Satisfaction with a digital support tool targeting alcohol consumption: perspectives from participants in a randomized control trial.

AIM: Intervention design may be improved through evaluating the feedback from those who have been exposed to such interventions. As such, here the perspectives of the intervention group from a recent randomized control trial investigating the effectiveness of a digital alcohol intervention, in terms of perceived suitability and usefulness of the support tool they engaged with, were investigated. METHODS: Respondents (N=475; 45% of the intervention group) answered five quantitative questions addressing user experience, completed the 10-item System Useability Scale, and were offered the opportunity to write free-text feedback. Quantitative measures were analysed using ordinal and linear regression with baseline characteristics as predictors, and free-text responses were evaluated using content analysis. RESULTS: Overall, respondents were positive towards the intervention in terms of it fitting their needs, the usefulness of the tools included, and the usefulness of text message content. The intervention was perceived as more helpful by respondents with lower total weekly alcohol consumption, higher self-reported confidence in their ability to reduce their drinking, and the perceived importance there of, at baseline. The free-text comments revealed the value of reminders as prompts to reflect on one's own drinking behaviour. Nonetheless, criticisms of the intervention were voiced, primarily highlighting the repetitive nature of the reminders and the lack of individuation in advice. Some also feltlike the intervention was impersonal and targeted only a specific drinking pattern. CONCLUSIONS: Experiences of the intervention group in this trial were generally positive, though there may be demand for more individualised, targeted intervention design.

The prevalence of neutropenia and association with infections in patients with systemic lupus erythematosus: a Swedish single-center study conducted over 14 years.

Hematologic abnormalities are common manifestations of SLE, although neutropenia is observed less frequently and is not included in the classification criteria. Nonetheless, neutropenia is a risk factor for infections, especially those caused by bacteria or fungi. We aimed to evaluate the impact of neutropenia in SLE through a systematic investigation of all infections in a large cohort of well-characterized patients, focusing on neutropenia, lymphopenia, and hypocomplementemia. Longitudinal clinical and laboratory parameters obtained at visits to the Rheumatology Unit, Linköping University Hospital, and linked data on all forms of healthcare utilization for all the subjects included in our regional SLE register during 2008-2022 were assessed. Data regarding confirmed infections were retrieved from the medical records. Overall, 333 patients were included and monitored during 3,088 visits to a rheumatologist during the study period. In total, 918 infections were identified, and 94 occasions of neutropenia (ANC < 1.5 × 109/L) were detected in 40 subjects (12%). Thirty neutropenic episodes in 15 patients occurred in association with infections, of which 13 (43%) required in-hospital care, 4 (13%) needed intensive care, and 1 (3%) resulted in death. Bayesian analysis showed that patients with ≥ 1 occasion of neutropenia were more likely to experience one or more infections (OR = 2.05; probability of association [POA] = 96%). Both invasiveness (OR = 7.08; POA = 98%) and severity (OR = 2.85; POA = 96%) of the infections were significantly associated with the present neutropenia. Infections are common among Swedish SLE patients, 12% of whom show neutropenia over time. Importantly, neutropenia is linked to both the invasiveness and severity of infections. Awareness of the risks of severe infections in neutropenic patients is crucial to tailor therapies to prevent severe illness and death.

Randomised study of the effects of sense of entitlement and conflict of interest contrarianism on researcher decision-making to work with the alcohol industry.

BACKGROUND: It is well established that the tobacco industry used research funding as a deliberate tactic to subvert science. There has been little wider attention to how researchers think about accepting industry funding. We developed, then tested, hypotheses about two psychological constructs, namely, entitlement and conflict of interest contrarianism (CoI-C) among alcohol researchers who had previously received industry funding. METHODS: A mixed-methods pilot study involved construct and instrument development, followed by an online survey and nested 3-arm randomised trial. We randomly allocated alcohol industry funding recipients to one of three conditions. In two experimental conditions we asked participants questions to remind them (and thus increase the salience) of their sense of entitlement or CoI-C. We compared these groups with a control group who did not receive any reminder. The outcome was a composite measure of openness to working with the alcohol industry. RESULTS: 133 researchers were randomised of whom 79 completed the experiment. The posterior distribution over effect estimates revealed that there was a 94.8% probability that reminding researchers of their CoI-C led them to self-report being more receptive to industry funding, whereas the probability was 68.1% that reminding them of their sense of entitlement did so. Biomedical researchers reported being more open to working with industry than did psychosocial researchers. CONCLUSION: Holding contrarian views on conflict of interest could make researchers more open to working with industry. This study shows how it is possible to study researcher decision-making using quantitative experimental methods.

Still just a matter of taste? Sensorial appreciation of seafood is associated with more frequent and diverse consumption.

Improving health and sustainability outcomes in WEIRD (Western, Educated, Industrial, Rich, Democratic) nations necessitates a reduction in red meat consumption. Seafood is often overlooked in achieving this goal. However, simply consuming more of familiar fish species places high stress on production of these species. For this reason, diversification of seafood consumption is also critical. Here the motives for seafood consumption (frequency and diversity) are investigated across two studies by adapting the 4Ns survey to the seafood category. This 16-item survey measures four factors underpinning meat consumption: namely that it is 'Natural', 'Necessary', 'Normal' and 'Nice'. Swedish consumers' hedonic and sensory expectations of two herring concepts (traditional pickled contra novel minced and presented as a burger) are also evaluated in relation to the 4Ns. Study 1 (N = 304) revealed that the seafood 4Ns scale had a similar underlying structure to that of meat and had good test-retest reliability. Study 2 (N = 514) showed that consumers expected to like the pickled herring (associated with being 'seasoned', 'salty', 'sweet', 'firm', 'juicy', 'chewy', and 'slimy') more than the minced herring (associated with being 'mushy', 'fishy', 'grainy', 'dry' and having 'small bones'), and that 'Nice' scores affected expectations of both herring concepts. Food neophobia correlated inversely with seafood consumption frequency, expected liking, the 'Nice' subscale, and food agency. Critically, in both studies, enjoyment of seafood (higher 'Nice' scores) predicted more frequent and diverse seafood consumption, whilst agreeing that seafood is 'Necessary' for health predicted only consumption frequency, not diversity. Communicating the positive sensory attributes of seafood and developing novel product concepts in ways that disconfirm sceptical consumers' negative sensory expectations may increase acceptance of both familiar and unfamiliar seafood concepts.

Effects of an interactive web-based support system via mobile phone on preference-based patient participation in patients living with hypertension - a randomized controlled trial in primary care.

OBJECTIVE: To estimate the effects of an interactive web-based support system via mobile phone on preference-based patient participation in patients with hypertension treated in primary care (compared with standard hypertensive care only). DESIGN: A parallel group, non-blinded, randomized controlled trial, conducted October 2018-February 2021. Besides standard hypertensive care, the intervention group received eight weeks of support via mobile phone to facilitate self-monitoring and self-management, tentatively providing for augmented patient engagement. SETTING: 31 primary healthcare centers in Sweden. SUBJECTS: 949 patients treated for hypertension. MAIN OUTCOME MEASURES: The effects on preference-based patient participation, that is, the match between a patient's preferences for and experiences of patient participation in their health and healthcare. This was measured with the 4Ps (Patient Preferences for Patient Participation) tool at baseline, after 8 weeks, and at 12 months. Data were registered electronically and analyzed with multilevel ordinal regression. RESULTS: At baseline, 43-51% had a complete match between their preferences for and experiences of patient participation. There was an indication of a positive effect by a higher match for 'managing treatment myself' at 8-weeks in the intervention group. Such preference-based participation in their health and healthcare was reversed at 12 months, and no further effects of the intervention on preference-based patient participation persisted after 12 months. CONCLUSION: The interactive web-based support system via mobile phone had a wavering effect on preference-based patient participation. There is a prevailing need to better understand how person-centered patient participation can be facilitated in primary care.

Although patient participation is essential when having a long-term condition, interventions optimizing individuals' engagement have not been fully identified.About half of the patients with hypertension in this study did not experience participation in the manner and extent they preferred.A web-based support system via mobile phone improved some aspects of patient participation in the short- but not long term.Strategies to better identify patients' preferences for patient participation are needed, to evaluate and improve the outcome of care.

Digital Alcohol Interventions Could Be Part of the Societal Response to Harmful Consumption, but We Know Little About Their Long-Term Costs and Health Outcomes.

Alcohol consumption causes both physical and psychological harm and is a leading risk factor for noncommunicable diseases. Digital alcohol interventions have been found to support those looking for help by giving them tools for change. However, whether digital interventions can help tackle the long-term societal consequences of harmful alcohol consumption in a cost-effective manner has not been adequately evaluated. In this Viewpoint, we propose that studies of digital alcohol interventions rarely evaluate the consequences of wider dissemination of the intervention under study, and that when they do, they do not take advantage of modeling techniques that allow for appropriately studying consequences over a longer time horizon than the study period when the intervention is tested. We argue that to help decision-makers to prioritize resources for research and dissemination, it is important to model long-term costs and health outcomes. Further, this type of modeling gives important insights into the context in which interventions are studied and highlights where more research is required and where sufficient evidence is available. The viewpoint therefore invites the researcher not only to reflect on which interventions to study but also how to evaluate their long-term consequences.

Effects of a text messaging smoking cessation intervention amongst online help-seekers and primary health care visitors: findings from a randomised controlled trial.

BACKGROUND: Smoking continues to be a leading risk factor for several diseases globally. We hypothesised that an intervention delivered via text messages could help individuals who were looking to quit. METHODS: A two-arm, parallel-groups, randomised controlled trial was employed. Both groups received treatment as usual, with the intervention group also receiving a 12-week text messaging intervention. Participants were adult, weekly or more frequent smokers, recruited online and in primary health care centres. Research personnel were blinded, while participants were not. Primary outcomes were prolonged abstinence and point prevalence of abstinence, 3 and 6 months post-randomisation. All randomised participants were included in analyses. RESULTS: Between 18 September 2020 and 16 June 2022, we randomised 1012 participants (intervention: 505, control: 507). Outcome data was available for 67% (n = 682) of participants at 3 months and 64% (n = 643) at 6 months. At 3 months, the odds ratio (OR) of prolonged abstinence was 2.15 (95% compatibility interval [CoI] = 1.51; 3.06, probability of effect [POE] > 99.9%, p < 0.0001), and for point prevalence of abstinence, it was 1.70 (95% CoI = 1.18; 2.44, POE = 99.8%, p = 0.0034) in favour of the text messaging intervention. At 6 months, the OR of prolonged abstinence was 2.38 (95% CoI = 1.62; 3.57, POE > 99.9%, p = < 0.0001), and for point prevalence, it was 1.49 (95% CoI = 1.03; 2.14, POE = 98.3%, p = 0.0349) in favour of the text messaging intervention. Analyses with imputed data were not markedly different. CONCLUSIONS: Amongst general population help-seekers-who on average had smoked for 25 years-access to a 12-week text messaging intervention produced higher rates of self-reported smoking abstinence in comparison to treatment as usual only. The intervention could be part of the societal response to the burden which smoking causes; however, findings are limited by risk of bias due to attrition, self-reported outcomes, and lack of blinding. TRIAL REGISTRATION: The trial was preregistered in the ISRCTN registry on 27/07/2020 (ISRCTN13455271).

Effectiveness of a Smartphone App (MINISTOP 2.0) integrated in primary child health care to promote healthy diet and physical activity behaviors and prevent obesity in preschool-aged children: randomized controlled trial.

BACKGROUND: Childhood overweight and obesity is a public health priority. We have previously reported the efficacy of a parent-oriented mobile health (mHealth) app-based intervention (MINISTOP 1.0) which showed improvements in healthy lifestyle behaviors. However, the effectiveness of the MINISTOP app in real-world conditions needs to be established. OBJECTIVE: To evaluate the real-world effectiveness of a 6-month mHealth intervention (MINISTOP 2.0 app) on children's intake of fruits, vegetables, sweet and savory treats, sweet drinks, moderate-to-vigorous physical activity, and screen time (primary outcomes), and on parental self-efficacy (PSE) for promoting healthy lifestyle behaviors, and children's body mass index (BMI) (secondary outcomes). METHODS: A hybrid type 1 effectiveness-implementation design was utilized. For the effectiveness outcomes, a two-arm, individually randomized controlled trial was conducted. Parents (n = 552) of 2.5-to-3-year-old children were recruited from 19 child health care centers across Sweden, and, randomized to either a control (standard care) or intervention group (MINISTOP 2.0 app). The 2.0 version was adapted and translated into English, Somali and Arabic to increase reach. All recruitment and data collection were conducted by the nurses. Outcomes were assessed at baseline and after six months, using standardized measures (BMI) and a questionnaire (health behaviors, PSE). RESULTS: Among the participating parents (n = 552, age: 34.1 ± 5.0 years), 79% were mothers and 62% had a university degree. Twenty-four percent (n = 132) of children had two foreign-born parents. At follow-up, parents in the intervention group reported lower intakes of sweet and savory treats (-6.97 g/day; p = 0.001), sweet drinks (-31.52 g/day; p < 0.001), and screen time (-7.00 min/day; p = 0.012) in their children compared to the control group. The intervention group reported higher total PSE (0.91; p = 0.006), PSE for promoting healthy diet (0.34; p = 0.008) and PSE for promoting physical activity behaviors (0.31; p = 0.009) compared to controls. No statistically significant effect was observed for children's BMI z-score. Overall, parents reported high satisfaction with the app, and 54% reported using the app at least once a week. CONCLUSION: Children in the intervention group had lower intakes of sweet and savory treats, sweet drinks, less screen time (primary outcomes) and their parents reported higher PSE for promoting healthy lifestyle behaviors. Our results from this real-world effectiveness trial support the implementation of the MINISTOP 2.0 app within Swedish child health care. TRIAL REGISTRATION: Clinicaltrials.gov NCT04147039; https://clinicaltrials.gov/ct2/show/NCT04147039.

Spontaneous Resolution of Uncomplicated Appendicitis may Explain Increase in Proportion of Complicated Appendicitis During Covid-19 Pandemic: a Systematic Review and Meta-analysis.

BACKGROUND: Reports of an increased proportion of complicated appendicitis during the Covid-19 pandemic suggest a worse outcome due to delay secondary to the restrained access to health care, but may be explained by a concomitant decrease in uncomplicated appendicitis. We analyze the impact of the pandemic on the incidences of complicated and uncomplicated appendicitis. METHOD: We did a systematic literature search in the PubMed, Embase and Web Of Science databases on December 21, 2022 with the search terms (appendicitis OR appendectomy) AND ("COVID" OR SARS-Cov2 OR "coronavirus"). Studies reporting the number of complicated and uncomplicated appendicitis during identical calendar periods in 2020 and the pre-pandemic year(s) were included. Reports with indications suggesting a change in how the patients were diagnosed and managed between the two periods were excluded. No protocol was prepared in advance. We did random effects meta-analysis of the change in proportion of complicated appendicitis, expressed as the risk ratio (RR), and of the change in number of patients with complicated and uncomplicated appendicitis during the pandemic compared with pre-pandemic periods, expressed as the incidence ratio (IR). We did separate analyses for studies based on single- and multi-center and regional data, age-categories and prehospital delay. RESULTS: The meta-analysis of 100,059 patients in 63 reports from 25 countries shows an increase in the proportion of complicated appendicitis during the pandemic period (RR 1.39, 95% confidence interval (95% CI 1.25, 1.53). This was mainly explained by a decreased incidence of uncomplicated appendicitis (incidence ratio (IR) 0.66, 95% CI 0.59, 0.73). No increase in complicated appendicitis was seen in multi-center and regional reports combined (IR 0.98, 95% CI 0.90, 1.07). CONCLUSION: The increased proportion of complicated appendicitis during Covid-19 is explained by a decrease in the incidence of uncomplicated appendicitis, whereas the incidence of complicated appendicitis remained stable. This result is more evident in the multi-center and regional based reports. This suggests an increase in spontaneously resolving appendicitis due to the restrained access to health care. This has important principal implications for the management of patients with suspected appendicitis.

Patient participation in end-stage kidney disease care: variation over time and effects of staff-directed interventions - a quasi-experimental study.

BACKGROUND: Among those elements establishing decent quality of care from a patient perspective, opportunities to participate in accord with one's individual needs and preferences are central. To date, little is known the extent of preference-based patient participation in kidney care, and what facilitates optimal conditions. This study investigated i) preference-based patient participation in kidney care over time, and ii) the effects of interventions designed to enhance person-centred patient participation. METHODS: A quasi-experimental study was conducted across nine kidney care sites in southeast Sweden. A cohort of 358 patients with stage IV chronic kidney disease (eGRF 15-19 ml/min) or V (eGRF < 15 mL/min) entered the study. Of these, 245 patients (with kidney replacement therapy or intermittent outpatient visits only) completed a survey on patient participation at four time points: every six months from August 2019 to May 2021, patients reported their preferences for and experiences of participation using the validated Patient Preferences for Patient Participation tool, the 4Ps. Between the first and second data collection points, interventions were provided for designated staff to facilitate person-centred participation, using two strategies for two subgroups at three sites each: the managers receiving a bundle of information via e-mail on patient participation in a standard dissemination procedure (three sites), or an additional half-year support program for implementation offered to 1-2 staff per site (three sites), with no intervention for a control group (three sites). The differences in 4Ps data between groups were analysed using multilevel ordinal regression. RESULTS: Over time and across all sites, most patients' experiences of participation fully or almost fully matched their engagement preferences (57%-90%). Still, up to 12% of patient reports indicated that their preferences and experiences were insufficiently matched: in these cases, the patients had preferred to be more involved than they had experienced, for example, in making healthcare plans and setting health-related goals. The interventions did not affect the levels of preference-based participation, but patients in the control group sites had slightly more consistent matches. CONCLUSIONS: Living with kidney failure necessitates patient engagement, but opportunities to participate in accordance with one's preferences are not fully provided for all patients. Additional efforts to support a common understanding and to ensure person-centred patient participation is still needed.

Don't throw the individual perspective out while waiting for systemic change.

Although it is clear that i-frame approaches cannot stand alone, the impact of s-frame changes can plateau. Combinations of these approaches may best reflect what we know about behavior and how to support behavioral change. Interactions between i-frame and s-frame thinking are explored here using two examples: alcohol consumption and meat consumption.

Effectiveness of a digital intervention versus alcohol information for online help-seekers in Sweden: a randomised controlled trial.

BACKGROUND: The ubiquity of Internet connectivity, and widespread unmet needs, requires investigations of digital interventions for people seeking help with their drinking. The objective of this study was to test the effectiveness of a digital alcohol intervention compared to existing online resources for help seekers. METHODS: This parallel randomised controlled trial included 2129 risky drinkers with access to a mobile phone and aged 18 years or older. Randomised sub-studies investigated consent procedures and control group design. Simple computerised randomisation was used. Participants were aware of allocation after randomisation; research personnel were not. The digital intervention was designed around weekly monitoring of alcohol consumption followed by feedback and tools for behaviour change. Primary outcomes were total weekly consumption (TWC) and frequency of heavy episodic drinking (HED), measured 2 and 4 months post-randomisation. RESULTS: Between 25/04/2019 and 26/11/2020, 2129 participants were randomised (intervention: 1063, control: 1066). Negative binomial regression was used to contrast groups, with both Bayesian and maximum likelihood inference. The posterior median incidence rate ratio (IRR) of TWC was 0.89 (95% CI = 0.81;0.99, 98.2% probability of effect, P-value = 0.033) at 2 months among 1557 participants and 0.77 (95% CI = 0.69;0.86, > 99.9% probability of effect, P-value < 0.001) at 4 months among 1429 participants. For HED, the IRR was 0.83 (95% CI = 0.75;0.93, > 99.9% probability of effect, P-value = 0.0009) at 2 months among 1548 participants and 0.71 (95% CI = 0.63;0.79, probability of effect > 99.9%, P-value < 0.0001) at 4 months among 1424 participants. Analyses with imputed data were not markedly different. CONCLUSIONS: A digital alcohol intervention produced self-reported behaviour change among online help seekers in the general population. The internal and external validity of this trial is strong, subject to carefully considered study limitations arguably inherent to trials of this nature. Limitations include higher than anticipated attrition to follow-up and lack of blinding. TRIAL REGISTRATION: The trial was prospectively registered ( ISRCTN48317451 ).

Compliance with recommendations limiting COVID-19 contagion among university students in Sweden: associations with self-reported symptoms, mental health and academic self-efficacy.

AIMS: The COVID-19 containment strategy in Sweden uses public health recommendations relying on personal responsibility for compliance. Universities were one of few public institutions subject to strict closure, meaning that students had to adapt overnight to online teaching. This study investigates the prevalence of self-reported recommendation compliance and associations with self-reported symptoms of contagion, self-experienced effects on mental health and academic self-efficacy among university students in Sweden in May-June 2020. METHODS: This was a cross-sectional 23 question online survey in which data were analysed by multinomial regression, taking a Bayesian analysis approach complemented by null hypothesis testing. RESULTS: A total of 4495 students consented to respond. Recommendation compliance ranged between 70% and 96%. Women and older students reported higher compliance than did men and younger students. Mild to moderate COVID-19 symptoms were reported by 30%, severe symptoms by fewer than 2%; 15% reported being uncertain and half of the participants reported no symptoms. Mental health effects were reported by over 80%, and changes in academic self-efficacy were reported by over 85%; in both these areas negative effects predominated. Self-reported symptoms and uncertainty about contagion were associated with non-compliance, negative mental health effects, and impaired academic self-efficacy. CONCLUSIONS: Students generally followed public health recommendations during strict closure of universities, but many reported considerable negative consequences related to mental health and academic self-efficacy. Digital interventions should be developed and evaluated to boost coping skills, build resilience and alleviate student suffering during the pandemic and future similar crises.

Avoiding Under- and Overrecruitment in Behavioral Intervention Trials Using Bayesian Sequential Designs: Tutorial.

Reducing research waste and protecting research participants from unnecessary harm should be top priorities for researchers studying interventions. However, the traditional use of fixed sample sizes exposes trials to risks of under- and overrecruitment by requiring that effect sizes be determined a priori. One mitigating approach is to adopt a Bayesian sequential design, which enables evaluation of the available evidence continuously over the trial period to decide when to stop recruitment. Target criteria are defined, which encode researchers' intentions for what is considered findings of interest, and the trial is stopped once the scientific question is sufficiently addressed. In this tutorial, we revisit a trial of a digital alcohol intervention that used a fixed sample size of 2129 participants. We show that had a Bayesian sequential design been used, the trial could have ended after collecting data from approximately 300 participants. This would have meant exposing far fewer individuals to trial procedures, including being allocated to the waiting list control condition, and the evidence from the trial could have been made public sooner.

mHealth intervention for multiple lifestyle behaviour change among high school students in Sweden (LIFE4YOUth): protocol for a randomised controlled trial.

BACKGROUND: National surveys in Sweden demonstrate that the majority of young people do not engage in health promoting behaviours at levels recommended by the Public Health Agency of Sweden. The objective of this study is to estimate the effectiveness of a novel mHealth intervention named LIFE4YOUth, which targets multiple lifestyle behaviours (alcohol, diet, physical activity, and smoking) among high school students in Sweden. METHODS: A 2-arm parallel groups single blind randomised controlled trial (1:1) will be employed to estimate the effectiveness of the novel mHealth intervention. Students will be recruited at high schools throughout Sweden, and will be included if they fulfil one of six criteria relating to unhealthy behaviours with respect to alcohol, diet, physical activity and smoking. Eligible participants will be randomised to either receive the novel intervention immediately, or to be placed on a waiting list for 4 months. The intervention consists of a combination of recurring screening, text messages, and an interactive platform which is adaptable to individual preferences. Outcome measures with respect to alcohol, diet, physical activity and smoking will be assessed through questionnaires at 2 and 4 months post randomisation. DISCUSSION: The findings of this trial could be generalised to a diverse high-school student population as our recruitment encompass a large proportion of schools throughout Sweden with various educational profiles. Furthermore, if effective, the mHealth intervention has good potential to be able to be scaled up and disseminated at high schools nationally. TRIAL REGISTRATION: Registered prospectively on 2020-05-20 in ISRCTN ( ISRCTN34468623 ).

MINISTOP 2.0: a smartphone app integrated in primary child health care to promote healthy diet and physical activity behaviours and prevent obesity in preschool-aged children: protocol for a hybrid design effectiveness-implementation study.

BACKGROUND: Childhood obesity is still a major health problem in many countries, including Sweden. Childhood obesity and obesity-related behaviours in childhood, such as low physical activity and unhealthy eating habits, tend to track into adulthood, which highlights the need for early prevention. Our aims are to evaluate whether a parent-oriented mobile health app (the MINISTOP 2.0 app) integrated into primary child health care can improve diet and physical activity behaviours and reduce the prevalence of overweight and obesity in preschool-aged children as well as to evaluate the implementation among child health care nurses and parents. METHODS: This trial uses a hybrid type 1 effectiveness-implementation design. Families (n = 500) who attend a routine visit to one of 15-20 primary child health care centres throughout Sweden, when their child is 2.5 years, are offered participation in a randomised controlled trial (effectiveness evaluation). After acceptance, families will be randomised (1:1) to control or intervention groups. The intervention group receives a 6-month parent-oriented smartphone intervention aimed at improving the dietary and activity behaviours of their child (the MINISTOP 2.0 app) and the control group receives routine child health care. Dietary habits, physical activity and screen time (primary outcomes), body weight and height in children, and parental self-efficacy (secondary outcomes) are measured at baseline and at 6 months post randomisation. Implementation outcomes (i.e. perceived acceptability, appropriateness, and feasibility) of the intervention will be assessed among primary child health care nurses and parents in the trial through questionnaires and qualitative interviews. DISCUSSION: This trial will evaluate whether the MINISTOP 2.0 app can be used in primary child health care to improve diet and physical activity behaviours, and prevent overweight and obesity, in preschool-aged children. If effectiveness is proven, and the MINISTOP 2.0 app is considered acceptable, appropriate and feasible, it can be implemented nationally as part of the preventive strategies to combat childhood obesity provided by routine child health care. TRIAL REGISTRATION: The trial was registered at the Clinicaltrials.gov register platform (ID NCT04147039 ) on 31 October 2019.

The P Value Line Dance: When Does the Music Stop?

When should a trial stop? Such a seemingly innocent question evokes concerns of type I and II errors among those who believe that certainty can be the product of uncertainty and among researchers who have been told that they need to carefully calculate sample sizes, consider multiplicity, and not spend P values on interim analyses. However, the endeavor to dichotomize evidence into significant and nonsignificant has led to the basic driving force of science, namely uncertainty, to take a back seat. In this viewpoint we discuss that if testing the null hypothesis is the ultimate goal of science, then we need not worry about writing protocols, consider ethics, apply for funding, or run any experiments at all-all null hypotheses will be rejected at some point-everything has an effect. The job of science should be to unearth the uncertainties of the effects of treatments, not to test their difference from zero. We also show the fickleness of P values, how they may one day point to statistically significant results; and after a few more participants have been recruited, the once statistically significant effect suddenly disappears. We show plots which we hope would intuitively highlight that all assessments of evidence will fluctuate over time. Finally, we discuss the remedy in the form of Bayesian methods, where uncertainty leads; and which allows for continuous decision making to stop or continue recruitment, as new data from a trial is accumulated.

An Electronic Screening and Brief Intervention for Hazardous and Harmful Drinking Among Swedish University Students: Reanalysis of Findings From a Randomized Controlled Trial Using a Bayesian Framework.

BACKGROUND: Due to a resurgent debate on the misuse of P values, the Journal of Medical Internet Research is hosting a standing theme issue inviting the reanalysis of (primarily digital health) trial data using a Bayesian framework. This first paper in this series focuses on an electronic screening and brief intervention (eSBI), targeting harmful and hazardous alcohol consumption, which student health care centers across Sweden have routinely administerd to all students during the past decade. The second Alcohol Email Assessment and Feedback Study Dismantling Effectiveness for University Students (AMADEUS-2) trial aimed to assess the effect of the eSBI on alcohol consumption among students who were harmful and hazardous drinkers. A two-arm randomized controlled trial design was employed, randomizing eligible participants to either a waiting list or direct access to an eSBI. Follow-up assessments were conducted 2 months after randomization. Subsequent analysis of the trial followed the conventional null hypothesis approach, and no statistical significance was found between groups at follow-up with respect to the number of standard drinks consumed weekly. However, in an unspecified sensitivity analysis, it was discovered that removing three potential outliers made the difference between the groups significant. OBJECTIVE: The objective of this study is to reperform the primary and sensitivity analysis of the AMADEUS-2 trial using a Bayesian framework and to compare the results with those of the original analysis. METHODS: The same regression models used in the original analysis were employed in this reanalysis (negative binomial regression). Model parameters were given uniform priors. Markov chain Monte Carlo was used for Bayesian inference, and posterior probabilities were calculated for prespecified thresholds of interest. RESULTS: Null hypothesis tests did not identify a statistically significant difference between the intervention and control groups, potentially due to a few extreme data points. The Bayesian analysis indicated a 93.6% probability that there was a difference in grams of alcohol consumed at follow-up between the intervention and control groups and a 71.5% probability that the incidence rate ratio was <0.96. Posterior probabilities increased when excluding three potential outliers, yet such post hoc analyses were not necessary to show the preference toward offering an eSBI to harmful and hazardous drinkers among university students. CONCLUSIONS: The null hypothesis framework relies on point estimates of parameters. P values can therefore swing heavily, depending on a single or few data points alone, casting doubt on the value of the analysis. Bayesian analysis results in a distribution over parameter values and is therefore less sensitive to outliers and extreme values. Results from analyses of trials of interventions where small-to-modest effect sizes are expected can be more robust in a Bayesian framework, making this a potentially better approach for analyzing digital health research data. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN) 02335307; http://www.isrctn.com/ISRCTN02335307.

Electronic Screening for Alcohol Use and Brief Intervention by Email for University Students: Reanalysis of Findings From a Randomized Controlled Trial Using a Bayesian Framework.

BACKGROUND: Almost a decade ago, Sweden became the first country to implement a national system enabling student health care centers across all universities to routinely administer (via email) an electronic alcohol screening and brief intervention to their students. The Alcohol email assessment and feedback study dismantling effectiveness for university students (AMADEUS-1) trial aimed to assess the effect of the student health care centers' routine practices by exploiting the lack of any standard timing for the email invitation and by masking trial participation from students. The original analyses adopted the conventional null hypothesis framework, and the results were consistently in the expected direction. However, since for some tests the P values did not pass the conventional .05 threshold, some of the analyses were necessarily inconclusive. OBJECTIVE: The outcomes of the AMADEUS-1 trial were derived from the first 3 items of the Alcohol Use Disorders Identification Test (AUDIT-C). The aim of this paper was to reanalyze the two primary outcomes of the AMADEUS-1 trial (AUDIT-C scores and prevalence of risky drinking), using the same models used in the original publication but applying a Bayesian inference framework and interpretation. METHODS: The same regression models used in the original analysis were employed in this reanalysis (linear and logistic regression). Model parameters were given uniform priors. Markov chain Monte Carlo was used for Bayesian inference, and posterior probabilities were calculated for prespecified thresholds of interest. RESULTS: Where the null hypothesis tests showed inconclusive results, the Bayesian analysis showed that offering an intervention at baseline was preferable compared to offering nothing. At follow-up, the probability of a lower AUDIT-C score among those who had been offered an intervention at baseline was greater than 95%, as was the case when comparing the prevalence of risky drinking. CONCLUSIONS: The Bayesian analysis allows for a more consistent perspective of the data collected in the trial, since dichotomization of evidence is not looked for at some arbitrary threshold. Results are presented that represent the data collected in the trial rather than trying to make conclusions about the existence of a population effect. Thus, policy makers can think about the value of keeping the national system without having to navigate the treacherous landscape of statistical significance. TRIAL REGISTRATION: ISRCTN Registry ISRCTN28328154; http://www.isrctn.com/ISRCTN28328154.

A Gentle Introduction to the Comparison Between Null Hypothesis Testing and Bayesian Analysis: Reanalysis of Two Randomized Controlled Trials.

The debate on the use and misuse of P values has risen and fallen throughout their almost century-long existence in scientific discovery. Over the past few years, the debate has again received front-page attention, particularly through the public reminder by the American Statistical Association on how P values should be used and interpreted. At the core of the issue lies a fault in the way that scientific evidence is dichotomized and research is subsequently reported, and this fault is exacerbated by researchers giving license to statistical models to do scientific inference. This paper highlights a different approach to handling the evidence collected during a randomized controlled trial, one that does not dichotomize, but rather reports the evidence collected. Through the use of a coin flipping experiment and reanalysis of real-world data, the traditional approach of testing null hypothesis significance is contrasted with a Bayesian approach. This paper is meant to be understood by those who rely on statistical models to draw conclusions from data, but are not statisticians and may therefore not be able to grasp the debate that is primarily led by statisticians.