Bradley R, Sherman KJ, Catz S, Calabrese C,
Oberg EB, Jordan L, Grothous L, Cherkin D. Adjunctive naturopathic care for
type 2 diabetes: patient-reported and clinical outcomes after one year. BMC
Complementary and Alternative Medicine 2012, 12:44 doi:10.1186/1472-6882-12-44
Background: Several
small, uncontrolled studies have found improvements in self-care behaviors and
reductions in clinical risk in persons with type 2 diabetes who received care
from licensed naturopathic physicians. To extend these findings and determine
the feasibility and promise of a randomized clinical trial, we conducted a
prospective study to measure the effects of adjunctive naturopathic care (ANC)
in primary care patients with inadequately controlled type 2 diabetes.
Methods: Forty
patients with type 2 diabetes were invited from a large integrated health care
system to receive up to eight ANC visits for up to one year. Participants were
required to have hemoglobin A1c (HbA1c) values between 7.5-9.5 % and at least one
additional cardiovascular risk factor (i.e., hypertension, hyperlipidemia or
overweight). Standardized instruments were administered by telephone to collect
outcome data on self-care, self-efficacy, diabetes problem areas, perceived
stress, motivation, and mood. Changes from baseline scores were calculated at
6- and 12-months after entry into the study. Six and 12-month changes in
clinical risk factors (i.e., HbA1c, lipid and blood pressure) were calculated
for the ANC cohort, and compared to changes in a cohort of 329 eligible,
non-participating patients constructed using electronic medical records data.
Between-cohort comparisons were adjusted for age, gender, baseline HbA1c, and
diabetes medications. Six months was pre-specified as the primary endpoint for
outcome assessment.
Results: Participants
made 3.9 ANC visits on average during the year, 78 % of which occurred within
six months of entry into the study. At 6-months, significant improvements were
found in most patient-reported measures, including glucose testing (P = 0.001),
diet (P = 0.001), physical activity (P = 0.02), mood (P = 0.001), self-efficacy
(P = 0.0001) and motivation to change lifestyle (P = 0.003). Improvements in
glucose testing, mood, self-efficacy and motivation to change lifestyle
persisted at 12-months (all P < 0.005). For clinical outcomes, mean HbA1c
decreased by −0.90 % (P = 0.02) in the ANC cohort at 6-months, a −0.51 % mean
difference compared to usual care (P = 0.07). Reductions at 12-months were not
statistically significant (−0.34 % in the ANC cohort, P = 0.14; -0.37 %
difference compared to the usual care cohort, P = 0.12).
Conclusions: Improvements
were noted in self-monitoring of glucose, diet, self-efficacy, motivation and
mood following initiation of ANC for patients with inadequately controlled type
2 diabetes. Study participants also experienced reductions in blood glucose
that exceeded those for similar patients who did not receive ANC. Randomized
clinical trials will be necessary to determine if ANC was responsible for these
benefits.
Nkenke E, Vairaktaris E, Bauersachs A, Eitner
S, Budach A, Knipfer C, Stelzle F. Acceptance of technology-enhanced learning
for a theoretical radiological science course: a randomized controlled trial. BMC Medical
Education 2012, 12:18
doi:10.1186/1472-6920-12-18
ABSTRACT
Background: Technology-enhanced
learning (TEL) gives a view to improved education. However, there is a need to
clarify how TEL can be used effectively. The study compared students' attitudes
and opinions towards a traditional face-to-face course on theoretical
radiological science and a TEL course where students could combine face-to-face
lectures and e-learning modules at their best convenience.
Methods: 42
third-year dental students were randomly assigned to the traditional
face-to-face group and the TEL group. Both groups completed questionnaires
before the beginning and after completion of the course on attitudes and
opinions towards a traditional face-to-face lectures and technology-enhanced
learning. After completion of the course both groups also filled in the
validated German-language TRIL (Trierer Inventar zur Lehrevaluation)
questionnaire for the evaluation of courses given at universities.
Results: Both groups
had a positive attitude towards e-learning that did not change over time. The
TEL group attended significantly less face-to-face lectures than the
traditional group. However, both groups stated that face-to-face lectures were
the basis for education in a theoretical radiological science course.The members
of the TEL group rated e-mail reminders significantly more important when they
filled in the questionnaire on attitudes and opinions towards a traditional
face-to-face lectures and technology-enhanced learning for the second time
after completion of the course.The members of the technology-enhanced learning
group were significantly less confident in passing the exam compared to the
members of the traditional group. However, examination results did not differ
significantly for traditional and the TEL group.
Conclusions: It seems
that technology-enhanced learning in a theoretical radiological science course
has the potential to reduce the need for face-to-face lectures. At the same
time examination results are not impaired. However, technology-enhanced learning
cannot completely replace traditional face-to-face lectures, because students
indicate that they consider traditional teaching as the basis of their
education.
Kiguba R, Kutyaabami P, Kiwuwa S, Katabira E,
Sewankambo NK. Assessing the quality of informed consent in a resource-limited
setting: A cross-sectional study. BMC Medical Ethics 2012, 13:21
doi:10.1186/1472-6939-13-21
Background: The process
of obtaining informed consent continues to be a contentious issue in clinical
and public health research carried out in resource-limited settings. We sought
to evaluate this process among human research participants in randomly selected
active research studies approved by the School of Medicine Research and Ethics
Committee at the College of Health Sciences, Makerere University.
Methods: Data were
collected using semi-structured interviewer-administered questionnaires on
clinic days after initial or repeat informed consent procedures for the
respective clinical studies had been administered to each study participant.
Results: Of the 600
participants interviewed, two thirds (64.2 %, 385/600) were female. Overall
mean age of study participants was 37.6 (SD = 7.7) years. Amongst all
participants, less than a tenth (5.9 %, 35/598) reported that they were not
given enough information before making a decision to participate. A similar
proportion (5.7 %, 34/597) reported that they had not signed a consent form
prior to making a decision to participate in the study. A third (33.7 %,
201/596) of the participants were not aware that they could, at any time,
voluntarily withdraw participation from these studies. Participants in clinical
trials were 50 % less likely than those in observational studies [clinical
trial vs. observational; (odds ratio, OR = 0.5; 95 % CI: 0.35-0.78)] to
perceive that refusal to participate in the parent research project would
affect their regular medical care.
Conclusions: Most of the
participants signed informed consent forms and a vast majority felt that they
received enough information before deciding to participate. On the contrary,
several were not aware that they could voluntarily withdraw their
participation. Participants in observational studies were more likely than
those in clinical trials to perceive that refusal to participate in the parent
study would affect their regular medical care.