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Copyright of Türkiye Klinikleri Journal of Ophthalmology is the property of Turkiye Klinikleri and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Purpose: The Social Difficulties Inventory (SDI-21) assesses everyday problems experienced by cancer patients, including difficulties with self-care, work and relationships. Early development and psychometric evaluation studies have validated the SDI-21 for computer administration. However, several recent studies have administered the SDI-21 on paper. We sought to test the score equivalence of electronic and paper versions of the SDI-21. Methods: A randomised two-arm crossover trial in a sample of cancer patients with varied diagnoses. Patients completed electronic (via the internet) and paper versions of the SDI-21, with half randomly assigned to complete the electronic version first ( n = 51) and half the paper version first ( n = 60). Patients were asked to complete both versions at home, within 2 weeks. Analyses were performed for the SDI-21 summary score and three subscales. Results: Score distributions and internal reliabilities for the paper and electronic versions were highly similar. There were no significant differences between mean summary or subscale scores for the two administration modes. All mean score differences (all <0.25 of a scale point) were well below the SDI-21's established minimally important differences, and all 95 % confidence intervals were narrow and included zero. Intraclass correlations between paper and electronic scores were uniformly high and significant (all ≥0.85) and above the standard acceptable level of reliability. Conclusions: Paper and electronic versions of the SDI-21 can be considered equivalent and used interchangeably. This is important because, despite the growth of electronic formats, paper versions are currently still necessary to ensure inclusive use of the SDI-21 with representative samples. [ABSTRACT FROM AUTHOR]

Objectives. Test-retest reliability of an asthma paper diary versus an electronic diary (e-diary) with an integrated peak flow meter was investigated. The equivalence of the two modes was also evaluated. Methods. Prospective, randomized crossover study design in adolescents (12-17 years) and adults (≥18 years). Key inclusion criteria were persistent asthma, Asthma Control Test (ACT) scores ≥16, use of inhaled corticosteroid with or without long-acting beta-agonist for ≥12 weeks, nocturnal awakenings <2 times in the past week, and activity limitations <1 per week. Participants were randomized to either paper then e-diary or e-diary then paper, to be completed for 14 days each. Results. Forty-seven participants completed all study visits. Weekly percentage of symptom-free days (SFDs) and rescue-free days (RFDs) were calculated. Intraclass correlation coefficients (ICCs) of Week 1 mean SFD and RFD (test) and Week 2 mean SFD and RFD (retest), respectively, were estimated in three groups defined as stable: (i) minimal changes in asthma symptoms, as measured by the global patient reported symptom change question, (ii) less than 15% change (absolute value) in 1 second FEV1 at adjacent study visits, and (iii) changes in ACT scores less than three points for each mode. SFD demonstrated acceptable ICC (≥0.70) using all three definitions of asthma stability for both modes. Conclusion. Acceptable reproducibility of the percentage of RFD (ICC = 0.78) was only observed for the e-diary using the FEV1 stability criterion. The ICCs for SFD and RFD were acceptable, 0.84 and 0.70, respectively, suggesting better reliability for the e-diary. [ABSTRACT FROM AUTHOR]

Objective: Patient-reported mood charts are frequently used in management of bipolar disorder. Although mood charts have recently been programmed in electronic devices such as mobile phones, little is known about the impact of the method of data capture on the psychometric properties and validity of these data. Methods: In an ongoing pilot study, a sample of outpatients with bipolar disorder were randomized to complete mood charts either on a mobile phone or with standard paper and pencil as part of a 12-week intervention (primary outcomes for the trial await study completion). We compared these conditions across a single item rating of mood state, and we hypothesized that mobile phone-based data capture would produce greater compliance to mood ratings, variability between and within participants, and concurrent validity with blinded clinician-rated affective symptom severity. Results: A total of 56 participants were randomized and 40 participants were included in the analyses. There were no significant differences between conditions on demographic or clinical variables. The rate of compliance was significantly higher in paper-and-pencil versus mobile phone ratings. Ratings demonstrated significantly more variability within individuals in the mobile phone condition. Mobile phone mood ratings were significantly correlated with clinician-rated depressive symptom severity across the study and with manic symptom severity at the week-6 assessment, whereas paper-and-pencil ratings were not significantly associated with clinician-rated depression or mania. Conclusions: Although preliminary, our results suggest a lower rate of compliance with mobile phones compared to paper-and-pencil daily mood rating in bipolar disorder, yet a greater ability to capture variability and concurrent validity in quantifying affective symptoms. This clinical trial is registered at www.clinicaltrials.gov as NCT01670123. [ABSTRACT FROM AUTHOR]

School-based evaluations of interventions are increasingly common in education research. Ideally, the results of these evaluations are used to make evidence-based policy decisions for students. However, it is difficult to make generalizations from these evaluations because the types of schools included in the studies are typically not selected randomly from a target population. This paper provides an overview of statistical methods for improving generalizations from intervention research in education. These are presented as a series of steps aimed at improving research design--particularly recruitment--as well as methods for assessing and summarizing generalizability and estimating treatment impacts for clearly defined target populations.

Background: The internet can provide evidence-based patient education to overcome time constraints of busy ambulatory practices. Health informationprescriptions (HIPs) can be effectivelyintegrated into clinic workflow, but compliance to visit health information sites such as Medline Plus is limited.Objective: Compare the efficacy of paper (pHIP)and email (eHIP) links to deliver HIPs; evaluate patient satisfaction with the HIP process and MedlinePlus information; assess reasons for noncompliance to HIPs.Method: Of 948 patients approached at two internal medicine clinics affiliated with an academic medical centre, 592 gave informed consent after meeting the inclusion criteria. In this randomised controlled trial, subjects were randomised to receive pHIP or eHIP for accessing an intermediate website that provided up to five MedlinePlus links for physician-selected HIP conditions. Patients accessing the intermediate website were surveyed by email to assess satisfaction with the health information.Survey non-responders were contacted by telephone to determine the reasons for no response.Results: One hundred and eighty-one patients accessed the website, with significantly more 'filling' eHIP than pHIP (38% vs 23%; P < 0.001). Most(82%) survey respondents found the website information useful, with 77% favouring email for future HIPs delivery. Lack of time, forgot, lost instructions or changed mind were reasons given for not accessing the websites.Conclusions: Delivery of MedlinePlus-based HIPs in clinic is more effective using email prescriptions than paper. Satisfaction with the HIP information was high, but overall response was low and deserves further investigation to improve compliance and related outcomes. [ABSTRACT FROM AUTHOR]

Abstract: Self-monitoring has traditionally been done using a paper record, which can be tedious and burdensome. A personal digital assistant (PDA) with dietary software can provide an alternative to a paper record. The study aimed to describe the differences in dietary changes at 6 months between participants randomly assigned to use a paper record or PDA for self-monitoring in a clinical trial of weight-loss treatment. Self-monitoring adherence and changes in weight and diet were assessed between 2006 and 2009. The sample (n=192) was 84% female and 78% white, with a mean age of 49 years and body mass index (calculated as kg/m2) of 34.1. At baseline, the groups did not differ in energy intake, percent calories from fat, and number of servings of the examined food groups. At 6 months, both groups had significant reductions in weight, energy intake, and percent calories from total fat and saturated fatty acids (P<0.001); no between-group differences were found. Compared to the paper record group, the PDA group significantly increased consumption of fruit (P=0.02) and vegetables (P=0.04) and decreased consumption of refined grains (P=0.02). Interactions among self-monitoring and the two groups were found in relation to changes in percent calories from total fat (P=0.02), monounsaturated fatty acids (P=0.002), and trans-fatty acids (P=0.04). Frequent self-monitoring was significantly associated with total sugar (P=0.02) and added sugar (P=0.01) intake in both groups. Our findings suggest that use of a PDA for self-monitoring might improve self-awareness of behavior and dietary changes. [Copyright &y& Elsevier]

Background Diaries are used in sexual behaviour research to reduce recall bias. Diary collection via mobile phone text messaging (SMS) has not been trialled previously in sexual behaviour research. This randomized controlled trial compared SMS, paper and online diaries on response rate, timeliness, completeness of data and acceptability. The correlation between behaviour reported in all three types of diaries and data collected in a retrospective questionnaire was also determined. Methods Participants were recruited by telephone and randomised into one of three groups. They completed weekly sexual behaviour diaries for 3 months by SMS, online or paper (by post). An online survey was conducted at the end of 3 months to compare retrospective reports to the diaries and assess opinions on the diary collection method. Results 72 participants were enrolled in the study, 24 in each group. Online diaries were more likely to be submitted late than SMS diaries (p<0.001). 3.9% of SMS diaries, 3.1% of paper diaries and 0.5% of online diaries were incomplete (p=0.001). Online data collection was the preferred mode for 51%. 65 participants completed the end point retrospective questionnaire. The correlation between the diary and questionnaire on sexual risk classification was substantial (κ=0.74) regardless of diary mode. Conclusions SMS is a convenient and timely method of collecting brief behavioural data, but online data collection was preferable to most participants and more likely to be complete. Data collected in retrospective sexual behaviour questionnaires were found to agree substantially with data collected through weekly self-reported diaries. [ABSTRACT FROM AUTHOR]

Background: Use of Botulinum toxin-A (BoNT-A) for treatment of upper limb spasticity in children with cerebral palsy has become routine clinical practice in many paediatric treatment centres worldwide. There is now high-level evidence that upper limb BoNT-A injection, in combination with occupational therapy, improves outcomes in children with cerebral palsy at both the body function/structure and activity level domains of the International Classification of Functioning, Disability and Health. Investigation is now required to establish what amount and specific type of occupational therapy will further enhance functional outcomes and prolong the beneficial effects of BoNT-A. Methods/Design: A randomised, controlled, evaluator blinded, prospective parallel-group trial. Eligible participants were children aged 18 months to 6 years, diagnosed with spastic hemiplegic cerebral palsy and who were able to demonstrate selective motor control of the affected upper limb. Both groups received upper limb injections of BoNT-A. Children were randomised to either the modified constraint-induced movement therapy group (experimental) or bimanual occupational therapy group (control). Outcome assessments were undertaken at pre-injection and 1, 3 and 6 months following injection of BoNT-A. The primary outcome measure was the Assisting Hand Assessment. Secondary outcomes included: the Quality of Upper Extremity Skills Test; Pediatric Evaluation of Disability Inventory; Canadian Occupational Performance Measure; Goal Attainment Scaling; Pediatric Motor Activity Log; modified Ashworth Scale and; the modified Tardieu Scale. Discussion: The aim of this paper is to describe the methodology of a randomised controlled trial comparing the effects of modified constraint-induced movement therapy (a uni-manual therapy) versus bimanual occupational therapy (a bimanual therapy) on improving bimanual upper limb performance of children with hemiplegic cerebral palsy following upper limb injection of BoNT-A. The paper outlines the background to the study, the study hypotheses, outcome measures and trial methodology. It also provides a comprehensive description of the interventions provided. Trial Registration: ACTRN12605000002684 [ABSTRACT FROM AUTHOR]

Background: The cost-effectiveness of using a mobile diary app as an adjunct in dialectical behavior therapy (DBT) in patients with borderline personality disorder is unknown.Objective: This study aims to perform an economic evaluation of a mobile diary app compared with paper-based diary cards in DBT treatment for patients with borderline personality disorder in a psychiatric outpatient facility.Methods: This study was conducted alongside a pragmatic, multicenter, randomized controlled trial. The participants were recruited at 5 Danish psychiatric outpatient facilities and were randomized to register the emotions, urges, and skills used in a mobile diary app or on paper-based diary cards. The participants in both groups received DBT delivered by the therapists. A cost-consequence analysis with a time horizon of 12 months was performed. Consequences included quality-adjusted life years (QALYs), depression severity, borderline severity, suicidal behavior, health care use, treatment compliance, and system usability. All relevant costs were included. Focus group interviews were conducted with patients, therapists, researchers, and industry representatives to discuss the potential advantages and disadvantages of using a mobile diary app.Results: A total of 78 participants were included in the analysis. An insignificantly higher number of participants in the paper group dropped out before the start of treatment (P=.07). Of those starting treatment, participants in the app group had an average of 37.1 (SE 27.55) more days of treatment and recorded an average of 3.16 (SE 5.10) more skills per week than participants in the paper group. Participants in both groups had a QALY gain and a decrease in depression severity, borderline severity, and suicidal behavior. Significant differences were found in favor of the paper group for both QALY gain (adjusted difference -0.054; SE 0.03) and reduction in depression severity (adjusted difference -1.11; SE 1.57). The between-group difference in total costs ranged from US $107.37 to US $322.10 per participant during the 12 months. The use of services in the health care sector was similar across both time points and groups (difference: psychiatric hospitalization <5 and <5; general practice -1.32; SE 3.68 and 2.02; SE 3.19). Overall, the patients showed high acceptability and considered the app as being easy to use. Therapists worried about potential negative influences on the therapist-patient interaction from new work tasks accompanying the introduction of the new technology but pointed at innovation potential from digital database registrations.Conclusions: This study suggests both positive and negative consequences of mobile diary apps as adjuncts to DBT compared with paper diary cards. More research is needed to draw conclusions regarding its cost-effectiveness.Trial Registration: ClinicalTrials.gov NCT03191565; http://clinicaltrials.gov/ct2/show/NCT03191565.International Registered Report Identifier (irrid): RR2-10.2196/17737. [ABSTRACT FROM AUTHOR]

Background: Tuberculosis (TB) remains a leading cause of death worldwide, with 98% of cases occurring in low- and middle-income countries (LMICs). The only vaccine licenced for the prevention of TB has limited protection for adolescents, adults and vulnerable populations. A safe and effective vaccine for all populations at risk is imperative to achieve global elimination of TB. We aimed to systematically review the efficacy and safety of TB vaccine candidates in late-phase clinical trials conducted in LMICs. Methods: Medline, Embase, CENTRAL, PubMed, Clinicaltrials.gov and Greylit.org were searched in June 2021 to identify phase 2 or later clinical randomised controlled trials that report the efficacy or safety (adverse events) of TB vaccine candidates with participants of any age living in an LMIC. TB vaccine candidates listed in the 2020 WHO Global TB Report were eligible for inclusion aside from BCG revaccination. Trials were excluded if all participants had active TB at baseline. Two reviewers independently assessed papers for eligibility, and for bias and quality using the Risk of Bias 2 tool and GRADE guidelines, respectively. We report efficacy rates and frequencies of adverse events from each included trial where available and qualitatively synthesise the findings. Results: Thirteen papers representing eleven trials met our inclusion criteria. Seven vaccine candidates were reviewed across seven countries: M72/AS01, RUTI, VPM1002, H56:IC31, MTBVAC, DAR-901 and ID93 + GLA-SE. Two trials reported on efficacy: an efficacy rate of 54% (95% CI 11.5, 76.2) was reported for M72/AS01 in adults with latent TB and 3% (95% CI -13.9, 17.7) for DAR-901 in healthy adolescents. However, the latter trial was underpowered. All vaccine candidates had comparable occurrences of adverse events between treatment arms and demonstrated acceptable safety profiles; though, RUTI resulted in one serious complication in a person living with HIV. M72/AS01 was the only vaccine considered safe across a diverse group of people including people living with HIV or latent TB and healthy infants and adolescents. Conclusion: Further efficacy trials for M72/AS01 are warranted to include additional populations at risk where safety has been demonstrated. Further safety trials are needed for the remaining vaccine candidates to confirm safety in vulnerable populations. [ABSTRACT FROM AUTHOR]

The article presents a synopsis on comprehensive non-surgical treatment which leads to improved walking ability in people with lumbar spinal stenosis. Topics discussed include dominant symptom of people with lumbar spinal stenosis; marginal differences between treatment groups in other more traditional outcomes; and training program offered to the comprehensive training and motivated patients.

The article discusses the approaches for gluteal tendinopathy which includes education plus exercise and corticosteroid injection.

The article discusses the airway pressure for infants with meconium aspiration syndrome which includes mechanical ventilation and medical care .

The article focuses on a 12-week pedometer-based intervention, delivered in primary care, produces long-term gains in physical activity. It mentions study illuminate the potential of pragmatic, pedometer-based interventions to impact on activity levels over more extended time frames; and also mentions the natural overlap between rehabilitation and physical activity presents an opportunity for physiotherapists to respond to major public health issue.

The article focuses on the effectiveness of inpatient rehabilitation for improving activities and participation in patients with multiple sclerosis (MS). It mentions whilst quality of life appeared to ‘substantially' improve on all measures at discharge within the treatment group; and also mentions comprehensive description of the intervention and its context is therefore essential to reliably implement interventions shown to be useful, and replicate or build on research findings.

The article focuses on a 12-week pedometer-based intervention, delivered in primary care, produces long-term gains in physical activity. It mentions the multi-component intervention included a pedometer, keeping a step-count diary, 12 weeks of goal setting, and a handbook that included behaviour change techniques; and also mentions participants in the control group were provided with a pedometer and instructions with no further support.

Introduction: More than 20 years have passed since we reported our results of treating patients with the acute respiratory distress syndrome (ARDS) with inhaled nitric oxide (iNO). The main finding was that iNO alleviated pulmonary hypertension (PH) by selective vasodilation of pulmonary vessels in ventilated lung areas. This, in turn, improved arterial oxygenation. Methods: We now set out to review the time span between the discovery of NO in 1987 and today in order to identify and describe interesting areas of research and clinical practice surrounding the application of iNO. Major Findings: Enhancement of ventilation-perfusion matching and alleviation of PH in ARDS, treatment of PH of the newborn, and treatment of perioperative PH in congenital heart disease serve as just a few exciting examples for the successful use of iNO. Breathing NO prevents PH induced by stored blood transfusions or sickle cell disease. Exploiting the anti-inflammatory properties of NO helps to treat malaria. Discussion: Regarding the use of iNO in ARDS, there remains the unresolved question of whether important outcome parameters can be positively influenced. At first glance, several randomized controlled trials and meta-analyses seem to send the clear message: 'There is none!' Careful analyses, however, leave sufficient room for doubt that the ideal study to produce the unequivocal proof for the inability of iNO to positively impact on important outcome parameters has, as yet, not been conducted. Conclusion: In summary, the discovery of and research on the many positive effects of iNO has improved care of critically ill patients worldwide. It is a noble effort to continue on this path. [ABSTRACT FROM AUTHOR]

Objectives: To compare data based on computerized and paper versions of health status questionnaires (HSQs) for sampling patient-reported outcomes (PROs) in patients with fibromyalgia (FM). In addition, to examine associations between patient characteristics (age, education, computer experience) and differences between versions. Finally, to evaluate the acceptability of computer-based questionnaires among patients with FM.Method: The study population comprised female patients diagnosed with FM. All patients completed six HSQs: the Fibromyalgia Impact Questionnaire (FIQ), the Major Depression Inventory (MDI), the 36-item Short Form Health Survey (SF-36), the painDETECT questionnaire (PDQ), the Coping Strategies Questionnaire (CSQ), and the Generalized Anxiety Disorder Self-Assessment Questionnaire (GAD-10), both on paper and using a touch screen. One HSQ was tested at a time in a repeated randomized cross-over design. The two versions were completed with a 5-min interval and between each HSQ the participants had a 5-min break. Means, mean differences with 95% confidence intervals (CIs), medians, median differences, and intraclass correlation coefficients (ICCs) were calculated for all HSQs, including relevant subscales. Associations between patient characteristics and differences between versions were explored using Spearman's correlation coefficients.Results: Twenty women, mean age 48.4 years, participated in the study. Except for one item, ICCs between touch-screen and paper versions of the HSQs examined indicated acceptable agreement (ICC = 0.71-0.99). Overall, mean and median differences revealed no differences between versions. No significant associations were observed for patient characteristics. None of the participants preferred paper questionnaires over computerized versions.Conclusions: The computerized HSQs using a touch screen gave comparable results to answers given on paper and were generally preferred by the participants. [ABSTRACT FROM AUTHOR]

Practitioners and policymakers often want estimates of the effect of an intervention for their local community, e.g., region, state, county. In the ideal, these multiple population average treatment effect (ATE) estimates will be considered in the design of a single randomized trial. Methods for sample selection for generalizing the sample ATE to date, however, focus only on the case of a single target population. In this paper, I provide a framework for sample selection in the multiple population case, including three compromise allocations. I situate the methods in an example and conclude with a discussion of the implications for the design of randomized evaluations more generally.

In education, multisite trials involve randomization of pupils into intervention and comparison groups within schools. Most analytical models in multisite educational trials ignore that the impact of an intervention may be school dependent. This study investigates the impact of statistical models on the uncertainty associated with an effect size using comparable outcomes and covariates from ten multisite educational trials funded by the UK's Education Endowment Foundation. Ordinary least squares (OLS) models often assume that the pupil's outcomes within schools are independent, which is not always true. Multilevel models address this limitation by incorporating heterogeneity between schools to account for intra-school dependency. This inflates the confidence interval of an effect size obtained from the multilevel models than from an OLS model. For a multisite trial, the heterogeneity between schools also includes the differences in the expected impact of intervention between schools. Ignoring this additional school-by-intervention variation in a multisite trial could affect both its interpretation and conclusions. A robust approach to estimate the confidence intervals for effect size from multisite trials is by treating effect size as a parameter with its distribution. This paper is important for evaluating evidence from multisite trials by accounting for all sources of variability.

Social-emotional learning (SEL) programs are frequently evaluated using randomized controlled trial (RCT) methodology as a means to assess program impacts. What is often missing in RCT studies is a robust parallel investigation of the multi-level implementation of the program. The field of implementation science bridges the gap between the RCT framework and understanding program impacts through the systematic data collection of program implementation components (e.g., adherence, quality, responsiveness). Data collected for these purposes can be used to answer questions regarding program impacts that matter to policy makers and practitioners in the field (e.g., Will the program work in practice? Under what conditions? For whom and why?). As such, the primary goal of this paper is to highlight the importance of studying implementation in the context of education RCTs, by sharing one example of a conceptualization and related set of implementation measures we created for a current study of ours testing the impacts of a SEL program for preschool children. Specifically, we describe the process we used to develop an implementation conceptual framework that highlights the importance of studying implementation at two levels: (1) the program implementation supports for teachers, and (2) teacher implementation of the curriculum in the classroom with students. We then discuss how we can use such multi-level implementation data to extend our understanding of program impacts to answer questions such as: "Why did the program work (or not work) to produce impacts?"; "What are the core components of the program?"; and "How can we improve the program in future implementations?".

Background: Recent evidence suggests that pre-school children with co-occurring phonological speech sound disorder (SSD) and expressive language difficulties are at a higher risk of ongoing communication and literacy needs in comparison with children with these difficulties in isolation. However, to date there has been no systematic or scoping review of the literature specific to interventions for children with this dual profile. Aims: To explore the evidence regarding interventions for pre-school children with co-occurring phonological SSD and expressive language difficulties, including the content/delivery of such interventions, areas of speech and language targeted, and a broad overview of study quality. Methods & Procedures: A scoping review methodology was used in accordance with the guidance from the Joanna Briggs Institute. Following a systematic search of Ovid Medline, Ovid Emcare, OVID Embase, CINAHL, Psychinfo and ERIC, 11 studies were included in the review. A researcher-developed data extraction form was used to extract specific information about each intervention, with the JBI appraisal tools used to provide a broad overview of the quality of each study. Main contribution: Included papers consisted of six randomized controlled trials (RCTs), two cohort studies, two case studies and one case series. Interventions fell into two main categories: (1) integrated interventions that combined content for both speech and language targets and/or explicitly used the same type of technique to improve both domains; and (2) single-domain interventions that explicitly included content to target speech or language only, but also aimed to improve the other domain indirectly. Study quality varied, with detail on the content, context and delivery of interventions often underspecified, hampering the replication and clinical applicability of findings. Conclusions & Implications: Early emerging evidence was identified to support both integrated speech and language interventions as well as single-domain interventions. However, caution should be exercised due to the variation in the quality and level of detail reported for the interventions. Future intervention studies may seek to address this by reporting in accordance with Template for Intervention Description and Replication (TIDieR) reporting guidelines. This approach would enable clinicians to consider the applicability of the intervention to individual children within differing settings.

Objective: To examine the impact of 3 data collection modes on the number of questions answered, data quality, and student preference. Methods: 275 urban seventh-grade students were recruited and randomly assigned to complete a pa­per survey (SAQ), PDA survey (PDA), or PDA survey with audio (APDA). Students completed a paper debriefing survey. Re­sults: APDA respondents completed sig­nificantly more questions compared to SAQ and PDA. PDA and APDA had signifi­cantly less missing data than did SAQ. No differences were found for student evaluation. Conclusions: Strong benefits may be gained by the use of APDA for ad­olescent school-based data collection. [ABSTRACT FROM AUTHOR]

Background: Haematopoietic stem cell transplantation (HSCT) has been tried in the last 15 years as a therapeutic option in patients with poor-prognosis autoimmune disease who do not respond to conventional treatments. Worldwide, more than 600 patients with multiple sclerosis (MS) have been treated with HSCT, most of them having been recruited in small, single-centre, phase 1–2 uncontrolled trials. Clinical and magnetic resonance imaging outcomes from case series reports or Registry-based analyses suggest that a major response is achieved in most patients; quality and duration of response are better in patients transplanted during the relapsing–remitting phase than in those in the secondary progressive stage.Objectives: An interdisciplinary group of neurologists and haematologists has been formed, following two international meetings supported by the European and American Blood and Marrow Transplantation Societies, for the purpose of discussing a controlled clinical trial, to be designed within the new scenarios of evolving MS treatments.Conclusions: Objectives of the trial, patient selection, transplant technology and outcome assessment were extensively discussed. The outcome of this process is summarized in the present paper, with the goal of establishing the background and advancing the development of a prospective, randomized, controlled multicentre trial to assess the clinical efficacy of HSCT for the treatment of highly active MS. [ABSTRACT FROM AUTHOR]

Introduction: Stroke care is complex and often provided by various healthcare organisations. Integrated care solutions are needed to optimise stroke care. In this paper, we describe the development of integrated stroke care in the region of Maastricht during the last 15 years. Description of integrated care case: Located in the south of the Netherlands, the region of Maastricht developed integrated stroke care to serve a population of about 180,000 people. Integration was needed to improve the continuity, coordination and quality of stroke care. The development of integrated care in Maastricht was a phased process. The last phase emphasized early discharge from hospital and assessing the best individual rehabilitation track in a specialized nursing home setting. Discussion and lessons learned: The development and implementation of integrated stroke care in the region of Maastricht led to fewer days in hospital, more patients being directly admitted to the stroke unit and an earlier start of rehabilitation. The implementation of early discharge from the hospital and rehabilitation assessment in a nursing home led to some unforeseen problems and lessons learned. [ABSTRACT FROM AUTHOR]

Objective: There is substantial evidence that poorly designed and reported research can mislead decision making in clinical care. This review investigates the methodological quality of Swedish trials of a wide array of psychological and social interventions. Method: The review includes 302 articles published in peer-reviewed journals during 1990-2014, which evaluated a psychological or social intervention; included a randomized or nonrandomized control group with a pre-post- or pre-follow-up design; and targeted individuals in order to prevent or rehabilitate from physical, psychological, or social problems. The results are based on the information reported in the articles. Results: Overall, methodological quality increased with time. However, more recent studies contained methodological deficits. For example, few had used blinded data collectors, reported power analyses, or searched for adverse events. Conclusion: The results indicate a potential risk of biased results in both older and newer trials. Possible implications for practice and research are discussed. [Paper presented at the Stockholm Conference on Behavioral and Social Intervention Research, 11-12 May, 2017.]

Purpose: This randomized controlled trial compared the efficacy between the Social Enterprise Intervention (SEI) and Individual Placement and Support (IPS) with homeless youth with mental illness to assess their impact on nonvocational outcomes. Method: Seventy-two homeless youth were recruited from one agency and randomized to the SEI (n = 36) or IPS (n = 36) conditions. Over 20 months, SEI participants received four SEI components, and IPS participants received eight IPS components. Data were collected on mental health, housing, and social support outcomes at baseline and one follow-up period. Results: Findings from mixed analysis of variance indicate that both SEI and IPS participants displayed statistically significant changes in their self-esteem, attention-deficit/hyperactivity disorder (ADHD) problems, inattention problems, living in a shelter, and living in a private residence. Conclusions: This is the first study to demonstrate the comparative efficacy and short-term nonvocational outcomes of SEI and IPS with homeless youth with mental illness. Assessment of long-term outcomes of both interventions is warranted. [Paper presented at the Stockholm Conference on Behavioral and Social Intervention Research, 11-12 May, 2017.]

Purpose: This systematic survey evaluates the completeness of reporting in pilot and feasibility randomized controlled trials investigating behavioral interventions based on the Consolidated Standards of Reporting Trials (CONSORT) extension for pilot trials. Methods: The authors searched Medline/Pubmed and randomly selected 100 articles from 2012 through 2016 to determine the proportion of reported CONSORT extension items. They examined study factors related to reporting, including year and country of publication, psychotherapy intervention, multiple centers, industry funding, and journal endorsement of CONSORT. Results: The authors found that the mean reporting score on the CONSORT extension was 51.6% (SD = 15.1). Studies of psychotherapy interventions had significantly higher reporting scores than other interventions (incidence rate ratio = 1.10, 95% confidence interval: 1.01-1.20). Conclusions: Our findings indicate that current reporting quality is suboptimal. Many included trials failed to provide rationale for piloting, assess feasibility objectives, or indicate clear progression to a future large trial. Reporting quality should be reevaluated following uptake of the 2016 CONSORT extension for pilot trials. [Paper presented at the Stockholm Conference on Behavioral and Social Intervention Research, 11-12 May, 2017.]

For the past 25 years, I have led multiple group-randomized trials, each focused on a specific underserved population of youth and each one evaluated health effects of complex interventions designed to prevent high-risk behaviors. I share my reflections on issues of intervention and research design, as well as how research results fostered my evolution toward addressing fundamental social determinants of health and well-being. Reflections related to intervention design emphasize the importance of careful consideration of theory of causes "and" theory of change, theoretical comprehensiveness versus fundamental determinants of population health, how high to reach, and health in all policies. Flowing from these intervention design issues are reflections on implications for research design, including the importance of matching the unit of intervention to the unit of assignment, the emerging field of public health law research, and consideration of design options and design elements beyond and in combination with random assignment. [Paper presented at the Stockholm Conference on Behavioral and Social Intervention Research, 11-12 May, 2017.]

Behavioral and social sciences randomized controlled trials (BSSTs) have a significant role in life sciences. Choosing an appropriate control or comparator group for BSSTs is critical, to provide true intervention effects. The objective of this study was to determine the types of control groups used in BSSTs, and the rationale provided to justify these choices. We conducted a systematic survey of BSST protocols published between January 2012 and October 2016 in the Cochrane Library and Medline databases. We randomly selected 200 protocols. The study selection and data extraction were performed independently in duplicate. The most frequent control groups were active concurrent (97/200, 48.5%), and no treatment concurrent controls (88/200, 44.0%). The majority of studies (71.5%) did not provide justification for comparators choice. We concluded that BSSTs trials compare interventions to active and no treatment controls however the majority of trials lacked rationale for the selection of the study comparator. [Paper presented at the Stockholm Conference on Behavioral and Social Intervention Research, 11-12 May, 2017.]

The purpose of this study is to investigate whether off-task multitasking activities with mobile technologies, specifically social networking sites and short messaging services, used during real-time lectures have an effect on grade performance in higher education students. Two experimental groups and one control group were used in this research. While participants in experimental groups 1 and 2 were allowed to navigate Facebook and to exchange short messaging service messages via mobile phones during real time in class lecturing, the control group participants were allowed to take notes using only pen and paper in the same lecturing conditions during three consecutive experimental sessions. The results showed that when students were given the opportunity of non-lecture-related multitasking using mobile phones writing/sending short messaging services and looking at Facebook profiles/reading news feed/looking at shared multimedia/reading wall messages during the lecture, their grade performance was hindered compared to traditional pen and paper note-taking. Engaging in social media use while trying to follow instruction may reduce learners' capacity for cognitive processing causing poor academic performance.

Background: In 2019, a randomized controlled trial (RCT) authored by Dr. Ismail was retracted due to concerns about data integrity. Since there are no policies in place to investigate other publications of authors of retracted studies, we investigated Dr. Ismail's other trials.Methods: We searched for RCTs authored by Dr. Ismail. We made pairwise comparisons of values in baseline and outcome tables between trials. We assessed whether the distributions of baseline characteristics were compatible with properly conducted randomization, using Monte Carlo simulations and the Kolmogorov-Smirnov test. We read the publications carefully for unusual features.Results: Dr. Ismail was author in eight published and one unpublished trial. In three of his first author studies we found multiple identical values in the baseline and/or outcome tables from different trials. At least some of the trials were unlikely to have followed a proper randomization process. There were a number of other unusual features in the papers we reviewed.Conclusions: It is probable that other trials published by Dr. Ismail contain questionable data. We call for a thorough investigation of the original trial data and related official documents. Our exercise suggests that the practice to assess research integrity should include all publications of authors with retracted fabricated articles. [ABSTRACT FROM AUTHOR]

Background and Aims: Increasing numbers of school‐based drug surveys are transitioning data collection to electronic tablets from paper‐and‐pencil, which may produce a survey mode effect and consequent discontinuity in time trends for population estimates of drug prevalence. This study tested whether (a) overall, self‐reported drug use prevalence is higher on electronic tablets versus paper‐and‐pencil surveys, (b) socio‐demographics moderate survey mode effects and (c) levels of missing data are lower for electronic tablet versus paper‐and‐pencil modes. Design A randomized controlled experiment. Setting: Results are nationally representative of students in the contiguous United States. Participants: A total of 41 866 8th, 10th and 12th grade students who participated in the 2019 Monitoring the Future school‐based survey administration. Intervention and comparator: Surveys were administered to students in a randomly selected half of schools with electronic tablets (intervention) and with paper‐and‐pencil format (comparator) for the other half. Measurements Primary outcome was the total number of positive drug use responses. Secondary outcomes were the percentage of respondents completing all drug questions, percentage of drug questions unanswered and mean number of missing drug items. Findings The relative risk (RR) for total number of positive drug use responses for electronic tablets versus paper‐and‐pencil surveys were small and their 95% confidence intervals (CI) included the value of one for reporting intervals of life‐time (RR = 1.03; 95% CI, 0.93–1.14), past 12 months (RR = 1.01; 95% CI, 0.91–1.11), past 30 days (RR = 1.05; 95% CI, 0.93–1.20) and for heavy use (RR = 1.10; 95% CI, 0.93–1.29). Multiplicative interaction tests indicated no moderation of these relative risks by race (white versus non‐white), population density, census region, public/private school, year of school participation, survey version or non‐complete drug responses. Levels of missing data were significantly lower for electronic tablets versus paper‐and‐pencil surveys. Conclusions: Adolescent drug prevalence estimates in the United States differed little across electronic tablet versus paper‐and‐pencil survey modes, and showed little to no effect modification by socio‐demographics. Levels of missing data were lower for electronic tablets. [ABSTRACT FROM AUTHOR]

The microbiome is a matter of interest for science, consumers and business. Our objective is to quantify that interest in academic journals and newspapers, both quantitatively and by study design. We calculated the number of articles on the microbiome from the total number of biomedicine articles featured in both PubMed and Spanish science news agency SINC, from 2008 to 2018. We used the Factiva database to identify news stories on microbiome papers in three general newspapers (The New York Times, The Times and El País) and three business newspapers (The Wall Street Journal, the Financial Times and Expansión), from 2007 to 2019. Then, we compared news stories with microbiome papers in PubMed, while also analyzing the frequencies of five study design types, both in the newspapers and in the papers themselves. Microbiome papers represented 0.8% of biomedicine papers in PubMed from 2008 to 2018 (increasing from 0.4% to 1.4%), while microbiome news published by SINC represented 1.6% of total biomedical news stories during the same period (increasing from 0.2% to 2.2%). The number of news stories on microbiome papers correlated with the number of microbiome papers (0.91, p < 0.001) featured in general newspapers, but not in business ones. News stories on microbiome papers represented 78.9% and 42.7% of all microbiome articles in general and business newspapers, respectively. Both media outlet types tended to over-report observational studies in humans while under-reporting environmental studies, while the representation of systematic reviews of randomized controlled trials, randomized controlled trials and animal/laboratory studies was similar when comparing newspapers and PubMed. The microbiome is receiving increasing attention in academic journals and newspapers. News stories on the microbiome in general and business newspapers are mostly based on research findings and are more interested in observational studies in humans and less in environmental studies compared to PubMed. [ABSTRACT FROM AUTHOR]

Background: Educational interventions are often complex, and their outcomes could be due to factors not focused on in the impact evaluation. Therefore, educational evaluations using a randomised control trial (RCT) design approach need to go beyond obtaining the impact results alone. Purpose: Process evaluation is embedded in the evaluation design in order to enhance contextual understanding of the outcome results achieved from an RCT. However, in the context of evaluation studies, reporting on the fidelity to the research design protocol is also important and can be undertaken by the same process evaluation approaches as used for studying the mechanism of interventions. Research design and method: This paper reports on two RCTs in which school staff led the trials themselves in their schools -- in an aggregated trial study managed and conducted at secondary school cluster-level, with expert advice from us, as independent evaluation advisors. The interventions implemented for evaluation were two highly structured programmes that targeted improvement in the literacy attainment of pupils who were at risk of failing to achieve the expected levels. Assessing the effect on literacy performance was the primary objective. However, the research design included methods for understanding the process of the interventions being implemented. Our main findings on the feasibility of aggregated trials led by schools are informed by our process evaluation, which included participant observations of the training, session observations of the interventions being implemented, and interviews with pupils, teachers and school leaders. Data on fidelity to the interventions were collected, and, using similar techniques, we also evaluated the feasibility of the research process led by school leaders and the possible barriers and challenges of RCT management by schools. We included information on randomisation procedures, perceptions of pupils and teachers involved in the study, and the programme website resources. Results: The primary outcome results of the trials showed promise from the interventions, in raising disadvantaged pupils' reading scores during transition from primary to secondary school stage. The process evaluation revealed considerable potential benefits from involving school leaders as evaluators, and the paper describes a way forward here. However, there were some indications that there was not full compliance with the randomisation process, and this might have resulted in initial imbalance of pre-tests scores between the treatment and control groups in one trial. Conclusion: Process evaluation cannot answer research questions regarding impact outcomes, but for a general understanding of outcomes it is important to report how the impact results have been achieved. This is where rich, in-depth data of the kind we describe can assist.

Ainsworth et al.'s paper "Sources of Bias in Outcome Assessment in Randomised Controlled Trials: A Case Study" examines alternative accounts for a large difference in effect size between 2 outcomes in the same intervention evaluation. It argues that the probable explanation relates to masking: Only one outcome measure was administered by those aware of participants' treatment assignment. This paper shows this conclusion is not substantiated by the evidence: The original paper fails to exclude alternative explanations, and what it takes as positive evidence for the preferred explanation is actually negative. While accepting the importance of masking in randomised controlled trials, this paper concludes that the original question was based on a misconception about effect sizes: Seen correctly as a measure of whole study design, the question of effect size difference between different outcome measures does not need asking. [For "Sources of Bias in Outcome Assessment in Randomised Controlled Trials: A Case Study," see EJ1052509.]

Abstract: Background: Longitudinal mood instability is the essential feature of bipolar disorder, however most rating scales are cross sectional in nature, and focus on acute symptoms. By contrast, the NIMH Life Chart Methodology (LCM) characterizes in detail the severity, duration, and frequency of mood episodes. Adherence to daily rating, however, tends to be low. In this study an online version of the LCM, designed to enhance adherence, was compared to the standard paper version. Methods: Patients from a mood disorders specialty clinic were randomized to the standard LCM or an online, open-source adaptation. The online version used hypertext links embedded in a daily email as the primary rating interface. Participants rated for 90days. The total number of days rated and the number of days with complete data were compared for the two groups. Results: Forty-eight patients participated in the study. The online group rated approximately twice as many days compared to the standard group (44.3 versus 20.4, p =.029). The online group also entered complete data for a larger portion of days (55.2% versus 27.7%, p =.039). Limitations: This was a small, short-term study. The implications for longer-term rating are unclear. Conclusions: Despite the advantages of documenting mood fluctuation on a daily basis, the LCM is not commonly used, in part because ensuring adequate adherence can be resource intensive. An easily accessible online adaptation that utilizes email checking behavior can make this tool available to a wider range of patients. [Copyright &y& Elsevier]

Background: In the context of a randomized controlled trial (RCT) on HIV testing in the emergency department (ED) setting, we evaluated preferences for survey modality and data quality arising from each modality. Methods: Enrolled participants were offered the choice of answering a survey via audio computer assisted self-interview (ACASI) or pen and paper self-administered questionnaire (SAQ). We evaluated factors influencing choice of survey modality. We defined unusable data for a particular survey domain as answering fewer than 75% of the questions in the domain. We then compared ACASI and SAQ with respect to unusable data for domains that address sensitive topics. Results: Of 758 enrolled ED patients, 218 (29%) chose ACASI, 343 chose SAQ (45%) and 197 (26%) opted not to complete either. Results of the log-binomial regression indicated that older (RR = 1.08 per decade) and less educated participants (RR = 1.25) were more likely to choose SAQ over ACASI. ACASI yielded substantially less unusable data than SAQ. Conclusions: In the ED setting there may be a tradeoff between increased participation with SAQ versus better data quality with ACASI. Future studies of novel approaches to maximize the use of ACASI in the ED setting are needed. [ABSTRACT FROM AUTHOR]

Addressing the problems of bullying in schools, this paper presents a novel and highly innovative pedagogical approach, building on the immersive power of virtual role-play. Educational role-play is widely accepted as a powerful instrument to change attitudes and behaviour, but faces some difficulties and disadvantages when applied to sensitive social issues in the classroom. This paper shows how the FearNot! software application, developed within the scope of the EU-funded projects VICTEC (Virtual ICT with Empathic Characters) and eCIRCUS (Education through Characters with emotional-Intelligence and Role-playing Capabilities that Understand Social interaction) uses virtual role-play and autonomous agents to provide children aged eight to eleven years of age with the opportunity to visit a virtual school environment populated by 3D animated synthetic characters that engage in bullying episodes. The characters' actions and the storyline are created as improvised dramas by use of emergent narrative, resulting in unscripted and highly believable interaction experiences for the learner. While the students are spectators to the bullying episodes that unfold among the FearNot! characters, the victimised character starts a conversation with the student in between the episodes, describing their experiences with bullying and how they feel as a result to it, and asking the student for advice. The aim of this approach and particularly of this interaction sequence in between the virtual bullying episodes is to sensitise primary school students to the potential problems that victims of persistent aggressive behaviour are facing: By triggering an empathic relationship between learners and characters, learners understand and vicariously feel into the plight of the victimised character. Empirical evidence from bullying research implies that bullies are regularly reinforced by bystanders that witness the bullying and turn their attention to it, but do not actively intervene to end it (Craig & Pepler 1996; Lean 1998; Salmivalli 1999; Hawkins et al. 2001). Hence, this intervention strategy targets these bystanders to stand up to the bully and help the victim, due to their heightened awareness and sensitivity to the grave consequences victims face. Preliminary evaluation results indicate that the children were willing to immerse themselves in the virtual drama and that they empathically engage with the characters, attributing a range of emotions to the characters depending on the events that happen within the respective scenario. An ongoing long-term intervention in school in the UK and Germany covers several interactions with the software over a ten week period of time.