Follow-Up of the Cues and Care Trial

2012 ◽  
Vol 34 (2) ◽  
pp. 65-81 ◽  
Author(s):  
Nancy Feeley ◽  
Phyllis Zelkowitz ◽  
Ian Shrier ◽  
Robyn Stremler ◽  
Ruta Westreich ◽  
...  

The long-term effects of the Cues intervention to reduce anxiety and enhance the interactive behavior of mothers of very low birth weight (VLBW) infants were investigated. A randomized trial comparing the Cues intervention to an attention control condition was conducted. A total of 122 mothers of newborns weighing < 1,500 g were randomized, and 96 participated in a follow-up assessment when the infants were 6 months corrected age. Maternal outcomes included anxiety, posttraumatic stress and depression, and mother–infant interaction. The Bayley Scales were used to assess infant development. Mother’s anxiety was not significantly lower in the Cues group (27.8 [ SD = 7.9]) compared with the control group (30.5 [ SD = 10.0]; p = 0.14). Mothers in the Cues group were not more sensitive in interactions with their infants. There were no differences between groups with respect to infant development. Thus, there was no evidence of any differential beneficial effects of the Cues program.

PEDIATRICS ◽  
1990 ◽  
Vol 85 (6) ◽  
pp. 1103-1107
Author(s):  
Janice Ware ◽  
H. William Taeusch ◽  
Roger F. SoIl ◽  
Marie C. McCormick

Several randomized clinical trials have shown that surfactant therapy improves the pulmonary status of infants with respiratory distress syndrome and has the potential to reduce morbidity and mortality in these infants. Relatively little is known, however, about the long-term consequences of surfactant treatment. In this report, the results of health and developmental assessment are described at 1 and 2 years of age of 32 survivors of an initial group of 41 infants enrolled in a randomized clinical trial of bovine surfactant therapy. The frequencies of abnormal findings were comparable in the two groups although there was a trend toward a greater frequency of allergic manifestations in the control group (6 of 16 (38%) vs 1 of 15 (7%), P = .08). Similarly, no differences were seen in the mental and motor scores of the Bayley Scales of Infant Development at either 1 or 2 years of age. This study and other recently published reports of follow-up studies of infants treated with surfactant provide encouraging evidence that major long-term side effects do not result from surfactant therapy.


1980 ◽  
Vol 3 (3) ◽  
pp. 273-286 ◽  
Author(s):  
Peter de Chateau

In a randomized, prospective study the long-term effects of early post-partum skin-toskin and suckling contact was studied. In follow-up studies 36 hours, 3 and 12 months after delivery maternal behaviour, infant behaviour, the duration of breast feeding and certain attitudes towards child rearing procedures were shown to develop differently in a group of mothers and infants with early post-natal contacts as compared to a control group. Three years after delivery parents with early contact appreciated their children's language development to be faster; the number of siblings born in these families was greater than in controls. In the discussion, the relative importance of the immediate postnatal period is emphasized, a more family oriented development seems to occur in the presence of early post-delivery interaction.


2014 ◽  
Vol 2014 ◽  
pp. 1-9 ◽  
Author(s):  
Erika Giannotti ◽  
Konstantinos Koutsikos ◽  
Maurizia Pigatto ◽  
Maria Elisa Rampudda ◽  
Andrea Doria ◽  
...  

Objective. To propose a rehabilitation protocol able to produce immediate and long-term beneficial effects on level of disability and overall performance in ADLs.Materials and Methods. Forty-one FM patients were randomized to an exercise and educational-behavioral programme group (experimental group, EG = 21) or to a control group (CG = 20). Each subject was evaluated before, at the end (T1), and after 6 months (T6) from the conclusion of the rehabilitation treatment using the Fibromyalgia Impact Questionnaire (FIQ), the visual analogue scale (VAS), the Health Assessment Questionnaire (HAQ), the fatigue severity scale (FSS), the 6-minute walking test (6MWT), tender points count (TPC), and spinal active range of motion. The exercise protocol included 20 sessions consisting in self-awareness, stretching, strengthening, spine flexibility, and aerobic exercises, which patients were subsequently educated to perform at home.Results. The two groups were comparable at baseline. At T1, the EG showed a positive trend in FIQ, VAS, HAQ, and FSS scales and significant improvement in 6MWT and in most spinal active range of motion measurements (Pbetween 0.001 and 0.04). The positive results were maintained at the follow-up.Conclusion. The proposed programme was well tolerated and produced immediate and medium-term beneficial effects improving function and strain endurance. This trial is registered withDRKS00005071on DRKS.


2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Jan Studnička ◽  
Eva Rencová ◽  
Milan Bláha ◽  
Pavel Rozsíval ◽  
Miriam Lánská ◽  
...  

Purpose. Determining long-term effects of rheohaemapheresis on the dry form of age-related macular degeneration.Methods. This study evaluates 19 patients, average age of 67.6 years, treated with rheohaemapheresis and 18 patients, average age of 72.8 years, comprising the control group. Minimum follow up period was 3.5 years. Each treated patient received a series of 8 sessions of rheohaemapheresis of 1.5 plasma volumes within 10 weeks. We measured the drusenoid pigment epithelium detachment (DPED), best-corrected visual acuity (BCVA), electroretinography (ERG), and rheological parameters.Results. In the treatment group, the baseline BCVA was 0.74 (0.36–1.0) 95% CI and BCVA after 3.5 years was 0.79 (0.41–1.0) 95% CI (P=0.726). In the control group, the baseline BCVA was 0.71 (0.15–1.0) 95% CI and BCVA after 3.5 years decreased to 0.7 (0.32–0.87) 95% CI (P=0.031). Baseline DPED was 6.78 ± 3.79 mm2; after 3.5 years, it decreased to 4.13 ± 3.84 mm2(P<0.001). In the control group, the baseline DPED was 4.09 ± 3.48 mm2; after 3.5 years, it increased to 6.69 ± 4.2 mm2(P=0.001). We noted increasing levels of positive wave peaking at 50 milliseconds (P50) after treatment (P=0.022) and a stable amplitude of photopic responses of treated patients.Conclusion. Over the long term, rheohaemapheresis reduced the DPED, improved the function of photoreceptors, and prevented the decline of BCVA.


2007 ◽  
Vol 51 (8) ◽  
pp. 2848-2854 ◽  
Author(s):  
Ioannis Skiadas ◽  
Angelos Pefanis ◽  
Apostolos Papalois ◽  
Aspasia Kyroudi ◽  
Helen Triantafyllidi ◽  
...  

ABSTRACT Although the beneficial effects of dexamethasone have frequently been investigated in various serious-infection settings, insufficient data on valve histology and cardiac function for infective endocarditis are available. The efficacy of moxifloxacin for the treatment of experimental aortic valve endocarditis due to methicillin-susceptible Staphylococcus aureus and the long-term effects of dexamethasone were evaluated in the current study. Sixty-eight rabbits were randomly assigned to four groups: A, B, C, and D. Group A consisted of 18 animals and functioned as a control group. Groups B and C consisted of 11 and 23 subjects, respectively, which received moxifloxacin for 5 days in a human-like pharmacokinetic simulation. Group D consisted of 16 animals that were administered moxifloxacin plus dexamethasone (0.25 mg/kg of body weight twice a day intravenously). The group B animals were sacrificed a day after the completion of treatment, and group C and D animals were sacrificed after 12 days in order to monitor any possible relapse and allow microbiological, histopathological, and echocardiographic evaluation of the long-term effects of glucocorticoids. No differences in survival, sterilization rates, or inflammatory infiltration and calcification of valve tissue were observed among the treated groups. However, the degrees of valve damage and collagenization were significantly worse, the fibroblast content was higher, and fractional shortening of the left ventricle fluctuated significantly in group C compared to group D (all groups, P < 0.05). We concluded that dexamethasone treatment for experimental S. aureus endocarditis attenuates valve destruction and preserves overall cardiac function without impeding the efficacy of moxifloxacin.


2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Jet B. Muskens ◽  
Pierre C. M. Herpers ◽  
Caroline Hilderink ◽  
Patricia A. M. van Deurzen ◽  
Jan K. Buitelaar ◽  
...  

Abstract Background Adolescents with acute psychiatric disorders are typically treated with long-term clinical admission. However, long term admission may be associated with a variety of negative outcomes. This pilot study presents a new model of care, that is, the combined application of intensive home treatment and the possibility of short term stay at a psychiatric high & intensive care. Methods In total 112 referred adolescents with mixed diagnoses participated in this longitudinal observational design. Clinical outcome was measured by the Health of the Nation Outcome Scales for Children and Adolescents (HoNOSCA) which measures the severity of multiple mental health problems. The HoNOSCA was clinician-rated at intake, after two months and after four months at discharge. Change in HoNOSCA total score was analysed with paired t-tests. Outcome moderators were gender, age, primary diagnosis, clinical admission, home treatment-time, medication and additional therapies. Follow up data were completed for 62 patients after two months and for 53 after four months. Results Participants aged between 11 and 18 years (M = 14.8 years, SD = 0.3; 52% female). Mean HoNOSCA total score at intake was 18.8 (SD = 5.2), after two months 13.0 (SD = 5.0); after four months resulting in a score of 9.3 (SD = 5.2). None of the moderators tested showed a significant effect on HoNOSCA scores. However, a control group could not be used because of the severe psychopathology and high risk for suicidality and the lack of an effective treatment intervention for a comparable study group. Conclusion With a symptom decrease of over 50% within four months as measured by the HoNOSCA, including less risk for hospitalization, this new model appears promising and of clinical relevance. Nevertheless, further research regarding stability of treatment outcome is warranted and evaluation of long-term effects of this model in follow-up studies is needed.


2021 ◽  
Vol 11 ◽  
Author(s):  
Shisheng Han ◽  
Tianwen Yao ◽  
Yan Lu ◽  
Min Chen ◽  
Yanqiu Xu ◽  
...  

Background: The efficacy and safety of immunosuppressive monotherapy agents were evaluated for immunoglobulin A nephropathy (IgAN) using a network meta-analysis approach.Methods: Randomized controlled trials (RCTs) published prior to October 1, 2019, using immunosuppressive agents for treating IgAN, were systematically searched in PubMed, Embase, Cochrane Library, and Web of Science databases. Relative risks (RRs) or standard mean differences with 95% confidence intervals (CIs) were estimated using the random-effects model. The primary outcomes were clinical remission, end-stage renal disease (ESRD), and serious adverse events (SAEs). The secondary outcomes were urinary protein excretion and serum creatinine.Results: Twenty-five RCTs with 2,005 participants were deemed eligible. Six medications were evaluated: corticosteroids, mycophenolate mofetil (MMF), tacrolimus (TAC), cyclosporine, leflunomide, and hydroxychloroquine (HCQ). Steroids (RR 1.50, 95% CI 1.17–1.93), MMF (RR 2.05, 95% CI 1.15–3.65), TAC (RR 3.67, 95% CI 1.06–12.63), and HCQ (RR 3.25, 95% CI 1.05–10.09) significantly improved clinical remission rates compared to supportive care alone. Only steroids reduced the risk of ESRD (RR 0.35, 95% CI 0.12–0.98); however, there were significantly more SAEs than in the control group (RR 2.90, 95% CI 1.37–6.13). No significantly different effects in serum creatinine levels were found among the therapies. MMF showed no significant improvement in remission when excluding studies with a follow-up of fewer than 2 years in the sensitivity analysis (RR 1.41, 95% CI 0.40–4.92). The effect of TAC in the decrease of proteinuria was reversed after discontinuing medication for 3 months; the long-term effects of HCQ could not be evaluated due to the short follow-up duration.Conclusion: Corticosteroids might induce remission and increase renal survival in IgAN; however, adverse reactions should be taken into consideration. MMF, TAC, and HCQ might improve the remission of proteinuria when treating IgAN, but showed no superiority compared to steroids, and the long-term effects require further study.


2020 ◽  
Author(s):  
Shisheng Han ◽  
Tianwen Yao ◽  
Yan Lu ◽  
Min Chen ◽  
Yanqiu Xu ◽  
...  

Abstract BackgroundThe efficacy and safety of immunosuppressive agent monotherapy were evaluated for Immunoglobulin A nephropathy (IgAN) using a network meta-analysis approach based on randomised controlled trials (RCTs).MethodsPubMed, Embase, the Cochrane library, and the Web of Science were systematically searched for RCTs published before October 2019 using immunosuppressive agents for treating IgAN. Quality assessments were performed according to the Cochrane Handbook. Pooled relative risks (RRs) or standard mean differences (SMDs) with corresponding 95% confidence intervals (CIs) were calculated for discrete or continuous variables, respectively. The primary outcomes were clinical remission, end-stage renal disease (ESRD), and serious adverse events (SAEs); the secondary outcomes were urinary protein excretion and serum creatinine. Data were synthesised by the random-effects model.ResultsTwenty-five RCTs with 2005 participants were deemed to be eligible, and six medications were evaluated: corticosteroids, mycophenolate mofetil (MMF), tacrolimus (TAC), cyclosporine (CsA), leflunomide (LEF), and hydroxychloroquine (HCQ). Compared to supportive care alone, steroids (RR 1.50, 95% CI 1.17–1.93), MMF (RR 2.05, 95% CI 1.15–3.65), TAC (RR 3.67, 95% CI 1.06–12.63), and HCQ (RR 3.25, 95% CI 1.05–10.09) each significantly improved clinical remission rates; only steroids reduced the risk of ESRD (RR 0.35, 95% CI 0.12–0.98), but the SAEs were significantly higher than those in the control group (RR 2.90, 95% CI 1.37–6.13). Furthermore, steroids, LEF, and HCQ showed lower proteinuria in the pairwise meta-analysis. There was no evidence of different effects of the therapies on serum creatinine levels. The effect of MMF, whereby it induced remission, was reversed when excluding studies with follow-up of fewer than two years in the sensitivity analysis (RR 1.41, 95% CI 0.40–4.92). The anti-proteinuric effect of TAC was reversed three months after discontinuing medication; the long-term effects of HCQ could not be evaluated due to the short follow-up.ConclusionsCorticosteroids might induce remission and increase renal survival in IgAN; however, the adverse reactions should be considered. TAC, LEF, HCQ, and MMF, might improve remission of proteinuria when treating IgAN, but showed no superiority compared to steroids, and the long-term effects require further study.


2016 ◽  
Vol 43 (4) ◽  
pp. 251-260 ◽  
Author(s):  
Dario Roccatello ◽  
Savino Sciascia ◽  
Simone Baldovino ◽  
Daniela Rossi ◽  
Mirella Alpa ◽  
...  

Background: In a prospective, single-center open study, we evaluated the very long-term effects of rituximab (RTX) administered to patients with severe mixed cryoglobulinemia (MC). Methods: RTX was administered to 31 patients with MC (type II in 29 cases and type III in 2) with diffuse membranoproliferative glomerulonephritis (16 cases), peripheral neuropathy (26) and large skin ulcers (7). All but 4 patients had serum anti-hepatitis C virus antibodies. RTX was administered at a dose of 375 mg/m2, according to a ‘4 + 2' protocol (days 1, 8, 15 and 22 plus 1 dose 1 and 2 months later). No other immunosuppressive drugs were added. Response was evaluated over a very long-term follow-up (mean 72.47 months, range 30-148). Results: Complete remission of pretreatment active manifestations was observed in all cases of purpuric lesions and non-healing vasculitic ulcers, and in 80% of the peripheral neuropathies. Cryoglobulinemic nephropathy significantly improved during follow-up, starting from the 2nd month after RTX (serum creatinine from 2.1 ± 1.7 to 1.5 ± 1.6 mg/dl, p ≤ 0.05; 24-hour proteinuria from 2.3 ± 2.1 to 0.9 ± 1.9 g/24 h, p ≤ 0.05). Improvement of cryoglobulinemic serological hallmarks, such as cryocrit and low complement C4, were observed. No clinically relevant side effects were recorded. Re-induction with RTX was carried out in 9 relapsed patients after a mean of 31.1 months (12-54), again with beneficial effects. The survival rate was 75% at 6 years and the probability of remaining symptom-free for 10 years without any therapy was of about 60% after a single ‘4 + 2' infusion cycle, while the probability of living symptom-free 5 years after relapsing was 80% if given the same treatment. Conclusion: In this open, prospective study, RTX appeared to be very effective and safe in the treatment of the most severe cases of MC.


2020 ◽  
Author(s):  
Annette Mönninghoff ◽  
Jan Niklas Kramer ◽  
Alexander Jan Hess ◽  
Kamila Ismailova ◽  
Gisbert W Teepe ◽  
...  

BACKGROUND Mobile health (mHealth) interventions can increase physical activity (PA); however, their long-term impact is not well understood. OBJECTIVE The primary aim of this study is to understand the immediate and long-term effects of mHealth interventions on PA. The secondary aim is to explore potential effect moderators. METHODS We performed this study according to the Cochrane and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. We searched PubMed, the Cochrane Library, SCOPUS, and PsycINFO in July 2020. Eligible studies included randomized controlled trials of mHealth interventions targeting PA as a primary outcome in adults. Eligible outcome measures were walking, moderate-to-vigorous physical activity (MVPA), total physical activity (TPA), and energy expenditure. Where reported, we extracted data for 3 time points (ie, end of intervention, follow-up ≤6 months, and follow-up &gt;6 months). To explore effect moderators, we performed subgroup analyses by population, intervention design, and control group type. Results were summarized using random effects meta-analysis. Risk of bias was assessed using the Cochrane Collaboration tool. RESULTS Of the 2828 identified studies, 117 were included. These studies reported on 21,118 participants with a mean age of 52.03 (SD 14.14) years, of whom 58.99% (n=12,459) were female. mHealth interventions significantly increased PA across all the 4 outcome measures at the end of intervention (walking standardized mean difference [SMD] 0.46, 95% CI 0.36-0.55; <i>P</i>&lt;.001; MVPA SMD 0.28, 95% CI 0.21-0.35; <i>P</i>&lt;.001; TPA SMD 0.34, 95% CI 0.20-0.47; <i>P</i>&lt;.001; energy expenditure SMD 0.44, 95% CI 0.13-0.75; <i>P</i>=.01). Only 33 studies reported short-term follow-up measurements, and 8 studies reported long-term follow-up measurements in addition to end-of-intervention results. In the short term, effects were sustained for walking (SMD 0.26, 95% CI 0.09-0.42; <i>P</i>=.002), MVPA (SMD 0.20, 95% CI 0.05-0.35; <i>P</i>=.008), and TPA (SMD 0.53, 95% CI 0.13-0.93; <i>P</i>=.009). In the long term, effects were also sustained for walking (SMD 0.25, 95% CI 0.10-0.39; <i>P</i>=.001) and MVPA (SMD 0.19, 95% CI 0.11-0.27; <i>P</i>&lt;.001). We found the study population to be an effect moderator, with higher effect scores in sick and at-risk populations. PA was increased both in scalable and nonscalable mHealth intervention designs and regardless of the control group type. The risk of bias was rated high in 80.3% (94/117) of the studies. Heterogeneity was significant, resulting in low to very low quality of evidence. CONCLUSIONS mHealth interventions can foster small to moderate increases in PA. The effects are maintained long term; however, the effect size decreases over time. The results encourage using mHealth interventions in at-risk and sick populations and support the use of scalable mHealth intervention designs to affordably reach large populations. However, given the low evidence quality, further methodologically rigorous studies are warranted to evaluate the long-term effects.


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