Search

Background and aims: Despite the high prevalence and negative effects of hazardous substance use, few young adults enter treatment. Community Reinforcement and Family Training (CRAFT), a support programme for concerned significant others of people with substance use disorders, has proved efficacious in promoting treatment entry. The aim of the current trial was to compare the efficacy of CRAFT with an active control for parents of young adults (aged 18–24 years) with hazardous substance use. Design: This was a randomized controlled superiority trial comparing CRAFT (n = 58) with an active control group receiving manualized counselling (n = 55), with outcome assessments at 6, 12 and 24 weeks (primary end‐point). A sequential design with a stopping rule was added post recruitment commencement. Setting: The study took place in two outpatient clinics for young adults in Stockholm, Sweden, and subsequently via video‐conference due to COVID‐19. Participants: Between October 2018 and May 2021, 113 participants (92% female) who were parents of young adults (87% male) were recruited. Recruitment was discontinued when 70% of the planned sample had been recruited, following an interim analysis of the primary outcome showing no difference between conditions. Intervention and comparator: Participants were randomized (ratio 1 : 1) to eight manual‐based individual CRAFT sessions or five individual manual‐based counselling sessions + one voluntary psychoeducative group session, delivered over maximum 14 weeks. Measurements The primary outcome measure was the rate of young adult entry in substance use treatment during the trial period (24 weeks). Findings At the 24 weeks follow‐up, 19 (33%) of CRAFT participants and 17 (31%) of counselling participants had reported young adult treatment entry, with no difference between conditions (odds ratio CRAFT versus counselling 0.84, 95% confidence interval = 0.35; 1.99, P = 0.700). Both conditions reported clinically relevant reductions in young adult substance use, but no change in participants' levels of depression, anxiety or stress. Conclusions: This trial showed no statistically significant evidence that Community Reinforcement and Family Training (CRAFT), a support programme for concerned significant others of people with substance use disorders, is more efficacious than manual‐based counselling regarding treatment entry for young adults. [ABSTRACT FROM AUTHOR]

Background and aims: Controlled drinking (CD) is an attractive treatment goal for a large proportion of individuals with alcohol use disorder (AUD), but the availability of treatment methods supporting a goal of CD is scarce. We tested if behavioural self‐control training (BSCT) was superior to motivational enhancement therapy (MET) for individuals with AUD with a treatment goal of CD. Design: Randomized controlled two‐group trial. Follow‐ups were conducted at 12 and 26 weeks (primary end‐point) after inclusion. Setting: Three specialized dependency care clinics in Stockholm, Sweden. Participants: Two hundred and fifty self‐referred adults (52% men) fulfilling criteria of AUD (DSM‐5) and a stated treatment goal of CD. Intervention and comparator: BSCT (n = 125), a five‐session treatment based on cognitive behavioural therapy versus the active comparator, MET (n = 125), containing four sessions based on Motivational Interviewing. Measurements Primary outcome measure was mean weekly alcohol consumption at the 26‐week follow‐up, adjusted for baseline consumption. Conclusions: A randomized controlled trial found no evidence of a difference between behavioural self‐control training and motivational enhancement therapy in reducing weekly alcohol consumption. Both groups substantially reduced consumption and behavioural self‐control training was superior in reducing hazardous drinking. [ABSTRACT FROM AUTHOR]

Background and Aims: Most alcohol‐dependent people have a moderate level of dependence. General practitioners (GPs) hesitate to engage in this area, and need to have access to treatment they find applicable and feasible to use. The aim of this present study was to test if an open‐ended internet‐based cognitive–behavioral therapy (iCBT) program added to treatment‐as‐usual (TAU) is more effective than TAU‐only for alcohol‐dependent patients in primary care. Design, Setting and Participants: The present study was a two‐group, parallel, randomized controlled superiority trial comparing iCBT+TAU versus TAU‐only at 3‐ and 12‐month follow‐ups. TAU was delivered at 14 primary care centers in Stockholm, Sweden. A total of 264 patients (mean age 51 years, of whom 148 were female and 116 were male) with alcohol dependence and hazardous alcohol consumption were enrolled between September 2017 and November 2019. Measurements: Participants were randomized at a ratio of 1:1 to iCBT, as a self‐help intervention added to TAU (n = 132) or to TAU‐only (n = 132). The GPs gave participants in both treatment arms feedback on the assessments and biomarkers and offered TAU at the primary care center. Primary outcome was weekly alcohol consumption in g/week at 12‐month follow‐up, analyzed according to intention‐to‐treat (n = 132 + 132). The per‐protocol analysis included participants who completed at least one module of iCBT (n = 102 + 132). Findings There was no significant difference in weekly alcohol consumption between iCBT+TAU and TAU in the intention‐to‐treat (ITT) analysis at 12‐month follow‐up [iCBT+TAU = 133.56 (95% confidence interval, CI = 100.94–166.19) and TAU = 176.20 (95% CI = 144.04–208.35), P = 0.068, d = 0.23]. In the per‐protocol analysis, including only those who initiated iCBT, the iCBT+TAU group showed lower mean weekly alcohol consumption compared with TAU [iCBT+TAU = 107.46 (95% CI = 71.17–143.74), TAU = 176.00 (95% CI = 144.21–207.80), P = 0.010, d = 0.42]. Conclusions: In Sweden, an internet‐based cognitive–behavioral program added to treatment‐as‐usual to reduce alcohol consumption showed weak evidence of a benefit at 12 months in the intention‐to‐treat analysis and good evidence of a benefit in the per‐protocol analysis. [ABSTRACT FROM AUTHOR]

Background and purpose: We investigated 952 subjects undergoing diagnostic lumbar puncture (LP) to study the effects of needle size, needle design and stylet reinsertion on the risk of post‐dural puncture headache (PDPH). Methods: This randomized double‐blind study was performed at Umeå University Hospital in Sweden during 2013–2018. Subjects were randomly assigned one of three needles [22 gauge (G) atraumatic, 25G atraumatic and 25G cutting] and stylet reinsertion before needle withdrawal or not. The main outcome measure was PDPH assessed by standardized telephone interview(s) 5 days after the LP, repeated until headache cessation. We used logistic regression to calculate odds ratios (ORs) with 95% confidence intervals (CI) for PDPH. Results: The mean (SD) age was 51.1 (16.7) years and 53.6% were females. The smaller bore (25G) atraumatic needle incurred a lower risk of headache compared with the larger bore (22G) atraumatic needle [22.0% (69/314) vs. 30.2% (98/324); OR, 0.65; 95% CI, 0.45–0.93] and compared with the cutting needle [32.8% (103/314); OR, 0.58; 95% CI, 0.40–0.82]. Reinserting the stylet before needle withdrawal did not reduce the risk of headache. Conclusions: These data suggest that a 25G atraumatic needle is superior to a larger atraumatic needle, and to a same‐sized cutting needle, in preventing PDPH after diagnostic LP. In contrast to one earlier report, this study did not find that stylet reinsertion was effective in preventing PDPH. This study provides class I evidence that a small atraumatic needle decreases the risk of PDPH and that stylet reinsertion does not influence PDPH risk. [ABSTRACT FROM AUTHOR]

Aims: Patients with advanced heart failure (AdHF) who are ineligible for heart transplantation (HTx) can become candidates for treatment with a left ventricular assist device (LVAD) in some countries, but not others. This reflects the lack of a systematic analysis of the usefulness of LVAD systems in this context, and of their benefits, limitations and cost-effectiveness. The SWEdish evaluation of left Ventricular Assist Device (SweVAD) study is a Phase IV, prospective, 1:1 randomized, non-blinded, multicentre trial that will examine the impact of assignment to mechanical circulatory support with guideline-directed LVAD destination therapy (GD-LVAD-DT) using the HeartMate 3 (HM3) continuous flow pump vs. guideline-directed medical therapy (GDMT) on survival in a population of AdHF patients ineligible for HTx.Methods: A total of 80 patients will be recruited to SweVAD at the seven university hospitals in Sweden. The study population will comprise patients with AdHF (New York Heart Association class IIIB-IV, INTERMACS profile 2-6) who display signs of poor prognosis despite GDMT and who are not considered eligible for HTx. Participants will be followed for 2 years or until death occurs. Other endpoints will be determined by blinded adjudication. Patients who remain on study-assigned interventions beyond 2 years will be asked to continue follow-up for outcomes and adverse events for up to 5 years.Conclusion: The SweVAD study will compare survival, medium-term benefits, costs and potential hazards between GD-LVAD-DT and GDMT and will provide a valuable reference point to guide destination therapy strategies for patients with AdHF ineligible for HTx. [ABSTRACT FROM AUTHOR]

Background: Although mindfulness‐based group therapies (MGTs) for depressive, anxiety or stress and adjustment disorders are promising, there is a substantial lack of knowledge regarding the long‐term improvements after such therapies in these common psychiatric disorders. Methods: Two hundred and fifteen patients were randomized in a randomized clinical trial (RCT) (ClinicalTrials.gov ID: NCT01476371) conducted in 2012 at 16 primary healthcare centres in southern Sweden. The patients were randomized to MGT or treatment as usual (TAU) and completed four psychometric self‐rated scales after 8 weeks of treatment. Approximately 12 months after the completion of the 8‐week treatment, the same scales were repeated. Ordinal and generalized linear‐mixed models, adjusted for cluster effects, were used for the analysis. Results: For all four psychometric scales (MADRS‐S [Montgomery‐Åsberg Depression Rating Scale‐S], HADS‐D, HADS‐A [Hospital Anxiety and Depression Scale A and D] and PHQ‐9 [Patient Health Questionnaire‐9]) the scores at the 1‐year follow‐up were significantly improved (all P values <0.001) in both groups. Furthermore, there were no significant differences between the MGT and TAU in the psychometric scores at the 1‐year follow‐up. Conclusions: To the best of our knowledge, this is the first RCT comparing the long‐term improvements after MGT with TAU. Although it cannot be excluded that our findings are a result of the natural course of common psychiatric disorders or other factors, they suggest a long‐term positive improvement after both MGT and TAU. [ABSTRACT FROM AUTHOR]

Objective: To compare vaginal misoprostol treatment with expectant management in early non-viable pregnancy with vaginal bleeding with regard to complete evacuation of the uterine cavity within 10 days after randomization.Methods: This was a parallel randomized controlled, open-label trial conducted in Skåne University Hospital, Sweden. Patients with anembryonic pregnancy or early fetal demise (crown-rump length ≤ 33 mm) and vaginal bleeding were randomly allocated to either expectant management or treatment with a single dose of 800 μg misoprostol administered vaginally. Patients were evaluated clinically and by ultrasound until complete evacuation of the uterus was achieved (no gestational sac in the uterine cavity and maximum anteroposterior diameter of the intracavitary contents < 15 mm as measured by transvaginal ultrasound on midsagittal view). Follow-up visits were planned at 10, 17, 24 and 31 days. Dilatation and evacuation (D&E) was recommended if miscarriage was not complete within 31 days, but was performed earlier at patient's request, or if there was excessive bleeding as judged clinically. Analysis was by intention to treat. The main outcome measure was number of patients with complete miscarriage without D&E ≤ 10 days.Results: Ninety-four patients were randomized to misoprostol treatment and 95 to expectant management. After exclusion of three patients and withdrawal of consent by two patients in the expectant management group, 90 women were included in this group. Miscarriage was complete ≤ 10 days in 62/94 (66%) of the patients in the misoprostol group and in 39/90 (43%) of those in the group managed expectantly (risk difference (RD) = 23%; 95% CI, 8-37%). At 31 days, the corresponding figures were 81/94 (86%) and 55/90 (61%) (RD = 25%; 95% CI, 12-38%). Two patients from each group underwent emergency D&E because of excessive bleeding and one of these in each group received blood transfusion. The number of patients undergoing D&E at their own request was higher in the expectantly managed group, 15/90 (17%) vs 3/94 (3%) in the misoprostol group (RD = 14%; 95% CI, 4-23%), as was the number of patients making out-of-protocol visits, 50/90 (56%) vs 27/94 (29%) (RD = 27%; 95% CI, 12-40%). Compared with the expectant management group, more patients in the misoprostol group experienced pain (71/77 (92%) vs 91/91 (100%); RD = 8%; 95% CI, 1-17%) and used painkillers (59/77 (77%) vs 85/91 (93%); RD = 17%; 95% CI, 5-29%). No major side effect was reported in any group.Conclusions: In women with early non-viable pregnancy and vaginal bleeding, misoprostol treatment is more effective than is expectant management for complete evacuation of the uterus. Both methods are safe but misoprostol treatment is associated with more pain than is expectant management. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd. [ABSTRACT FROM AUTHOR]

Objectives To evaluate approximal caries increment among 12- to 16-year-olds in a low caries prevalence area in Sweden after a 3.5-year school-based fluoride (F) varnish programme with Bifluorid 12 and Duraphat. Methods The design was a RCT study with 1365 adolescents, divided into following four groups: Group 1 Bifluorid 12 two applications/year; Group 2 Duraphat two applications/year; Group 3 Bifluorid 12 four applications/year and Group 4 no F varnish at school. 1143 children (84%) completed the study. Approximal caries was registered on bitewing radiographs. Results There were no statistically significant differences in caries prevalence among the groups either at baseline or after 3.5 years . The caries increment for Group 1 was 1.34 ± 2.99 (mean ± SD), 1.24 ± 2.84 for Group 2, 1.07 ± 2.66 for Group 3 and 1.25 ± 2.75 for Group 4, with no statically significant differences either between Bifluorid 12 and Duraphat with the same frequency of F varnish applications or between the F groups and the control group. Conclusions In an area with low caries prevalence in Sweden, the supplementary caries-preventive effect of school-based F varnish applications, to regular use of F toothpaste at home and to regular caries prevention given at the Public Dental Clinics, appears to be nonsignificant regarding approximal caries increment. [ABSTRACT FROM AUTHOR]

Objective To compare early induction and expectant management regarding delivery outcomes and the experience of delivery in nulliparous women with prolonged latent phases. Design Randomized controlled trial. Setting One delivery unit in a Swedish hospital. Population Nulliparous women at term experiencing continuous contractions impeding rest (women's report) and exceeding 18 h, a cervical dilation of less than 4 cm, intact membranes and with a singleton fetus in cephalic presentation. Methods The women were randomly allocated to either early induction ( n = 65) or expectant management ( n = 64). All participants received medication for therapeutic rest. The early induction group was induced five hours after medication, and the expectant group awaited spontaneous onset of labor. The Wijma Delivery Experience Questionnaire (W- DEQ version B) was filled in after delivery. Main outcome measures The primary outcome was mode of delivery. Secondary outcomes included birth experience, duration of labor, postpartum hemorrhage, and neonatal outcomes. Results The cesarean section rate was 15 of 65 (23.1%) in the early induction group and 24 of 64 (37.5%) in the expectant group ( p = 0.076, OR 2.00, 95% CI 0.93-4.31). No significant differences were shown regarding delivery, neonatal outcomes or birth experience. Conclusions No significant differences were shown between the two groups in the rate of cesarean sections or the experience of delivery. According to the actual results, the power to detect a difference was only 45%. The cesarean section rate was high in both groups, regardless of intervention. [ABSTRACT FROM AUTHOR]

Aim: To compare two different regimens for children diagnosed with type 1 diabetes: hospital-based care or hospital-based home care (HBHC), referring to specialist care in a home-based setting. Method: The trial took place in Sweden with a randomized controlled design and included 60 children, aged 3-15 years. After 2-3 days with hospital-based care, children were randomized to either continued hospital-based care or to HBHC for 6 days. The primary outcome was the child's metabolic control after 2 years. Secondary outcomes were set to evaluate the family and child situation as well as the healthcare services. This article presents data 6 months after diagnosis. Results: Results showed equivalence between groups in terms of metabolic control, insulin dose, parents' employment and working hours as well as parents' and significant others' absence from work related to the child's diabetes. Parents in the HBHC were more satisfied with the received health care and showed less subsequent healthcare resource use. The level of risk for the family's psychosocial distress assessed at diagnosis was associated with the subsequent use of resources, but not with metabolic control. Conclusion: HBHC was found to be an equally safe and effective way of providing care as hospital-based care at the onset of type 1 diabetes for children who are medically stable. [ABSTRACT FROM AUTHOR]

Objective To compare the treatment outcome of scaling and root planing ( SRP) in combination with systemic antibiotics, local antibiotic therapy and/or periodontal surgery. Material and Methods One hundred and eighty-seven patients were assigned to eight groups treated by SRP plus none, one, two or three adjunctive treatments and monitored for 24 months in a randomized controlled clinical trial using a 2 × 2 × 2 factorial design. Systemic amoxicillin + metronidazole ( SMA), local tetracycline delivery ( LTC) and periodontal surgery (SURG) were evaluated as adjuncts. Changes in clinical attachment level ( CAL) and probing pocket depth ( PPD) were statistically evaluated by ancova of main effects. Results Effects of adjunctive therapy to SRP were minimal at 3 months. Between 3 and 6 months PPD reduction occurred particularly in patients receiving periodontal surgery. After 6 months, both CAL gain and PPD reduction reached a plateau that was maintained at 24 months in all groups. The 24-month CAL gain was improved by SMA (0.50 mm) while PPD was reduced by SMA (0.51 mm) and SURG (0.36 mm). Smoking reduced CAL gain and PPD reduction. Conclusion Patients receiving adjunctive therapies generally exhibited improved CAL gain and/or PPD reduction when compared with the outcome of SRP alone. Only additive, not synergistic effects of the various adjunctive therapies were observed. [ABSTRACT FROM AUTHOR]

Aims: To test the efficacy of a therapist-guided high-intensity internet intervention compared with an unguided low-intensity internet intervention among individuals with alcohol use disorder., Design: A three-group randomized controlled trial with follow-up assessments post-treatment (12 weeks) and 6 months post-randomization (primary end-point)., Settings: General population sample in Sweden., Participants: A total of 166 on-line self-referred adults (49% males) with a score of 14 (females)/16 (males) or more on the Alcohol Use Disorders Identification Test, a preceding week alcohol consumption of 11 (females)/14 (males) or more standard drinks and an alcohol use disorder according to a diagnostic interview., Interventions and Comparators: Both the high- (n = 72) and low-intensity internet interventions (n = 71) consisted of modules based on relapse prevention. Controls were on a waiting-list (n = 23), and were only followed until the post-treatment follow-up. Participants were randomized at a 7 : 7 : 2 ratio., Measurements: Primary outcome was self-reported alcohol consumption in the preceding week measured as (1) number of standard drinks and (2) number of heavy drinking days at the 6-month follow-up., Findings: Alcohol use disorders were largely in the severe category (74.7%), with the majority of participants having had alcohol problems for more than 5 years. Attrition was 13 and 22% at the post-treatment and 6-month follow-up, respectively. At the 6-month follow-up, an intent-to-treat analysis showed no significant differences in alcohol consumption between the high- and low-intensity interventions [standard drinks d = -0.17, 95% confidence interval (CI) = -0.50 to 0.16; heavy drinking days: d = -0.07, 95% CI = -0.40 to 0.26]. Prevalence of negative effects was somewhat low (8-14%) in both intervention groups, as was deterioration (3-5%)., Conclusions: At 6-month follow-up, there were no significant differences between a therapist-guided high-intensity internet intervention and an unguided low-intensity internet intervention in reducing alcohol consumption among individuals with an alcohol use disorder., (© 2019 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.)