scholarly journals Design and conduct of a multicenter randomized clinical trial on the impact of a post-intensive care unit multidisciplinary follow-up on the quality of life (suivi-rea) (Preprint)

2021 ◽  
Author(s):  
Friedman Diane ◽  
Lamiae Grimaldi ◽  
Alain Cariou ◽  
Philippe Aegerter ◽  
Stéphane Gaudry ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Intensive Care ◽  
Controlled Trial ◽  
Social Evaluation ◽  
Double Blind ◽  
Icu Discharge ◽  
One Year ◽  
The Impact

UNSTRUCTURED Introduction: Critically ill patients are at risk to develop a Post-Intensive Care Syndrome (PICS), which is characterized by physical, psychological and cognitive impairments and dramatically impacts the quality of life. No intervention has been shown to improve the quality of life (QoL). Because of the interdependency of its domains, we hypothesized that a medical, psychological and social follow-up would improve the QoL by mitigating the PICS. Methods and analysis: We conducted a multicenter, double-blind, randomized controlled trial comparing a multidisciplinary to a standard post-ICU follow-up. In the intervention arm, multidisciplinary follow-up consisted of medical, psychological and social evaluation at ICU discharge and at 3, 6 and 12 months after ICU discharge. In the placebo group, patients were seen only at 12 months by the multidisciplinary team. The baseline characteristics at ICU discharge were collected in all patients. The primary outcome was the quality of life at one year, assessed with help of EuroQoL 5 dimensions (EQ5D). Secondary outcomes were mortality, cognitive, psychological and functional status, the social and professional reintegration as well as the rate of re-hospitalization and outpatient consultations at one year. The first patient was randomized on 20/12/2012 and the last patient on 01/09/2017 out of 546 patients who were enrolled across 11 ICUs. At present, data management is still ongoing, and all parties involved in the trial remain blinded. Ethics and dissemination – Research Ethics Committee of Saint-Germain-en-Laye, France, initial approval received on 08/07/2011. Results will be disseminated via peer-reviewed publication and presentation at international conferences. Trial registration: Clinicaltrials.gov identifier NCT01796509 (registered on 21/02/2013).

scholarly journals Intensive care units follow-up: a scoping review protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e037725
Author(s):  
Danielle Prevedello ◽  
Marco Fiore ◽  
Jacques Creteur ◽  
J C Preiser
Keyword(s):  
Quality Of Life ◽  
Intensive Care ◽  
Scoping Review ◽  
Grey Literature ◽  
Icu Discharge ◽  
Scoping Reviews ◽  
The Impact

IntroductionIncreasing numbers of patients are surviving critical illness, leading to growing concern about the potential impact of the long-term consequences of intensive care on patients, families and society as a whole. These long-term effects are together known as postintensive care syndrome and their presence can be evaluated at intensive care unit (ICU) follow-up consultations. However, the services provided by these consultations vary across hospitals and units, in part because there is no validated standard model to evaluate patients and their quality of life after ICU discharge. We describe a protocol for a scoping review focusing on models of ICU follow-up and the impact of such strategies on improving patient quality of life.Methods and analysisIn this scoping review, we will search the literature systematically using electronic databases (MEDLINE - from database inception to June 15th 2020) and a grey literature search. We will involve stakeholders as recommended by the Joanna Briggs Institute approach developed by Peters et al. The research will be conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines.Ethics and disseminationThis study does not require ethics approval, because data will be obtained through a review of published primary studies. The results of our evaluation will be published in a peer-reviewed journal and will also be disseminated through presentations at national and international conferences.

scholarly journals Task-oriented exercises improve disability of working patients with surgically-treated proximal humeral fractures. A randomized controlled trial with one-year follow-up

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Marco Monticone ◽  
Igor Portoghese ◽  
Daniele Cazzaniga ◽  
Valentina Liquori ◽  
Giuseppe Marongiu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Rehabilitation Program ◽  
Group Differences ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
One Year ◽  
Task Oriented

Abstract Background General physiotherapy is a common means of rehabilitation after surgery for proximal humeral fracture (PHF). Better-targeted exercises seem worthy of investigation and the aim of this study was to assess the efficacy of a rehabilitation program including task-oriented exercises in improving disability, pain, and quality of life in patients after a PHF. Methods By means of a randomized controlled trial with one-year follow-up, 70 working patients (mean age of 49 ± 11 years; 41 females), who were selected for open reduction and internal fixation with plates caused by PHF, were randomized to be included in an experimental (n = 35) or control group (n = 35). There was a permuted-block randomization plan, and a list of program codes was previously created; subsequently, an automatic assignment system was used to conceal the allocation. The first group underwent a supervised rehabilitation program of task-oriented exercises based on patients’ specific job activities, and occupational therapy. The second group underwent general physiotherapy, including supervised mobility, strengthening and stretching exercises. Both groups individually followed programs of 60-min session three times per week for 12 weeks in the outpatient setting. The Disability Arm Shoulder Hand questionnaire (DASH; scores range from 0 to 100; primary outcome), a Pain intensity Numerical Rating Scale (scores range 0 to 10; secondary outcomes), and the Short-Form Health Survey (scores range from 0 to 100; secondary outcomes) assessed the interventions. Participants were evaluated before surgery, before and after rehabilitation (primary endpoint), and at the one-year follow-up (secondary endpoint). A linear mixed model analysis for repeated measures was carried out for each outcome measure (p < 0.05). Results Time, group and time by group showed significant effects for all outcome measures in favour of the experimental group. The DASH and the DASH work achieved clinically important between-group differences of 16.0 points (95% confidence interval [C.I.] 7.3 to 24.7) and 19.7 (95% C.I. 9.0 to 30.5) at follow-up, respectively. The NRS achieved a between-group difference of 2.9 (95% C.I. 1.0 to 3.9) at follow-up. As for SF-36, there were between-group differences ranging from 17.9 to 37.0 at follow-up. Conclusions A rehabilitation program based on task-oriented exercises was useful in improving disability, pain, and quality of life in working patients after PHFs. Improvements lasted for at least 12 months. Trial registration On 16/12/2019, the trial was retrospectively registered in the ISRCTN registry with the ID number 17996552.

scholarly journals Ropivacaine 75mg versus placebo in perineal infiltration for analgesic efficacy at mid- and long-term for episiotomy repair in postpartum women- The ROPISIO study: a two-center, randomized, double-blind, placebo-controlled trial.

2020 ◽  
Author(s):  
Claire CARDAILLAC ◽  
Stéphane Ploteau ◽  
Aurélie Le Thuaut ◽  
Vincent Dochez ◽  
Norbert Winer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Perineal Pain ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Mediolateral Episiotomy ◽  
The Impact

Abstract Background Perineal pain due to episiotomy is commonly reported and can be severe enough to disturb the mother-infant dyad during the postpartum period. Its incidence at day 7 postpartum varies from 63% to 74%. Recent studies have already investigated the analgesic efficacy of perineal infiltration of ropivacaine after episiotomy, but have only focused on the immediate postpartum period (at 24 and 48 hours after birth). Large, adequately powered, multicenter, randomized controlled trials are required to evaluate the impact of ropivacaine infiltration on perineal pain and mid- and long-term quality of life before the widespread use of ropivacaine to prevent perineal pain after episiotomy can be recommended. Methods The ROPISIO study is a two-center, randomized, double-blind, placebo-controlled trial in La Roche sur Yon and Nantes, France. It will involve 272 women with vaginal singleton delivery and mediolateral episiotomy at term (≥ 37 weeks). Perineal infiltration (ropivacaine 75mg or placebo) will be administrated just after vaginal birth and before episiotomy repair. The primary outcome will be the analgesic efficacy at day 7 postpartum (mid-term), defined by the numerical rating scale of pain (ENS NRS) strictly superior to 3/10 on the perineal repair area. Secondary outcomes will be the analgesic efficacy (ENS NRS), the impact of pain on daily behavior, on the quality of life (36-Item Short Form Health Survey), on the occurrence of symptoms of postpartum depression (Edinburgh Postnatal Depression Scale) and on sexuality (Female Sexual Function Index) at 3 and 6 months (long-term) using validated online questionnaires. This study will have 90% power to show approximately 30% relative risk reduction in the incidence of perineal pain at day 7, from 70.0% to 50.0%. Discussion Ropivacaine is a promising candidate drug, inexpensive, easy to administer, and would be suitable to include in the routine management of deliveries in labor ward. This study will investigate if perineal ropivacaine infiltration just after birth can reduce mid- and long-term postpartum pain and increase quality of life in women with mediolateral episiotomy.

scholarly journals Ropivacaine 75mg versus placebo in perineal infiltration for analgesic efficacy at mid- and long-term for episiotomy repair - The ROPISIO study: a two-center, randomized, double-blind, placebo-controlled trial

2019 ◽  
Author(s):  
Claire CARDAILLAC ◽  
Stéphane Ploteau ◽  
Aurélie Le Thuaut ◽  
Vincent Dochez ◽  
Norbert Winer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Perineal Pain ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Mediolateral Episiotomy ◽  
The Impact

Abstract Background Perineal pain due to episiotomy is commonly reported and can be severe enough to disturb the mother-infant dyad during the postpartum period. Its incidence at day 7 postpartum varies from 63% to 74%. Recent studies have already showed the analgesic efficacy of perineal infiltration of ropivacaine after episiotomy, but have only focused on the immediate postpartum period (at 24 and 48 hours after birth). Large, adequately powered, multicenter, randomized controlled trials are required to evaluate the impact of ropivacaine infiltration on perineal pain and quality of life at mid- and long-term before the widespread use of ropivacaine to prevent perineal pain after episiotomy can be recommended. Methods The ROPISIO study is a two-center, randomized, double-blind, placebo-controlled trial in La Roche sur Yon and Nantes, France. It will involve 272 women with vaginal singleton delivery and mediolateral episiotomy at term (≥ 37 weeks). Perineal infiltration (ropivacaine 75mg or placebo) will be administrated just after vaginal birth and before episiotomy repair. The primary outcome will be the analgesic efficacy at day 7 postpartum (mid-term), defined by the numerical scale of pain (ENS) strictly superior to 3/10 on the perineal repair area. Secondary outcomes will be the analgesic efficacy (ENS), the impact of pain on daily behavior, on the quality of life (36-Item Short Form Health Survey), on the occurrence of symptoms of postpartum depression (Edinburgh Postnatal Depression Scale) and on sexuality (Female Sexual Function Index) at 3 and 6 months (long-term) using validated online questionnaires. This study will have 90% power to show a 30% reduction in the incidence of perineal pain at day 7, from 70.0% to 50.0%. Discussion This study will investigate if perineal ropivacaine infiltration just after birth can reduce mid- and long-term postpartum pain and increase quality of life in women with mediolateral episiotomy. Ropivacaine was a promising candidate drug, inexpensive, easy to administer, and easy to add on the routine management of deliveries in labor ward.

scholarly journals Cost-Effectiveness of perioperative Vaginally Administered estrogen in postmenopausal women undergoing prolapse surgery (EVA trial): study protocol for a multicenter double-blind randomized placebo-controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Eva V. Vodegel ◽  
Sandra E. Zwolsman ◽  
Astrid Vollebregt ◽  
Ruben G. Duijnhoven ◽  
Judith E. Bosmans ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Postmenopausal Women ◽  
Controlled Trial ◽  
Estrogen Therapy ◽  
Double Blind ◽  
Pop Surgery ◽  
Vaginal Estrogen ◽  
Vaginal Estrogen Therapy

Abstract Background Surgery for pelvic organ prolapse (POP) is associated with high recurrence rates. The costs associated with the treatment of recurrent POP are huge, and the burden from women who encounter recurrent POP, negatively impacts their quality of life. Estrogen therapy might improve surgical outcome for POP due to its potential beneficial effects. It is thought that vaginal estrogen therapy improves healing and long-term maintenance of connective tissue integrity. Hence, this study aims to evaluate the cost-effectiveness of perioperative vaginal estrogen therapy in postmenopausal women undergoing POP surgery. Methods The EVA trial is a multi-center double-blind randomized placebo-controlled trial conducted in the Netherlands comparing the effectiveness and costs-effectiveness of vaginal estrogen therapy. This will be studied in 300 postmenopausal women undergoing primary POP surgery, with a POP-Q stage of ≥ 2. After randomization, participants administer vaginal estrogen cream or placebo cream from 4 to 6 weeks preoperative until 12 months postoperative. The primary outcome is subjective improvement of POP symptoms at 1 year follow-up, measured with the Patient Global Impression of Improvement (PGI-I) scale. Secondary outcomes are POP-Q anatomy in all compartments, re-interventions, surgery related complications, general and disease specific quality of life, sexual function, signs and complaints of vaginal atrophy, vaginal pH, adverse events, costs, and adherence to treatment. Follow up is scheduled at 6 weeks, 6 months and 12 months postoperative. Data will be collected using validated questionnaires and out-patient visits including gynecological examination performed by an independent gynecologist. Discussion This study investigates whether perioperative vaginal estrogen will be cost-effective in the surgical treatment of POP in postmenopausal women. It is hypothesized that estrogen therapy will show a reduction in recurrent POP symptoms and a reduction in reoperations for POP, with subsequent improved quality of life among women and cost savings. Trial registrationNetherlands Trial Registry: NL6853; registered 19-02-2018, https://www.trialregister.nl/trial/6853. EudraCT: 2017-003144-21; registered: 24-07-2017.

scholarly journals Patients suffering from psychological impairments following critical illness are in need of information

2020 ◽  
Vol 8 (1) ◽  
Author(s):  
Johan H. Vlake ◽  
Michel E. van Genderen ◽  
Anna Schut ◽  
Martijn Verkade ◽  
Evert-Jan Wils ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Critical Illness ◽  
Psychological Trauma ◽  
Icu Discharge ◽  
Information Brochure ◽  
The Impact ◽  
To Receive ◽  
Icu Treatment

Abstract Background Because critical illness survivors frequently experience several long-term psychological impairments altering quality of life after ICU, there is a trend towards increasing follow-up care, mainly via ICU follow-up clinics. Despite these and other initiatives, understanding of patient’s post-ICU needs to help them cope with their problems and subsequently improve quality of life is largely lacking. Our aim was therefore to assess the needs, expectations and wishes in ICU survivors to receive information with the purpose to help them better grasp ICU treatment. In addition, we assessed the perceived burden of psychological trauma after ICU treatment and the health-related quality of life (HRQoL) up to 2.5 years after ICU discharge. Methods In a multicentre, retrospective cross-sectional cohort study, the needs and preferred intervention methods were assessed using a self-composed inventory in adult mechanically ventilated ICU survivors (n = 43). Additionally, the Impact of Event Scale Revised, the Beck Depression Inventory, the EuroQol-5D-5L, and the Short-Form 12 were used to assess psychological burden and HRQoL. Results A substantial proportion of all ICU survivors (59%, 95% CI 44% to 74%) suffered from psychological impairments after ICU treatment. Seventy-five percent of these patients expressed a wish to receive information, but only 36% desired to receive this information using a commonly used information brochure. In contrast, 71% of these patients had a wish to receive information using a video film/VR. Furthermore, only 33% of these patients was satisfied with the information provided by their treating hospital. Patients with psychological PICS reported a worse HRQoL as compared to a normative Dutch sample (P < 0.001) and as compared to patients without psychological PICS (P < 0.01). Conclusions In a Dutch cohort of critical illness survivors, a substantial part of ICU survivors suffer from psychological impairments, such as PTSD and depression, which was associated with a worse HRQoL. These patients are in need of information, have no desire using an information brochure, but are willing to receive information using a video film/virtual reality module. These results support the exploration of such an intervention.

Preschoolers’ health-related quality of life following the implementation of a childcare physical activity intervention

2018 ◽  
Vol 43 (5) ◽  
pp. 453-459 ◽  
Author(s):  
Stephanie Truelove ◽  
Andrew M. Johnson ◽  
Leigh M. Vanderloo ◽  
Molly Driediger ◽  
Shauna M. Burke ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Controlled Trial ◽  
Health Related Quality ◽  
Post Intervention ◽  
Related Quality ◽  
Health Related ◽  
The Impact

Being active offers many physical and emotional benefits contributing to a higher health-related quality of life (HRQoL); however, this relationship remains unexplored among preschoolers (aged 2.5–5 years). This study examined the impact of the Supporting Physical Activity in the Childcare Environment (SPACE), which was an intervention implemented using a cluster randomized controlled trial on preschoolers’ HRQoL. Childcare centres were randomly allocated to the experimental (n = 11) or control (n = 11) conditions, and preschoolers’ HRQoL was measured using the parent-report Pediatric Quality of Life Inventory 4.0 (3 subscales: physical, psychosocial, and total HRQoL) at baseline, post-intervention (i.e., week 8), and 6- and 12-month follow-up. A linear mixed-effects model was used to determine if preschoolers in the experimental condition displayed an increased HRQoL post-intervention and at follow-up compared with preschoolers in the control condition. Preschoolers (n = 234) with HRQoL data at baseline and one additional time-point were retained for analyses. Body mass index was not found to impact significantly on the intervention, and no statistically significant interaction effects were found for any of the 3 HRQoL variables. In conclusion, the SPACE intervention had no impact on preschoolers’ HRQoL. Given the scarcity of research in this population, additional exploration is necessary to better understand the potential impact of physical activity participation on preschoolers’ HRQoL.

scholarly journals The Impact of Medical Conditions on the Quality of Life of Survivors at Discharge From Intensive Care Unit

Medicina ◽  
2011 ◽  
Vol 47 (5) ◽  
pp. 38 ◽  
Author(s):  
Andrius Klimašauskas ◽  
Ieva Sereikė ◽  
Aušra Klimašauskienė ◽  
Gintautas Kėkštas ◽  
Juozas Ivaškevičius
Keyword(s):  
Quality Of Life ◽  
Intensive Care Unit ◽  
Intensive Care ◽  
Organ System ◽  
Therapeutic Interventions ◽  
Prolonged Stay ◽  
Role Physical ◽  
Icu Discharge ◽  
The Impact

Background and Objective. Impaired health-related quality of life (HRQOL) is one of the possible outcomes after discharge from an intensive care unit (ICU). Evaluation of patient health status on discharge from the ICU would help identify factors influencing changes in HRQOL after ICU discharge. The objective of the study was to identify whether health state on discharge from prolonged stay in the ICU has any influence on survivors’ HRQOL 6 months after intensive care. Material and Methods. A prospective study of patients with the prolonged length of stay (exceeding 7 days) in the ICU was conducted. The study covered the impact of organ system dysfunction (SOFA score), number of therapeutic interventions (TISS-28 score), and critical illness neuromuscular abnormalities (CINMA) on discharge from the ICU on HRQOL 6 months following ICU discharge. Results. In total, 137 patients were included in the study. The SOFA score on the last day in the ICU was 2.91 (SD, 1.57); the TISS-28 score on the last day in the ICU was 21.79 (SD, 4.53). Decreased physical functioning (PF) and role physical (RP) were identified. Circulatory impairment on discharge from the ICU had an impact on decreased PF (P=0.016), role physical (P=0.066), and role emotional (P=0.001). Patients with dysfunction in more than one organ system on ICU discharge had decreased role emotional (P=0.016). Severe CINMA was diagnosed in 18 patients. They had decreased PF (P=0.007) and RP (P=0.019). Patients with the TISS-28 score above or equal to 20 points showed lower HRQOL in the PF domain (P=0.077) and general health (P=0.038). Conclusions. HRQOL in patients with prolonged stay in the ICU is particularly impaired in the domains of physical functioning and role physical. It is associated with circulatory impairment, CINMA, and greater number of therapeutic interventions on discharge from the ICU.

scholarly journals Ropivacaine 75mg versus placebo in perineal infiltration for analgesic efficacy at mid- and long-term for episiotomy repair - The ROPISIO study: a two-center, randomized, double-blind, placebo-controlled trial

2019 ◽  
Author(s):  
Claire CARDAILLAC ◽  
Stéphane Ploteau ◽  
Aurélie Le Thuaut ◽  
Vincent Dochez ◽  
Norbert Winer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Perineal Pain ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Mediolateral Episiotomy ◽  
The Impact

Abstract Background Perineal pain due to episiotomy is commonly reported and can be severe enough to disturb the mother-infant dyad during the postpartum period. Its incidence at day 7 postpartum varies from 63% to 74%. Recent studies have already showed the analgesic efficacy of perineal infiltration of ropivacaine after episiotomy, but have only focused on the immediate postpartum period (at 24 and 48 hours after birth). Large, adequately powered, multicenter, randomized controlled trials are required to evaluate the impact of ropivacaine infiltration on perineal pain and quality of life at mid- and long-term before the widespread use of ropivacaine to prevent perineal pain after episiotomy can be recommended. Methods The ROPISIO study is a two-center, randomized, double-blind, placebo-controlled trial in La Roche sur Yon and Nantes, France. It will involve 272 women with vaginal singleton delivery and mediolateral episiotomy at term (≥ 37 weeks). Perineal infiltration (ropivacaine 75mg or placebo) will be administrated just after vaginal birth and before episiotomy repair. The primary outcome will be the analgesic efficacy at day 7 postpartum (mid-term), defined by the numerical scale of pain (ENS) strictly superior to 3/10 on the perineal repair area. Secondary outcomes will be the analgesic efficacy (ENS), the impact of pain on daily behavior, on the quality of life (36-Item Short Form Health Survey), on the occurrence of symptoms of postpartum depression (Edinburgh Postnatal Depression Scale) and on sexuality (Female Sexual Function Index) at 3 and 6 months (long-term) using validated online questionnaires. This study will have 90% power to show a 30% reduction in the incidence of perineal pain at day 7, from 70.0% to 50.0%. Discussion This study will investigate if perineal ropivacaine infiltration just after birth can reduce mid- and long-term postpartum pain and increase quality of life in women with mediolateral episiotomy. Ropivacaine was a promising candidate drug, inexpensive, easy to administer, and easy to add on the routine management of deliveries in labor ward.

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