Flare in knee and hip osteoarthritis (OA) is more than just an exacerbation of pain. Unstructured, semistructured, and focus group interviews followed by Delphi surveys with patients and health professionals (HP) generated candidate domains of an OA flare. Content analysis of interviews with 29 patients and 16 HP extracted 180 statements, which were grouped into 9 clusters. Delphi consensus with 50 patients (Australia, Canada, and France) and 116 HP (17 countries on 4 continents) identified 5 flare domains: pain, swelling, stiffness, psychological aspects, and effect of symptoms. Elements for a preliminary definition of an OA flare are proposed. Registered at clinicaltrials.govNCT02892058.
ObjectiveTo evaluate the feasibility of an innovative peer intervention promoting healthy eating and physical activity, which purposefully selected peer facilitators according to socioeconomic status to target less-advantaged overweight receivers.SettingNine high schools, two middle schools.ParticipantsOne hundred and fifty-six adolescents were approached to become facilitators, of whom 18 were trained. Thirty-two of 56 potential receivers agreed to participate.InterventionThe peer intervention was carried out in 2013–2014 and embedded in a larger trial: PRALIMAP-INÈS (Promotion de l’ALIMentation et l’Activité Physique-INEgalité de Santé). Facilitanoators were selected and trained to organise weight-control activities with specific peer receivers participating in the programme.Primary and secondary outcome measuresDifferent types of data were collected to assess demand, acceptability, implementation and practicality of the intervention. For the facilitators, this included 6 training sessions, 11 mid-programme interviews, 4 end-of-programme sessions, telephone notes and text message exchanges. All six potential receivers in one school were also interviewed. Sociodemographic and health characteristics were also analysed.ResultsAgreeing to participate was more likely when asked by a peer compared with a professional (51.2% discordant pairs; p<0.02). Twelve activities, mostly based on physical activity and implemented during weekends or holidays, were carried out. The mean age of active receivers was 16 and their body mass index was higher than other participants. For both facilitators and active receivers, there were more participating girls. Qualitative analysis reveals key implementation challenges for facilitators. Interviews with the receivers highlight social difficulties, with most feeling bad about their appearance and wanting to lose weight. Those who participated in peer activities were very positive about the experience especially social support.ConclusionsThe present study suggests the peer intervention is feasible provided organisational difficulties are addressed. Good practice recommendations are formulated, including a longer training session, organising a joint meeting with the facilitators and receivers, matching dyads on place of residence and multiplying modes of contact.Trial registration numberNCT01688453.
A high number of recent studies have shown that a positive fluid balance is independently associated with impaired prognosis in specific populations of patients hospitalized in intensive care unit (ICU): acute kidney injury, acute respiratory distress syndrome (ARDS), sepsis, high risk surgery. However, to date, there is no evidence that control of fluid overload reduces mortality in critically ill patients.The main objective is to assess the efficacy of a strategy limiting fluid overload on mortality in unselected critically ill patients hospitalized in ICU. We hypothesized that a strategy based on a weight-driven recommendation of restricted fluid intake, diuretics, and ultrafiltration initiated from 48 hours up to 14 days after admission in critically ill patients would reduce all-cause mortality as compared to usual care. We use a stepped wedge cluster randomized controlled trial combined with a quasi-experimental (before-and-after) study. Patients under mechanical ventilation, admitted since > 48h and <72h in ICU, and with no discharge planned for the next 24h are eligible. A total of 1,440 patients are expected to be enrolled in 12 ICUs. Sociodemographic and clinical data are collected at inclusion, and outcomes are collected during the follow-up. Primary outcome is all-cause mortality at 60 days after admission. Secondary outcomes are patients weight differences between admission and day7 (or day 14), 28-day, in-hospital, and 1-year mortality, end-organ damages, and unintended harmful events. Analyses will be held in intention-to-treat. If POINCARE-2 strategy proves effective, then guidelines on fluid balance control might be extended to all critically ill patients.
Background In critically ill patients, positive fluid balance is associated with excessive mortality. The POINCARE-2 trial aimed to assess the effectiveness of a fluid balance control strategy on mortality in critically ill patients. Methods POINCARE-2 was a stepped wedge cluster open-label randomized controlled trial. We recruited critically ill patients in twelve volunteering intensive care units from nine French hospitals. Eligible patients were ≥ 18 years old, under mechanical ventilation, admitted to one of the 12 recruiting units for > 48 and ≤ 72 h, and had an expected length of stay after inclusion > 24 h. Recruitment started on May 2016 and ended on May 2019. Of 10,272 patients screened, 1361 met the inclusion criteria and 1353 completed follow-up. The POINCARE-2 strategy consisted of a daily weight-driven restriction of fluid intake, diuretics administration, and ultrafiltration in case of renal replacement therapy between Day 2 and Day 14 after admission. The primary outcome was 60-day all-cause mortality. We considered intention-to-treat analyses in cluster-randomized analyses (CRA) and in randomized before-and-after analyses (RBAA). Results A total of 433 (643) patients in the strategy group and 472 (718) in the control group were included in the CRA (RBAA). In the CRA, mean (SD) age was 63.7 (14.1) versus 65.7 (14.3) years, and mean (SD) weight at admission was 78.5 (20.0) versus 79.4 (23.5) kg. A total of 129 (160) patients died in the strategy (control) group. Sixty-day mortality did not differ between groups [30.5%, 95% confidence interval (CI) 26.2–34.8 vs. 33.9%, 95% CI 29.6–38.2, p = 0.26]. Among safety outcomes, only hypernatremia was more frequent in the strategy group (5.3% vs. 2.3%, p = 0.01). The RBAA led to similar results. Conclusion The POINCARE-2 conservative strategy did not reduce mortality in critically ill patients. However, due to open-label and stepped wedge design, intention-to-treat analyses might not reflect actual exposure to this strategy, and further analyses might be required before completely discarding it. Trial registration POINCARE-2 trial was registered at ClinicalTrials.gov (NCT02765009). Registered 29 April 2016.
Objectives To compare in the early postpartum the perinatal experience during a COVID‐19 related lockdown (‘lockdown’ group) and a pandemic control group subject to looser restrictions. Design and setting This national multicentre prospective cohort study took place in four French maternity units. Population Women were recruited during the postpartum stay for the lockdown and pandemic control groups, according to their enrolment period. Both faced the same labour and delivery restrictions but only the pandemic control group could have a postpartum visitor. Main outcome measures The primary outcome was the perinatal experience during childbirth, assessed by the Labour Agentry Scale (LAS) self‐administered questionnaire, completed before discharge. Results The study included 596 women and analysed 571 of them: 260 in the lockdown group and 311 in the pandemic control group. The mean LAS score was lower in the lockdown group (161.1 ± 26.8, 95% confidence interval [CI] 157.8–164.3 versus 163.3 ± 24.0, 95% CI 160.6–166.0; P = 0.289). In multivariable analysis, the LAS score was lower in the lockdown group (−6.2 points, P = 0.009), in women with caesarean (−21.6 points, P < 0.001) versus spontaneous deliveries, and among women financially impacted by the lockdown (−6.4 points, P = 0.007) or who experienced restrictions during childbirth (−8.1 points, P < 0.001). The LAS score rose with the prenatal care quality score (P < 0.001). Conclusions The perinatal experience was more negatively affected by lockdown restrictions than by the looser pandemic restrictions for controls, but mode of delivery remained the main factor influencing this experience.
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