ABSTRACT
Keywords: Peripheral arterial disease;Exercise;Behaviour change Purpose: Walking is recommended for adults with peripheral arterial disease. However, provision of supervised walking programmes is variable and adherence to self-directed walking tends to be low. MOtivating Structured walking Activity for Intermittent Claudication (MOSAIC) is a physiotherapist-led, structured, home-based intervention that incorporates motivational interviewing and behaviour change principles to increase participants’ motivation and commitment to walking. This trial investigated whether MOSAIC improved walking performance compared to usual care in adults with peripheral arterial disease. Methods: This multicentre, parallel group, two-arm, randomised, controlled superiority trial enrolled participants from six NHS Trusts between January 2018 and March 2020. Inclusion criteria comprised: aged ≥50 years with established peripheral arterial disease and intermittent claudication. Exclusion criteria included: unstable disease;walking >90 min/week;contraindications to exercise or completed/offered any medically supervised exercise in previous/upcoming six-months. The primary outcome was six-minute walk distance (6MWD, metres (m)) at three-months (clinically meaningful change: ≥8 m). Secondary outcomes included pain-free walking distance measured during six-minute walk test (PFWD, seconds), self-reported walking limitation (Walking Estimated-Limitation Calculated by History, WELCH, range 0–100;self-reported maximum walking distance, SR-MWD (m)), activities of daily living (Nottingham Extended Activities of Daily Living Questionnaire, NEADL, range 0–66), and quality of life (Vascular Quality of Life Questionnaire-6, VASuQoL-6, range 6–24). All measures were collected at baseline and three-months by an assessor masked to participant allocation. The self-reported outcomes were also collected at six-months. Consenting participants were randomly assigned (by King's Clinical Trials Unit remote computer-generated randomisation system) to receive either MOSAIC (two face-to-face and two telephone consultations delivered over three-months by trained physiotherapists, a pedometer and a bespoke manual) or usual care. Participants and physiotherapists were not masked to group allocation. Participant recruitment and collection of primary outcome data at three-months was ceased early due to COVID-19 restrictions. All self-reported six-month outcomes were collected as per protocol. Outcomes were evaluated on an intention-to-treat basis using multiple regression with baseline value and stratification factors as covariates. Results: 190 participants (mean age (Standard Deviation) 68 (9) years, 57 (30%) female, 150 (79%) White) were recruited (95/group). At three-months, participants receiving MOSAIC had greater mean 6MWD compared to participants receiving usual care (adjusted mean difference (95% confidence interval (95%CI): 16.4 m (3.8, 29.1)). Secondary outcomes also indicated greater improvement for those receiving MOSAIC than usual care (adjusted mean differences (95% CI): PFWD (31.2 s (6.3, 56.0));WELCH (10.2 points (5.6, 14.8));SR-MWD (251 s (11.0;194.9));NEADL (2.8 points (0.1;5.4));VASuQoL-6 (0.6 points (−0.2;1.4)). At six months, there was a sustained improvement in WELCH in participants receiving MOSAIC compared to usual care (adjusted mean difference (95% CI): 7.4 points (2.5, 1.3)). Results for the other secondary outcomes were inconclusive (SR-MWD (309.9 s (−17.8;637.6)), NEADL (−1.6 points (−4.6, 1.5)), VASuQoL-6 (0.6 points (−0.4;1.6)). Thirty-seven adverse events (25 MOSAIC, 12 usual care) were reported. Conclusion(s): MOSAIC is an effective treatment for the management of peripheral arterial disease and could be integrated into physiotherapy practice to support walking behaviour change. Impact: MOSAIC is an effective treatment for the management of peripheral arterial disease and could be integrated into physiotherapy practice to support walking behaviour change. Funding acknowledgements: This work was suppor ed by The Dunhill Medical Trust [grant number: [R477/0516].
ABSTRACT
The coronavirus pandemic has had an immediate and far-reaching effect on the care of urological patients. The pandemic monitor of the German Society for Urology was able to record the restrictions on patient care in urological practices and clinics by means of regular surveys of the members. A total of 689 responses at four survey time points were included. In April there was a reduction in urological inpatients to 44% and the number of patients in practices dropped to 50%. Available operating theater capacities for urological patients were 45% in April, normalized to 90% in June and fell again to 50% in December. Elective operations could not be performed at all or only to a very limited extent in most hospitals in April and December. While urgent operations could be treated to 100% in more than 75% of the clinics in April, in December more than half of the clinics stated that they could not treat all patients with urgent indications. To some extent (8-19%) practices and clinics had to resort to a pandemic-related supraregional referral of patients. The reduction of outpatients in urological practices in April normalized to 95% in June and remained stable during the second wave of the pandemic. The increase in urological emergencies in practices observed at the beginning of the pandemic did not show up in November and December. The coronavirus pandemic has led to a significant reduction in the care of urological patients, which in particular in the second wave also affects urgent operations.