Randomized Controlled Trials as Topic

The use and development of mobile interventions are experiencing rapid growth. In "just-in-time" mobile interventions, treatments are provided via a mobile device, and they are intended to help an individual make healthy decisions 'in the moment,' and thus have a proximal, near future impact. Currently, the development of mobile interventions is proceeding at a much faster pace than that of associated data science methods. A first step toward developing data-based methods is to provide an experimental design for testing the proximal effects of these just-in-time treatments. In this paper, we propose a 'micro-randomized' trial design for this purpose. In a micro-randomized trial, treatments are sequentially randomized throughout the conduct of the study, with the result that each participant may be randomized at the 100s or 1000s of occasions at which a treatment might be provided. Further, we develop a test statistic for assessing the proximal effect of a t...

chemotherapy is a rapidly evolving area in the management of early operable breast cancer. This approach achieves significant responses in around 80% of patients, with a reduction in the need for immediate mastectomy in patients presenting with large primaries, with no evidence of increased local recurrence. So far randomised trials suggest that survival is as good with primary chemotherapy as with post-operative adjuvant chemotherapy. Primary chemotherapy offers the potential short term turnout response as a predictor for longer term survival. More importantly, it allows serial biological measurements of treated breast cancers which, in turn, may aid the selection of appropriate treatment for individual patients and allow the rapid assessment of new therapies.

Background: literature cited that, acute heart failure imposes marked limitation of biopsychosocial functioning and compromising quality of life. Thus, this study aims to evaluate the impact of selfcare educational program on knowledge and functional health status of elderly patients with acute heart failure. Research hypotheses: Acute heart failure elderly patients who are exposed to self-care educational program will exhibit higher post-test total and subtotal mean knowledge scores (H 1 ), higher post-test total and subtotal mean practice scores (H 2 ), higher mean scores of physical functional independence (H 3 ), lower post total mean psychological distress scores (H 4 ) and lower post total mean social dysfunction scores (H 5 ) in the immediate post and one month later after program implementation assessment than pre program mean scores. Design: A quasiexperimental one group pre-posttest research design was utilized. Sample: A purposive sample of 30 acute heart failure elderly patients were recruited from selected Intensive Care Units affiliated to Cairo University Hospitals. Tools; Four tools were used to collect data pertinent to the study; 1-personal characteristics and medical data sheet, 2-knowledge assessment questionnaire about acute heart failure self care management, 3-biopsychosocial functional health status assessment sheet and 4-Observational checklist for acute heart failure elderly patients' physical exercises. Results: findings of the study revealed that, more than half of the studied sample were females, their age ranged from 65 to less than 70 years, married and can read and write. Four out of five research hypotheses can be supported (H 1 , H 2 , H 4 &H 5 ) however, the fifth hypothesis (H 3 ) can be partially supported at p values of 0.05. Personal characteristics were correlated with total knowledge, total practice, total physical function, total psychological distress and total social dysfunction scores, correlations were found between total social dysfunction scores during immediate post and one month after program implementation and the patients' age at X 2 = 42.1 &50.0 at p= 0017 and 0,002 respectively. Also, there was a significant correlation between total knowledge and total practice scores immediate post and one month after the program at r = 0.35 and 0.38 at p values= 0.01 and 0.00 respectively. Conclusion: It might be concluded that self care educational program might be feasible and beneficial and resulted in significant increase in knowledge and promoting biopsychosocial health functioning among acute heart failure elderly patients admitted to ICUs. Recommendations: Replication of this program and evaluation of its effectiveness on a nationwide large scale project to gain more generalization and to improve knowledge and functional health status of elderly with acute heart failure is essential.

Objective: To identify systematically all the studies reporting outcomes and complications of stereotactic radiosurgery for trigeminal neuralgia and to evaluate them against predefined quality criteria. Methods: Inclusion criteria for outcome analysis included thorough demographic documentation, defined diagnostic and outcome criteria, a minimum of 30 patients treated with 12 months median/mean follow up, not more than 20% lost to follow up, Kaplan-Meier actuarial analysis, primary trigeminal neuralgia, not more than 10% of patients retreated for failure or early recurrence, and minimum dose of 70 Gy. Results: Of 38 studies identified, four could be used to evaluate rates of pain relief on a yearly basis, and two for actuarial rates of complete pain relief; seven provided data on latencies and 18 were used to evaluate complications. Pain relief typically occurs within three months. Complete relief is initially achieved by three quarters of the patients, but half maintain this outcome at three years. One half or less can permanently stop drug treatments. Sensory disturbance, including anaesthesia dolorosa, is the most frequent complication of stereotactic radiosurgery. Conclusions: Outcomes after stereotactic radiosurgery appear in line with other ablative techniques. Results are better when it is used as primary treatment in patients with typical symptoms. Current data are largely observational and the quality is generally poor. This technique should be evaluated in a randomised, controlled trial with universal outcome measures, actuarial methodology, and validated measures of patient satisfaction and quality of life.

To review the efficacy of interventions used in the treatment of acute and chronic cluster headache. Searching MEDLINE (from 1966MEDLINE (from to 1998) ) and the Cochrane Controlled Trials Register (Issue 2, 1998) were searched using the MeSH term 'cluster headache' and textwords 'migranous neuralgia' and 'Horton's neuralgia'. The papers found were then searched for further references. Only papers in English which stated the diagnostic criteria were included in the review. No inclusion criteria relating to the study design were stated. The included studies were randomised controlled trials (RCTs), controlled clinical trials (CCTs), and randomised and non-randomised crossover trials. Studies that assessed interventions for either the treatment of acute attacks or prophylaxis of cluster headache were eligible for inclusion. The specific interventions included in the review were: pizotifen, 1 to 4 mg daily (1 study); prednisolone, 30 mg for acute attack, or 20 mg as prophylaxis (1 study); dihydroergotamine nasal spray, 1 mg (1 study); oxygen, 100%, 6 L/minute for 15 minutes (1 study); lithium 900 mg/day and verapamil 360 mg/day (1 study); sumatriptan, 6 mg and 100 mg (1 study); leuprolide, 3.75 mg (1 study); intranasal capsaicin (2 studies); sumatriptan, 100 mg 8-hourly for 7 days (1 study); melatonin, 10 mg/day for 14 days (1 study); lithium carbonate, 800 mg for 7 days (1 study). No exclusion criteria relating to the participants were explicitly stated in the review. The participants had episodic cluster headache (n=269), cluster headache (type unspecified; n=60) and chronic cluster headache (n=197). The primary outcome assessed was pain relief. The author did not state how the papers were selected for the review, or how many reviewers performed the selection. The author did not state that they assessed validity. How were the studies combined? The studies were discussed narratively according to the intervention. There was no attempt to combine the results of the different studies due to the number of different interventions examined.

Background Oral lichen planus (OLP) is one of the commoner conditions seen in oral medicine clinics. Current treatments are palliative rather than curative. Numerous treatments have been tried but many have not been evaluated in randomized controlled trials (RCTs). Objectives To review the effectiveness and safety of any therapy compared with placebo for the treatment of symptomatic OLP. Methods A systematic review of 11 RCTs, totalling 223 patients was done. The main outcome measures used were improvement of signs (erythema, reticulation, ulceration) and symptoms (pain, discomfort) usually after 8 weeks of therapy. Results Eleven interventions were grouped into four therapeutic classes (topical ciclosporins, topical or systemic retinoids, topical steroids and phototherapy) for comparison. No therapy was replicated exactly. Trials recording the same outcomes in each therapeutic class were pooled. The largest number of pooled trials was four. Small odds ratios with very wide confidence intervals indicating statistically significant but imprecisely known treatment benefits were seen in all but one trial. Only systemic agents were associated with treatment toxicities; all other side-effects were mild and mainly local. Conclusions The results are tempered by the small study sizes, lack of replication, lack of standardized outcome measures and the very high likelihood of publication bias. Therefore this review provides only circumstantial evidence for the superiority of the assessed interventions over placebo for the palliation of symptomatic OLP. There is a need for larger placebo-controlled RCTs with carefully selected and standardized outcome measures.

Background: Electronic 270 transverse-array EUS (TA-EUS) provides high-quality cross-sectional images but cannot guide FNA. Linear EUS (L-EUS) provides longitudinal images of malignancies and the ability to guide FNA. Objective: We conducted a prospective randomized comparison of TA-EUS and L-EUS for the staging of upper-GI (UGI) malignancies. Design: Forty-three patients underwent L-EUS immediately followed by TA-EUS (N Z 27, 63%) or TA-EUS immediately followed by L-EUS (N Z 16, 37%). Patients: Forty-three subjects (mean age, 64 years; 37 men) with an UGI malignancy (4 stomach and 38 esophageal) were evaluated with both TA-EUS and L-EUS. Interventions: Abnormal lymph nodes were sampled by FNA for cytology. Results: There was agreement on the T stage by linear and radial techniques in 38 of 43 subjects (88%). Twentyseven of 43 patients (63%) had abnormal lymph nodes by linear or transverse-array imaging. L-EUS demonstrated 66 abnormal lymph nodes in 27 subjects (average of 2.4 nodes/subject). TA-EUS demonstrated 90 abnormal lymph nodes in 27 subjects (average of 3.3 nodes/subject, P Z .009, compared with L-EUS). In 16 of the 27 subjects, an FNA was performed, which was positive in 13 cases (81%) and negative in 3 cases (10%) for malignancy. Conclusions: TA-EUS and L-EUS provide similar results of T staging of UGI malignancies. However, the number of abnormal lymph nodes detected by TA-EUS was more than by L-EUS. These findings suggest that radial or transverse-array EUS imaging should be the primary method for staging of UGI malignancies.

Although several studies have assessed the effects of nut consumption (tree nuts, peanuts, and soy nuts) on blood pressure (BP), the results are conflicting. The aim was to conduct a systematic review and meta-analysis of published randomized controlled trials (RCTs) to estimate the effect of nut consumption on BP. The databases MEDLINE, SCOPUS, ISI Web of Science, and Google Scholar were searched for RCTs carried out between 1958 and October 2013 that reported the effect of consuming single or mixed nuts (including walnuts, almonds, pistachios, cashews, hazelnuts, macadamia nuts, pecans, peanuts, and soy nuts) on systolic BP (SBP) or diastolic BP (DBP) as primary or secondary outcomes in adult populations aged ≥18 y. Relevant articles were identified by screening the abstracts and titles and the full text. Studies that evaluated the effects for <2 wk or in which the control group ingested different healthy oils were excluded. Mean ± SD changes in SBP and DBP in each treatment gr...

containing products to promote weight loss or to enhance athletic performance has garnered a great deal of recent attention, due in part to a number of wellpublicized adverse events reportedly associated with the use of ephedra-or ephedrine alkaloid-containing products. These reports have led several groups to ask the US Food and Drug Administration (FDA) to ban the production and sale of ephedra products. Advocates counter that ephedra is safe and effective. The US Department of Health and Human Services requested this synthesis of available evidence regarding efficacy and safety of ephedra use to clarify the existing state of the science on ephedrine alkaloids. The National Institutes of Health will use this information to guide an expanded research effort to better understand the safety of ephedrine alkaloids.

Objective-HIV-related stigma has been shown to impede HIV-antibody testing and safer sexual practices in adults. Less is known about the effects of stigma on group-based prevention programs among at-risk youth. This study examined the longitudinal relationships between HIV-related stigma and gains in HIV-knowledge. Methods-Data were provided by 1654 African-American adolescents who participated in a large multi-city prevention trial (Project iMPACCS). Participants were randomly assigned to an empirically-validated skill-based intervention (Focus on Youth) or a general health promotion control group. Both stigma and knowledge were assessed at pre-and post-intervention assessments. Results-Results from a covariance model suggested that adolescents participating in FOY showed improvements in HIV-knowledge and decreases in HIV-related stigma when compared to controls. The treatment effect on HIV-related stigma was comprised of a direct effect and an indirect effect through change in HIV knowledge. After controlling for baseline associations between HIV-related stigma and HIV knowledge, higher baseline stigma was shown to reduce gains in knowledge in both the treatment and control groups. suggest that HIV-stigma can interfere with how youth identify with and internalize messages from group-based prevention trials.

HIV-related stigma inhibits optimal HIV prevention and treatment among African-Americans. Regional differences in HIV/AIDS prevalence may be related to stigma among young African-Americans. Baseline data (N=1,606) from an HIV prevention intervention were used to investigate regional differences in HIV-related stigma and knowledge among African-American adolescents in four midsized cities in the Northeastern and Southeastern US. Analyses indicated greater HIVrelated stigma among adolescents from the southeast relative to adolescents from the northeast (F=22.23;p<0.0001). Linear regression indicated a negative relationship between HIV stigma and HIV knowledge (b=-0.65;p<0.0001). Addressing HIV/AIDS in high prevalence locales should include efforts to reduce HIV-related stigma.

Objective: To identify systematically all the studies reporting outcomes and complications of stereotactic radiosurgery for trigeminal neuralgia and to evaluate them against predefined quality criteria. Methods: Inclusion criteria for outcome analysis included thorough demographic documentation, defined diagnostic and outcome criteria, a minimum of 30 patients treated with 12 months median/mean follow up, not more than 20% lost to follow up, Kaplan-Meier actuarial analysis, primary trigeminal neuralgia, not more than 10% of patients retreated for failure or early recurrence, and minimum dose of 70 Gy. Results: Of 38 studies identified, four could be used to evaluate rates of pain relief on a yearly basis, and two for actuarial rates of complete pain relief; seven provided data on latencies and 18 were used to evaluate complications. Pain relief typically occurs within three months. Complete relief is initially achieved by three quarters of the patients, but half maintain this outcome at three years. One half or less can permanently stop drug treatments. Sensory disturbance, including anaesthesia dolorosa, is the most frequent complication of stereotactic radiosurgery. Conclusions: Outcomes after stereotactic radiosurgery appear in line with other ablative techniques. Results are better when it is used as primary treatment in patients with typical symptoms. Current data are largely observational and the quality is generally poor. This technique should be evaluated in a randomised, controlled trial with universal outcome measures, actuarial methodology, and validated measures of patient satisfaction and quality of life.

The Dex-CSDH trial is a randomised, double-blind, placebo-controlled trial of dexamethasone for patients with a symptomatic chronic subdural haematoma. The trial commenced with an internal pilot, whose primary objective was to assess the feasibility of multi-centre recruitment. Primary outcome data collection and safety were also assessed, whilst maintaining blinding. We aimed to recruit 100 patients from United Kingdom Neurosurgical Units within 12 months. Trial participants were randomised to a 2-week course of dexamethasone or placebo in addition to receiving standard care (which could include surgery). The primary outcome measure of the trial is the modified Rankin Scale at 6 months. This pilot recruited ahead of target; 100 patients were recruited within nine months of commencement. 47% of screened patients consented to recruitment. The primary outcome measure was collected in 98% of patients. No safety concerns were raised by the independent data monitoring and ethics committe...

Bugg (in press) {published data only} Bugg A, Mason S. Preventing post-traumatic stress disorder following a traumatic injury: evaluation of the Pennebaker writing paradigm. Doctor of Clinical Psychology. Sheffield: Sheffield, In press (submitted):Complete.

Introduction: The introduction of Hepatitis B vaccination in the general community requires understanding the factors that determines its uptake. This is specifically essential for planning, implementation and evaluation of the effectiveness of the program. This study investigated the uptake and associated factors of Hepatitis B Vaccination among clients attending Budwale Health Center in Eastern Uganda. Methods: Facility based cross-sectional study was conducted from July to December, 2022. Interviewer administered questionnaire was used to collect data from 403 respondents who were aged 18 years and above attending a government health facility. Data was analyzed using SPSS version 20. Vaccination uptake was determined by descriptive statistics, measures of association were done using modified Poisson regression to estimate the association between the factors and vaccination uptake. Scores on knowledge questions were categorized using bloom's cut off point into good knowledge (>80%), moderate knowledge (60-79%) and poor knowledge (< 60 %). Results: Vaccination uptake was at 68.7% which is the recommended 90% required to achieve herd immunity. Slightly above half of the participants (51.8%) and 35.7% had moderate and good and knowledge about HBV vaccination and infection respectively. Age category (28-37 years) were more likely to be vaccinated than other age categories. PR=1.21 95% CI:(1.025, 1.418) P=0. 024.Clients who had moderate knowledge were more likely to be vaccinated compared to those with poor knowledge PR=2.81,95%CI:(1.830,4.306) P=0.001. The study also found that the cost of vaccines, presence of health workers, distance of health facilities from the home, long waiting queues and occupational risks were the main reasons for low uptake of vaccine. Conclusion and recommendation: The uptake of HB vaccination was moderate among the studied group which was influenced by individual factors such as knowledge on HB as well as health services access factors. Therefore, due attention should be given to filling the knowledge gaps through education and sensitization, and addressing the barriers to accessing vaccination services.

Periodontitis is a bacterially-induced, chronic inflammatory disease that destroys the connective tissues and bone that support teeth. Active periodontal treatment aims to reduce the inflammatory response, primarily through eradication of bacterial deposits. Following completion of treatment and arrest of inflammation, supportive periodontal therapy (SPT) is employed to reduce the probability of re-infection and progression of the disease; to maintain teeth without pain, excessive mobility or persistent infection in the long term, and to prevent related oral diseases.According to the American Academy of Periodontology, SPT should include all components of a typical dental recall examination, and importantly should also include periodontal re-evaluation and risk assessment, supragingival and subgingival removal of bacterial plaque and calculus, and re-treatment of any sites showing recurrent or persistent disease. While the first four points might be expected to form part of the rout...

There are five main types of surgery and, despite some of them being in use since the 1990s, we found only one trial that met the inclusion criteria. There was very low quality evidence that the implantation of an artificial urinary sphincter (a manufactured device to prevent urine leaking out) might be more effective than injectable treatment, but with more adverse effects and higher costs. There was no evidence about the other types of surgery.

Technical and Further Education (TAFE) colleges are the primary provider of vocational education in Australia. Most TAFE students are young adults, a period when health risk behaviours become established. Furthermore, high rates of smoking, risky alcohol consumption, inadequate fruit and vegetable intake and insufficient physical activity have been reported in TAFE students. There have been no intervention studies targeting multiple health risk behaviours simultaneously in this population. The proposed trial will examine the effectiveness of providing TAFE students with electronic feedback regarding health risk behaviours and referral to a suite of existing online and telephone services addressing smoking, risky alcohol consumption, fruit and vegetable intake, and physical activity levels. A two arm, parallel, cluster randomised trial will be conducted within TAFE campuses in New South Wales (NSW), Australia. TAFE classes will be randomly allocated to an intervention or control cond...

Objectives-To determine the incidence of vitamin D deficiency in neonates with congenital heart disease and whether differences exist by race. In addition, we determined the effect of cardiopulmonary bypass on vitamin D levels, and explored associations between 25hydroxyvitamin D [25(OH)D] levels and postoperative outcomes. Study design-A secondary analysis of a prospective randomized controlled trial in 70 neonates undergoing cardiac surgery was performed. 25(OH)D levels were collected in the operating room prior to skin incision (baseline), at the cessation of cardiopulmonary bypass and 24 hours postoperatively. Associations between these levels and clinical outcomes were explored. Vitamin D deficiency was defined as a 25(OH)D level <20 ng/ml. Results-Vitamin D deficiency was present in 84% (59/70); concentrations in African-Americans (n=20) were significantly lower than Caucasian/other (n=50) (10.2 ±4.2ng/ml vs. 16.0 ±5.6ng/ml, p<0.0001). The 24 hour postoperative 25(OH)D level were not different from baseline and correlated with a reduced postoperative inotropic requirement (r=-0.316, p=0.008).

Background: Non-Vitamin K Antagonist Oral Anticoagulants (NOACs) are increasingly used in clinical practice for patients with atrial fibrillation (AF) undergoing catheter ablation. Catheter ablation is an established treatment option for patients with AF, however, it is associated with significant complications such as ischemic stroke and bleeding. We aimed to compare by meta-analytical techniques, the safety and efficacy of NOACs vs. warfarin. Methods: PUBMED, EMBASE, CENTRAL and Scopus were searched for randomized trials comparing uninterrupted NOACs and warfarin in patients undergoing AF catheter ablation. Ischemic and hemorrhagic stroke, major and minor bleeding, cardiac tamponade and access related complications were compared between the two groups. Results: A total of 4 trials with 1173 patients were included in the meta-analysis. NOACs and warfarin, resulted in similar risk of ischemic stroke [Odds ratio (OR); 0.50; 95% confidence interval (CI): (0.12-2.08); P=0.34), major bleeding [0.33(0.09-1.13); P=0.08] including cardiac tamponade [0.54(0.03-9.05); P=0.67] and minor bleeding [1.13(0.80-1.59); P=0.48], and lower risk of access-related complications [0.56(0.31-1.00); P=0.05)]. The findings of this meta-analysis showed that compared to warfarin, periprocedural anticoagulation with NOACs, result in reduced access-related complications and the incidence of ischemic stroke and bleeding was similar in the two groups.

The objectives of the study are to assess the efficacy of sterile water for injection (SWI) in reducing labor pain, compare it with a saline procedure, and see which one is superior. Parameters assessed were pain relief based on the numeric pain rating scale (NPRS) and duration of labor from intervention to delivery associated with administration of subcutaneous SWI versus normal saline injection (NSI). Methods: This is a prospective randomized interventional hospital-based comparative study of mothers who were in active labor with back pain and undergoing treatment in the labor room of Eden Hospital, Medical College and Hospital, Kolkata. The study was conducted on 66 willing pregnant mothers, divided into two groups of 33 each with one injected with normal saline and the other with sterile water. Results: The NPRS score was almost equal in 2 groups at 15 min, but with an increase in duration, it was seen that the score was low in the sterile water group compared to the normal saline group. The association was statistically significant (p<0.05). Conclusion: This study hypothesized that subcutaneous SWI for relieving labor pain is better than subcutaneous NSI. Based on this study, it is concluded that both the SWI and NSI reduce labor pain, but the SWI produced a significantly greater reduction of pain as measured by the numeric pain rating score and also better satisfaction. Therefore, SWI is a safe, simple, and cost-effective method and can be used as a pain-relieving method, especially in the absence of other pain-relieving options.

Background: A lack of safe and reliable treatments for abdominal pain-related functional gastrointestinal disorders (FGIDs) has prompted interest in new therapies. Aim: To systematically evaluate the effect of dietary fibers for treating abdominal pain-related FGIDs in children. Methods: In December 2011, MEDLINE, EMBASE and the Cochrane Library were searched for randomized controlled trials (RCTs) evaluating fiber supplementation in children with FGIDs. Results: Only 3 RCTs were identified, which enrolled a total of 167 children and adolescents (5-17 years old) with recurrent abdominal pain. Only 1 study used the Rome III criteria. Patients were supplemented with different dietary fiber types for 4-6 weeks. The use of dietary fibers did not influence the proportion of responders to treatment, and improvement did not occur in reported clinically relevant outcomes such as no pain or a significant decrease in pain intensity (risk ratio 1.17, 95% confidence interval 0.75-1.81). Conclusion: There is no evidence that supplementation with fiber as a dietary manipulation may be useful for treating children with FGIDs. However, one should not overlook the fact that the main limitation for recommendation of the routine fiber use in clinical practice derives from the weak quality and paucity of available studies.

Objective. The Fibromyalgia Impact Questionnaire (FIQ) is a disease-specific composite instrument that measures the effect of problems experienced by patients with fibromyalgia (FM). Utilization of the FIQ in measuring changes due to interventions in FM requires derivation of a clinically meaningful change for that instrument. Analyses were conducted to estimate the minimal clinically important difference (MCID), and to propose FIQ severity categories. Methods. Data from 3 similarly designed, 3-month placebo-controlled, clinical treatment trials of pregabalin 300, 450, and 600 mg/day in patients with FM were modeled to estimate the change in the mean FIQ total and stiffness items corresponding to each category on the Patient Global Impression of Change. FIQ severity categories were modeled and determined using established pain severity cutpoints as an anchor. Results. A total of 2228 patients, mean age 49 years, 93% women, with a mean baseline FIQ total score of 62 were treated in the 3 studies. Estimated MCID on a given measure were similar across the studies. In a pooled analysis the estimated MCID (95% confidence interval) was 14% (13; 15) and for FIQ stiffness it was 13% (12; 14). In the severity analysis a FIQ total score from 0 to < 39 was found to represent a mild effect, ≥ 39 to < 59 a moderate effect, and ≥ 59 to 100 a severe effect. The analysis indicates that a 14% change in the FIQ total score is clinically relevant, and results of these analyses should enhance the clinical utility of the FIQ in research and practice.

Heart failure is a systemic disorder characterised by tissue hypoxia and secondary organ dysfunction which occurs in response to various myocardial insults that include ischaemia, viral infections, and toxins. In addition to maladaptive neurohumoral activation, heart failure is associated with an inflammatory state that appears to have a detrimental effect on cardiac function and prognosis. This has led to the suggestion that anti-inflammatory interventions may have therapeutic potential in the symptomatic and prognostic treatment of patients with heart failure. This review considers the role of inhibition of the cytokine tumour necrosis factor α in the treatment of heart failure.

Heart failure is a systemic disorder characterised by tissue hypoxia and secondary organ dysfunction which occurs in response to various myocardial insults that include ischaemia, viral infections, and toxins. In addition to maladaptive neurohumoral activation, heart failure is associated with an inflammatory state that appears to have a detrimental effect on cardiac function and prognosis. This has led to the suggestion that anti-inflammatory interventions may have therapeutic potential in the symptomatic and prognostic treatment of patients with heart failure. This review considers the role of inhibition of the cytokine tumour necrosis factor α in the treatment of heart failure.

To analyze the recent evidence on robotic hysterectomy while highlighting its benefits and challenges. Increased rates of robotic hysterectomy have led to decreasing rates of abdominal hysterectomy, after rates of the latter approach have been stagnant for many years. Robotic surgery has also the possible advantage of a relatively short learning curve, even though the case number required to reach proficiency may be actually closer to 100 cases. Recent studies comparing robotic and laparoscopic hysterectomy for benign indications have not demonstrated a clear advantage for either approach in terms of complications, blood loss, and hospital stay. The higher cost of robotic hysterectomy remains a significant disadvantage of this surgical approach, although the total cost may decrease with increasing surgeon's experience (via shorter operative time) and may be offset in some circumstances by reduced hospital stay and cost of complications compared with abdominal hysterectomy.

Background: Adoption of a healthy diet has been identified as the cornerstone in the prevention and management of chronic diseases. However, non-adherence to lifestyle changes raises an important issue since adherence level to dietary advice is a key determinant of the effectiveness of dietary treatment. Therefore, based on the results of a Cochrane systematic review on interventions for enhancing adherence to dietary advice for preventing and managing chronic diseases in adults, the aim of this study is to assess the importance and applicability of interventions enhancing adherence to dietary advice in the Canadian context. Methods/Design: In phase 1, dietitians' opinion will be assessed through a Delphi study regarding the importance and the applicability in the Canadian context of the interventions found the most effective to enhance adherence to dietary advice through a Cochrane systematic review. In phase 2, findings of the Cochrane systematic review assessing the effects of interventions for enhancing adherence to dietary advice will be reported in a practical format on an online knowledge translation tool for dietitians and other health professionals. Discussion: In recent years, there has been an increasing recognition of the failure to translate research findings into clinical practice. Therefore, knowledge translation efforts need to prioritize effective interventions that will be the most relevant for practice and end-users by adapting them to the local context. Our study will provide decision makers in the field of dietetic practice with essential knowledge on adherence for elaborating educational activities for academic or professional settings that will respond to dietitians' priorities in terms of importance and applicability to day-to-day practice.

Qualité de vie et vécu de la maladie, avant et après hystérectomie vaginale, chez les femmes admises au Centre Hospitalier Universitaire de Brazzaville Evaluation of quality of life and subjective experience of the disease before and after vaginal hysterectomy among women admitted to the University Hospital in Brazzaville

Nous rapportons un cas exceptionnel de double prolapsus du col utérin par voie vaginale et du fond utérin par voie anale, chez une femme enceinte de 6 mois. La patiente était âgée de 26 ans, deuxième geste, primipare, avec notion de prolapsus rectal dans l'enfance. La prise en charge a consisté en une réduction manuelle immédiate sous anesthésie générale associée au repos sous surveillance clinique. La grossesse s'est soldée par une expulsion spontanée d'un foetus mort-né, trois jours après la réduction. Mots clés : Grossesse, Double prolapsus utérin. We report an exceptional case of a double prolapse, the uterine cervix by the vagina and the uterine fundus by the rectal roote, in a six month pregnant woman. The patient, was 26-year-old, gravida 2 para 1 and she had a history of rectal prolapse during her childhood. Management consisted of immediate manual reduction under general anaesthesia associated with bed rest and clinical surveillance. Pregnancy outcome was a spontaneous stillbirth three days after the prolapses reduction.

Background. Temporomandibular joint dysfunctions pose a problem in terms of both diagnosis and therapy. This is due to the complex causes of the disease and numerous subjective symptoms that are difficult to assess objectively. Objectives. The aim of the present study was to assess the effectiveness of therapy in patients with temporomandibular joint dysfunctions. Material and Methods. The material comprised a group of 43 patients (including 33 women and 10 men), who had a follow-up examination (examination I) minimum 6 months following a first visit (examination 0) when temporomandibular joint dysfunctions were diagnosed and the treatment proposed. Of the 43 persons included in the follow-ups, 86% had undergone the treatment recommended during examination 0 -i.e. a total of 37 persons, including 10 men and 27 women. The examination was carried out using a clinical dysfunction index (Di) and anamnestic questionnaire devised by Helkimo. In addition, during examination I, patients answered questions from the prepared questionnaire. Results. A statistically significant difference (p < 0.00) was noted in the mean values of clinical indicator Di in examination I in relation to the values obtained during examination 0. A total number of 30 patients assessed the treatment they received positively, 3 negatively and 4 of them were not fully satisfied with the obtained results. Conclusions. The majority of patients assessed the received treatment positively, as was confirmed in the clinical status. More objective instruments for measuring the condition of patients with temporomandibular joint dysfunctions are recommended (Dent.

Introduction
Tuberculosis (TB) remains a major global health issue, affecting 10-20% of children worldwide. Zambia is one of the 30 high-burden TB countries. Diagnosing Mycobacterium tuberculosis in children is particularly challenging. Early detection and treatment are crucial for effective management and preventing severe disease progression. This study aimed to assess TB prevalence in children at Arthur Davison Children's Hospital in Ndola, Zambia, using GeneXpert on gastric lavage samples and X-ray imaging.
Method
This was a cross-sectional study conducted at Arthur Davison Children’s Hospital from October 2021 to February 2022. Children aged 0 to 10 years with suspected presumptive tuberculosis were enrolled for diagnostic evaluation. Tuberculosis diagnosis was performed using the GeneXpert polymerase chain reaction analyzer on gastric lavage samples, compared with findings from chest X-ray imaging. Data analysis was carried out using descriptive statistics in the Statistical Package for Social Sciences (SPSS) version 22, with statistical significance set at p < 0.05.
Results
Out of the 138 participants enrolled, the prevalence of tuberculosis was 13.8% based on X-ray imaging and 1.4% using the GeneXpert analyzer. Males had a higher prevalence of tuberculosis (52.6%) compared to females (47.4%). The age group of participants who were mostly affected was 0-4 years (68.4%). The agreement between the two diagnostic methods, measured by Cohen's Kappa Coefficient, was 0, indicating no agreement. The p-value for the comparison was 1.19.
Conclusion
The findings of this study highlight significant presence of tuberculosis among children under 10 years of age at Arthur Davison Children’s Hospital. However, there was no agreement between the diagnostic methods used, namely GeneXpert and X-ray imaging. Further comprehensive studies are recommended to investigate the potential for false positives associated with X-ray imaging or false negatives on the GeneXpert analyzer.

The objective of this article is to discuss issues surrounding the conduct of &quot;piggyback evaluations,&quot; in which health-economic data are collected within an otherwise typical clinical trial. We review the methodologic literature on piggyback economic evaluations, as well as selected empiric studies. We summarize the challenges encountered in the conduct of these studies, alternative ways of addressing these challenges, and their future role in pharmacoeconomic research. Piggyback evaluations have certain advantages over other types of pharmacoeconomic studies. An economic evaluation can benefit from the experimental design that maximizes the trial&#39;s internal validity, and it is often more practical to collect economic data alongside a trial rather than to fund a stand-alone economic study. However, piggyback evaluations are subject to problems deriving from the competing nature of clinical versus economic study objectives, which can give rise to tension in such fundame...

Reviewed are all the published clinical trials of glycine-based oral rehydration salts (ORS), L-alanine-based ORS, L-glutamine-based ORS, maltodextrin-based ORS, and rice-based ORS, as well as the results of several recently completed, but unpublished, studies of these formulations that were supported by WHO. All experimental ORS formulations contained the same concentrations of salts as citrate-based WHO-ORS; all trials were randomized comparisons with WHO-ORS, and all except those with rice-based ORS were double-blind studies. The rate of stool loss and, less frequently, the duration of diarrhoea were used as indicators of clinical performance to compare ORS formulations. The following conclusions were reached concerning the efficacy and use of modified ORS formulations. Rice-based ORS (50 g/l) is superior to WHO-ORS for patients with cholera, and for such patients it can be recommended in any situation where its preparation and use are practical. Rice-based (50 g/l) and WHO-ORS solutions are equally effective for treating children with acute non-cholera diarrhoea, when feeding is resumed promptly following initial rehydration, as has been consistently recommended by WHO. Since rice-based ORS is not superior to WHO-ORS for such children, there is no apparent reason to advise a change from glucose to pre-cooked rice in the recommended formulation for WHO-ORS. Maltodextrin-based ORS formulations (50 g/l) and WHO-ORS appear to be equally effective for treating children with acute non-cholera diarrhoea; there is no reason to advise a change from glucose to maltodextrin in the recommended formulation for WHO-ORS. Amino-acid-containing ORS formulations are not recommended for either non-cholera or cholera diarrhoea, since they are more costly and have no clinical advantage over WHO-ORS for children with acute non-cholera diarrhoea or over rice-based ORS for persons with cholera.

Stroke is the major cause of disability in the community. Most strokes are due to blocked arteries in the brain. Evidence is accumulating that clot-busting drugs improve outcome after ischaemic stroke. Recombinant tissue plasminogen activator (rt-PA) is licensed for the treatment of selected patients within three hours of acute ischaemic stroke in many parts of the world, and stroke services are being developed so that eligible patients can receive this treatment as soon as possible after the onset of stroke symptoms. However, thrombolysis can cause bleeding into the brain, so the treatment should only be given when the benefits outweigh the risks. Controversy still exists about the risks and benefits in certain groups of patients, and there is variation in practice between stroke physicians, reflecting these uncertainties.

BackgroundAfter a 1999 National Cancer Institute (NCI) clinical alert was issued, chemoradiotherapy has become widely used in treating women with cervical cancer. Two subsequent systematic reviews found that interpretation of the benefits was complicated, and some important clinical questions were unanswered.Patients and MethodsWe initiated a meta-analysis seeking updated individual patient data from all randomized trials to assess the effect of chemoradiotherapy on all outcomes. We prespecified analyses to investigate whether the effect of chemoradiotherapy differed by trial or patient characteristics.ResultsOn the basis of 13 trials that compared chemoradiotherapy versus the same radiotherapy, there was a 6% improvement in 5-year survival with chemoradiotherapy (hazard ratio [HR] = 0.81, P &lt; .001). A larger survival benefit was seen for the two trials in which chemotherapy was administered after chemoradiotherapy. There was a significant survival benefit for both the group of t...

Practical clinical trials (PCT) are randomized experiments under typical practice conditions with the aim of testing the "real life" benefits and risks of therapeutic interventions. Influential PCTs have been conducted in cardiology, oncology, and internal medicine. Psychotropic medications are widely and increasingly used in medical practice. This review examines recent progress in conducting PCTs in psychopharmacology. The January 2000 -October 2014 MEDLINE, Scopus, and ClinicalTrials.gov databases were searched for peer-reviewed publications of PCTs with at least 100 subjects per treatment arm. Most PCTs in psychiatry evaluated mental health services or psychosocial interventions rather than specific pharmacotherapies. Of 157 PCTs in psychiatry, 30 (19%) were in psychopharmacology, with a median of 2 publications per year and no increase over the period of observation. Sample size ranged from 200 to 18,154; only 11 studies randomized 500 patients or more. Psychopharmacology PCTs were equally likely to be funded by industry as by public agencies. There were 10 PCTs of antidepressants, for a total of 4,206 patients (in comparison with at least 46 PCT of antihypertensive medications, for a total of 208,014 patients). Some psychopharmacology PCTs used suicidal behavior, treatment discontinuation, or mortality as primary outcome, and produced effectiveness and safety data that have influenced both practice guidelines and regulatory decisions. PCTs can constitute an important source of information for clinicians, patients, regulators, and policy makers, but have been relatively underutilized in psychopharmacology. Electronic medical records and integrated practice research networks offer promising platforms for a more efficient conduct of PCTs.

Background: Previous research has shown that cerebral T1 hypointense lesions are positively correlated with the disability of multiple sclerosis (MS) patients. Hence, they could be used as an objective marker for evaluating the progression of the disease. Up to this date, there has not been a systematic evaluation of the effects of disease-modifying therapies (DMTs) on this prognostic marker.

Objectives: To evaluate the effects of FDA-approved DMTs on the numbers and volume of T1 hypointense lesions in adult patients with MS.

Methods: We included studies with the mentioned desired outcomes. In March 2021, we searched MEDLINE (Ovid), Embase, and CENTRAL to find relevant studies. All included studies were assessed for the risk of bias using the RoB-2 tool. Extracted data were analyzed using a random-effects model. Certainty of evidence was assessed using GRADE.

Results: Thirteen studies with 7484 participants were included. Meta-analysis revealed the mean difference between the intervention and comparator groups for the number of lesions was −1.3 (95% CI: −2.1, −0.5) and for the mean volume of lesions was −363.1 (95% CI: −611.6, −114.6). Certainty of evidence was judged to be moderate. Heterogeneity was considerable.

Discussion: DMTs reduce the number and volume of T1 hypointense lesions. Although, these findings must be interpreted cautiously due to the high values of heterogeneity.