, launch and initial community evaluation, and finally, wider launch and evaluation at a viral hepatitis conference. Results: We produced an app called “Hep B Story” for use with iPad, iPhone, Android tablets, and mobile phones or personal computers. The app is culturally appropriate, audiovisual, interactive, and users can choose either English or Yolŋu Matha (the most common language in East Arnhem Land) as their preferred language. The initial evaluation demonstrated a statistically significant improvement in Hep B-related knowledge for 2 of 3 questions (P=.01 and .02, respectively) and overwhelmingly positive opinion regarding acceptability and ease of use (median rating of 5, on a 5-point Likert-type scale when users were asked if they would recommend the app to others). Conclusions: We describe the process of development of a bilingual hepatitis B-specific app for Indigenous Australians, using a PAR framework. The approach was found to be successful with positive evaluations.

Citing this Article

Right click to copy or hit: ctrl+c (cmd+c on mac)

Latest Submissions Open for Peer-Review:

View All Open Peer Review Articles
  • DPVD (Diabetes Prevention with active Vitamin D) trial: A randomized controlled trial of the effect of eldecalcitol on the incidence of type 2 diabetes among pre-diabetic individuals

    Date Submitted: Jul 5, 2015

    Open Peer Review Period: Jul 6, 2015 - Jul 20, 2015

    Type 2 diabetes is an important risk factor for cardiovascular disease and for a variety of complications. Moreover, the incidence of type 2 diabetes is currently increasing and has become a major bur...

    Type 2 diabetes is an important risk factor for cardiovascular disease and for a variety of complications. Moreover, the incidence of type 2 diabetes is currently increasing and has become a major burden to healthcare systems and societies worldwide.1 In Japan, there are approximately 7.1 million persons with diabetes and 109,000 persons per year are diagnosed with diabetes.2 Additionally, 552 million people worldwide will have type 2 diabetes by the year 2030.3 The incidence of type 2 diabetes from pre-diabetes (impaired fasting glucose [IFG] and/or impaired glucose tolerance [IGT]) is about 10% (5.8–13.2%).4-7 While diabetes is an irreversible state, pre-diabetes can be reverted to a normal glucose state. Therefore, many clinical trials have aimed to evaluate the reduction of the incidence of type 2 diabetes by targeting individuals with pre-diabetes. Active vitamin D is currently prescribed as the drug of choice for osteoporosis and hypocalcemia, but it was reported that vitamin D and active vitamin D have additional metabolic effects aside from that on bone and calcium metabolism.8,9 One of the additional effects of vitamin D is that exerted on the glucose metabolism. Many studies reported that the serum 25(OH)D3 level is inversely associated with the incidence of type 2 diabetes.10-14 Thus, some small clinical trials have evaluated whether vitamin D and active vitamin D have an effect to improve insulin resistance and glucose metabolism, but the results are still controversial.15-22 None of the studies reported so far tested whether active vitamin D could prevent diabetes. Thus, we plan to conduct a randomized controlled trial to evaluate whether active vitamin D can prevent the incidence of type 2 diabetes among pre-diabetic individuals, and whether it can normalize blood glucose levels. In 2011, a new active vitamin D (eldecalcitol) became a prescription drug for osteoporosis and hypocalcemia in Japan. It showed superior efficacy in preventing bone fracture to existing active vitamin D drugs. Active vitamin D is inexpensive and has no intake restrictions. Additionally, the drug compliance of eldecalcitol should be better than that of vitamin D-containing dietary supplements. Although hypercalcemia could be a side effect, if patients have normal renal function, the excess serum calcium would be excreted through the urine. Furthermore, this side effect is very rare. Clinical Trials Registry Number: UMIN 000010758 https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000012436&type=summary&language=E

  • Smartphone applications for university students with hazardous alcohol use: Study protocol for two consecutive randomized controlled trials

    Date Submitted: Jul 2, 2015

    Open Peer Review Period: Jul 4, 2015 - Jul 18, 2015

    Background: About 50% of university students are known to overconsume alcohol, and drinking habits in later adulthood are to some extent established during higher educational studies. Several studies...

    Background: About 50% of university students are known to overconsume alcohol, and drinking habits in later adulthood are to some extent established during higher educational studies. Several studies have demonstrated that Internet-based interventions have positive effects on drinking habits among university students. Our recent study evaluated two smartphone applications targeting drinking choices at party occasions via personalized feedback on estimated blood alcohol concentration (eBAC). No changes in drinking parameters were found over a seven-week period apart from an increase in number of drinking occasions among men for one of the apps tested. Also, throughout the study up to 30% of the study participants drank at levels higher than the recommended number of standard drinks per week (9 for women and 14 for men) in Sweden [1]. Objective: 1. To evaluate revised versions of the two smartphone applications tested in our prior trial, in a new, 3-armed randomized controlled trial among university students with at least hazardous drinking habits according (Study 1). 2. After 6 weeks, to target study participants showing alcohol consumption higher than the national recommended levels for standard drinks per week, by offering them participation in a second, 2-armed randomized trial evaluating an additional smartphone application with skill enhancement tasks (Study 2). 3. To follow participants at 6, 12 and 18 weeks after recruitment to Study 1 and at 6 and 12 weeks after recruitment to Study 2. Methods: Two randomized controlled trials are conducted. Study 1: Students are recruited at four Swedish universities, via direct e-mail and advertisements on Facebook and student union web sites. Those who provide informed consent, have a smartphone, and show at least hazardous alcohol consumption according to the Alcohol Use Disorders Identification Test (AUDIT, ≥6 for women and ≥8 points for men) are randomized into three groups. Group 1 has access to the Swedish government alcohol monopoly’ s app, Promillekoll, offering real-time estimated blood alcohol concentration (eBAC) calculation; Group 2 has access to a web-based app, PartyPlanner, developed by the research group, offering real-time eBAC calculation with planning and follow-up functions; and Group 3 participants are controls. Follow-up is conducted at 6, 12 and 18 weeks. Study 2. Participants who at the first 6-week follow-up show drinking levels higher than 9 (W) or 14 (M) standard drinks (12 g alcohol) per week, are offered participation in Study 2. Those who consent are randomized to either access to a skills training app, TeleCoach™ or to a wait-list control group. Results: Latent Markov models for Study 1 and mixed models analyses for Study 2 will be performed. Conclusions: If smartphone interventions for reducing hazardous alcohol use are found to be effective, the prospects for positively influencing substance use-related health among university students can considerably improve. Clinical Trial: ClinicalTrials.gov NCT02064998

  • Lifestyle Modification Experiences of African American Breast Cancer Survivors: A Needs Assessment

    Date Submitted: Jul 2, 2015

    Open Peer Review Period: Jul 2, 2015 - Jul 16, 2015

    Background: Background: Little is known about the rates of obesity among African American (AA) breast cancer survivors (BCSs), the availability and use of lifestyle modification methods suitable for t...

    Background: Background: Little is known about the rates of obesity among African American (AA) breast cancer survivors (BCSs), the availability and use of lifestyle modification methods suitable for this population, and the impact of changes in dietary intake and physical activity on health-related quality of life (HR-QoL). Objective: The objectives of the formative research (2013-2015) completed as part of this protocol were to describe obesity rates, dietary intake, and physical activity as lifestyle modification strategies; examine predictors of engagement in these strategies post-diagnosis; and learn more about salient features of lifestyle interventions from AA BCSs participating in a breast cancer support group. Methods: The needs assessment included four components: 1) a literature review to determine existing lifestyle modification strategies of AA BCSs; 2) secondary data analysis of the 2010 National Health Interview Survey, Cancer Control Supplement to examine HR-QoL; 3) administration, to 200 AA BCSs, of an assessment tool relating to weight and breast cancer history, dietary intake, and physical activity through a variety of approaches (e.g., on-line, mail, in-person, and telephone); and 4) focus group discussions to frame lifestyle interventions. Results: Preliminary findings indicate that AA BCSs are underrepresented in lifestyle intervention research, have disparities in HR-QoL outcomes, do not meet current cancer prevention guidelines, and have recommendations for effective strategies for lifestyle modification. Conclusions: As analyses of the needs assessment are completed, the research team is partnering with community coalitions and breast cancer support groups in Miami, Chicago, Houston, Los Angeles, and Philadelphia to develop community-engaged intervention approaches for promoting adherence to cancer prevention guidelines. Objective: The specific objectives of this formative research were to consider obesity rates, dietary intake, and physical activity as targets for lifestyle modification strategies; to examine predictors of engagement in these strategies post-diagnosis; and to learn more about salient features of lifestyle interventions from AA BCSs. Since there are gaps in care for AA BCSs [22], a fragmented transition from active treatment to survivorship [23], and long-term implications of inadequate dietary intake on recurrence [24], Survivors Involving Supporters to Take Action in Advancing Health (SISTAAH) Talk, a BrCa support group, was selected as the study population because it is an untapped, indigenous resource for learning about and promoting lifestyle changes. The objective of SISTAAH Talk is to provide a forum for AA women to communicate about and make sense of their BrCa experience in order to achieve improved physical and mental health outcomes. We anticipate that inclusion of the target population in determining their lifestyle modification needs and experiences will result in development of testable interventions. Methods: Literature Review The first step in the needs assessment was completing a systematic review of the literature for English language articles in MEDLINE, MEDLINE In-Process (MEIP), and the Cochrane Library (CCTR [Central Register of Controlled Trials]). No date restrictions were applied, and free-text and MeSH terms were used to identify studies including (but not limited to), lifestyle practices, dietary intake, physical activity, psychosocial factors, and quality of life. Next, to search for areas of interest, terms were combined, e.g., weight loss AND African American AND women AND interventions. The search did not include abstracts from conferences. Relevant, full-text publications that were potentially relevant were screened for inclusion based on the following criteria: • Study design (prospective or retrospective observational studies, randomized clinical trials, or meta-analyses). • Population (AA women) • Lifestyle modification (diet, physical activity, weight control/loss) • Psychosocial factors (quality of life, anxiety and cancer-related fears, negative body image, depression, relationship changes, financial stress) Secondary Data Analyses Next, data from the national surveys were used to describe lifestyle and cancer risk behaviors of AA women. Baseline dietary intake, physical activity, and cancer risk behaviors of this population were established through an examination of the following secondary datasets: 1. The Behavioral Risk Factor Surveillance System (BRFSS) is a state-based system of health surveys that collects information on health risk behaviors, preventive health practices, and health care access primarily related to chronic disease and injury [33]. The BRFSS measure of physical activity was used to capture typical weekly physical activity and scored in metabolic equivalent minutes/day (MET min-1 x day-1), including duration and intensity. 2. The National Health and Nutrition Examination Survey (NHANES) is a program of studies designed to assess the health and nutritional status of adults and children in the United States [34]. Our methods for measuring weight loss were adapted from the NHANES weight history questionnaire. Modifications were made by combining questions on self-directed diet changes (e.g., “ate less food,” “ate less fat,” and “switched to foods with lower calories”) into a single item (“dieted on your own without joining a program or following a special diet book”) and separating commercial programs and self-help programs. 3. The National Health Interview Survey (NHIS) is the principal source of information on the health of the civilian, non-institutionalized population of the United States [35]. The NHIS Cancer Control Supplement (CCS), administered every five years, focuses on issues pertaining to knowledge, attitudes, and practices in cancer-related health behaviors, screening, and risk assessment. The NHIS CCS is co-sponsored by the National Cancer Institute and the Centers for Disease Control and Prevention. The cancer survivorship portion of the survey was included in our assessment tool and used to examine HR-QoL. The final step was to condense lifestyle modification data. Results from the literature search and secondary data analysis were summarized to describe evidence-based, lifestyle modification efforts among AA women. Lifestyle needs assessment tool development Validated scales (related to dietary intake/physical activity, weight loss history, and cancer risk) were selected from the datasets described above for inclusion in the needs assessment. Criteria for selection were based on the capacity of the measures to answer three questions: 1. Are AA BCSs aware of the relationship between lifestyle modification in preventing BrCa recurrence and enhancing quality of life during and after treatment? 2. If offered, will AA BCSs engage in lifestyle modification activities? 3. Which lifestyle modification strategies are most appealing to the targeted population? The final tool assessed: • Demographics (race/ethnicity, age, gender, education, income, religious affiliation, marital status, insurance, employment) • Knowledge, attitudes and beliefs or KABs (BrCa survival/prognosis, diet/physical activity interventions) • BrCa history (BrCa diagnosis and treatment history, menopausal status, treatment side effects) • Lifestyle modification needs and experiences (physical activity levels, dietary intake, self-reported current height and weight, self- reported weight at time of diagnosis, current weight loss attempt, number of weight loss attempts since BrCa diagnosis, weight loss methods tried) • HR-QoL related to adjustment to BrCa, i.e., cancer-specific HR-QoL (e.g., emotional, physical, and social well-being), depression, fear of recurrence, diminished physical strength, change in relationships, change in body image, and financial stress Good readability, layout, and design were factors in developing the assessment tool. The Flesch reading ease (FRE) score was used to assess readability. The reading ease scores on the FRE scale are 0-100. If the score of a written text is less than 60, the document is considered difficult to read by the general public. A draft of the assessment tool was administered to 10 AA BCSs to determine the time required to complete and adjusted unclear items. The assessment tool was re-tested prior to finalization. The final needs assessment had a readability score of less than 80. All data collection instruments and consent forms were reviewed and approved by the Morehouse School of Medicine Institutional Review Board. Lifestyle needs assessment tool administration A form letter to participants was developed. It stressed the usefulness of the information garnered from the tool to develop lifestyle interventions for AA BCSs and encouraged the subjects to complete the assessment tool. Because the tool is an initial step in developing lifestyle interventions specific to the targeted population, engagement during the needs assessment phase is imperative to long-term success (e.g., developing lifestyle interventions). The final step was providing modes for administration of the assessment tool. Based on past research experiences with AA BCSs, we were aware of the need for multiple modes for administering the measure. In an assessment of BrCa gene-environmental interactions among multigenerational AA women with SISTAAH Talk members, we visited homes, met at infusion centers, communicated by telephone, and employed similar approaches to reach the targeted population [36-37]. Assessment tools were self-administered electronically online, by email, or by mail to home addresses. They were also administered by an interviewer in-person or by telephone. Focus group discussions Four focus groups were conducted with 8-12 BCSs engaged in 90-minute sessions to address intervention content. A moderator initiated each discussion with a structured set of questions. Sample size was determined based on the principle of saturation, which suggests that, with as few as four discussions, no additional information will be obtained. This qualitative sampling technique was used to ensure that perspectives across age groups were obtained. An interview guide was developed for this purpose. Responses were digitally recorded, transcribed verbatim, manually coded, and summarized. Data were analyzed by Qualitative Content Analysis [38]. Coding steps included developing preliminary themes, creating additional codes based on themes that arise, developing non-substantive codes, and producing detailed codes for analysis of specific topics. NVIVO 10, a computer-assisted qualitative data analysis software was used to facilitate the coding process (i.e., to determine the degree of agreement/disagreement across themes and to calculate inter-rater reliability scores) [39]. A process of double-coding was used to overcome coder differences in reliability scores. Recurring themes were identified, the research team came to consensus on coded themes, and themes were summarized for analysis. Statistical Analysis Descriptive statistics were performed by determining means and standard deviations (SDs) for continuous variables and frequencies and percentages for categorical variables from demographic, KABs, BrCa history, lifestyle modification experiences, and needs as well as psychosocial factors captured by the assessment tool. The t-score units, calculated by means and SDs for scores, were used to estimate the HR-QoL for four items and for physical and mental status. Multivariable linear and logistic regression analyses were performed to assess the influence of the multidimensional aspects of HR-QoL after adjusting for confounding demographic variables (age, marital status, and education) as covariates. The t-scores, odds ratios, and related 95% confidence intervals were derived from multivariable analyses. The significance level was set at 0.05, and all tests were two-sided. All statistical analyses were accomplished with SAS version 9.2 (SAS Institute, Cary, NC). Results: PRELIMINARY RESULTS The literature review revealed that, although lifestyle changes can halve the risk of recurrence and reduce the risk of BrCa-associated mortality by one third, many patients do not engage in such strategies. Limited research on AAs exists because they have been underrepresented in studies examining health behaviors that improve BrCa survival [41]. One of the few studies with AA women, the Women’s Healthy Eating and Living (WHEL) Study, which showed that, at baseline, AA survivors were more likely to be obese (45% vs. 25% for whites), to consume more calories from fat (+3.2%), to have fewer servings of fruits (-0.7/day), and to be less successful at making and maintaining dietary changes than whites [42-43]. Greenlee et al. [44] conducted a randomized controlled trial with the commercially available Curves program, following 42 Hispanic and AA BCSs for 6 months. The trial resulted in weight loss that was not maintained at 6 months after the intervention. A community-based pilot study of 24 AA BCSs engaged in walking as physical activity [45] resulted in increases in steps walked per day and decreases in BMI, body weight, and waist/hip circumferences, with most changes maintained at 3 months. A pre-post design, that included one of two weekly sessions dedicated to exercise, was used to test a 6-month intervention with 23 AA BCSs [46]; participants experienced changes in weight, BMI, and social support. In a 16-week, home-based motivational exercise program for 13 AA BCSs, there was a post-intervention increase in total minutes of physical activity and improved physical functioning [47-48]. In the secondary data analysis, female AAs aged 35 and older (n=62) were compared to AA female survivors of other cancers (SOCs) (n=74) and to AA women with no history of cancer (NHCs) (n=1,566) of the same age. Differences in HR-QoL were assessed, including four items each and summary physical and mental health estimated in t-score units. All analyses were weighted and adjusted for age, marital status, and education. There were no statistically significant differences for BCSs and NHCs, but the SOCs reported poorer physical health relative to NHCs [t=5.8, 95% CI: 2.8 – 8.8]. Further, there were no statistically significant differences between BCSs and NHCs, but SOCs reported poorer mental health relative to NHCs [t=3.3, 95% CI: 0.6 – 5.9]. A comparison of differences between SOCs and NHCs showed three items in which SOCs were more likely to report poorer physical health relative to NHCs (ability to carry out physical activities [OR=3.4; 95% CI: 1.7 – 6.7], level of fatigue [OR=2.0; 95% CI: 1.1 – 3.7], and level of pain [OR=3.3; 95% CI: 1.3 – 3.9]). AA BCSs (n=240; mean age: 56.90 years; standard deviation [SD]: 11.8; range: 25-92 years old) completed a self-administered lifestyle assessment survey. More than half reported poor physical functioning; were overweight/obese (68%); did not limit portion sizes to control weight (89%); consumed <5 vegetables and fruits/day (75%) and >5 servings red (75%) and processed meats/week (94%). Four focus group discussions (n = 42; mean age: 45.73 years; standard deviation [SD]: 7.91; range: 35–75 years old) identified barriers to and intervention approaches for enhancing dietary intake and themes emerging from content analysis converged into the following categories: “talk” as central; peer-facilitated sessions; support group approach; no “pamphlet only” control group; ”hands on” or interactive nutrition education; supporters (co-survivors) and community-based (not “placed”) research. Conclusions: With the successful implementation of this protocol for health needs assessment and the availability of preliminary findings from qualitative analyses, our study team is now planning health promotion trials in partnership with community coalitions and BrCa support groups in Miami, Chicago, Houston, Los Angeles, and Philadelphia to develop community-engaged intervention approaches for promoting adherence to cancer prevention guidelines. The focus of these proposed studies, which are at the protocol development and planning stage, is on increasing physical activity and improving diet among AA BCSs, with the goal of reducing risk of BrCa recurrence, improving survival, and increasing HR-QoL in this at-risk population. We anticipate that both feasibility trials and cluster-randomized controlled trials will be undertaken once the study protocols have undergone peer review and extramural funding is secured.

  • Designing an Internationally-Accessible Web-based Questionnaire to Discover Risk Factors for Amyotrophic Lateral Sclerosis

    Date Submitted: Jul 1, 2015

    Open Peer Review Period: Jul 1, 2015 - Jul 10, 2015

    Background: Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease with a typical survival of three to five years. Epidemiological studies using paper-based questionnaires in i...

    Background: Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease with a typical survival of three to five years. Epidemiological studies using paper-based questionnaires in individual countries or continents have failed to find widely-accepted risk factors for the disease. The many advantages of online versus paper-based questionnaires have been extensively reviewed, but few online epidemiological studies into human neurodegenerative diseases have so far been undertaken. Objective: To design a web-based questionnaire to identify environmental risk factors for ALS and to enable international comparisons of these risk factors. Methods: A web-based epidemiological questionnaire for ALS has been developed, based on experience gained from administering a previous continent-wide paper-based questionnaire for this disease. New and modified questions have been added from our previous paper-based questionnaire, from literature searches, and from validated ALS questionnaires supplied by other investigators. New criteria to allow the separation of familial and sporadic ALS have been included. The questionnaire addresses many risk factors that have already been proposed for ALS, as well as a number that have not yet been rigorously examined. To encourage participation respondents maintain anonymity since no personally-identifying information is requested. The survey is being translated into a number of languages, which will allow most people around the world to read and answer it in their own language. Results: After the questionnaire had been online for 4 months it had 379 respondents, compared to only 46 respondents for the same initial period using a paper-based questionnaire. The questionnaire is soon to be promoted in a number of different countries through ALS associations in these countries and via disease registries. Feedback about the ease of use of the online questionnaire from respondents, including from those with physical disability, has been positive. Conclusions: Web-based questionnaires are a time- and resource-efficient method for performing large epidemiological studies of neurodegenerative diseases such as ALS. The ability to compare risk factors between different countries using the same analysis tool will be of particular value for finding robust risk factors that underlie ALS.

  • A cross-sectional study on ‘Attitudes to and Understanding of Risk of Acquisition of HIV’ (AURAH) study: Design, Methods and Participant Characteristics.

    Date Submitted: Jun 28, 2015

    Open Peer Review Period: Jun 28, 2015 - Jul 12, 2015

    Background: The annual number of new HIV infections in the UK among men who have sex with men has risen year on year and, among heterosexuals remains high. Increasing HIV transmission among men who ha...

    Background: The annual number of new HIV infections in the UK among men who have sex with men has risen year on year and, among heterosexuals remains high. Increasing HIV transmission among men who have sex with men is consistent with evidence of ongoing sexual risk behaviour in this group and targeted prevention strategies for this population are needed. Methods/Design: The AURAH study (Attitudes to and Understanding of Risk of Acquisition of HIV) was designed to investigate and assess knowledge of, and attitudes to, HIV transmission risks, as well as physical and mental health, lifestyle and behaviours in HIV negative or undiagnosed people in the UK. It aimed to recruit a large sample of sexually active people, with a focus on key demographic subgroups affected by HIV in the UK, men who have sex with men and black African men and women. Participants that attended 20 sexual health clinics across the UK in 2013-2014 were invited to participate and complete a confidential, self-administered pen and paper questionnaire. Consent also included an option to provide details for future contact about further research, specifically an online prospective cohort study called AURAH2, which commenced in March 2015. Discussion: The study researchers approached a total of 4393 patients in the 20 clinics and obtained 2630 (60%) completed questionnaires over a 17 month period. Of those who participated 2036 (77%) were in the key subgroups of interest, 590 were black Africans (331 females and 259 males) and 1473 were MSM - with 27 in both these categories. 766 MSM participants from AURAH who provided contact details have been invited to join the follow-on web-based prospective cohort questionnaire study, AURAH2. The results from AURAH will be a significant resource to understand the attitudes and sexual behaviour of those at risk of acquisition of HIV within the UK. This will inform future prevention efforts and targeted health promotion initiatives in the HIV negative population.

  • Mamma Mia: From theory to intervention – Mapping the development of an internet intervention for postpartum depression

    Date Submitted: Jun 24, 2015

    Open Peer Review Period: Jun 28, 2015 - Jul 12, 2015

    Background: 10–15% of new mothers experience depression postpartum. An internet-based intervention (‘Mamma Mia’) was developed with the primary aims of preventing depressive symptoms and enhanci...

    Background: 10–15% of new mothers experience depression postpartum. An internet-based intervention (‘Mamma Mia’) was developed with the primary aims of preventing depressive symptoms and enhancing subjective well-being among pregnant and postpartum women. A secondary aim of Mamma Mia was to ease the transition of becoming a mother by providing knowledge, techniques, and support during pregnancy and after birth. Objective: The aim of the current article is to provide a systematic and comprehensive description of the intervention rationale and the development of Mamma Mia. Methods: For this purpose, we used Intervention Mapping (IM) protocol as descriptive tool, which consists of six steps: 1) a needs assessment, 2) definition of change objectives, 3) selection of theoretical methods and practical strategies, 4) development of program components, 5) planning adoption and implementation, and 6) planning evaluation. For this purpose, we used Intervention Mapping (IM) protocol as descriptive tool, which consists of six steps: 1) a needs assessment, 2) definition of change objectives, 3) selection of theoretical methods and practical strategies, 4) development of program components, 5) planning adoption and implementation, and 6) planning evaluation. Results: Mamma Mia is a fully automated internet intervention available for computers, tablets, and smartphones. It starts in gestational week 18–24 and lasts to the baby is about 6 months, and applies a tunneled design to guide the woman through the program in a step-by-step fashion in accordance with the psychological preparations of becoming a mother. The intervention is delivered by e-mail and interactive websites, combining text, pictures, pre-recorded audio files, and user input. It targets risk and protective factors for postpartum depression such as pre- and postpartum attachment, couple satisfaction, social support, and subjective well-being, as identified in the needs assessment. The plan is to implement Mamma Mia directly to users and as part of ordinary services at well-baby clinics, and to evaluate the effectiveness of Mamma Mia in a randomized controlled trial and assess users’ experiences with the program. Conclusions: The Intervention Mapping of Mamma Mia has made clear the rationale for the intervention, and linked theories and empirical evidence to program contents and materials. This meets the recent calls for intervention descriptions and may inform future studies, development of interventions, and systematic reviews.