What's missing in missing data? Omissions in survey responses among parents of children with advanced cancer

Background: Missing data is a common phenomenon with survey-based research; patterns of missing data may elucidate why participants decline to answer certain questions. Objective: To describe patterns of missing data in the Pediatric Quality of Life and Evaluation of Symptoms Technology (PediQUEST) study, and highlight challenges in asking sensitive research questions. Design: Cross-sectional, survey-based study embedded within a randomized controlled trial. Setting: Three large children's hospitals: Dana-Farber/Boston Children's Cancer and Blood Disorders Center (DF/BCCDC); Children's Hospital of Philadelphia (CHOP); and Seattle Children's Hospital (SCH). Measurements: At the time of their child's enrollment, parents completed the Survey about Caring for Children with Cancer (SCCC), including demographics, perceptions of prognosis, treatment goals, quality of life, and psychological distress. Results: Eighty-six of 104 parents completed surveys (83% response). The proportion of missing data varied by question type. While 14 parents (16%) left demographic fields blank, over half (n=48; 56%) declined to answer at least one question about their child's prognosis, especially life expectancy. The presence of missing data was unrelated to the child's diagnosis, time from progression, time to death, or parent distress (p>0.3 for each). Written explanations in survey margins suggested that addressing a child's life expectancy is particularly challenging for parents. Conclusions and Relevance: Parents of children with cancer commonly refrain from answering questions about their child's prognosis, however, they may be more likely to address general cure likelihood than explicit life expectancy. Understanding acceptability of sensitive questions in survey-based research will foster higher quality palliative care research. © Copyright 2014, Mary Ann Liebert, Inc. 2014.

Sucrose and lollypops to reduce immunisation pain in toddlers and young children: two pilot randomised controlled trials

Aims To evaluate the feasibility, acceptability and preliminary efficacy of sweet taste in reducing pain in toddlers and pre-school children during immunisation and to use the results to inform a sample size estimation for future full-scale trials. Background Sweet solutions reduce procedural pain in newborn infants and in infants beyond the newborn period. It is unclear if sweet taste continues to reduce procedural pain in children older than one year of age. Design Two parallel design pilot randomised controlled trials (RCTs). Methods Children attending an Immunisation Drop-in Clinic at a children's hospital in Australia participated in one of two pilot RCTs: 1) a double-blinded RCT of 33% sucrose compared to water in toddlers receiving their 12- or 18-month immunisation or 2) a non-blinded RCT of lollypop compared to standard care (active distraction using bubble and pin wheel blowing) in pre-school children aged 3-5 years. Primary outcomes included cry incidence and duration and pain score using the FLACC. Results Interventions, standard care and all aspects of the study were acceptable to children, parents and immunisation nurses. More toddlers in the sucrose group received their 12-month immunisation and more injections (n=35) compared to toddlers randomised to water (n=26). There were no significant differences in crying time or pain scores between intervention and control groups in either pilot RCT. Conclusion The study interventions are acceptable to children and parents. Full-scale trials would be feasible to conduct. Implications for clinical practice Toddlers receiving their 12-month immunisation should be the focus of future full-scale RCTs.

Dealing with alcohol-related problems in the night-time economy: a study protocol for mapping trends in harm and stakeholder views surrounding local community level interventions

This project will provide a comprehensive investigation into the prevalence of alcohol-related harms and community attitudes in the context of community-based interventions being implemented to reduce harm in two regional centres of Australia. While considerable experimentation and innovation to address these harms has occurred in both Geelong and Newcastle, only limited ad-hoc documentation and analysis has been conducted on changes in the prevalence of harm as a consequence, leaving a considerable gap in terms of a systematic, evidence-based analysis of changes in harm over time and the need for further intervention. Similarly, little evidence has been reported regarding the views of key stakeholder groups, industry, government agencies, patrons or community regarding the need for, and the acceptability of, interventions to reduce harms. This project will aim to provide evidence regarding the impact and acceptability of local initiatives aimed at reducing alcohol-related harms.

Development, feasibility and usability of an online psychological intervention for men with prostate cancer: my road ahead

Men with prostate cancer are not routinely offered psychosocial support despite strong evidence that being diagnosed with prostate cancer poses significant quality of life concerns and places the patient at elevated risk of developing a range of mental health disorders. The objective of this study was to develop an online psychological intervention for men with prostate cancer and to pilot test the feasibility and acceptability of the intervention. Development of the intervention involved a multidisciplinary collaboration, adapting face-to-face and group intervention strategies for an online format. The full online intervention and moderated forum were pilot tested with 64 participants who were recruited from urology practices in Melbourne, Victoria, Australia. After consenting to participate and creating a personal account in the online programme, participants completed baseline demographic questionnaires. Participants were provided access to the programme for 6-12. weeks. After completing the programme participants completed an online survey to assess intervention and forum utilisation and satisfaction, as well as suggest intervention refinements following their use of the intervention. Patient satisfaction was calculated using mean responses to the satisfaction questionnaire. The intervention was received positively with 47.82% of participants highly satisfied with the programme, and 78.26% said they would recommend it to a friend. Participants' qualitative feedback indicated good acceptability of the online intervention. A number of technical and participant engagement issues were identified and changes recommended as a result of the feasibility testing.

Self-monitoring of blood glucose versus self-monitoring of urine glucose in adults with newly diagnosed Type 2 diabetes receiving structured education: a cluster randomized controlled trial.

AIMS: To compare the effectiveness and acceptability of self-monitoring of blood glucose with self-monitoring of urine glucose in adults with newly diagnosed Type 2 diabetes. METHODS: We conducted a multi-site cluster randomized controlled trial with practice-level randomization. Participants attended a structured group education programme, which included a module on self-monitoring using blood glucose or urine glucose monitoring. HbA1c and other biomedical measures as well as psychosocial data were collected at 6, 12 and 18 months. A total of 292 participants with Type 2 diabetes were recruited from 75 practices. RESULTS: HbA1c levels were significantly lower at 18 months than at baseline in both the blood monitoring group [mean (se) -12 (2) mmol/mol; -1.1 (0.2) %] and the urine monitoring group [mean (se) -13 (2) mmol/mol; -1.2 (0.2)%], with no difference between groups [mean difference adjusted for cluster effect and baseline value = -1 mmol/mol (95% CI -3, 2); -0.1% (95% CI -0.3, 0.2)]. Similar improvements were observed for the other biomedical outcomes, with no differences between groups. Both groups showed improvements in total treatment satisfaction, generic well-being, and diabetes-specific well-being, and had a less threatening view of diabetes, with no differences between groups at 18 months. Approximately one in five participants in the urine monitoring arm switched to blood monitoring, while those in the blood monitoring arm rarely switched (18 vs 1% at 18 months; P < 0.001). CONCLUSIONS: Participants with newly diagnosed Type 2 diabetes who attended structured education showed similar improvements in HbA1c levels at 18 months, regardless of whether they were assigned to blood or urine self-monitoring.

The population cost-effectiveness of a parenting intervention designed to prevent anxiety disorders in children

BACKGROUND: Prevention and early intervention for anxiety disorders has lagged behind many other forms of mental disorder. Recent research has demonstrated the efficacy of a parent-focussed psycho-educational programme. The programme is directed at parents of inhibited preschool children and has been shown to reduce anxiety disorders at 1 and 3 years following intervention. The current study assesses the cost-effectiveness of this intervention to determine whether it could provide value-for-money across a population. METHOD: A cost-utility economic framework, using Disability-Adjusted-Life-Years (DALYs) as the outcome, was adopted. Economic modelling techniques were used to assess the incremental cost-effectiveness ratio (ICER) of the intervention within the Australian population context, which was modelled as add-on to current practice. The perspective was the health sector. Uncertainty was measured using multivariate probabilistic testing and key assumptions were tested using univariate sensitivity analysis. RESULTS: The median ICER for the intervention was AUD$8,000 per DALY averted with 99.8% of the uncertainty iterations falling below the threshold value-for-money criterion of AUD$50,000 per DALY averted. The results were robust to sensitivity testing. CONCLUSIONS: Screening young children in a preschool setting for an inhibited temperament and providing a brief intervention to the parents of children with high levels of inhibition appears to provide very good value-for-money and worth considering in any package of preventive care. Further evaluation of this intervention under routine health service conditions will strengthen conclusions. Acceptability issues associated with this intervention, particularly to preschool staff and parents, need to be considered before wide-scale adoption is undertaken.

Reducing electronic media use in 2-3 year-old children: feasibility and efficacy of the Family@play pilot randomised controlled trial

BACKGROUND: Participation in electronic media use among 2-3 year olds is high and associated with adverse health and developmental outcomes. This study sought to test the feasibility and potential efficacy of a family-based program to decrease electronic media (EM) use in 2-3-year-old children. METHODS: Family@play was a six-session pilot randomised controlled trial delivered to parents of 2-3 year-old children from August to September 2012 in a community environment in the Illawarra region of New South Wales, Australia. Development of program content was guided by Social Cognitive and Family Systems Theories. The primary outcome was children's electronic media use. Secondary outcomes included children's time in sitting, standing and stepping. Data collectors were blinded to group allocation. Parents completed comprehensive process evaluation measures and participated in focus group discussions following completion of the program. Regression analyses were undertaken and effect sizes calculated using principles of intention to treat. RESULTS: Twenty-two participants (n = 12 intervention; n = 10 control) provided complete baseline data; complete data from 16 participants (n = 6 intervention; n = 10 control) were available post-intervention. Process evaluation results were high, showing the acceptability of the program. Compared with children in the control group, there were greater decreases in total EM use among children in the intervention group (adjusted difference [95 % CI] = -31.2 mins/day [-71.0-8.6] Cohen's d = 0.70). Differences for other outcomes were in the hypothesised direction and ranged from small for postural (sitting, standing, stepping) outcomes to moderate to large for individual electronic media (e.g. TV viewing, DVD/video viewing). CONCLUSIONS: This is the first family-based study to engage families of 2-3 year old children outside the United States and target multiple EM behaviours. Family@play was shown to be a feasible and acceptable intervention to deliver to families of 2-3 year old children. Potential efficacy is evident from moderate to large effect sizes. A larger trial is warranted to test the efficacy of the program. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ( ACTRN12612000470897 ).

Inulin and maltodextrin can replace fat in baked savoury legume snacks

A baked yellow split pea cracker was developed with fat replacement (0%, 25%, 50%, 75% and 100%) using inulin, hydroxypropyl methylcellulose and maltodextrin. Effects of fat replacement on physical (water activity, moisture content, colour and hardness), nutritional properties and consumer acceptance (nine-point hedonic rating) of snacks were investigated. Water activity (0.15-0.32) and moisture (1.28-3.16%) readings were consistent, and products were considered shelf stable. High levels of fat replacement (100%) were detrimental to snack colour and hardness. Snacks with 75% fat replacement using inulin and maltodextrin received similar mean overall acceptability scores (6.40 ± 1.36 and 6.26 ± 1.37, respectively) to the control and a similar commercial product. These snacks were eligible to claim that they were a 'good source' of protein (requirement; ≥10 g per serve) and an 'excellent source' of dietary fibre (requirement; ≥7 g per serve) while providing 'reduced' fat content (≤25% than reference food) based on the Australian Food Standards Code.

A pilot, multisite, randomized controlled trial of a self-directed coping skills training intervention for couples facing prostate cancer : accrual, retention, and data collection issues

PURPOSE: To examine the acceptability of the methods used to evaluate Coping-Together, one of the first self-directed coping skill intervention for couples facing cancer, and to collect preliminary efficacy data. METHODS: Forty-two couples, randomized to a minimal ethical care (MEC) condition or to Coping-Together, completed a survey at baseline and 2 months after, a cost diary, and a process evaluation phone interview. RESULTS: One hundred seventy patients were referred to the study. However, 57 couples did not meet all eligibility criteria, and 51 refused study participation. On average, two to three couples were randomized per month, and on average it took 26 days to enrol a couple in the study. Two couples withdrew from MEC, none from Coping-Together. Only 44 % of the cost diaries were completed, and 55 % of patients and 60 % of partners found the surveys too long, and this despite the follow-up survey being five pages shorter than the baseline one. Trends in favor of Coping-Together were noted for both patients and their partners. CONCLUSIONS: This study identified the challenges of conducting dyadic research, and a number of suggestions were put forward for future studies, including to question whether distress screening was necessary and what kind of control group might be more appropriate in future studies.

Mobile phone app aimed at improving iron intake and bioavailability in premenopausal women: a qualitative evaluation

BACKGROUND: Low iron intake can lead to iron deficiency, which can result in impaired health and iron-deficiency anemia. A mobile phone app, combining successful dietary strategies to increase bioavailable iron with strategies for behavior change, such as goal setting, monitoring, feedback, and resources for knowledge acquisition, was developed with the aim to increase bioavailable iron intake in premenopausal women.

OBJECTIVE: To evaluate the content, usability, and acceptability of a mobile phone app designed to improve intake of bioavailable dietary iron.

METHODS: Women aged 18-50 years with an Android mobile phone were invited to participate. Over a 2-week period women were asked to interact with the app. Following this period, semistructured focus groups with participants were conducted. Focus groups were audio recorded and analyzed via an inductive open-coding method using the qualitative analysis software NVivo 10. Themes were identified and frequency of code occurrence was calculated.

RESULTS: Four focus groups (n=26) were conducted (age range 19-36 years, mean 24.7, SD 5.2). Two themes about the app's functionality were identified (frequency of occurrence in brackets): interface and design (134) and usability (86). Four themes about the app's components were identified: goal tracker (121), facts (78), photo diary (40), and games (46). A number of suggestions to improve the interface and design of the app were provided and will inform the ongoing development of the app.

CONCLUSIONS: This research indicates that participants are interested in iron and their health and are willing to use an app utilizing behavior change strategies to increase intake of bioavailable iron. The inclusion of information about the link between diet and health, monitoring and tracking of the achievement of dietary goals, and weekly reviews of goals were also seen as valuable components of the app and should be considered in mobile health apps aimed at adult women.

Prioritizing climate change adaptation options for iconic marine species

© 2015, Springer Science+Business Media Dordrecht. Adaptation options in response to climate impact scenarios for marine mammals and seabirds were developed based on the IPCC vulnerability framework. Under this framework, vulnerability to the physical effects of climate change can be reduced by adaptation options that reduce exposure of individuals, reduce the sensitivity of individuals, and increase the adaptive capacity of individual/species to cope with climate change. We evaluated options in each vulnerability category with three screening tools collectively forming an approach we term sequential adaptation prioritization for species. These tools were designed to evaluate (i) technical aspects (cost-benefit-risk, CBR), (ii) institutional barriers, and (iii) potential social acceptability. The CBR tool identified which adaptation options were high cost and low benefit, might be discarded, and which were high benefit and low cost, might be rapidly implemented (depending on risk). Low cost and low benefit options might not be pursued, while those that are high cost, but high benefit deserve further attention. Even with technical merit, adaptation options can fail because of institutional problems with implementation. The second evaluation tool, based on the conceptual framework on barriers to effective climate adaptation, identifies where barriers may exist, and leads to strategies for overcoming them. Finally, adaptation options may not be acceptable to society at large, or resisted by vocal opponents or groups. The social acceptability tool identifies potentially contested options, which may be useful to managers charged with implementing adaptation options. Social acceptability, as scored by experts, differed from acceptability scored by the public, indicating the need to involve the public in assessing this aspect. Scores from each tool for each scenario can be combined to rank the suite of adaptation options. This approach provides useful tools to assist conservation managers in selecting from a wide range of adaptation strategies; the methodology is also applicable to other conservation sectors.

Smartphone apps to improve fitness and increase physical activity among young people: protocol of the Apps for IMproving FITness (AIMFIT) randomized controlled trial

BACKGROUND: Physical activity is a modifiable behavior related to many preventable non-communicable diseases. There is an age-related decline in physical activity levels in young people, which tracks into adulthood. Common interactive technologies such as smartphones, particularly employing immersive features, may enhance the appeal and delivery of interventions to increase levels of physical activity in young people. The primary aim of the Apps for IMproving FITness (AIMFIT) trial is to evaluate the effectiveness of two popular "off-the-shelf" smartphone apps for improving cardiorespiratory fitness in young people.

METHODS/DESIGN: A three-arm, parallel, randomized controlled trial will be conducted in Auckland, New Zealand. Fifty-one eligible young people aged 14-17 years will be randomized to one of three conditions: 1) use of an immersive smartphone app, 2) use of a non-immersive app, or 3) usual behavior (control). Both smartphone apps consist of an eight-week training program designed to improve fitness and ability to run 5 km, however, the immersive app features a game-themed design and adds a narrative. Data are collected at baseline and 8 weeks. The primary outcome is cardiorespiratory fitness, assessed as time to complete the one mile run/walk test at 8 weeks. Secondary outcomes are physical activity levels, self-efficacy, enjoyment, psychological need satisfaction, and acceptability and usability of the apps. Analysis using intention to treat principles will be performed using regression models.

DISCUSSION: Despite the proliferation of commercially available smartphone applications, there is a dearth of empirical evidence to support their effectiveness on the targeted health behavior. This pragmatic study will determine the effectiveness of two popular "off-the-shelf" apps as a stand-alone instrument for improving fitness and physical activity among young people. Adherence to app use will not be closely controlled; however, random allocation of participants, a heterogeneous group, and data analysis using intention to treat principles provide internal and external validity to the study. The primary outcome will be objectively assessed with a valid and reliable field-based test, as well as the secondary outcome of physical activity, via accelerometry. If effective, such applications could be used alongside existing interventions to promote fitness and physical activity in this population. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12613001030763. Registered 16 September 2013.

How feasible are lifestyle modification programs for disease prevention in general practice?

Vascular disease is a leading cause of death and disability. While it is preventable, little is known about the feasibility or acceptability of implementing interventions to prevent vascular disease in Australian primary health care. We conducted a cluster randomised controlled trial assessing prevention of vascular disease in patients aged 40–65 by providing a lifestyle modification program in general practice. Interviews with 13 general practices in the intervention arm of this trial examined their views on implementing the lifestyle modification program in general practice settings. Qualitative study, involving thematic analysis of semi-structured interviews with 11 general practitioners, four practice nurses and five allied health providers between October 2009 and April 2010. Providing brief lifestyle intervention fitted well with routine health-check consultations; however, acceptance and referral to the program was dependent on the level of facilitation provided by program coordinators. Respondents reported that patients engaged with the advice and strategies provided in the program, which helped them make lifestyle changes. Practice nurse involvement was important to sustaining implementation in general practice, while the lack of referral services for people at risk of developing vascular disease threatens maintenance of lifestyle changes as few respondents thought patients would continue lifestyle changes without long-term follow up. Lifestyle modification programs to prevent vascular disease are feasible in general practice but must be provided in a flexible format, such as being offered out of hours to facilitate uptake, with ongoing support and follow up to assist maintenance. The newly formed Medicare Locals may have an important role in facilitating lifestyle modification programs for this target group.

An efficacy trial of brief lifestyle intervention delivered by generalist community nurses (CN SNAP trial)

Background
Lifestyle risk factors, in particular smoking, nutrition, alcohol consumption and physical inactivity (SNAP) are the main behavioural risk factors for chronic disease. Primary health care (PHC) has been shown to be an effective setting to address lifestyle risk factors at the individual level. However much of the focus of research to date has been in general practice. Relatively little attention has been paid to the role of nurses working in the PHC setting. Community health nurses are well placed to provide lifestyle intervention as they often see clients in their own homes over an extended period of time, providing the opportunity to offer intervention and enhance motivation through repeated contacts. The overall aim of this study is to evaluate the impact of a brief lifestyle intervention delivered by community nurses in routine practice on changes in clients' SNAP risk factors.

Methods/Design
The trial uses a quasi-experimental design involving four generalist community nursing services in NSW Australia. Services have been randomly allocated to an 'early intervention' group or 'late intervention' (comparison) group. 'Early intervention' sites are provided with training and support for nurses in identifying and offering brief lifestyle intervention for clients during routine consultations. 'Late intervention site' provide usual care and will be offered the study intervention following the final data collection point. A total of 720 generalist community nursing clients will be recruited at the time of referral from participating sites. Data collection consists of 1) telephone surveys with clients at baseline, three months and six months to examine change in SNAP risk factors and readiness to change 2) nurse survey at baseline, six and 12 months to examine changes in nurse confidence, attitudes and practices in the assessment and management of SNAP risk factors 3) semi-structured interviews/focus with nurses, managers and clients in 'early intervention' sites to explore the feasibility, acceptability and sustainability of the intervention.

Discussion
The study will provide evidence about the effectiveness and feasibility of brief lifestyle interventions delivered by generalist community nurses as part of routine practice. This will inform future community nursing practice and PHC policy.

Should I and Can I?: a mixed methods study of clinician beliefs and attitudes in the management of lifestyle risk factors in primary health care

Background
Primary health care (PHC) clinicians have an important role to play in addressing lifestyle risk factors for chronic diseases. However they intervene only rarely, despite the opportunities that arise within their routine clinical practice. Beliefs and attitudes have been shown to be associated with risk factor management practices, but little is known about this for PHC clinicians working outside general practice. The aim of this study was to explore the beliefs and attitudes of PHC clinicians about incorporating lifestyle risk factor management into their routine care and to examine whether these varied according to their self reported level of risk factor management.

Methods
A cross sectional survey was undertaken with PHC clinicians (n = 59) in three community health teams. Clinicians' beliefs and attitudes were also explored through qualitative interviews with a purposeful sample of 22 clinicians from the teams. Mixed methods analysis was used to compare beliefs and attitudes for those with high and low levels of self reported risk factor management.

Results
Role congruence, perceived client acceptability, beliefs about capabilities, perceived effectiveness and clinicians' own lifestyle were key themes related to risk factor management practices. Those reporting high levels of risk factor screening and intervention had different beliefs and attitudes to those PHC clinicians who reported lower levels.

Conclusion
PHC clinicians' level of involvement in risk factor management reflects their beliefs and attitudes about it. This provides insights into ways of intervening to improve the integration of behavioural risk factor management into routine practice.