Jim McCambridge, PhD, Faculty of Public Health & Policy, London School of Hygiene and Tropical Medicine, London, UK; Marcus Bendtsen, MSc, Department of Medicine and Health, and Department of Computer and Information Science, Linköping University, Linköping, Sweden; Nadine Karlsson, PhD, Department of Medicine and Health, Linköping University, Linköping, Sweden; Ian R. White, PhD, MRC, Biostatistics Unit, Institute of Public Health, Cambridge, UK; Per Nilsen, PhD, Preben Bendtsen, PhD, Department of Medicine and Health, Linköping University, Linköping, Sweden.
Brief interventions can be efficacious in changing alcohol consumption and increasingly take advantage of the internet to reach high-risk populations such as students.
To evaluate the effectiveness of a brief online intervention, controlling for the possible effects of the research process.
A three-arm parallel groups design was used to explore the magnitude of the feedback and assessment component effects. The three groups were: alcohol assessment and feedback (group 1); alcohol assessment only without feedback (group 2); and no contact, and thus neither assessment nor feedback (group 3). Outcomes were evaluated after 3 months via an invitation to participate in a brief cross-sectional lifestyle survey. The study was undertaken in two universities randomising the email addresses of all 14 910 students (the AMADEUS-1 study, trial registration: ISRCTN28328154).
Overall, 52% (n = 7809) of students completed follow-up, with small differences in attrition between the three groups. For each of the two primary outcomes, there was one statistically significant difference between groups, with group 1 having 3.7% fewer risky drinkers at follow-up than group 3 (P = 0.006) and group 2 scoring 0.16 points lower than group 3 on the three alcohol consumption questions from the Alcohol Use Disorders Identification Test (AUDIT-C) (P = 0.039).
This study provides some evidence of population-level benefit attained through intervening with individual students.
This randomized prospective study examines durability of improvement in general symptomatology, psychosocial functioning and interpersonal problems, and compares the long-term efficacy of analytic and systemic group psychotherapy in women 1 year after completion of treatment for childhood sexual abuse.
Women (n = 106) randomly assigned to analytic or systemic psychotherapy completed the Symptom Checklist-90-R, Global Assessment of Functioning, Global Life Quality, Registration Chart Questionnaire, and Flashback Registration at pre-treatment, post-treatment, and at a 1-year follow-up.
Post-treatment gains were significant for both treatment modalities on all measures, but significantly larger after systemic therapy. Significant treatment response was maintained 1-year post-treatment, but different trajectories were observed: 1 year after treatment completion, improvements for analytic therapy were maintained, whereas they decreased after systemic therapy, resulting in no statistically significant difference in gains between the groups at the 1-year follow-up. Despite maintaining significant gains, more than half of the patients remained above cut-off for caseness concerning general symptomatology at post-treatment and at 1-year follow-up.
The findings stress the importance of long-term follow-up data in effect studies. Different trajectories were associated with the two treatments, but improvement in the two treatment groups did not differ significantly at the 1-year follow-up. Implications of the difference in trajectories for treatment planning are discussed.
Both analytic and systemic group therapy proved efficient in improving general symptomatology, psychosocial functioning, and interpersonal problems in women with a history of CSA and gains were maintained at a 1-year follow-up. Despite maintaining statistically significant gains at the 1-year follow-up, 54% of the patients remained above the cut-off for caseness with respect to general symptomatology, which may indicate a need for further treatment. Different pre-post follow-up treatment trajectories were observed between the two treatment modalities. Thus, while systemic group therapy showed a significantly better outcome immediately after termination, gains in the systemic treatment group decreased during follow-up, while gains were maintained during follow-up in analytic group therapy.
Currently, far too many older adults consume inappropriate prescriptions, which increase the risk of adverse drug reactions and unnecessary hospitalizations. A health education program directly informing patients of prescription risks may promote inappropriate prescription discontinuation in chronic benzodiazepine users.
This is a cluster randomized controlled trial using a two-arm parallel-design. A total of 250 older chronic benzodiazepine users recruited from community pharmacies in the greater Montreal area will be studied with informed consent. A participating pharmacy with recruited participants represents a cluster, the unit of randomization. For every four pharmacies recruited, a simple 2:2 randomization is used to allocate clusters into intervention and control arms. Participants will be followed for 1 year. Within the intervention clusters, participants will receive a novel educational intervention detailing risks and safe alternatives to their current potentially inappropriate medication, while the control group will be wait-listed for the intervention for 6 months and receive usual care during that time period. The primary outcome is the rate of change in benzodiazepine use at 6 months. Secondary outcomes are changes in risk perception, self-efficacy for discontinuing benzodiazepines, and activation of patients initiating discussions with their physician or pharmacist about safer prescribing practices. An intention-to-treat analysis will be followed.The rate of change of benzodiazepine use will be compared between intervention and control groups at the individual level at the 6-month follow-up. Risk differences between the control and experimental groups will be calculated, and the robust variance estimator will be used to estimate the associated 95% confidence interval (CI). As a sensitivity analysis (and/or if any confounders are unbalanced between the groups), we will estimate the risk difference for the intervention via a marginal model estimated via generalized estimating equations with an exchangeable correlation structure.
Targeting consumers directly as catalysts for engaging physicians and pharmacists in collaborative discontinuation of benzodiazepine drugs is a novel approach to reduce inappropriate prescriptions. By directly empowering chronic users with knowledge about risks, we hope to imitate the success of individually targeted anti-smoking campaigns.
ClinicalTrials.gov identifier: NCT01148186.
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Acute promyelocytic leukaemia is a chemotherapy-sensitive subgroup of acute myeloid leukaemia characterised by the presence of the PML-RARA fusion transcript. The present standard of care, chemotherapy and all-trans retinoic acid (ATRA), results in a high proportion of patients being cured. In this study, we compare a chemotherapy-free ATRA and arsenic trioxide treatment regimen with the standard chemotherapy-based regimen (ATRA and idarubicin) in both high-risk and low-risk patients with acute promyelocytic leukaemia.
In the randomised, controlled, multicentre, AML17 trial, eligible patients (aged =16 years) with acute promyelocytic leukaemia, confirmed by the presence of the PML-RARA transcript and without significant cardiac or pulmonary comorbidities or active malignancy, and who were not pregnant or breastfeeding, were enrolled from 81 UK hospitals and randomised 1:1 to receive treatment with ATRA and arsenic trioxide or ATRA and idarubicin. ATRA was given to participants in both groups in a daily divided oral dose of 45 mg/m(2) until remission, or until day 60, and then in a 2 weeks on-2 weeks off schedule. In the ATRA and idarubicin group, idarubicin was given intravenously at 12 mg/m(2) on days 2, 4, 6, and 8 of course 1, and then at 5 mg/m(2) on days 1-4 of course 2; mitoxantrone at 10 mg/m(2) on days 1-4 of course 3, and idarubicin at 12 mg/m(2) on day 1 of the final (fourth) course. In the ATRA and arsenic trioxide group, arsenic trioxide was given intravenously at 0·3 mg/kg on days 1-5 of each course, and at 0·25 mg/kg twice weekly in weeks 2-8 of course 1 and weeks 2-4 of courses 2-5. High-risk patients (those presenting with a white blood cell count >10?×?10(9) cells per L) could receive an initial dose of the immunoconjugate gemtuzumab ozogamicin (6 mg/m(2) intravenously). Neither maintenance treatment nor CNS prophylaxis was given to patients in either group. All patients were monitored by real-time quantitative PCR. Allocation was by central computer minimisation, stratified by age, performance status, and de-novo versus secondary disease. The primary endpoint was quality of life on the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 global health status. All analyses are by intention to treat. This trial is registered with the ISRCTN registry, number ISRCTN55675535.
Between May 8, 2009, and Oct 3, 2013, 235 patients were enrolled and randomly assigned to ATRA and idarubicin (n=119) or ATRA and arsenic trioxide (n=116). Participants had a median age of 47 years (range 16-77; IQR 33-58) and included 57 high-risk patients. Quality of life did not differ significantly between the treatment groups (EORTC QLQ-C30 global functioning effect size 2·17 [95% CI -2·79 to 7·12; p=0·39]). Overall, 57 patients in the ATRA and idarubicin group and 40 patients in the ATRA and arsenic trioxide group reported grade 3-4 toxicities. After course 1 of treatment, grade 3-4 alopecia was reported in 23 (23%) of 98 patients in the ATRA and idarubicin group versus 5 (5%) of 95 in the ATRA and arsenic trioxide group, raised liver alanine transaminase in 11 (10%) of 108 versus 27 (25%) of 109, oral toxicity in 22 (19%) of 115 versus one (1%) of 109. After course 2 of treatment, grade 3-4 alopecia was reported in 25 (28%) of 89 patients in the ATRA and idarubicin group versus 2 (3%) of 77 in the ATRA and arsenic trioxide group; no other toxicities reached the 10% level. Patients in the ATRA and arsenic trioxide group had significantly less requirement for most aspects of supportive care than did those in the ATRA and idarubicin group.
ATRA and arsenic trioxide is a feasible treatment in low-risk and high-risk patients with acute promyelocytic leukaemia, with a high cure rate and less relapse than, and survival not different to, ATRA and idarubicin, with a low incidence of liver toxicity. However, no improvement in quality of life was seen.
The introduction of biological tumor necrosis factor inhibitors has improved the treatment of rheumatoid arthritis (RA) but at a substantial cost. These drugs have been shown to lead to superior radiological outcomes compared with a combination of conventional disease-modifying antirheumatic drugs over 2 years.
To investigate whether radiological superiority translates into better work loss outcomes.
Multicenter, 2-arm, parallel, randomized, active-controlled, open-label trial. Patients with early RA (symptom duration
Comment In: JAMA Intern Med. 2013 Aug 12;173(15):1414-523817526
Comment In: Dtsch Med Wochenschr. 2013 Oct;138(44):223624150698
Women not offered screening mammography reported higher levels of negative psychosocial aspects than women offered screening. This was demonstrated in a questionnaire survey where 1000 women were included: 500 women living in areas where the public authorities had never offered screening mammography and 500 women living in areas where women had been invited to screening mammography for >10 years. After this baseline survey, nationwide screening mammography was implemented. The aim of this follow-up study was to resurvey the 1000 women and to investigate if the identified difference in reported psychosocial aspects had disappeared or been reduced because of the nationwide screening implementation.
The 1000 women included in the previous survey were posted part I of the questionnaire Consequences of Screening in Breast Cancer (COS-BC1) in August 2011, nearly 5 years after they received the COS-BC1 the first time.
A total of 677 women returned the questionnaire. There was no statistically significant difference between the two groups in reported psychosocial aspects. Women new to screening reported less negative psychosocial aspects compared with the previous survey.
An implementation of a screening mammography programme provides reassurance for those women invited to the screening. This reassurance is in contrast to the unbalanced proportion between the intended benefits and the unintended harms of the screening programme.
The effect of bystander interventions on long-term functional outcomes among survivors of out-of-hospital cardiac arrest has not been extensively studied.
We linked nationwide data on out-of-hospital cardiac arrests in Denmark to functional outcome data and reported the 1-year risks of anoxic brain damage or nursing home admission and of death from any cause among patients who survived to day 30 after an out-of-hospital cardiac arrest. We analyzed risks according to whether bystander cardiopulmonary resuscitation (CPR) or defibrillation was performed and evaluated temporal changes in bystander interventions and outcomes.
Among the 2855 patients who were 30-day survivors of an out-of-hospital cardiac arrest during the period from 2001 through 2012, a total of 10.5% had brain damage or were admitted to a nursing home and 9.7% died during the 1-year follow-up period. During the study period, among the 2084 patients who had cardiac arrests that were not witnessed by emergency medical services (EMS) personnel, the rate of bystander CPR increased from 66.7% to 80.6% (P
To evaluate how municipality-based post-discharge follow-up visits including a general practitioner and municipal nurse affect early readmission among high-risk older people discharged from a hospital department of internal medicine.
Centrally randomized single-centre pragmatic controlled trial comparing intervention and usual care with investigator-blinded outcome assessment.
The intervention was home visits with a general practitioner and municipal nurse within seven days of discharge focusing on medication, rehabilitation plan, functional level, and need for further health care initiatives. The visit was concluded by planning one or two further visits. Controls received standard health care services.
People aged 65 + years discharged from Holbæk University Hospital, Denmark, in 2012 considered at high risk of readmission.
The primary outcome was readmission within 30 days. Secondary outcomes at 30 and 180 days included readmission, primary health care, and municipal services. Outcomes were register-based and analysis used the intention-to-treat principle.
A total of 270 and 261 patients were randomized to intervention and control groups, respectively. The groups were similar in baseline characteristics. In all 149 planned discharge follow-up visits were carried out (55%). Within 30 days, 24% of the intervention group and 23% of the control group were readmitted (p = 0.93). No significant differences were found for any other secondary outcomes except that the intervention group received more municipal nursing services.
This municipality-based follow-up intervention was only feasible in half the planned visits. The intervention as delivered had no effect on readmission or subsequent use of primary or secondary health care services.
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Reviews of randomized controlled trials (RCTs) of cognitive behavioural therapy (CBT) for anxiety disorders have reported large pre- to post-treatment within-group effect sizes on measures of anxiety when supplied in therapist consultations and in technology-supported settings. However, the stringent experimental control of RCTs results in a lack of external validity, which limits the generalizability of findings to real-world frontline clinical practice. We set out to examine the specification of a protocol for study of the effectiveness of cell phone-supported CBT for in situ management of anxiety disorders.
Nominal group methods were used for requirements analysis and protocol design. Making a distinction between different forms of technology-supported therapy, examination of therapists' role, and implementing trials in existing organizational and community contexts were found to be the central requirements in the protocol.
The resulting protocol (NCT01205191 at clinicaltrials.gov) for use in frontline clinical practice in which effectiveness, adherence, and the role of the therapists are analyzed, provides evidence for what are truly valuable cell phone-supported CBT treatments and guidance for the broader introduction of CBT in health services.
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The biological equivalency of ergocalciferol (D2) and cholecalciferol (D3) has been debated; several comparisons have appeared in the adult literature but are scarce in pediatrics. The objective of this study was to compare increases in plasma 25-hydroxyvitamin D [25(OH)D] concentrations and attainment of 50 and 75 mol/L status cutoffs following 3 mo of daily supplementation with D2 compared with D3. Healthy, breast-fed, 1-mo-old infants (n = 52) received 10 µg (400 ic) of either D2 or D3 daily. At 1 and 4 mo of age, plasma 25-hydroxyergocalciferol and 25-hydroxycholecalciferol concentrations were determined by liquid chromatography tandem MS (LC-MS/MS) and total 25(OH)D by chemiluminescent immunoassay (DiaSorin Liaison). Data were analyzed using t tests and ?² by intent to treat. A total of 23% of infants were deficient (=24.9 nmol/L) at baseline and 2% at follow-up on the basis of LC-MS/MS. At 4 mo, 96% were breastfed and there were no differences in compliance, breastfeeding rates, or sun exposure among groups. The change in total 25(OH)D measured by LC-MS/MS did not differ between the D2 (17.6 ± 26.7 nmol/L) and D3 (22.2 ± 20.2 nmol/L) groups. In the combined groups, the baseline plasma 25(OH)D concentration was inversely related to the change in total 25(OH)D (r = -0.52; P
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