Background: Improving physical activity, especially in combination with optimizing protein intake, after surgery has a potential positive effect on recovery of physical functioning in patients after gastrointestinal and lung cancer surgery. The aim of this randomized controlled trial is to evaluate the efficacy of a blended intervention to improve physical activity and protein intake after hospital discharge on recovery of physical functioning in these patients. Methods: In this multicenter single-blinded randomized controlled trial, 161 adult patients scheduled for elective gastrointestinal or lung cancer surgery will be randomly assigned to the intervention or control group. The purpose of the Optimal Physical Recovery After Hospitalization (OPRAH) intervention is to encourage self-management of patients in their functional recovery, by using a smartphone application and corresponding accelerometer in combination with coaching by a physiotherapist and dietician during three months after hospital discharge. Study outcomes will be measured prior to surgery (baseline) and one, four, eight, and twelve weeks and six months after hospital discharge. The primary outcome is recovery in physical functioning six months after surgery, and the most important secondary outcome is physical activity. Other outcomes include lean body mass, muscle mass, protein intake, symptoms, physical performance, self-reported limitations in activities and participation, self-efficacy, hospital readmissions and adverse events. Discussion: The results of this study will demonstrate whether a blended intervention to support patients increasing their level of physical activity and protein intake after hospital discharge improves recovery in physical functioning in patients after gastrointestinal and lung cancer surgery. Trial registration: The trial has been registered at the International Clinical Trials Registry Platform at 14–10-2021 with registration number NL9793. Trial registration data are presented in Table 1.
Background: Tangential excision of burned tissue followed by skin grafting is the cornerstone of burn surgery. Hydrosurgery has become popular for tangential excision, with the hypothesis that enhanced preservation of vital dermal tissue reduces scarring. The aim of this trial was to compare scar quality after hydrosurgical versus conventional debridement before split-skin grafting. Methods: A double-blind randomized within-patient multicentre controlled trial was conducted in patients with burns that required split-skin grafting. One wound area was randomized to hydrosurgical debridement and the other to Weck knife debridement. The primary outcome was scar quality at 12 months, assessed with the observer part of the Patient and Observer Scar Assessment Scale (POSAS). Secondary outcomes included complications, scar quality, colour, pliability, and histological dermal preservation. Results: Some 137 patients were randomized. At 12 months, scars of the hydrosurgical debrided wounds had a lower POSAS observer total item score (mean 2.42 (95 per cent c.i. 2.26 to 2.59) versus 2.54 (95 per cent c.i. 2.36 to 2.72; P = 0.023)) and overall opinion score (mean 3.08 (95 per cent c.i. 2.88 to 3.28) versus 3.30 (95 per cent c.i. 3.09-3.51); P = 0.006). Patient-reported scar quality and pliability measurements were significantly better for the hydrosurgically debrided wounds. Complication rates did not differ between both treatments. Histologically, significantly more dermis was preserved with hydrosurgery (P < 0.001). Conclusion: One year after surgery scar quality and pliability was better for hydrosurgically debrided burns, probably owing to enhanced histological preservation of dermis. Registration number: Trial NL6085 (NTR6232 (http://www.trialregister.nl)).
Background: A pragmatic, stepped wedge trial design can be an appealing design to evaluate complex interventions in real-life settings. However, there are certain pitfalls that need to be considered. This paper reports on the experiences and lessons learned from the conduct of a cluster randomized, stepped wedge trial evaluating the effect of the Hospital Elder Life Program (HELP) in a Dutch hospital setting to prevent older patients from developing delirium. Methods: We evaluated our trial which was conducted in eight departments in two hospitals in hospitalized patients aged 70 years or older who were at risk for delirium by reflecting on the assumptions that we had and on what we intended to accomplish when we started, as compared to what we actually realized in the different phases of our study. Lessons learned on the design, the timeline, the enrollment of eligible patients and the use of routinely collected data are provided accompanied by recommendations to address challenges. Results: The start of the trial was delayed which caused subsequent time schedule problems. The requirement for individual informed consent for a quality improvement project made the inclusion more prone to selection bias. Most units experienced major difficulties in including patients, leading to excluding two of the eight units from participation. This resulted in failing to include a similar number of patients in the control condition versus the intervention condition. Data on outcomes routinely collected in the electronic patient records were not accessible during the study, and appeared to be often missing during analyses. Conclusions: The stepped wedge, cluster randomized trial poses specific risks in the design and execution of research in real-life settings of which researchers should be aware to prevent negative consequences impacting the validity of their results. Valid conclusions on the effectiveness of the HELP in the Dutch hospital setting are hampered by the limited quantity and quality of routine clinical data in our pragmatic trial. Executing a stepped wedge design in a daily practice setting using routinely collected data requires specific attention to ethical review, flexibility, a spacious time schedule, the availability of substantial capacity in the research team and early checks on the data availability and quality.
Meestal is er geen specifieke oorzaak te vinden voor nekpijn. Fysiotherapie richt zich daarom op algemene zaken, zoals spierkracht en beweeglijkheid. We onderzoeken of er effectieve behandelingen zijn voor subgroepen met niet-specifieke nekpijn. Met deze inzichten kunnen we fysiotherapie verbeteren.Doel We willen inzicht krijgen in effectieve behandelingen bij subgroepen patiënten met niet-specifieke nekpijn. Dit leidt uiteindelijk tot kostenvermindering voor de maatschappij en een sneller en beter herstel van de patiënten. Resultaten Dit onderzoek loopt nog. Na afronding vind je hier een samenvatting van alle resultaten. Tot nu toe is duidelijk geworden dat de volgende behandelingen effectief kunnen zijn bij patiënten met niet-specifieke nekpijn: Behandelingen gericht op kracht en uithoudingsvermogen. Behandelingen gericht op coördinatie met gebruik van visuele feedback. Een voorbeeld hiervan is patiënten met een laserlamp een parcours laten uitvoeren op een scherm. De resultaten van het onderzoek worden verwerkt in het bachelor- en masteronderwijs en cursussen binnen het werkveld. Looptijd 01 december 2015 - 01 december 2020 Aanpak Dit onderzoek bestaat uit verschillende delen: We onderzoeken wat er vanuit wetenschappelijk onderzoek al bekend is over de relatie tussen beperking in activiteit en een passende behandeling. We voeren een Delphi-studie uit onder deskundigen naar het behandelen van mensen met niet-specifieke nekpijn. We vragen ze naar een overeenstemming over de relatie tussen beperking in activiteit en een algemene behandeling, zoals het trainen van spierkracht. We onderzoeken of beweegoefeningen en/of manipulaties, als meest onderzochte behandelingen bij mensen met nekpijn, zo zijn beschreven dat we het kunnen hergebruiken. In de laatste studie onderzoeken we of beweegoefeningen en/of manipulaties effectief zijn in het herstellen van de beweeglijkheid. Het gaat hierbij om een subgroep van mensen met nekpijn die ook beperkt zijn in hun beweeglijkheid. Rapporten tot nu toe: The clinical reasoning process in randomized clinical trials with patients with non-specific neck pain is incomplete: A systematic review. Maissan F, Pool J, de Raaij E, Mollema J, Ostelo R, Wittink H. Musculoskelet Sci Pract. 2018 Jun;35:8-17 Clinical reasoning in unimodal interventions in patients with non-specific neck pain in daily physiotherapy practice, a Delphi study. Maissan F, Pool J, Stutterheim E, Wittink H, Ostelo R., Musculoskelet Sci Pract. 2018 Oct;37:8-16
