2 resultados para cluster randomised control trial

em Helda - Digital Repository of University of Helsinki


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This study examined the efficacy of a participatory ergonomics intervention in preventing musculoskeletal disorders (MSDs) and changing unsatisfactory psychosocial working conditions among municipal kitchen workers. The occurrence of multiple-site musculoskeletal pain (MSP) and associations between MSP and psychosocial factors at work over time were studied secondarily. A cluster randomized controlled trial was conducted during 2002-2005 in 119 municipal kitchens with 504 workers. The kitchens were randomized to an intervention (n = 59) and control (n = 60) group. The intervention lasted 11 to 14 months. The workers identified strenuous work tasks and sought solutions for decreasing physical and mental workload. The main outcomes were the occurrence of and trouble caused by musculoskeletal pain in seven anatomical sites, local musculoskeletal fatigue after work, and musculoskeletal sick leaves. Psychosocial factors at work (job control, skill discretion, co-worker relationships, supervisor support, mental strenuousness of work, hurry, job satisfaction) and mental stress were studied as intermediate outcomes of the intervention. Questionnaire data were collected at three months intervals during the intervention and the one-year post-intervention follow-up. Response rates varied between 92 % and 99 %. In total, 402 ergonomic changes were implemented. In the control group, 80 changes were spontaneously implemented within normal activity. The intervention did not reduce perceived physical workload and no systematic differences in any health outcomes were found between the intervention and control groups during the intervention or during the one-year follow-up. The results suggest that the intervention as studied in the present trial was not more effective in reducing perceived physical workload or preventing MSDs compared with no such intervention. Little previous evidence of the effectiveness of ergonomics interventions in preventing MSDs exists. The effects on psychosocial factors at work were adverse, especially in the two of the participating cities where re-organization of foodservices timed simultaneously with the intervention. If organizational reforms at workplace are expected to occur, the execution of other workplace interventions at the same time should be avoided. The co-occurrence of musculoskeletal pain at several sites is observed to be more common than pain at single anatomical sites. However, the risk factors of MSP are largely unknown. This study showed that at baseline, 73 % of the women reported pain in at least two, 36 % in four or more, and 10 % in six to seven sites. The seven pain symptoms occurred in over 80 different combinations. When co-occurrence of pain was studied in three larger anatomical areas (neck/low back, upper limbs, lower limbs), concurrent pain in all three areas was the most common combination (36 %). The 3-month prevalence of MSP (≥ 3 of seven sites) varied between 50 % and 61 % during the two-year follow-up period. Psychosocial factors at work and mental stress were strong predictors for MSP over time and, vice versa, MSP predicted psychosocial factors at work and mental stress. The reciprocality of the relationships implies either two mutually dependent processes in time, or some shared common underlying factor(s).

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A lack of suitable venous graft material or poor outflow is an increasingly encountered situation in peripheral vascular surgery. Prosthetic grafts have clearly worse patency than vein grafts in femorodistal bypass surgery. The use of an adjuvant arteriovenous fistula (av-fistula) at the distal anastomosis has been postulated to improve the flow and thus increase prosthetic graft patency. In theory the adjuvant fistula might have the same effect in a compromised outflow venous bypass. A free flap transfer also augments graft flow and may have a positive effect on an ischaemic limb. The aim of this study was to evaluate the possible benefit of an adjuvant av-fistula and an internal av-fistula within a free flap transfer on the patency and outcome of an infrapopliteal bypass. The effect of the av-fistula on bypass haemodynamics was also assessed along with possible adverse effects. Patients and methods: 1. A prospective randomised multicentre trial comprised 59 patients with critical leg ischaemia and no suitable veins for grafting. Femorocrural polytetrafluoroethylene (PTFE) bypasses with a distal vein cuff, with or without an adjuvant av-fistula, were performed. The outcome was assessed according to graft patency and leg salvage. 2. Haemodynamic measurements were performed to a total of 50 patients from Study I with a prolonged follow-up. 3. Nine critically ischaemic limbs were treated with a modified radial forearm flap transfer in combination with a femorodistal bypass operation. An internal av-fistula was created within the free flap transfer to increase flap artery and bypass graft flow. 4. The effect of a previous free flap transfer on bypass haemodynamics was studied in a case report. 5. In a retrospective multicentre case-control study, 77 infrapopliteal vein bypasses with an adjuvant av-fistula were compared with matched controls without a fistula. The outcome and haemodynamics of the bypasses were recorded. Main results: 1. The groups with and without the av-fistula did not differ as regards prosthetic graft patency or leg salvage. 2. The intra- and postoperative prosthetic graft flow was significantly increased in the patients with the av-fistula. However, this increase did not improve patency. There was no difference in patency between the groups, even in the extended follow-up. 3. The vein graft flow increased significantly after the anastomosis of the radial forearm flap with an internal av-fistula. 4. A previously performed free flap transfer significantly augmented the flow of a poor outflow femoropedal bypass graft. 5. The adjuvant av-fistula increased the venous infrapopliteal bypass flow significantly. The increased flow did not, however, lead to improved graft patency or leg salvage. Conclusion: An adjuvant av-fistula does not improve the patency of a femorocrural PTFE bypass with a distal vein cuff despite the fact that the flow values increased both in the intraoperative measurements and during the immediate postoperative surveillance. The adjuvant av-fistula increased graft flow significantly also in a poor outflow venous bypass, but regardless of this the outcome was no improved. The adjuvant av-fistula rarely caused adverse effects. In a group of diabetic patients, the flow in a vascular bypass graft was augmented by an internal av-fistula within a radial forearm flap and similarly in a patient with a previous free flap transfer, a high intraoperative graft flow was achieved due to the free flap shunt effect.