bility of the results while this also could have introduced heterogeneity. The proportion of men and women differed between groups and only half of the sample met DSM-IV criteria for major depression. However, with exception of the unadjusted analysis, all the models were controlled for gender and the presence of major depression was tested as an adjusting variable in all the models and included when necessary. Also, a sensitivity analysis of the patients that presented major depression according to DSM-IV criteria has been included. Moreover, patients could decide whether to refill their prescription and move from one to another pharmacy in successive visits. Consequently, 26% of the patientsin the intervention group did not receive the intervention as allocated. However, we think that this is representative of daily clinical practice and that this greatly improves the generalisability of the results.
1. Rubio-Valera M, Bosmans J, Fernández A, Peñarrubia-María M, March M, Travé P, et al. (2013) Cost- Effectivenessof a CommunityPharmacistInterventioninPatientswithDepression: A RandomizedControlledTrial (PRODEFAR Study). PLoS ONE 8(8): e70588. doi: 10.1371/journal.pone.0070588 PMID: 23950967
We urge caution, however, not only in comparing our results to QALYs, but also in using QALYs as a measure for substance abuse prevention and treatment in an overarching social utility exercise (e.g. league table) because they overlook broader societal benefits and concerns . As a single quantitative scale, QALYs assign less weight to the disabled and elderly in health care rationing and introduce problems of incommensurability [46,47]. Moreover, since incremental CEAs yield ICERs that are reflective of their comparators, a low ICER may either indicate an ineffective and/or costly comparator or highly effective and/or inexpensive intervention. Thus, it is important, as we did in this study, to compare interventions to clinically relevant comparators. Economic considerations should follow clinical input in the decision making process .
Objective: To evaluate the effectivenessof a teaching program for hospital discharge ofpatients submitted to radical prostatectomy based on the self-efficacy construct of the Cognitive Social Theory. Method: A controlled clinical trial carried out on a 2-month follow-up of 68 prostatectomized men randomized into intervention group (n = 34) and control (n = 34). The intervention group received routine guidance from the service plus the teaching program. The control group only received routine guidance from the service. The data collection instruments were: sociodemographic and clinical questionnaire, self-efficacy scale, hospital depression and anxiety scale, household care knowledge questionnaire, and an item on satisfaction with a score of 1 to 5. Results: There was a significant difference between the intragroups for satisfaction (p<0.001) and knowledge (p<0.001) of the pre-test to the post-test. In the intervention group, there were significant changes between the times for anxiety (p=0.011) and knowledge (p<0.001). Conclusion: The teaching program with a combination of oral guidance, written instruction and telephone follow-up was effective in improving knowledge about home care and personal satisfaction. Brazilian Registry of Clinical Trials: RBR-5n95rm.
Background. Bronchiolitis, which is usually caused by the respiratory syncytial virus (RSV), is the commonest infection of the lower respiratory tract (the lungs and the passages through which air enters the lungs) in infants. A third of all children have bronchiolitis during their first year of life. The illness begins with stuffiness, a runny nose, a mild cough, and mild fever. Then, as the smallest airways in the lung (the bronchioles) become inflamed (swell) and blocked with mucus, the cough worsens, and the infant may develop a wheeze, shallow breathing, and a rapid heartbeat. Most cases of bronchiolitis are mild and clear up within two weeks without any treatment but some infants develop severe disease. Such infants struggle to get enough air into their lungs, drawing in their chest with each breath (chest recession). They have trouble eating and drinking, and the oxygen level in their blood can drop dangerously low. About 1% of previously healthy infants need hospitalization because of severe bronchiolitis. These severely affected infants are not normally given any medications but, where necessary, they are given oxygen therapy, fed through a tube into their stomach, and given fluids through a vein. Why Was This Study Done? In some countries, chest physiotherapy is routinely given to infants with bronchiolitis even though this is not a recommended treatment inter- nationally. In France, for example, virtually all outpatients with bronchiolitis receive a form of chest physiotherapy known as increased exhalation technique with assisted cough (IET + AC). IET—manual chest compression—is de- signed to clear mucus from the bronchioles whereas AC— coughing triggered by applying pressure to the top of the breastbone—facilitates clearance of the large airways. But is IET + AC an effective treatment for bronchiolitis? In this study, the researchers undertook a multicenter, randomized, controlledtrial to answer this question. A randomizedtrial is a study in which patients are randomly allocated to receive either the treatment under study or a control treatment. Usually in such trials, noone is aware of the treatment allocations until the trial has been completed. This is called blinding and avoids unconscious biases being introduced into the results. In this trial, although the parents, caregivers, and outcome assessors were blinded, the physiotherapists and the infants were aware of treatment allocations. The physiotherapists were not involved in patient assessment, however, and the infants were sufficiently young that their knowledge of their treatment was unlikely to bias the results. What Did the Researchers Do and Find? The researchers enrolled nearly 500 children aged 15 days to 2 years who were admitted to seven French hospitals for a first episode of acute bronchiolitis. They randomly allocated the patients to receive IET + AC (intervention group) or nasal suction (control group) three times a day from a physiotherapist
The present intervention included high-income, highly educated elderly patients and low-income women with few years of schooling in the same group. This hetero- geneity did not seem to have any negative impact on understanding, participation, or involvement in the study intervention. It should be emphasized that artistic ability is not a requirement for participation in art therapy sessions. Therefore, the applicability of art therapy in different situa- tions, contexts, and populations, as well as its cost- effectiveness, are also relevant aspects to be explored in future studies. 39 Research on art therapy is still incipient, especially in the field of medicine, where quantitative validation is in high demand. Furthermore, the term ‘‘art therapy’’ is somewhat imprecise, as ‘‘art’’ refers to visual art and ‘‘art as therapy’’ is related to a broader category that includes music, dance, and drama therapy as well. 40 It bears stressing that, given the heterogeneity of approaches, expressive techniques, and ways in which workshops are conducted by art therapists, leading to a wide range of strategies, concepts, and modalities, it is difficult to compare studies and assess the overall effects of art therapy. 35
Over the last decades, various strategies for supporting caregivers have been developed. Systematic reviews and meta- analyses indicate mixed results with respect to the effectivenessof these interventions on caregiver mood or burden [11,12]. Information and support alone may be helpful, but appears to address the psychological needs of caregivers only marginally [13,14]. Programs that demonstrate beneficial effects involve both patients and their families, are more intensive and are designed to meet each caregiver’s individual needs [13,15]. Results of the NYU Caregiver Intervention (NYUCI), a multi-component intervention that included family counseling, individual counseling sessions, support group participation and continuous availability of ad hoc counseling have demonstrated that counseling and support interventions designed to mobilize support of naturally existing family networks, appear to be effective in reducing depressive symptoms in caregivers [16,17] and in delaying nursing home placement of the dementia patient [18,19]. However, it is unclear whether family meetings alone have preventive effects. Therefore, in this study we investigated whether structured family meetings are more effective than usual care in the prevention ofdepression or anxiety disorders in caregivers. We also evaluated the effects on the severity of depressive and anxiety symptoms, caregiver burden and quality of life of the caregiver.
The primary outcome measure was the Centre for Epidemio- logic Studies Depression scale (CES-D ), a 20-item self-report scale used to measure change in the severity of depressive symptoms. The CES-D has previously been demonstrated to have good psychometric properties [17,18]. In the current study, the internal reliability of the CES-D at baseline was 0.74 (Cronbach’s alpha) and the 14 week test-retest reliability in the Control group (baseline to post intervention) was 0.59 (Pearson correlation). Demographic information was collected in the screening survey or the baseline survey including gender, age, marital status, level of education completed, and employment status. Measures of self- reported clinical characteristics including current and past history ofdepression, help seeking for depression and disability associated withdepressionin the past month were also collected. In addition, items were included to measure participant perceived credibility of website interventions and participant randomisation preference at baseline. Finally, a series of secondary outcome measures were collected. Details of the latter, which are not the subject of the current paper, are available in the previously published description of the trial protocol .
A total of 127 patients were screened, of whom 50 were in- cluded in the study after initial assessment. One participant in the SG and 2 in the CG dropped out during the intervention, leaving 49 participants at midline and 47 participants at the inal assessment (Fig. 1). Patients who left treatment refused to undergo other evaluations; for these patients, any missing data were replaced with the last known value, even if this was the baseline value. Both groups were homogenous at baseline for all variables. Table I displays the population characteristics regarding age, duration of disease, gender, race, education level, profession, hand dominance, more affected hand, pain, HAQ, dASH, grip strength and pinch strength at baseline.
The World Health Organization recommends that malaria be confirmed by parasitological diagnosis before treatment using Artemisinin-based Combination Therapy (ACT). Despite this, many health workers in malaria endemic countries continue to diagnose malaria based on symptoms alone. This study evaluates interventions to help bridge this gap between guidelines and provider practice. A stratified cluster-randomizedtrialin 42 communities in Enugu state compared 3 scenarios: Rapid Diagnostic Tests (RDTs) with basic instruction (control); RDTs with provider training (provider arm); and RDTs with provider training plus a school-based communityintervention (provider-school arm). The primary outcome was the proportion ofpatients treated according to guidelines, a composite indicator requiring patients to be tested for malaria and given treatment consistent with the test result. The primary outcome was evaluated among 4946 (93%) of the 5311 patients invited to partici- pate. A total of 40 communities (12 in control, 14 per intervention arm) were included in the analysis. There was no evidence of differences between the three arms in terms of our com- posite indicator (p = 0.36): stratified risk difference was 14% (95% CI -8.3%, 35.8%; p = 0.26) in the provider arm and 1% (95% CI -21.1%, 22.9%; p = 0.19) in the provider-school arm, compared with control. The level of testing was low across all arms (34% in control; 48% provider arm; 37% provider-school arm; p = 0.47). Presumptive treatment of uncompli- cated malaria remains an ingrained behaviour that is difficult to change. With or without extensive supporting interventions, levels of testing in this study remained critically low. Governments and researchers must continue to explore alternative ways of encouraging providers to deliver appropriate treatment and avoid the misuse of valuable medicines.
The equipment and methodology used for gait analysis has progressed substantially in recent years. The information derived from plantar pressure and ground reaction forces measures is important in gait and posture research for diagnosing lower limb problems and injury prevention [61–65]. The assessment of plantar pressure and ground reaction forces measures also allow the analysis of the effects of a treatment [66–68]. As an example, patientswith diabetic peripheral neuropathy have elevated plantar pressures and require more time in the stance-phase during gait . The potential use of gait analysis inpatientswith diabetes has led to improvements in health care including treatment and prevention of ulceration and development of targeted exercise interventions. However, our results are nonetheless important regarding the main outcomes considering that higher plantar pressure values have been associated with a change in walking strategy and an increase in fall risk. Gait speed less than 0.8m/s is considered a predictor of poor health status, and impaired sub-clinical neurological and muscular [41,70,71]. For frail populations gait impairment is a common symptom of frailty and the literature defines a slow gait speed of ≤0.8 m/s (taking longer than 5 s to walk 4 m) as a cut-point for identify frailty among older adults .
While the RDA recommendation for 1–3 year old children is 1200 Kcal, the children in the current study were consuming only half that amount, similar to the National Nutrition Monitoring Bureau (NNMB) data for 1–3 year old children with rural background, indicating a huge gap in energy intake [25,26]. Several studies have earlier recognized safe and adequate complementary feeding of breast fed infants as a critical factor in preventing growth failure [26,27,28]. An intervention study conducted by Bhandari et al that evaluated the effect of micronutrient fortified complementary feed and nutrition coun- seling on growth and morbidity failed to show any effect on linear growth except for a modest effect on weight gain . The authors speculated lack of effect due to increased inter-current infections in the micronutrient fortified complementary feed group . Similarly, in our study also diarrhea duration appeared to be playing a significant role in limiting the growth of the children, Table 6. Skin fold thickness of the children during the study period from 3 to 24 months of age.
or oligoarticular arthritis with the knee being the more symptomatic joint for over 6 wks; age between 18 and 60 y; use of stable doses of oral corticosteroids for the previous 30 d and use of stable doses of DMARDs (disease modifying antirheumatic drugs) for the previous 3 mo; a score between 5 and 10 on a visual analog scale for pain (VAS, range 0-10 cm); reading and writing skills; and no risk of pregnancy (women with a history of hysterectomy, tubal ligation, or menopause). Written informed consent was obtained from all subjects, and the Ethics Committee approved the study. Exclusion criteria were as follows: patientswith collagen diseases other than RA; pregnant or breast-feeding women; intra-articular knee injection in the previous 3 mo (or other joints); prior knee surgery or skin lesion; suspected septic arthritis or ruptured popliteal cyst (knee); urinary incontinence; any interventionin the knee in the previous 3 mo. Radiographs were performed with loads on the knees submitted to the procedure at the beginning of the study and later classiied through “blinded” radiographic analysis according to the Kellgren-Lawrence scale for secondary osteoarthritis. 28
Eligible patients at our outpatient departments were randomly assigned in a one to one ratio to receive either pregabalin or placebo. A pseudo-random code was computer generated for the randomization blocks that had a size of six. Stratification oftrial participants was based on the absence or presence of diabetes mellitus to minimize unbalance in distribution of undiagnosed diabetic polyneuropathy. Patients received increasing doses of either pregabalin or matching placebo for the study period of 3 weeks. Initial dose was 75 mg pregabalin twice a day (BID). After three days this was increased to 150 mg pregabalin BID, with a further increase to 300 mg BID after one week and for the rest of the study period. An equivalent regime was followed in the placebo arm. The same oral dosing schedule was prescribed to all patients. Daily dosages were split into two equivalent doses, one administered in the morning between 7 a.m. and 10 a.m. and one in the evening between 7 p.m. and 10 p.m. In the case of unacceptable side effects experienced by patients, a single downward dose titration was allowed. Patients had to stay on that final dosage for the remaining study period. Patients were instructed to taper their study medication after three weeks of treatment, by halving their dose for seven days, and then to stop medication. Patients and those administrating study medication, assessing outcomes, and analyzing data were blinded to group assignment.
Abstract: The objective of this study was to compare the effectivenessof two manual toothbrushes (conventional and orthodontic). The follow- ing clinical parameters were used: VPI (visible plaque index) and GBI (gingival bleeding index). Patients, 64 total (30 males and 34 females), in the permanent dentition, with a mean age of 17.8 years, were randomly selected from a practice specializing in orthodontics. Each participant re- ceived audio-visual instructions on oral hygiene as well as a kit of materi- als containing two manual toothbrushes (orthodontic and conventional). Each toothbrush was randomly allocated to one side of the mouth (split- mouth design) and used for a period of approximately 4 weeks. The VPI and GBI were measured by a single calibrated examiner before (T 0 ) and after (T 1 ) the implementation of interventions. The Mann-Whitney test was used to compare the VPI values between the groups, and the Stu- dent t-test for independent samples was used to compare GBI values. The level of signiicance was set at 5%. No statistically signiicant difference was observed between the groups at T 0 for both VPI and GBI, and at T 1 for the GBI. The manual orthodontic toothbrush produced a statistically lower VPI (P ≤ 0.05) at T 1 , but this did not seem to be of clinical impor- tance.
METHOD: A randomizedcontrolledtrialwith a 6-month follow-up period was performed in 70 adults, aged 45 years or older, with type 2 diabetes who were taking insulin and who had an HbA1c level $8%. Patientsin the control group (CG) (n = 36) received standard care, patientsin the intervention group (IG) (n = 34) received an individualized pharmacotherapeutic care plan and diabetes education. The primary outcome measure was change in HbA1c. Secondary outcomes included diabetes and medication knowledge, adherence to medication, insulin injection and home blood glucose monitoring techniques and diabetes-related quality of life. Outcomes were evaluated at baseline and 6 months using questionnaires.
Mardani-Kivi et al presented results about a triple blinded randomizedcontrolledtrialwith gabapentin inpatients that underwent anterior cruciate ligament (ACL) reconstruction (1). In their manuscript, the introduction section is very illustrative about the subject. With respect to methodology, it is well known that the physical diagnosis of ACL injury is particularly difficult in several patients, and partial ACL tears are also difficult to diagnose on physical examination. In this particular case, how did the authors obtain the diagnosis of ACL in the patients? Likewise, ACL reconstruction can be delayed several weeks or months until the swelling has decreased and there is an appropriate range of motion. For this reason, I want to ask: was the cause of the ACL injury homogeneous in all patients?; was the time delay of the surgery the same for everyone; and was the type of damage the same for all participants?
This research has shown that patientswith RA had a low consumption of antioxidant micronutrients: vitamins A, C and zinc. Therefore, we can emphasize the importance of dietary guidance based on major sources of antioxi- dant micronutrients, especially fruits, raw vegetables, ish and oilseeds in order to contribute to the prevention of joint damage and loss of rheumatic function.
Given the longitudinal and repeated nature of the outcomes, we transformed the data from wide to long and designated it as panel data. Because the outcomes are correlated across time periods, we used population-average models, i.e. generalized estimating equations (GEE) to estimate the average impact of the intervention over time. Because we did not want to impose any constraints on the outcome data models, we used an unstructured covariance matrix. Spe- cifically, a Poisson regression model was used for number of binge drinking days, a logit regres- sion model was used for any binge drinking days and any alcohol-related injury, and a linear regression model was used for drinks per drinking day. A treatment by time interaction was included in the models to display the effect of the intervention over time with respect to each outcome. Models controlled for covariates that were potentially associated with outcomes, including sex, age, race, college enrollment, and enrollment site. To ensure that imputation estimates were not biased, we then performed Listwise deletion (i.e., using complete cases only). To understand how the SMS intervention differs from self-monitoring, the SA+F and SA groups were both compared to the control group. Estimated treatment effects are reported with 95% confidence intervals.
The content addressed during the calls, as well as the length, was different depending on the group. In the Control Group, each call last- ed approximately three minutes, during which the date of the next appointment at the radiotherapy outpatient clinic was confirmed and instructions were given on the correct amount of fluid intake; and in the Intervention Group, the duration of the call was approximately 15 minutes, when specif- ic and objective information on radiotherapy was provided. For the Intervention Group, the first call followed the following script: the first three minutes were intended to ask how the participant was feeling about radiotherapy; during the next seven minutes, information on radiotherapy (what radiotherapy is and what the benefits are) was of- fered; in the last five minutes of the call, the par- ticipant could ask questions about the telephone intervention itself or solve any doubts about the treatment; the call was terminated by scheduling the date and time for the next telephone contact. The second call followed the same structure as the first, with the difference that the guidelines pro- vided more specifically concerned the possible ef- fects of radiotherapy and the ways of proceeding if these effects occurred.