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BackgroundThis study compares well-being, recurrences, and deaths of early-stage cutaneous melanoma patients in follow-up, as recommended in the Dutch guideline, with that of patients in a stage-adjusted reduced follow-up schedule, 3 years after diagnosis, as well as costs.MethodsOverall, 180 eligible pathological American Joint Committee on Cancer (AJCC) stage IB–IIC, sentinel node staged, melanoma patients (response rate = 87%, 48% male, median age 57 years), randomized into a conventional (CSG, n = 93) or experimental (ESG, n = 87) follow-up schedule group, completed patient-reported outcome measures (PROMs) at diagnosis (T1): State-Trait Anxiety Inventory–State version (STAI-S), Cancer Worry Scale (CWS), Impact of Event Scale (IES), and RAND-36 (Mental and Physical Component scales [PCS/MCS]). Three years later (T3), 110 patients (CSG, n = 56; ESG, n = 54) completed PROMs, while 42 declined (23%).ResultsRepeated measures analyses of variance (ANOVAs) showed a significant group effect on the IES (p = 0.001) in favor of the ESG, and on the RAND-36 PCS (p = 0.02) favoring the CSG. Mean IES and CWS scores decreased significantly over time, while those on the RAND-36 MCS and PCS increased. Effect sizes were small. Twenty-five patients developed a recurrence or second primary melanoma, of whom 13 patients died within 3 years. Cox proportional hazards models showed no differences between groups in recurrence-free survival (hazard ratio [HR] 0.71 [0.32–1.58]; p = 0.400) and disease-free survival (HR 1.24 [0.42–3.71]; p = 0.690). Costs per patient after 3 years (computed for 77.3% of patients) were 39% lower in the ESG.ConclusionThese results seemingly support the notion that a stage-adjusted reduced follow-up schedule forms an appropriate, safe, and cost-effective alternative for pathological AJCC stage IB–IIC melanoma patients to the follow-up regimen as advised in the current melanoma guideline.

AbstractObjectiveTo determine if virtual care with remote automated monitoring (RAM) technology versus standard care increases days alive at home among adults discharged after non-elective surgery during the covid-19 pandemic.DesignMulticentre randomised controlled trial.Setting8 acute care hospitals in Canada.Participants905 adults (≥40 years) who resided in areas with mobile phone coverage and were to be discharged from hospital after non-elective surgery were randomised either to virtual care and RAM (n=451) or to standard care (n=454). 903 participants (99.8%) completed the 31 day follow-up.InterventionParticipants in the experimental group received a tablet computer and RAM technology that measured blood pressure, heart rate, respiratory rate, oxygen saturation, temperature, and body weight. For 30 days the participants took daily biophysical measurements and photographs of their wound and interacted with nurses virtually. Participants in the standard care group received post-hospital discharge management according to the centre’s usual care. Patients, healthcare providers, and data collectors were aware of patients’ group allocations. Outcome adjudicators were blinded to group allocation.Main outcome measuresThe primary outcome was days alive at home during 31 days of follow-up. The 12 secondary outcomes included acute hospital care, detection and correction of drug errors, and pain at 7, 15, and 30 days after randomisation.ResultsAll 905 participants (mean age 63.1 years) were analysed in the groups to which they were randomised. Days alive at home during 31 days of follow-up were 29.7 in the virtual care group and 29.5 in the standard care group: relative risk 1.01 (95% confidence interval 0.99 to 1.02); absolute difference 0.2% (95% confidence interval −0.5% to 0.9%). 99 participants (22.0%) in the virtual care group and 124 (27.3%) in the standard care group required acute hospital care: relative risk 0.80 (0.64 to 1.01); absolute difference 5.3% (−0.3% to 10.9%). More participants in the virtual care group than standard care group had a drug error detected (134 (29.7%) v 25 (5.5%); absolute difference 24.2%, 19.5% to 28.9%) and a drug error corrected (absolute difference 24.4%, 19.9% to 28.9%). Fewer participants in the virtual care group than standard care group reported pain at 7, 15, and 30 days after randomisation: absolute differences 13.9% (7.4% to 20.4%), 11.9% (5.1% to 18.7%), and 9.6% (2.9% to 16.3%), respectively. Beneficial effects proved substantially larger in centres with a higher rate of care escalation.ConclusionVirtual care with RAM shows promise in improving outcomes important to patients and to optimal health system function.Trial registrationClinicalTrials.gov NCT04344665.

Physical inactivity is an important cause of noncommunicable diseases. Interventions can increase short-term physical activity (PA), but health benefits require maintenance. Few interventions have evaluated PA objectively beyond 12 months. We followed up two pedometer interventions with positive 12-month effects to examine objective PA levels at 3-4 years. Long-term follow-up of two completed trials: Pedometer And Consultation Evaluation-UP (PACE-UP) 3-arm (postal, nurse support, control) at 3 years and Pedometer Accelerometer Consultation Evaluation-Lift (PACE-Lift) 2-arm (nurse support, control) at 4 years post-baseline. Randomly selected patients from 10 United Kingdom primary care practices were recruited (PACE-UP: 45-75 years, PACE-Lift: 60-75 years). Intervention arms received 12-week walking programmes (pedometer, handbooks, PA diaries) postally (PACE-UP) or with nurse support (PACE-UP, PACE-Lift). Main outcomes were changes in 7-day accelerometer average daily step counts and weekly time in moderate-to-vigorous PA (MVPA) in ≥10-minute bouts in intervention versus control groups, between baseline and 3 years (PACE-UP) and 4 years (PACE-Lift). PACE-UP 3-year follow-up was 67% (681/1,023) (mean age: 59, 64% female), and PACE-Lift 4-year follow-up was 76% (225/298) (mean age: 67, 53% female). PACE-UP 3-year intervention versus control comparisons were as follows: additional steps/day postal +627 (95% CI: 198-1,056), p = 0.004, nurse +670 (95% CI: 237-1,102), p = 0.002; total weekly MVPA in bouts (minutes/week) postal +28 (95% CI: 7-49), p = 0.009, nurse +24 (95% CI: 3-45), p = 0.03. PACE-Lift 4-year intervention versus control comparisons were: +407 (95% CI: -177-992), p = 0.17 steps/day, and +32 (95% CI: 5-60), p = 0.02 minutes/week MVPA in bouts. Neither trial showed sedentary or wear-time differences. Main study limitation was incomplete follow-up; however, results were robust to missing data sensitivity analyses. Intervention participants followed up from both trials demonstrated higher levels of objectively measured PA at 3-4 years than controls, similar to previously reported 12-month trial effects. Pedometer interventions, delivered by post or with nurse support, can help address the public health physical inactivity challenge. PACE-UP isrctn.com ISRCTN98538934; PACE-Lift isrctn.com ISRCTN42122561.

ObjectiveTo determine the effect of prophylactic dextrose gel for prevention of neonatal hypoglycaemia on neurodevelopment and executive function at 2 years’ corrected age.DesignProspective follow-up of a randomised trial.SettingNew Zealand.PatientsParticipants from the pre-hypoglycaemia Prevention with Oral Dextrose (pre-hPOD) trial randomised to one of four dose regimes of buccal 40% dextrose gel or equivolume placebo.Main outcome measuresCoprimary outcomes were neurosensory impairment and executive function. Secondary outcomes were components of the primary outcomes, neurology, anthropometry and health measures.ResultsWe assessed 360 of 401 eligible children (90%) at 2 years’ corrected age. There were no differences between dextrose gel dose groups, single or multiple dose groups, or any dextrose and any placebo groups in the risk of neurosensory impairment or low executive function (any dextrose vs any placebo neurosensory impairment: relative risk (RR) 0.77, 95% CI 0.50 to 1.19, p=0.23; low executive function: RR 0.50, 95% CI 0.24 to 1.06, p=0.07). There were also no differences between groups in any secondary outcomes. There was no difference between children who did or did not develop neonatal hypoglycaemia in the risk of neurosensory impairment (RR 1.05, 95% CI 0.68 to 1.64, p=0.81) or low executive function (RR 0.73, 95% CI 0.34 to 1.59, p=0.43).ConclusionProphylactic dextrose gel did not alter neurodevelopment or executive function and had no adverse effects to 2 years’ corrected age, but this study was underpowered to detect potentially clinically important effects on neurosensory outcomes.

Background The aim of the SURECAN trial is to evaluate a person-centred intervention, based on Acceptance and Commitment Therapy (ACT Plus ( +)), for people who have completed treatment for cancer with curative intent, but are experiencing poor quality of life. We present the statistical analysis plan for assessing the effectiveness and cost-effectiveness of the intervention in improving quality of life 1 year post randomisation. Methods and design SURECAN is a multi-centre, pragmatic, two-arm, partially clustered randomised controlled superiority trial comparing the effectiveness of ACT + added to usual care with usual aftercare. The target sample size is 344 (172 per arm), randomised centrally in a 1:1 ratio. Results The primary outcome is the total score of the Functional Assessment of Cancer Therapy scale-General (FACT-G) at 52 weeks, analysed using a partially nested mixed-effects model with heteroskedastic error terms. Secondary outcomes include scores at 16 and 52 weeks: FACT-G subscales; Fear of Cancer Recurrence Inventory (FCR4); positive and negative Impact of Cancer scales (IOCv2); Hospital Anxiety and Depression scale (HADS); Chalder Fatigue Scale (CFQ); and physical activity, measured on a modified version of the Godin scale. Health economic analyses will determine the incremental cost-effectiveness ratio (ICER) in terms of quality-adjusted life years (QALYs) derived from the Euroqol 5-Dimension 5-Level (EQ-5D-5L) compared to usual care at 52 weeks. Discussion This manuscript is the statistical analysis plan (SAP) and economic evaluation for the SURECAN trial. Any exploratory or post hoc analyses will be identified as such in the respective analysis report. Trial registration The trial was prospectively registered. ISRCTN: ISRCTN67900293. Registered on 09 December 2019.

Care following transient ischaemic attack (TIA) and minor stroke is variable and often leaves patients feeling abandoned and uncertain. We developed a theoretically-informed, multifaceted intervention which comprised nurse-led, structured follow-up at 4 weeks after TIA/minor stroke to identify and address patient needs. This study evaluated the feasibility and acceptability of both the intervention and procedures to inform a future randomised controlled trial. We conducted a multicentre, randomised feasibility study with mixed-methods process evaluation (ISRCTN registry reference: ISRCTN39864003). We collected patient reported outcome measures (PROMs) at 1, 12 and 24 weeks and clinical data at baseline and 24 weeks. The process evaluation comprised qualitative interviews with a sub-sample, feedback questionnaires, and observations of intervention delivery. We recruited 54 patients over 12 months, achieving 90% of the target sample size (n = 60). PROMs return rates were 94.4% (51/54), 85.2% (46/54) and 71.1% (27/38) at 1, 12, and 24-weeks, respectively. Intervention fidelity was high and the intervention largely aligned with the theoretical underpinnings. The process evaluation illustrated how patients benefitted from the intervention through support they would not have received through usual care. This included direct referral or signposting to support services, information and education, actionable advice, and reassurance about and normalisation of recovery. The trial design was feasible and acceptable for both patients and clinicians. Nurse-led, structured follow-up after TIA and minor stroke is feasible, acceptable and valued by patients and clinicians. Our intervention can identify and help address unmet needs. A definitive randomised trial to evaluate intervention effectiveness and cost-effectiveness is feasible and acceptable.

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.

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 The aim of the study was to evaluate the health economics of nurse-led telephone follow-up contacts (TFUs) within six weeks after benign hysterectomy in a societal perspective, using a cost minimization analysis model. Methods A randomized, single-blinded, controlled, Swedish multicenter study comprising 487 women undergoing benign hysterectomy. The women were allocated 1:1:1:1 to either Group A (no TFUs), Group B (one clinically structured TFU the day after discharge), Group C (as B, but with additional TFUs once weekly for six weeks, in total six TFUs), or Group D (as C, but by applying a coaching technique). Time consumption for planned TFUs, informal care, and the number of unplanned telephone contacts and visits were recorded. Costs were assessed using a cost-per-patient price list for Linköping University Hospital. Results The total cost per patient more than doubled in the groups with repeated TFUs (Groups C and D) compared with no TFUs (Group A). Group D demonstrated fewer unplanned telephone contacts and lower informal care costs. Group B, with only one TFU, exhibited the highest time consumption for TFU. The additional costs of six TFUs, with or without coaching, substantially increased the costs. The coaching TFU group (Group D) had the lowest cost for informal care. Conclusion TFUs appeared to be costly and an inefficient way of using healthcare resources after benign hysterectomy. The coaching TFU seemed to reduce unplanned telephone contacts and lower informal care costs. Careful consideration of the costs and the impact on clinical outcomes is important before implementing TFU after surgery. Trial registration This study is registered retrospectively in ClinicalTrial.gov: NCT01526668 on January 27, 2012. Date of enrollment of first patient: October 11; 2011.

Purpose Open wedge high tibial osteotomy is a widespread treatment option in patients with varus malalignment and medial compartment osteoarthritis. There is no standardised protocol for post-operative rehabilitation available. The purpose of this study was to compare two post-operative rehabilitation protocols and to evaluate the clinical outcome of early full weight-bearing after open wedge HTO. Methods One hundred and twenty consecutive patients with varus malalignment and medial compartment osteoarthritis received an open wedge HTO using an angular locking plate fixation between December 2008 and December 2011. All patients were assigned randomly into one of two groups with different post-operative rehabilitation protocols (11-day vs. 6-week 20-kg partial weight-bearing). Clinical outcome was evaluated using established instruments (Lequesne, Lysholm, HSS and IKDC scores) preoperatively, 6, 12 and 18 months post-operatively. Deformity analysis was performed preoperatively and during follow-up. Results All clinical scores showed a significant pre- to post-operative improvement. After 6 months, there was a higher improvement in the group of early full weight-bearing. The difference between preoperative and 6-month follow-up for the group with early full weight-bearing and for the group with 20-kg PWB for 6 weeks was 28 ± 26 and 18 ± 22, respectively, for the Lysholm score and −5.0 ± 5.1 and −3.0 ± 3.6, respectively, for the Lequesne score. Conclusions Early full weight-bearing (11-day 20-kg partial weight-bearing) after open wedge HTO without bone graft leads to earlier improvement of the clinical results and can be recommended for post-operative rehabilitation after open wedge HTO and fixation with an angular locking plate. Level of evidence Therapeutic study, Level I.