Content
Volume 8, 2004
Symptom assessment and quality of life in hypertensive patients following modification
of antihypertensive therapy to a regimen containing valsartan
R Goodman, JW Lanese, CR Singson, HR Savage, KL Khooblall, SD Parsley, K Yokoyama,
QC Doan, R Kaczmarek, F Frech, M Whitman
Pages 1-14 ¦ Abstract ¦
Evaluation of a service reconfiguration for managing intravenous iron supplementation
in non-haemodialysis patients with chronic renal failure
G Peebles, S Stanley
Pages 15-25 ¦ Abstract ¦
Health-related quality of life and treatment satisfaction and preference in a
community assessment study of extended-release mixed amphetamine salts for children
with attention-deficit/hyperactivity disorder
FR Sallee, PJ Ambrosini, FA Lopez, L Shi, MA Michaels on behalf of the LADD.CAT
Study Group
Pages 27-49 ¦ Abstract ¦
Implementation of an observational study in a hospital setting: experiences from
the Assessment of Cost and ouTcomes of chemotherapy In an Observational setting
in patients with Non-small cell lung cancer (ACTION) study
A Kielhorn, A Szczepura, H Anderson, FL Pimentel, H Riska, BEEM can den Borne,
M Thomas, S Bhalla, on behalf of the ACTION Study Group
Pages 51-62 ¦ Abstract ¦
Evaluation of user preference for a needleless factor VIII delivery device for
haemophilia
patients
R Butler, PLarson, SMannix, JBrewster, AMueller-Beckhaus, DMacLean, ALloyd, AM
Rentz
Pages 63-78 ¦ Abstract ¦
Goodman R, Lanese JW, Singson CR et al
Symptom assessment and quality of life in hypertensive patients following modification
of antihypertensive therapy to a regimen containing valsartan
J Outcomes Res 2004; 8: 1-14
The objective of the study was to evaluate the effects of a change in medication
on symptomology and quality of life (QOL) in patients experienceing bothersome
side effects from their antihypertensive medications. Physicians altered antihypertensive
regimens and monitored patients for 7 weeks (± 1 week) after the change in therapy
according to usual clinical practice. Most regimens were changed to either valsartan
or valsartan with hydrochlorothiazide (HCTZ). Endpoints included symptomology,
QOL as assessed by the Medical Outcomes Study 12-Item Short Form, and safety evaluations
(blood pressure and adverse events). Of the 550 patients who were prescribed valsartan
or valsartan and HCTZ, data for 397 patients were evaluable for symptomology ad
420 patients for QOL assessments. The most common therapies at baseline were angiotensin-converting
enzyme inhibitors (25%) and calcium channel blockers (15%). Following the change
in therapy, the severity of cough, headache, and oedema were reduced in 93%, 86%
and 87% of patients, respectively. QOL improved significantly for both the physical
component summary [mean increase (SD) from 44.9 (SD 10.5) to 46.9 (SD 10.0)] and
the mental component summary [from 48.6 (sd 10.8) to 51.5 (SD 9.3)] scores (p<0.05
for both). Mean systolic blood pressure (BP) declined from 151 (SD 18) to 140
(SD 17) mmHg and mean diastolic BP from 89 (SD 11) to 83 (SD 9) mmHg. Patients
who had intolerable symptoms with their previous antihypertensive medications
experienced reduced symptoms and improved QOL while maintaining BP control following
a change to valsartan or valsartan and HTCZ.
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Peebles G, Stanley S
Evaluation of a service reconfiguration for managing intravenous iron supplementation
in non-haemodialysis patients with chronic renal failure
J Outcomes Res 2004; 8: 15-25
There is a growing population of patients with chronic kidney disease. Guidelines,
outlining 'best care', promote the use of early intervention for anaemia management.
This presents an additional funding pressure and imposes a significantly increased
workload on individual renal units.
At Sunderland Royal Infirmary, iron sucrose was routinely administered to renal
replacement patients, to both those receiving haemodialysis and those on continuous
ambulatory peritoneal dialysis (CAPD). In addition, anaemia management of the
expanding cohort of pre-dialysis patients resulted in a growing number of these
individuals being administered intravenous iron supplementation. This additional,
and growing workload, led to an increased waiting list and waiting times for treatment.
It was recognised that to provide optimal iron replacement, it was necessary for
patients to make repeated weekly visits to the clinic for administration of their
iron infusions. Compliance was often poor, and optimal iron management was difficult
to achieve.
The introduction of an alternative iron supplement, in the form of low-molecular-weight
iron dextran complex (CosmoFer®, Vitaline Pharmaceuticals Ltd, UK) that can be
administered as a total dose infusion (TDI), offered an attractive alternative
to iron sucrose, especially for non-haemodialysis patients. The duration of administration
of a TDI necessitated a reconfigured approach to intravenous iron administration
for non-haemodialysis.
By opening our haemodialysis facility on a Sunday, once a month, we have been
able to eliminate the waiting list and reduce waiting times. This cost impact
study reveals that by adopting a policy of administering low-molecular-weight
iron dextran complex as a TDI, substantial cost savings can be made while improving
clinical outcomes.
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Sallee FR, Ambrosini PJ, Lopez FA, Shi L, Michaels MA, on behalf of the LADD.CAT
Study Group
Health-related quality of life and treatment satisfaction and preference in a
community assessment study of extended-release mixed amphetamine salts for children
with attention-deficit/hyperactivity disorder
J Outcomes Res 2004; 8: 27-49
Children aged 6-12 years (n=2,968) with DSM-IV-defined attention-deficit/hyperactivity
disorder (ADHD) participated in a prospective, open-label, multicentre, non-comparative
community assessment study. Baseline stimulant treatment regimen (Adderall® [Shire
US Inc, Newport, KY, USA] immediate-release methylphenidate, or Concerta® [McNeil
Consumer and Specialty Pharmaceuticals, Fort Washington, PA, USA]) was converted
to an approximately equivalent once-daily dose of 10, 20 or 30 mg Adderall XR®
(Shire US Inc, Newport, KY, USA; mixed amphetamine salts extended release [MAS
XR]) according to a medication-conversion algorithm.
Health-related quality of life (HRQL) was assessed by the Pediatric Quality of
Life Inventory™ 4.0 (PedsQL™); treatment satisfaction and preference were assessed
by parent and physician questionnaires. Mean PedsQL™ total score at baseline was
74.5 compared with 81.0 after 7 weeks of treatment with MAS XR; the 6.4-point
improvement was statistically significant (p<0.0001; 1-sample t-test). Children
with ADHD who are being managed in a community practice setting may experience
significant clinical benefit, including improved HRQL and parent treatment satisfaction
and preference after conversion to a treatment regimen including MAS XR.
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Kielhorn A, Szczepura A, Anderson H et al, on behalf of the ACTION Study Group
Implementation of an observational study in a hospital setting: experiences from
the Assessment of Cost and ouTcomes of chemotherapy In an Observational setting
in patients with advanced Non-small cell lung cancer (ACTION) study
J Outcomes Res 2004; 8: 51-62
Observational studies offer an alternative approach to conducting clinical research,
in which the course of patient care is not directed. ACTION (Assessment of Cost
and ouTcomes of chemotherapy In an Observational setting in patients with advanced
Non-small cell lung cancer) is a large, 18-month prospective European observational
study. It is the first study of its kind and aims to provide information about
the costs and outcomes of treating patients with advanced non-small cell lung
cancer (NSCLC) in routine clinical practice. This paper describes the setting
up of ACTION, problems encountered with its implementation, and details of its
methods and current status. It is hoped that ACTION will provide a meaningful
guide to health care policy and prescribing in Europe, by gathering information
internationally regarding first- and second-line chemotherapy of advanced NSCLC
in clinical practice and how this affects costs, outcomes and quality of life.
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Butler R, Larson P, Mannix S, Brewster J, Mueller-Beckhaus A, MacLean D, Lloyd A, Rentz AM
Evaluation of user preference for a needleless factor VIII delivery device for
haemophilia
patients
J Outcomes Res 2004; 8: 63-78
The objective of this cross-sectional study was to assess the preference for
BIO-SET® (a needleless device for reconstitution of medicinal products) compared
with the conventional method and a double-spike reconstitution device for the
preparation of recombinant factor VIII (rFVIII). The study was conducted with
volunteers who infuse factor VIII concentrates
(haemophilia A patients, caregivers and nurses). Participants performed timed
rounds, completed preference questionnaires and defined components requiring disposal
as medical waste. The preference questionnaire assessed safety/worry, ease/confidence
and
overall preference.
A total of 161 participants were recruited into the study (35 patients, 67 caregivers
and 59 nurses). Participants preferred BIO-SET in terms of worry/safety, ease/confidence
and overall preference. Compared with the other methods, participants completed
preparation of infusion with BIO-SET in the shortest time, and average medical
waste weight was lowest for BIO-SET. Results showed that participants prefer the
BIO-SET reconstitution device above other methods for preparing factor VIII concentrate
for infusion.
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