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Purpose Critical illness is associated with long-term increased mortality and impaired quality of life (QoL). We assessed whether multidisciplinary consultations would improve outcome at 12 months (M12) after intensive care unit (ICU) discharge.Methods We performed an open, multicenter, parallel-group, randomized clinical trial. Eligible are patients discharged alive from ICU in 11 French hospitals between 2012 and 2018. The intervention group had a multidisciplinary face-to-face consultation involving an intensivist, a psychologist, and a social worker at ICU discharge and then at M3 and M6 (optional). The control group had standard post-ICU follow-up. A consultation was scheduled at M12 for all patients. The QoL was assessed using the EuroQol-5 Dimensions-5 Level (Euro-QoL-5D-5L) which includes five dimensions (mobility, self-care, usual activities, pain, and anxiety/depression), each ranging from 1 to 5 (1: no, 2: slight, 3: moderate, 4: severe, and 5: extreme problems). The primary endpoint was poor clinical outcome defined as death or severe-to-extreme impairment of at least one EuroQoL-5D-5L dimension at M12. The information was collected by a blinded investigator by phone. Secondary outcomes were functional, psychological, and cognitive status at M12 consultation.Results 540 patients were included (standard, n = 272; multidisciplinary, n = 268). The risk for a poor outcome was significantly greater in the multidisciplinary group than in the standard group [adjusted odds ratio 1.49 (95% confidence interval, (1.04–2.13)]. Seventy-two (13.3%) patients died at M12 (standard, n = 32; multidisciplinary, n = 40). The functional, psychological, and cognitive scores at M12 did not statistically differ between groups.Conclusions A hospital-based, face-to-face, intensivist-led multidisciplinary consultation at ICU discharge then at 3 and 6 months was associated with poor outcome 1 year after ICU.

Telemedicine can help mitigate important health care challenges, such as demographic changes and the current COVID-19 pandemic, in high-income countries such as Germany. It gives physicians and patients the opportunity to interact via video consultations, regardless of their location, thus offering cost and time savings for both sides. We aimed to investigate whether telemedicine can be implemented efficiently in the follow-up care for patients in orthopedic and trauma surgery, with respect to patient satisfaction, physician satisfaction, and quality of care. We conducted a prospective randomized controlled trial in a German university hospital and enrolled 60 patients with different knee and shoulder conditions. For follow-up appointments, patients received either an in-person consultation in the clinic (control group) or a video consultation with their physician (telemedicine group). Patients' and physicians' subsequent evaluations of these follow-up appointments were collected and assessed using separate questionnaires. On the basis of data from 52 consultations after 8 withdrawals, it was found that patients were slightly more satisfied with video consultations (mean 1.58, SD 0.643) than with in-clinic consultations (mean 1.64, SD 0.569), although the difference was not statistically significant (P=.69). After excluding video consultations marred by technical problems, no significant difference was found in physician satisfaction between the groups (mean 1.47, SD 0.516 vs mean 1.32, SD 0.557; P=.31). Further analysis indicated that telemedicine can be applied to broader groups of patients and that patients who have prior experience with telemedicine are more willing to use telemedicine for follow-up care. Telemedicine can be an alternative and efficient form of follow-up care for patients in orthopedic and trauma surgery in Germany, and it has no significant disadvantages compared with in-person consultations in the clinic. German Clinical Trials Register DRKS00023445; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023445.

Although around 10% of Indians experience depression, anxiety, or alcohol use disorders, very few receive adequate mental health care, especially in rural communities. Stigma and limited availability of mental health services contribute to this treatment gap. The Systematic Medical Appraisal Referral and Treatment Mental Health project aimed to address this gap. This study aimed to evaluate the effectiveness of an intervention in increasing the use of mental health services and reducing depression and anxiety scores among individuals at high risk of common mental disorders. A before-after study was conducted from 2014 to 2019 in 12 villages in Andhra Pradesh, India. The intervention comprised a community antistigma campaign, with the training of lay village health workers and primary care doctors to identify and manage individuals with stress, depression, and suicide risk using an electronic clinical decision support system. In total, 900 of 22,046 (4.08%) adults screened by health workers had increased stress, depression, or suicide risk and were referred to a primary care doctor. At follow-up, 731 out of 900 (81.2%) reported visiting the doctor for their mental health symptoms, compared with 3.3% (30/900) at baseline (odds ratio 133.3, 95% CI 89.0 to 199.7; P<.001). Mean depression and anxiety scores were significantly lower postintervention compared with baseline from 13.4 to 3.1 (P<.001) and from 12.9 to 1.9 (P<.001), respectively. The intervention was associated with a marked increase in service uptake and clinically important reductions in depression and anxiety symptom scores. This will be further evaluated in a large-scale cluster randomized controlled trial.

ObjectivesTo test the long-term effectiveness of a total diet replacement programme (TDR) for routine treatment of obesity in a primary care setting.MethodsThis study was a pragmatic, two-arm, parallel-group, open-label, individually randomised controlled trial in adults with obesity. The outcomes were change in weight and biomarkers of diabetes and cardiovascular disease risk from baseline to 3 years, analysed as intention-to-treat with mixed effects models.InterventionsThe intervention was TDR for 8 weeks, followed by food-reintroduction over 4 weeks. Behavioural support was provided weekly for 8 weeks, bi-weekly for the next 4 weeks, then monthly for 3 months after which no further support was provided. The usual care (UC) group received dietary advice and behavioural support from a practice nurse for up to 3 months.ResultsOutcome measures were collected from 179 (66%) participants. Compared with baseline, at 3 years the TDR group lost −6.2 kg (SD 9.1) and usual care −2.7 kg (SD 7.7); adjusted mean difference −3.3 kg (95% CI: −5.2, −1.5), p < 0.0001. Regain from programme end (6 months) to 3 years was greater in TDR group +8.9 kg (SD 9.4) than UC + 1.2, (SD 9.1); adjusted mean difference +6.9 kg (95% CI 4.2, 9.5) P < 0.001. At 3 years TDR led to greater reductions than UC in diastolic blood pressure (mean difference −3.3 mmHg (95% CI:−6.2; −0.4) P = 0.024), and systolic blood pressure (mean differences −3.7 mmHg (95% CI: −7.4; 0.1) P = 0.057). There was no evidence of differences between groups in the change from baseline to 3 years HbA1c (−1.9 mmol/mol (95% CI: −0.7; 4.5; P = 0.15), LDL cholesterol concentrations (0.2 mmol/L (95% CI −0.3, 0.7) P = 0.39), cardiovascular risk score (QRISK2) (−0.37 (95% CI −0.96; 0.22); P = 0.22).ConclusionsTreatment of people with obesity with a TDR programme compared with support from a practice nurse leads to greater weight loss which persists to at least 3 years, but there was only evidence of sustained improvements in BP and not in other aspects of cardiometabolic risk.

Purpose This study assessed the feasibility of implementing a novel model of integrated prostate cancer care involving an online prostate cancer-specific holistic needs assessment (sHNA) and shared digital communication between patients and their healthcare professionals (HCPs). The sHNA produces a semi-automated care plan that is finalised in consultation between the patient and their practice nurse. Methods Men living with and beyond prostate cancer were invited to participate in a 9-month non-randomised cluster controlled feasibility study. The intervention group was asked to complete the sHNA on three occasions. Data were collected using Patient Reported Outcome Measures (PROMs) at baseline, 10 and 24 weeks, and 9 months. Outcomes included recruitment, retention, acceptability, and engagement with the sHNA and PROMs. Results Fourteen general practices (8 intervention and 6 control), and 41 men (29 intervention and 12 control) participated. Initial patient engagement with the sHNA was high, with all but one receiving practice nurse-led follow-up and an individualised care plan. The sHNA proved useful in identifying ‘red flag’ symptoms, and helping practice nurses decide when to seek further medical care for the patients. There was a high level of acceptability for patients and HCPs. However, integration of care did not occur as intended because of problems linking hospital and general practice IT systems. Conclusion While the study demonstrated the feasibility of implementing the sHNA, it did not meet the a priori progression criteria; as such, undertaking a definitive randomised controlled trial is not appropriate until the identified methodological and technical issues have been addressed.

A substantial number of patients with chronic low back pain (CLBP) have axial spondyloarthritis (axSpA), but early recognition of these patients is difficult for general practitioners (GPs). The Case Finding Axial Spondyloarthritis (CaFaSpA) referral strategy has shown to be able to identify patients with CLBP at risk for axSpA, but its impact on clinical daily practice is yet unknown. To assess the effect of the CaFaSpA referral strategy on pain caused by disability in primary care patients with CLBP. Within this clustered randomized controlled trial 93 general practices were randomized to either the CaFaSpA referral model (intervention) or usual primary care (control). In each group primary care patients between 18 and 45 years with CLBP were included. The primary outcome was disability caused by CLBP, measured with the Roland Morris Disability Questionnaire (RMDQ) at baseline and four months. Secondary outcome was the frequency of new axSpA diagnosis. Descriptive analyses were performed, and a linear mixed-effects model was used. In total 679 CLBP patients were included of which 333 patients were allocated to the intervention group and 346 to the control group. Sixty-four percent were female and mean age was 36.2 years. The mean RMDQ score at baseline was 8.39 in the intervention group and 8.61 in the control group. At four months mean RMDQ score was 7.65 in the intervention group and 8.15 in the control group. This difference was not statistically significant (p = 0.50). Six (8%) out of the 75 finally referred patients, were diagnosed with axSpA by their rheumatologist. The CaFaSpA referral strategy for axSpA did not have an effect on disability after four months caused by CLBP. However, the strategy is able to detect the axSpA patient within the large CLBP population sufficiently. Trial registration number: NCT01944163, Clinicaltrials.gov.

IntroductionIschaemic heart disease is the single most common cause of death worldwide. Traditionally, distinguishing patients with cardiac ischaemia from patients with less alarming disease, in prehospital triage of chest pain, is challenging for both general practitioners and ambulance paramedics. Less than 20% of patients with chest pain, transferred to the emergency department (ED), have an acute coronary syndrome (ACS) and the transportation and analysis at the ED of non-ACS patients result in substantial healthcare costs and a great patient burden. Advanced risk stratification, with the help of cardiac troponin measurements, seems crucial to improve prehospital diagnostic accuracy.Methods and analysisThe URGENT 2.0 trial is a randomised controlled trial in which the primary objective is to reduce the referral of non-cardiac chest pain (NCCP) patients, using a modified HEART score including a high-sensitivity capillary point-of-care high-sensitivity cardiac troponin I measurement. Patients are included by ambulance paramedics and 1:1 randomised for (1) regular care (control group) or (2) modified HEART score analysis (intervention group) and non-referral in case of a low modified HEART score (0–3). In total, 852 patients will be included. Follow-up will be performed at 30 days, 6 months and 12 months. Both referral rates of NCCP patients and the occurrence of major adverse cardiac events are defined as primary outcome measures.Ethics and disseminationThe medical ethics committee Zuyderland-Zuyd Hogeschool (Netherlands) has approved this trial (reference numbers NL71820.096.19 and METCZ20190139). Written informed consent will be obtained from all participating patients. The results of this trial will be disseminated in one main paper and in additional papers with subgroup analyses.Trial registrationClinicalTrials.gov, NCT04904107.

Abstract Objective To assess how pressures from patients on doctors in the consultation contribute to referral and investigation. Design Observational study nested within a randomised controlled trial. Setting Five general practices in three settings in the United Kingdom. Participants 847 consecutive patients, aged 16-80 years. Main outcomes measures Patient preferences and doctors' perception of patient pressure and medical need. Results Perceived medical need was the strongest independent predictor of all behaviours and confounded all other predictors. The doctors thought, however, there was no or only a slight indication for medical need among a significant minority of those who were examined (89/580, 15%), received a prescription (74/394, 19%), or were referred (27/125, 22%) and almost half of those investigated (99/216, 46%). After controlling for patient preference, medical need, and clustering by doctor, doctors' perceptions of patient pressure were strongly associated with prescribing (adjusted odds ratio 2.87, 95% confidence interval 1.16 to 7.08) and even more strongly associated with examination (4.38, 1.24 to 15.5), referral (10.72, 2.08 to 55.3), and investigation (3.18, 1.31 to 7.70). In all cases, doctors' perception of patient pressure was a stronger predictor than patients' preferences. Controlling for randomisation group, mean consultation time, or patient variables did not alter estimates or inferences. Conclusions Doctors' behaviour in the consultation is most strongly associated with perceived medical need of the patient, which strongly confounds other predictors. However, a significant minority of examining, prescribing, and referral, and almost half of investigations, are still thought by the doctor to be slightly needed or not needed at all, and perceived patient pressure is a strong independent predictor of all doctor behaviours. To limit unnecessary resource use and iatrogenesis, when management decisions are not thought to be medically needed, doctors need to directly ask patients about their expectations.

Background The referral letter is an important document facilitating the transfer of care from a general practitioner (GP) to secondary care. Hospital doctors have often criticised the quality and content of referral letters, and the effectiveness of improvement efforts remains uncertain. Methods A cluster randomised trial was conducted using referral templates for patients in four diagnostic groups: dyspepsia, suspected colorectal cancer, chest pain and chronic obstructive pulmonary disease. The GP surgery was the unit of randomisation. Of the 14 surgeries served by the University Hospital of North Norway Harstad, seven were randomised to the intervention group. Intervention GPs used referral templates soliciting core clinical information when initiating a new referral in one of the four clinical areas. Intermittent surgery visits by study personnel were also carried out. A total of 500 patients were included, with 281 in the intervention and 219 in the control arm. Referral quality scoring was performed by three blinded raters. Data were analysed using multi-level regression modelling. All analyses were conducted on intention-to-treat basis. Results In the final multilevel model, referrals in the intervention group scored 18 % higher (95 % CI (11 %, 25 %), p  < 0.001) on the referral quality score than the control group. The model also showed that board certified GPs and GPs in larger surgeries produced referrals of significantly higher quality. Conclusion In this study, the dissemination of referral templates coupled with intermittent surgery visits produced higher quality referrals. Trial registration This trial has been registered at ClinicalTrials.gov. The trial registration number is NCT01470963 .