Intention-to-Treat Analyse

Zusammenfassung. Zielsetzung: Der demographische Wandel lässt eine höhere Anzahl älterer Personen mit Alkoholproblemen erwarten, deren therapeutische Versorgung bislang unzureichend ist. Mit der internationalen, randomisiert-kontrollierten ELDERLY-Studie wurden zwei Varianten einer ambulanten psychotherapeutischen Behandlung für Personen ab 60 Jahren mit einer Alkoholkonsumstörung nach DSM-5 (AS) in drei Ländern erprobt. Methodik: Nach der Baseline-Befragung wurden die zufällig zugeordneten Behandlungsgruppen nach 1, 3, 6 und 12 Monaten erneut untersucht. Erfasst wurden Veränderungen (Zeit und Gruppe) hinsichtlich Trinkmenge, Anzahl abstinenter Tage, Anzahl Tage Rauschtrinken und Tage risikoarmen Konsums sowie Anzahl zutreffender DSM-5-Kriterien für AS. Complete-Case- und Intention-to-treat-Analysen werden für die deutsche Teilstichprobe vorgestellt (n=203). Ergebnisse: Für beide Behandlungsgruppen ergaben sich stabil bis zu 12 Monate nach Baseline ein Anstieg der Abstinenzrate (18 %; t0: 4 %), des Anteils der Personen ohne einen Tag mit riskantem Konsum (45 %, t0: 4 %) sowie ohne Rauschtrinken (68 %, t0: 15 %). Auch zeigte sich eine Verringerung der Trinkmenge (Median bei 27 g Reinalkohol pro Trinktag; t0: 58 g) und Anzahl erfüllter AS-Kriterien (Median bei 2; t0: 5). Schlussfolgerungen: Die Verbesserungen des Trinkverhaltens und der AS-Symptome waren trotz relativ kurzer Behandlungsdauer stabil. Motivierende Interventionen, insbesondere die persönliche Rückmeldung zum Trinkverhalten, bewirken auch bei älteren Personen mit alkoholbezogenen Störungen Verhaltensänderungen. Ein therapeutischer Nihilismus ist unangebracht; vielmehr sollten spezifische Bedürfnisse der Zielgruppe beachtet und in passenden Versorgungsangeboten umgesetzt werden.

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Manual therapies for pain relief in patients with headache

Revista Neurociências ◽

10.34024/rnc.2015.v23.8053 ◽

2015 ◽

Vol 23 (1) ◽

pp. 89-96

Author(s):

Débora Wanderley ◽

Andrea Lemos ◽

Larissa de Andrade Carvalho ◽

Daniella Araújo de Oliveira

Keyword(s):

Treatment Effect ◽

Cervicogenic Headache ◽

Allocation Concealment ◽

Tension Type Headache ◽

Manual Therapies ◽

Osteopathic Manipulation ◽

Intention To Treat ◽

Headache Relief ◽

Type Headache ◽

Treat Analysis

Objective. This systematic review aimed to assess the efficacy of manual therapies for headache relief. Method. A systematic search in MEDLINE, LILACS, Cochrane, CINAHL, Scopus and Web of Science databases was conducted for randomized and quasi-randomized trials, with no restrictions for language or year of publication. The descriptors were ‘Headache’, ‘Headache disorders’ and ‘Musculoskeletal manipulations’, in addition to the keyword ‘Manual therapy’ and its equivalents in Portuguese. We included studies that compared massage, chiropractic manipulation, osteopathic manipulation and other spinal manipulation to groups with no intervention, other physiotherapeutic modalities or to a sham group. Results. Seven of the 567 articles initially screened were selected, including patients with tension type headache, cervicogenic headache or migraine. It was not possible to assess the magnitude of the treatment effect on the findings of this review. The main limitations were the absence of randomization and adequate allocation concealment, the lack of blinded evaluators and intention-to-treat analysis and inadequate statistical analysis. Conclusions. We were unable to determine the size of the treatment effect due to the selective description of findings. Owing to the high risk of bias in the articles included, the available evidence regarding the efficacy of manual therapies for headache relief is insufficient.

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EFFICACY OF TREATMENT OF H.PYLORI EARDICATION WITH STANDARD TRIPLE THERAPY IN PEPTIC ULCER PATIENTS

Journal of Medicine and Pharmacy ◽

10.34071/jmp.2011.3.17 ◽

2011 ◽

pp. 122-129

Author(s):

Quang Di Bui ◽

Phuoc Lam Nguyen

Keyword(s):

Peptic Ulcer ◽

Adverse Effects ◽

Triple Therapy ◽

Cross Sectional Study ◽

Cross Sectional ◽

Duodenal Ulcers ◽

Ulcer Disease ◽

Intention To Treat ◽

Standard Triple Therapy

Objectives: The aim of study is to evaluate the efficacy, tolerability and adverse effects of a standard triple therapy including Rabeprazole, Clarithromycin and Amoxicilline at Sai gon Hoan My hospital in order to consider treatment H.pylori for patients who have not yet eradicated before or need to be undertaked by alternative regimens. Methods: By descriptive cross-sectional study, the authors have examined 116 patients sufferring from peptic ulcer received 10-day therapy including Rabe (20mg b.d) plus Clari(500mg b.d) plus Amoxi(1g b.d). Eradication is confirmed with endoscopy after 4 weeks from completing of treatment. Results and Discussion: 100% of patients were initially included and noboby was dropped out of the follow-up satges. The mean age was 49 in which 62% was male, 73(62,9%) presented duodenal ulcer, 28(24,1%) gastric ulcer and 15(13%) simultaneous gastric and duodenal ulcers. All patients took medications correctly. Per-protocol and intention to treat eradication rates were both 75%(95% CI=73,4-78,3). Additionally, 62(53,4%) patients had at least one risky factor for peptic ulcer disease, smoking being the most common one 44(37,9%).The adverse effects were reported overall in 67% of the patients, mainly including changed taste, very bitter, tired 49%, trouble sleeping 12% and diarrhea 5%. Conclusion: this ten-day standard triple therapy used in this study is ineffective with high adverse effects.The first line eradication with new regimens should be alternative.

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Long-Term Safety and Efficacy of Prebiotic Enriched Infant Formula—A Randomized Controlled Trial

Nutrients ◽

10.3390/nu13041276 ◽

2021 ◽

Vol 13 (4) ◽

pp. 1276

Author(s):

Franka Neumer ◽

Orenci Urraca ◽

Joaquin Alonso ◽

Jesús Palencia ◽

Vicente Varea ◽

...

Keyword(s):

Infant Formula ◽

Controlled Trial ◽

Fecal Microbiota ◽

First Year ◽

Double Blind Study ◽

Double Blind ◽

Term Infants ◽

Intention To Treat ◽

Prebiotic Oligosaccharides ◽

First Year Of Life

The present study aims to evaluate the effects of an infant formula supplemented with a mixture of prebiotic short and long chain inulin-type oligosaccharides on health outcomes, safety and tolerance, as well as on fecal microbiota composition during the first year of life. In a prospective, multicenter, randomized, double-blind study, n = 160 healthy term infants under 4 months of age were randomized to receive either an infant formula enriched with 0.8 g/dL of Orafti®Synergy1 or an unsupplemented control formula until the age of 12 months. Growth, fever (>38 °C) and infections were regularly followed up by a pediatrician. Digestive symptoms, stool consistency as well as crying and sleeping patterns were recorded during one week each study month. Fecal microbiota and immunological biomarkers were determined from a subgroup of infants after 2, 6 and 12 months of life. The intention to treat (ITT) population consisted of n = 149 infants. Both formulae were well tolerated. Mean duration of infections was significantly lower in the prebiotic fed infants (p < 0.05). The prebiotic group showed higher Bifidobacterium counts at month 6 (p = 0.006), and higher proportions of Bifidobacterium in relation to total bacteria at month 2 and 6 (p = 0.042 and p = 0.013, respectively). Stools of infants receiving the prebiotic formula were softer (p < 0.05). Orafti®Synergy1 tended to beneficially impact total daily amount of crying (p = 0.0594). Supplementation with inulin-type prebiotic oligosaccharides during the first year of life beneficially modulates the infant gut microbiota towards higher Bifidobacterium levels at the first 6 months of life, and is associated with reduced duration of infections.

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Randomized Trial for Weight Loss Using a Digital Therapeutic Application

Journal of Diabetes Science and Technology ◽

10.1177/19322968211000815 ◽

2021 ◽

pp. 193229682110008

Author(s):

Tryggvi Thorgeirsson ◽

Johanna E. Torfadottir ◽

Erlendur Egilsson ◽

Saemundur Oddsson ◽

Thrudur Gunnarsdottir ◽

...

Keyword(s):

Weight Loss ◽

Mobile Application ◽

Intervention Group ◽

Lifestyle Change ◽

Noncommunicable Diseases ◽

Control Group ◽

Intention To Treat ◽

Protocol Group ◽

Lifestyle Program ◽

Program Intervention

Background: Smartphones present a near-ubiquitous channel through which structured lifestyle change can reduce risk or progression of the most common noncommunicable diseases. We explored whether a digital structured lifestyle program enhances weight loss. Methods: We randomized overweight and obese participants attending a four-month lifestyle change program to either standard weekly coaching sessions (controls), or standard treatment supplemented with a digital therapeutic mobile application (intervention). Changes in body mass index after four months were the main outcome measure. Odds ratios of achieving 5% weight loss were estimated with unconditional logistic regression. Results: Of 234 eligible persons, 146 (62%) agreed to participate, were block-randomized, showed up for the baseline measures, and constituted the intention-to-treat (ITT) sample ( n = 95 intervention group, n = 51 control group). In the intervention group, 70 (74%) downloaded the mobile application and completed the program (intervention per-protocol). Significant weight loss and BMI reduction were observed for both the intention-to-treat intervention group ( P < 0.05, P = 0.01) and the per-protocol intervention group ( P < 0.0001, P < 0.0001). For the intervention per-protocol group, the odds ratio of achieving 5% weight loss, compared to not treated per-protocol, was 3.3 (95% CI 1.3-8.2), adjusting for age and weight at baseline.Attendance to weekly coaching sessions decreased by 18% during the program in the control group while it increased by 3% amongst the per-protocol group ( P = 0.004). Conclusions: These preliminary findings support the benefit of a digital therapeutic to enhance weight reduction and attendance in a structured lifestyle change program. Larger trials of longer duration are needed to confirm these findings.

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The Treatment Effect of Liver Transplantation versus Liver Resection for HCC: A Review and Future Perspectives

Cancers ◽

10.3390/cancers13153730 ◽

2021 ◽

Vol 13 (15) ◽

pp. 3730

Author(s):

Berend R. Beumer ◽

Roeland F. de Wilde ◽

Herold J. Metselaar ◽

Robert A. de Man ◽

Wojciech G. Polak ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Liver Transplantation ◽

Liver Resection ◽

Early Stage ◽

Disease Free Survival ◽

Milan Criteria ◽

Term Survival ◽

Equal Distribution ◽

Intention To Treat ◽

Treat Analysis

For patients presenting with hepatocellular carcinoma within the Milan criteria, either liver resection or liver transplantation can be performed. However, to what extent either of these treatment options is superior in terms of long-term survival is unknown. Obviously, the comparison of these treatments is complicated by several selection processes. In this article, we comprehensively review the current literature with a focus on factors accounting for selection bias. Thus far, studies that did not perform an intention-to-treat analysis conclude that liver transplantation is superior to liver resection for early-stage hepatocellular carcinoma. In contrast, studies performing an intention-to-treat analysis state that survival is comparable between both modalities. Furthermore, all studies demonstrate that disease-free survival is longer after liver transplantation compared to liver resection. With respect to the latter, implications of recurrences for survival are rarely discussed. Heterogeneous treatment effects and logical inconsistencies indicate that studies with a higher level of evidence are needed to determine if liver transplantation offers a survival benefit over liver resection. However, randomised controlled trials, as the golden standard, are believed to be infeasible. Therefore, we suggest an alternative research design from the causal inference literature. The rationale for a regression discontinuity design that exploits the natural experiment created by the widely adopted Milan criteria will be discussed. In this type of study, the analysis is focused on liver transplantation patients just within the Milan criteria and liver resection patients just outside, hereby ensuring equal distribution of confounders.

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Krebstherapie – 68Ga-PSMA-PET/CT beim rezidivierten Prostatakarzinom richtungweisend und kosteneffektiv

Gesundheitsökonomie & Qualitätsmanagement ◽

10.1055/a-1244-6542 ◽

2020 ◽

Vol 25 (04) ◽

pp. 184-185

Author(s):

Susanne Krome

Keyword(s):

Prostate Cancer ◽

Cancer Recurrence ◽

Intention To Treat ◽

Biochemisches Rezidiv ◽

Choline Pet ◽

Psma Pet ◽

Pet Ct ◽

Prostate Cancer Recurrence ◽

Treat Analysis

Schwenck J et al. Intention-to-Treat Analysis of 68Ga-PSMA and 11C-Choline PET/CT Versus CT for Prostate Cancer Recurrence After Surgery. J Nucl Med 2019; 60: 1359–1365 15–40 % der Patienten mit einem Prostatakarzinom erleiden postoperativ ein biochemisches Rezidiv. In der retrospektiven Analyse beeinflussten die Bildgebungsverfahren die Häufigkeit einer richtigen Therapiewahl. Die Autoren empfehlen die 68Ga-PSMA-PET/CT, die die höchste Genauigkeit aufwies. Unter Berücksichtigung der Kosten für inadäquate Behandlungen entstünden keine ökonomischen Nachteile.

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Roxadustat for anemia in patients with end-stage renal disease incident to dialysis

Nephrology Dialysis Transplantation ◽

10.1093/ndt/gfab051 ◽

2021 ◽

Author(s):

Robert Provenzano ◽

Evgeny Shutov ◽

Liubov Eremeeva ◽

Svitlana Korneyeva ◽

Lona Poole ◽

...

Keyword(s):

Rescue Therapy ◽

Controlled Trial ◽

Epoetin Alfa ◽

Open Label ◽

Treatment Groups ◽

Intention To Treat ◽

Primary Endpoints ◽

Stage Renal Disease ◽

End Stage ◽

Event Rates

Abstract Background We evaluated the efficacy and safety of roxadustat vs. epoetin alfa for the treatment of chronic kidney disease (CKD) related anemia in patients new to dialysis. Methods This was a phase 3, open-label, epoetin alfa-controlled trial. Eligible adults were on hemodialysis/peritoneal dialysis for ≥2 weeks and ≤4 months before randomization and had mean hemoglobin ≤10.0 g/dL. Primary endpoints were mean hemoglobin (g/dL) change from baseline averaged over weeks 28–52 regardless of rescue therapy (non-inferiority criterion: lower limit of 95% CI for treatment difference > −0.75) and percentage of patients achieving a hemoglobin response between weeks 1–24 censored for rescue therapy (non-inferiority margin for between-group difference: −15%). Adverse events were monitored. Results The intention-to-treat population included patients randomized to roxadustat (n = 522) or epoetin alfa (n = 521). Mean (SD) hemoglobin changes from baseline averaged over weeks 28–52 were 2.57 (1.27) and 2.36 (1.21) in the roxadustat and epoetin alfa groups. Roxadustat was non-inferior (least-squares mean difference: 0.18 [95% CI: 0.08, 0.29]) to epoetin alfa. Percentages of patients with a hemoglobin response were 88.2% and 84.4% in the roxadustat and epoetin alfa groups. Roxadustat was non-inferior to epoetin alfa (treatment-group difference: 3.5% [95% CI: −0.7%, 7.7%]). Adverse event rates were comparable between treatment groups. Conclusions Roxadustat was efficacious for correcting and maintaining hemoglobin levels compared to epoetin alfa. Roxadustat had an acceptable safety profile.

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Metformin use and long-term risk of benign prostatic hyperplasia: a population-based cohort study

BMJ Open ◽

10.1136/bmjopen-2020-041875 ◽

2020 ◽

Vol 10 (12) ◽

pp. e041875

Author(s):

Mette Nørgaard ◽

Bianka Darvalics ◽

Reimar Wernich Thomsen

Keyword(s):

Cohort Study ◽

Benign Prostatic Hyperplasia ◽

Cox Regression ◽

Population Based ◽

Prostatic Hyperplasia ◽

Haemoglobin A1c ◽

First Line ◽

Intention To Treat ◽

Lowering Drug

ObjectiveTo assess whether metformin use affects risk of benign prostatic hyperplasia (BPH) by comparing the risk of BPH in men with type 2 diabetes who initiated first-line treatment with either metformin or sulfonylurea monotherapy between 2000 or 2006 in Northern Denmark. In this period, sulfonylurea and metformin were both frequently used as first-line glucose-lowering drug (GLD) treatment.DesignA population-based cohort study.SettingNorthern Denmark.ParticipantsAll men who filled at least two prescriptions for metformin or for sulfonylurea, respectively, during their first 6 months of GLD treatment. Follow-up started 6 months after treatment start.Primary outcome measuresRates of subsequent BPH, identified based on community prescriptions for BPH-related treatment or hospital BPH diagnoses, and rates of transurethral resection of the prostate (TURP). Rates in metformin and sulfonylurea users were compared overall and stratified by 6-month haemoglobin A1c (HbA1c) using Cox regression and an intention-to-treat (ITT) approach and an as-treated analysis.ResultsDuring follow-up, less than five persons were lost to follow-up due to emigration. In 3953 metformin initiators with a median follow-up of 10 years, the 10-year cumulative BPH incidence was 25.7% (95% CI 24.2 to 27.1). Compared with 5958 sulfonylurea users (median follow-up 8 years, 10-year cumulative incidence 27.4% (95% CI 26.2 to 28.6)), the crude HR for BPH was 0.83 (95% CI 0.77 to 0.89) and adjusted HR in the ITT analyses was 0.97 (95% CI 0.88 to 1.06). For TURP, the adjusted HR was 0.96 (95% CI 0.63 to 1.46). In the as-treated analysis, adjusted HR for BPH was 0.91 (95% CI 0.81 to 1.02).ConclusionsCompared with sulfonylurea, metformin did not substantially reduce the incidence of BPH in men with diabetes.

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Do Nutrition Education Approaches With Preschoolers and Their Caregivers Influence Retention of Biofortified Orange-Fleshed Sweetpotato on Farms?: Evidence From Homa Bay County, Kenya

Food and Nutrition Bulletin ◽

10.1177/03795721211025445 ◽

2021 ◽

pp. 037957212110254

Author(s):

Sylvester O. Ojwang ◽

David J. Otieno ◽

Julius J. Okello ◽

Penina Muoki ◽

Rose A. Nyikal

Keyword(s):

Nutrition Education ◽

Early Childhood Development ◽

Controlled Trial ◽

Text Messages ◽

Sub Saharan Africa ◽

Childhood Development ◽

Control Group ◽

Micronutrient Deficiencies ◽

Household Level ◽

Intention To Treat

Background: Biofortified staples have been promoted widely in sub-Saharan Africa to combat micronutrient deficiencies. Contemporary projects are increasingly using elementary schools to target households with these foods. Objective: This study assessed the effects of integrated nutrition education approaches, targeting preschoolers and their caregivers, on retention of orange-fleshed sweetpotato (OFSP) on farms in the second season after lapse of free vine dissemination initiatives. Methods: Rural farming households, with preschoolers and no prior engagement with OFSP, were targeted. A multistage sample of 431 preschooler–caregiver pairs was recruited for a cluster-randomized controlled trial. After issuing routine OFSP promotion activities, 15 village-level clusters of the pairs were randomized into 1 control group (3 villages) and 3 treatment arms (4 villages each) for the interventions. Baseline and follow-up household-level survey data were collected from the caregivers. The interventions included: (1) OFSP-branded exercise books, posters, and a poem to preschoolers only; (2) OFSP-oriented mobile phone-mediated text messages to caregivers only; and (3) both 1 and 2 provided to individual households concurrently. Interventions 1 and 2 were single-channeled, while 3 was multichanneled. We estimated the intention-to-treat (ITT) and treatment-on-the-treated (TOT) effects using a binary logit model and a special regressor method, respectively. Results: Only the multichanneled nutrition education approach had significant effects (ITT = 0.167, P = .001; TOT = .243, P = .007) on the caregivers’ likelihood to retain OFSP on their farms. Conclusions: The finding implies that multichanneled agriculture-nutrition education interventions through Early Childhood Development institutions can be effective in ensuring sustainable adoption of OFSP.

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