| 1. |
- Hagell, Peter, et al.
(author)
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Apomorphine formulation may influence subcutaneous complications from continuous subcutaneous apomorphine infusion in Parkinson's disease
- 2020
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In: Journal of Neurology. - 0340-5354 .- 1432-1459. ; 267:11, s. 3411-3417
-
Journal article (peer-reviewed)abstract
- Continuous subcutaneous (s.c.) apomorphine infusion is an effective therapy for Parkinson's disease (PD), but a limitation is the formation of troublesome s.c. nodules. Various chemically non-identical apomorphine formulations are available. Anecdotal experiences have suggested that shifting from one of these (Apo-Go PumpFill®; apoGPF) to another (Apomorphine PharmSwed®; apoPS) may influence the occurrence and severity of s.c. nodules. We, therefore, followed 15 people with advanced PD (median PD-duration, 15 years; median "off"-phase Hoehn and Yahr, IV) on apoGPF and with troublesome s.c. nodules who were switched to apoPS. Data were collected at baseline, at the time of switching, and at a median of 1, 2.5, and 7.3 months post-switch. Total nodule numbers (P < 0.001), size (P < 0.001), consistency (P < 0.001), skin changes (P = 0.058), and pain (P ≤ 0.032) improved over the observation period. PD severity and dyskinesias tended to improve and increase, respectively. Apomorphine doses were stable, but levodopa doses increased by 100 mg/day. Patient-reported apomorphine efficacy tended to increase and all participants remained on apoPS throughout the observation period; with the main patient-reported reason being improved nodules. These observations suggest that patients with s.c. nodules caused by apoGPF may benefit from switching to apoPS in terms of s.c. nodule occurrence and severity. Alternatively, observed benefits may have been due to the switch itself. As nodule formation is a limiting factor in apomorphine treatment, a controlled prospective study comparing local tolerance with different formulations is warranted.
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| 2. |
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| 3. |
- Malmström, Eva-Maj, et al.
(author)
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Influence of prolonged unilateral cervical muscle contraction on head repositioning - Decreased overshoot after a 5-min static muscle contraction task.
- 2010
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In: Manual Therapy. - : Elsevier BV. - 1356-689X. ; 15, s. 229-234
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Journal article (peer-reviewed)abstract
- The ability to reproduce a specified head-on-trunk position can be an indirect test of cervical proprioception. This ability is affected in subjects with neck pain, but it is unclear whether and how much pain or continuous muscle contraction factors contribute to this effect. We studied the influence of a static unilateral neck muscle contraction task (5 min of lateral flexion at 30% of maximal voluntary contraction) on head repositioning ability in 20 subjects (10 women, 10 men; mean age 37 years) with healthy necks. Head repositioning ability was tested in the horizontal plane with 30 degrees target and neutral head position tests; head position was recorded by Zebris((R)), an ultrasound-based motion analyser. Head repositioning ability was analysed for accuracy (mean of signed differences between introduced and reproduced positions) and precision (standard deviation of the differences). Accuracy of head repositioning ability increased significantly after the muscle contraction task, as the normal overshoot was reduced. An average overshoot of 7.1 degrees decreased to 4.6 degrees after the muscle contraction task for the 30 degrees target and from 2.2 degrees to 1.4 degrees for neutral head position. The increased accuracy was most pronounced for movements directed towards the activated side. Hence, prolonged unilateral neck muscle contraction may increase the sensitivity of cervical proprioceptors.
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| 4. |
- Ericsson, Olle, et al.
(author)
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Clinical validation of a novel automated cell-free DNA screening assay for trisomies 21, 13, and 18 in maternal plasma.
- 2019
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In: Prenatal diagnosis. - : Wiley. - 1097-0223 .- 0197-3851. ; 39:11, s. 1011-1015
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Journal article (peer-reviewed)abstract
- To evaluate clinical performance of a new automated cell-free (cf)DNA assay in maternal plasma screening for trisomies 21, 18, and 13, and to determine fetal sex.Maternal plasma samples from 1200 singleton pregnancies were analyzed with a new non-sequencing cfDNA method, which is based on imaging and counting specific chromosome targets. Reference outcomes were determined by either cytogenetic testing, of amniotic fluid or chorionic villi, or clinical examination of neonates.The samples examined included 158 fetal aneuploidies. Sensitivity was 100% (112/112) for trisomy 21, 89% (32/36) for trisomy 18, and 100% (10/10) for trisomy 13. The respective specificities were 100%, 99.5%, and 99.9%. There were five first pass failures (0.4%), all in unaffected pregnancies. Sex classification was performed on 979 of the samples and 99.6% (975/979) provided a concordant result.The new automated cfDNA assay has high sensitivity and specificity for trisomies 21, 18, and 13 and accurate classification of fetal sex, while maintaining a low failure rate. The study demonstrated that cfDNA testing can be simplified and automated to reduce cost and thereby enabling wider population-based screening.
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| 5. |
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| 6. |
- Ghatnekar, Ola, 1968-
(author)
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The burden of stroke in Sweden : studies on costs and quality of life based on Riks-Stroke, the Swedish stroke register
- 2013
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Doctoral thesis (other academic/artistic)abstract
- The costs for stroke management and reduced health related quality of life (QoL) can extend throughout life as mental and physical disabilities are common. The aim of this thesis was to quantify this stroke-related burden with data from Riks-Stroke (RS), the Swedish stroke register.Costs for hospital and primary care, secondary drug prevention, home and residential care services, and production losses were estimated for first-ever stroke patients registered in the RS. The present value lifetime costs were estimated from the expected survival and discounted by 3%. Quality of life was estimated with the EQ-5D instrument on a subset of patients at 3 months after the index event and mapped to patient-reported outcome measures in the RS. Standard descriptive and analytic (multivariate regressions) statistical methods were used.The life-time societal present value cost per patient in 2009 was approximately €69,000 whereof home and residential care due to stroke was 59% and indirect costs for productivity losses accounted for 21% (year 2009 prices). Women had higher costs than men in all age groups. Treatment at stroke units had a low incremental cost per life-year gained compared to patients who were not treated at such facilities. The estimated disutility from stroke was greatest for women and the oldest, and compared to 1997 the cost per patient increased after a revised assumption. Hospitalisation costs were stable while long-term costs for ADL support increased in part due to a changed age structure. Patients with atrial fibrillation (AF; 24%) had €367 higher inpatient costs compared to non-AF stroke patients €8,914 (P<0.01; year 2001 prices). As the index case fatality was higher among AF patients, the cost difference was higher for patients surviving the first 28 days. A multivariate regression showed that AF, diabetes, stroke severity, and death during the 3-year follow-up period were independent cost drivers. Three regression techniques (OLS, Tobit, CLAD) were chosen for mapping EQ-5D utilities to patient-reported outcome measures in the RS. The mean utility was overestimated with all models and had lower variance than the original data.In conclusion, total societal lifetime cost for 22,000 first-ever stroke patients in 2009 amounted to €1.5 billion (whereof production losses were €314 million). About 56,600 QALYs were lost due to premature death and disability. Including a preference-based QoL instrument in the RS would allow cost-utility analyses, but it is important to control for confounders in comparator arms to avoid bias.
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| 7. |
- Gubanski, Michael, et al.
(author)
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Randomized phase II study of sequential docetaxel and irinotecan with 5-fluorouracil/folinic acid (leucovorin) in patients with advanced gastric cancer : the GATAC trial
- 2010
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In: Gastric Cancer. - : Springer Science and Business Media LLC. - 1436-3291 .- 1436-3305. ; 13:3, s. 155-161
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Journal article (peer-reviewed)abstract
- Background. The optimal chemotherapy in patients with advanced gastric carcinoma (GC) is yet to be determined. We compared sequential administration of docetaxel and irinotecan, both in combination with infused 5-fluorouracil/leucovorin (5-Fu/Lv), and randomly assigned patients to start with either of the two. Methods. Patients with previously untreated locally advanced or metastatic GC and with measurable lesions (response evaluation criteria in solid tumors; RECIST) were randomly assigned to start with docetaxel 45 m (arm T) or irinotecan 180 mg/m(2) (arm C) with bolus/44-h infusion of 5-Fu/Lv (day 1 every 2 weeks). After four courses, there was a pre-scheduled crossover to the alternative regimen for four additional courses. Results. Eighty-one patients were randomized and 78 started treatment. Complete and partial responses were seen in 31 (40%) patients after 8 weeks and in 32 (41%) after 16 weeks, with similar results in both study arms. The median overall survival (OS) was 11.5 and 10.6 months in arms T and C, respectively (P = 0.3). The two schedules were feasible and did not differ in the overall rate of severe adverse events (SAEs). Conclusion. This is the first randomized comparison of two of the newer cytostatic drugs in GC therapy. No differences favoring either arm T or arm C were found with respect to response rate, OS, or toxicity. The median OS of 11 months indicates that sequential administration of the two combinations is effective and is similar to triple combinations. Thus, comparable efficacy to platinum combinations appears to be obtained with newer, less toxic regimens when given sequentially.
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| 8. |
- Hagell, Peter, et al.
(author)
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Apomorphine formulation influences subcutaneous complications in continuous apomorphine pump therapy for Parkinson’s disease
- 2017
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In: Movement Disorders.
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Conference paper (other academic/artistic)abstract
- Objective: To explore if the occurrence and severity of subcutaneous (sc) nodules is influenced by the pharmaceutical formulation of apomorphine used for sc infusion in advanced Parkinson’s disease (PD).Background: Apomorphine infusion is an effective therapy in advanced PD, but a limitation is troublesome sc nodules. Various chemically non-identical apomorphine formulations are available. Anecdotal clinical experience has suggested that shifting from one of these (Apo-Go PumpFill; apoGPF) to another (Apomorphine PharmSwed; apoPS, developed in Sweden) may influence the occurrence and severity of sc nodules.Methods: In this multicenter open-label prospective observational study, 15 people with advanced PD (mean PD- duration, 13.4 years; median Hoehn & Yahr, IV) on apoGPF since a mean of 2.1 years and with troublesome sc nodules were switched to apoPS. Ongoing interventions to treat existing nodules (ultrasound, massage, Hirudoid cream) continued, and apomorphine as well as other drugs was managed according to clinical routines. Data were collected between May 2015 and March 2017; at baseline, at the time of switching (about 2 weeks later), and up to 1.7-4.2 (mean, 2.5) months post-switch follow-up. Primary outcomes were total nodule numbers, size (mm diameter for the 5 worst nodules), consistency (scored 0-3 for the 5 worst nodules), and associated skin changes (scored 0-4 for the 5 worst nodules) and pain (scored 0-5). Patients also rated their perceived PD severity and motor complications (UPDRS IV). Patient preferences 5-12 months post-switch (2-9 months after follow-up) were also recorded.Results: Apomorphine and L-dopa doses did not change over the observation period (P≥0.400). Baseline nodule numbers (7.4 vs. 4.6; P<0.003), size (92.9 vs. 54.1 mm; P=0.016), consistency (11 vs. 5; P=0.003), skin changes (3 vs. 1.5; P=0.205), and average pain (1 vs. 0; P=0.020) improved 11 weeks post-switch. Patient-reported PD severity (P=0.020) and motor fluctuations improved (P=0.051), whereas dyskinesias tended to increase (P=0.205). At 5-12 months post-switch, 13 patients had decided to remain on apoPS; mainly due to improved nodules.Conclusions: These observations suggest that apoPS may have a better safety profile compared to apoGPF in terms of sc nodule occurrence and severity. There is a need for larger, randomized controlled studies for firmer conclusions.
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| 9. |
- Hagell, Peter, et al.
(author)
-
Apomorphine formulation influences subcutaneous complications in continuous apomorphine pump therapy for Parkinson’s disease
- 2017
-
Conference paper (other academic/artistic)abstract
- Objective: To explore if the occurrence and severity of subcutaneous (sc) nodules is influenced by the pharmaceutical formulation of apomorphine used for sc infusion in advanced Parkinson’s disease (PD). Background: Apomorphine infusion is an effective therapy in advanced PD, but a limitation is troublesome sc nodules. Various chemically non-identical apomorphine formulations are available. Anecdotal clinical experience has suggested that shifting from one of these (Apo-Go PumpFill; apoGPF) to another (Apomorphine PharmSwed; apoPS, developed in Sweden) may influence the occurrence and severity of sc nodules. Methods: In this multicenter open-label prospective observational study, 15 people with advanced PD (mean PD- duration, 13.4 years; median Hoehn & Yahr, IV) on apoGPF since a mean of 2.1 years and with troublesome sc nodules were switched to apoPS. Ongoing interventions to treat existing nodules (ultrasound, massage, Hirudoid cream) continued, and apomorphine as well as other drugs was managed accordingto clinical routines. Data were collected between May 2015 and March 2017; at baseline, at the time of switching (about 2 weeks later), and up to 1.7-4.2 (mean, 2.5) months post-switch follow-up. Primary outcomes were total nodule numbers, size (mm diameter for the 5 worst nodules), consistency (scored 0-3 for the 5 worst nodules), and associated skin changes (scored 0-4 for the 5 worst nodules) and pain (scored 0-5). Patients also rated their perceived PD severity and motor complications (UPDRS IV). Patient preferences 5-12 months post-switch (2-9 months after follow-up) were also recorded. Results: Apomorphine and L-dopa doses did not change over the observation period (P≥0.400). Baseline nodule numbers (7.4 vs. 4.6; P<0.003), size (92.9 vs. 54.1 mm; P=0.016), consistency (11 vs. 5; P=0.003), skin changes (3 vs. 1.5; P=0.205), and average pain (1 vs. 0; P=0.020) improved 11 weeks post-switch. Patient-reported PD severity (P=0.020) and motor fluctuations improved (P=0.051), whereas dyskinesias tended to increase (P=0.205). At 5-12 months post-switch, 13 patients had decided to remain on apoPS; mainly due to improved nodules. Conclusions: These observations suggest that apoPS may have a better safety profile compared to apoGPF in terms of sc nodule occurrence and severity. There is a need for larger, randomized controlled studies for firmer conclusions.
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| 10. |
- Hagell, Peter, et al.
(author)
-
Apomorphine formulation may influence subcutaneous complications from continuous subcutaneous apomorphine infusion in Parkinson's disease
- 2020
-
In: Journal of Neurology. - : D. Steinkopff-Verlag. - 0340-5354 .- 1432-1459. ; 267:11, s. 3411-3417
-
Journal article (peer-reviewed)abstract
- Continuous subcutaneous (s.c.) apomorphine infusion is an effective therapy for Parkinson's disease (PD), but a limitation is the formation of troublesome s.c. nodules. Various chemically non-identical apomorphine formulations are available. Anecdotal experiences have suggested that shifting from one of these (Apo-Go PumpFill®; apoGPF) to another (Apomorphine PharmSwed®; apoPS) may influence the occurrence and severity of s.c. nodules. We, therefore, followed 15 people with advanced PD (median PD-duration, 15 years; median "off"-phase Hoehn and Yahr, IV) on apoGPF and with troublesome s.c. nodules who were switched to apoPS. Data were collected at baseline, at the time of switching, and at a median of 1, 2.5, and 7.3 months post-switch. Total nodule numbers (P < 0.001), size (P < 0.001), consistency (P < 0.001), skin changes (P = 0.058), and pain (P ≤ 0.032) improved over the observation period. PD severity and dyskinesias tended to improve and increase, respectively. Apomorphine doses were stable, but levodopa doses increased by 100 mg/day. Patient-reported apomorphine efficacy tended to increase and all participants remained on apoPS throughout the observation period; with the main patient-reported reason being improved nodules. These observations suggest that patients with s.c. nodules caused by apoGPF may benefit from switching to apoPS in terms of s.c. nodule occurrence and severity. Alternatively, observed benefits may have been due to the switch itself. As nodule formation is a limiting factor in apomorphine treatment, a controlled prospective study comparing local tolerance with different formulations is warranted.
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