BackgroundCritically ill patients are subject to severe skeletal muscle wasting during intensive care unit (ICU) stay, resulting in impaired short- and long-term functional outcomes and health-related quality of life. Increased protein provision may improve functional outcomes in ICU patients by attenuating skeletal muscle breakdown. Supporting evidence is limited however and results in great variety in recommended protein targets.MethodsThe PRECISe trial is an investigator-initiated, bi-national, multi-center, quadruple-blinded randomized controlled trial with a parallel group design. In 935 patients, we will compare provision of isocaloric enteral nutrition with either a standard or high protein content, providing 1.3 or 2.0 g of protein/kg/day, respectively, when fed on target. All unplanned ICU admissions with initiation of invasive mechanical ventilation within 24 h of admission and an expected stay on ventilator support of at least 3 days are eligible. The study is designed to assess the effect of the intervention on functional recovery at 1, 3, and 6 months following ICU admission, including health-related quality of life, measures of muscle strength, physical function, and mental health. The primary endpoint of the trial is health-related quality of life as measured by the Euro-QoL-5D-5-level questionnaire Health Utility Score. Overall between-group differences will be assessed over the three time points using linear mixed-effects models.DiscussionThe PRECISe trial will evaluate the effect of protein on functional recovery including both patient-centered and muscle-related outcomes.Trial registrationClinicalTrials.gov Identifier: NCT04633421. Registered on November 18, 2020. First patient in (FPI) on November 19, 2020. Expected last patient last visit (LPLV) in October 2023.
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Background: Medically unexplained symptoms (MUS) are highly prevalent and pose a burden both on patients and on health care. In a pilot study psychosomatic therapy delivered by specialised therapists for patients with MUS showed promising results with regard to patient’s acceptability, feasibility and effects on symptoms. The aim of this study is to establish whether psychosomatic therapy by specialised psychosomatic exercise therapists is costeffective in decreasing symptoms and improving functioning in patients who frequently consult their general practitioner (GP) with MUS. Methods: A randomised effectiveness trial with an economic evaluation in primary care with 158 patients aged 18 years and older who are frequently consulting their GP with MUS. Patients will be assigned to psychosomatic therapy in addition to usual care or usual care only. Psychosomatic therapy is a multi-component and tailored intervention, aiming to empower patients by applying psycho-education, relaxation techniques, mindfulness, cognitive approaches and/or graded activity. Patients assigned to the psychosomatic therapy receive 6 to 12 sessions of psychosomatic therapy, of 30–45 min each, delivered by a specialised exercise or physical therapist. Primary outcome measure is patient-specific functioning and disability, measured with the Patient-Specific Functional Scale (PSFS). Secondary outcome measures are symptom severity, consultation frequency and referrals to secondary care, patient satisfaction, quality of life and costs. Assessments will be carried out at baseline, and after 4 and 12 months. An economic evaluation alongside the trial will be conducted from a societal perspective, with quality-adjusted life years (QALYs) as outcome measure. Furthermore, a mixed-methods process evaluation will be conducted. Discussion: We expect that psychosomatic therapy in primary care for patients who frequently attend the GP for MUS will improve symptoms and daily functioning and disability, while reducing consultation frequency and referrals to secondary care. We expect that the psychosomatic therapy provides value for money for patients with MUS.Trial registration: Netherlands Trial Register, ID: NL7157 (NTR7356). Registered 13 July 2018.Keywords: Psychosomatic therapy, Study protocol, Primary care, Randomised controlled trial, Medically unexplained symptoms, Cost-effectiveness
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ObjectiveTo evaluate the effectiveness of psychosomatic therapy versus care as usual in primary care for patients with persistent somatic symptoms (PSS).MethodsWe conducted a pragmatic, two-armed, randomised controlled trial among primary care patients with PSS in the Netherlands that included 39 general practices and 34 psychosomatic therapists. The intervention, psychosomatic therapy, consisted of 6–12 sessions delivered by specialised exercise- and physiotherapists. Primary outcome measure: patient's level of functioning. Secondary outcomes: severity of physical and psychosocial symptoms, health-related quality of life, health-related anxiety, illness behaviour and number of GP contacts.ResultsCompared to usual care (n = 85), the intervention group (n = 84) showed no improvement in patient's level of functioning (mean difference − 0.50 [95% CI -1.10 to 0.10]; p = .10), and improvement in health-related anxiety (mean difference − 1.93 [95% CI -3.81 to −0.04]; p = .045), over 12 months. At 5-month follow-up, we found improvement in physical functioning, somatisation, and health-related anxiety. The 12-month follow-up revealed no therapy effects. Subgroup analyses showed an overall effect in patient's level of functioning for the group with moderate PSS (mean difference − 0.91 [95% CI -1.78 to −0.03]; p = .042). In the year after the end of therapy, the number of GP contacts did not differ significantly between the two groups.ConclusionWe only found effects on some secondary outcome measures, and on our primary outcome measure especially in patients with moderate PSS, the psychosomatic therapy appears promising for further study.Trial registration: the trial is registered in the Netherlands Trial Registry, https://trialsearch.who.int/Trial2.aspx?TrialID=NTR7356 under ID NTR7356.
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