Evidence Of Difference In Outcomes Research Articles

Squamous Cell Carcinoma of the Oral Tongue in Young Patients: Outcomes and Implications for Treatment.

Squamous cell carcinoma oral tongue (SCCOT) in patients below 45years is relatively uncommon in literature; however, there have been increasing trends in incidence. Previous studies showed conflicting data, with no conclusive evidence of differences in outcome compared with older patients. The aim of our study was to determine if younger patients with tongue cancer in India had different clinico-pathological characteristics, prognostic determinants or survival than their older counterparts. Retrospective analysis of 425 adult patients of SCCOT, with 114 patients < 45years of age (younger group) and 311 patients ≥ 45years of age (older group), treated with surgery and adjuvant as indicated. Clinical and pathological features were described. Survival analysis was performed using Kaplan Meier's method and multivariate analysis was performed for recurrence and survival using Cox proportional hazards ratio. Younger patients had a higher incidence of adverse pathological features (APFs) like lymphovascular invasion (p = 0.01), perineural invasion (p = 0.009), poorer differentiation (p = 0.044), nodal involvement (p = 0.021), extranodal extension (p = 0.003) and local recurrence (p = 0.008). All of these factors were noted to impact survival. However, on multivariate analysis for APFs, age was not an independent predictor of recurrence or survival. Younger patients with squamous cell carcinoma of tongue have an increased risk of APFs and local recurrence. The clinical observation that young patients have a worse outcome is likely due to the association of APFs rather than age being an independent prognostic factor. Further study is required to show if tumour biology in this cohort is distinct.

Resultado del tratamiento percutáneo de la reestenosis de stents farmacoactivos: ¿depende de si el stent tenía o no recubrimiento polimérico?

Introduction and objectivesOutcomes of patients undergoing percutaneous intervention for drug-eluting stent (DES) restenosis are poorer than those in patients with bare-metal stent restenosis. It is unknown if this is related to the presence of polymer coating. We sought to compare outcomes after interventions for in-stent restenosis (ISR) of polymer-free DES vs durable polymer DES. MethodsPatients enrolled in the ISAR-TEST 5 randomized trial who underwent repeat percutaneous intervention for ISR during follow-up were included. Angiographic outcomes at 6 to 8 months and clinical outcomes at 2 years were analyzed and compared between 2 groups according to whether the restenosed stent was a polymer-free or a durable polymer DES. Multivariate analysis was used to adjust for differences between groups. ResultsA total of 326 patients with ISR were included: 220 with ISR in polymer-free DES and 106 with ISR in durable polymer DES. Angiographic follow-up was available for 83.4% of patients. No difference was observed in recurrent binary restenosis between the 2 groups (31.7% vs 27.0%; P=.38; Padjusted=.29). At 2 years, the composite of death, myocardial infarction, or repeat target lesion revascularization were similar between the 2 groups (35.7% vs 34.0%; HR=1.04, 95%CI, 0.70-1.55; P=.83; Padjusted=.79). The rate of repeat target lesion revascularization was also similar in the 2 groups (29.8% vs 31.5%; HR=0.91, 95%CI, 0.60-1.39; P=.68; Padjusted=.62). ConclusionsIn patients undergoing reintervention for DES-ISR, we found no evidence of differences in outcomes according to whether the restenosed stent was a polymer-free or durable polymer DES.

Outcomes following hip and knee replacement in diabetic versus nondiabetic patients and well versus poorly controlled diabetic patients: a prospective cohort study

Background and purpose — The impact of diabetes and glycemic control before joint replacement on clinical and patient-reported outcomes is unclear. We compared pain, function, complications, and length of hospital stay in diabetic and nondiabetic patients receiving primary total hip (THR) or knee replacement (TKR) and compared these outcomes in patients with poorly controlled versus well-controlled diabetes.Patients and methods — We conducted a prospective cohort study of patients undergoing primary THR (n = 300) or TKR (n = 287) for osteoarthritis. Self-reported diabetes and glycemic control (HbA1c ≤ or >7%) extracted from medical notes were used. Adjusted comparisons were performed with generalized linear models including body mass index (BMI) and comorbidities.Results — Diabetes prevalence was 11% (THR 8%; TKR 14%). Diabetic patients were more likely to have a higher BMI and greater number of comorbidities. The median length of hospital stay was 1 day longer in diabetic patients (p = 0.004), but this attenuated after adjustments for BMI and comorbidities (p = 0.3). Inpatient pain was greater for diabetic patients but attenuated following adjustment. The 12-month postoperative WOMAC subscales were similar by diabetes status following adjustment. There was little evidence of difference in outcomes according to glycemic control.Interpretation — The associations between diabetes and worse postoperative outcomes in patients undergoing THR or TKR for osteoarthritis appear to be predominantly due to associated obesity and comorbidities. In diabetic patients there is little evidence of association between postoperative outcome and preoperative glycemic control. The underlying mechanisms and causal pathways of obesity, diabetes, and multimorbidity that lead to worse outcomes after joint replacement are not well known.

Efficacy and Safety of Induction Therapy in Kidney Transplantation: A Network Meta-Analysis

BackgroundRejection and infection can occur after kidney transplantation and are important factors in preserving graft kidney function. The use of immunosuppressant agents in transplantation is therefore important, and the question of which induction therapy should be used as an immunosuppressant is controversial. ObjectiveThe goal of this study was to assess the comparative benefits and harms of various maintenance immunosuppressive induction agents in adults undergoing kidney transplantation by using a network meta-analysis and to generate rankings of the different immunosuppressive regimens according to their safety and efficacy. MethodsCENTRAL, MEDLINE, EMBASE, Science Citation Index Expanded, World Health Organization International Clinical Trials Registry Platform, and trial registers were searched until May 2017 to identify randomized controlled trials on immunosuppression for kidney transplantation. ResultsTwenty-seven studies involving 4484 participants were eligible for analysis. Induction and maintenance treatments were administered for 12 months. There was no evidence of differences in outcomes between therapies on all-cause mortality, graft loss, cytomegalovirus, BK virus, neutropenia, thrombocytopenia, and biopsy-proven acute rejection. However, compared with intravenous basiliximab (an interleukin-2 receptor antagonist [IL-2RA]), the most effective treatments to decrease biopsy-proven acute rejection were intravenous alemtuzumab and rabbit antithymocyte globulin (rATG). The odds ratios were 0.45 (95% confidence interval [CI], 0.29–40.78) and 0.63 (95% CI, 0.42–0.95), respectively. As a side effect, rATG was accompanied by more bacterial infection than the IL-2RA (OR, 1.8 [95% CI, 1.01–2.8]). ConclusionsThe determination of induction in kidney transplantation is important for future prognosis of the graft kidney. Alemtuzumab and rATG exhibited lower biopsy-proven acute rejection than the IL-2RA. As a side effect, rATG produced frequent bacterial infections.

Different oral corticosteroid regimens for acute asthma.

Asthma is a common long-term breathing condition that affects approximately 300 million people worldwide. People with asthma may experience short-term worsening of their asthma symptoms; these episodes are often known as 'exacerbations', 'flare-ups', 'attacks' or 'acute asthma'. Oral steroids, which have a potent anti-inflammatory effect, are recommended for all but the most mild asthma exacerbations; they should be initiated promptly. The most often prescribed oral steroids are prednisolone and dexamethasone, but current guidelines on dosing vary between countries, and often among different guideline producers within the same country. Despite their proven efficacy, use of steroids needs to be balanced against their potential to cause important adverse events. Evidence is somewhat limited regarding optimal dosing of oral steroids for asthma exacerbations to maximise recovery while minimising potential side effects, which is the topic of this review. To assess the efficacy and safety of any dose or duration of oral steroids versus any other dose or duration of oral steroids for adults and children with an asthma exacerbation. We identified trials from the Cochrane Airways Group Specialised Register (CAGR), ClinicalTrials.gov (www.ClinicalTrials.gov), the World Health Organization (WHO) trials portal (www.who.int/ictrp/en/) and reference lists of all primary studies and review articles. This search was up to date as of April 2016. We included parallel randomised controlled trials (RCTs), irrespective of blinding or duration, that evaluated one dose or duration of oral steroid versus any other dose or duration, for management of asthma exacerbations. We included studies involving both adults and children with asthma of any severity, in which investigators analysed adults and children separately. We allowed any other co-intervention in the management of an asthma exacerbation, provided it was not part of the randomised treatment. We included studies reported as full text, those published as abstract only and unpublished data. Two review authors independently screened the search results for included trials, extracted numerical data and assessed risk of bias; all data were cross-checked for accuracy. We resolved disagreements by discussion with the third review author or with an external advisor.We analysed dichotomous data as odds ratios (ORs) or risk differences (RDs) using study participants as the unit of analysis; we analysed continuous data as mean differences (MDs). We used a random-effects model, and we carried out a fixed-effect analysis if we detected statistical heterogeneity. We rated all outcomes using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) system and presented results in 'Summary of findings' tables. We included 18 studies that randomised a total of 2438 participants - both adults and children - and performed comparisons of interest. Included studies assessed higher versus lower doses of prednisolone (n = 4); longer versus shorter courses of prednisolone (n = 3) or dexamethasone (n = 1); tapered versus non-tapered courses of prednisolone (n = 4); and prednisolone versus dexamethasone (n = 6). Follow-up duration ranged from seven days to six months. The smallest study randomised just 15 participants, and the largest 638 (median 93). The varied interventions and outcomes reported limited the number of meaningful meta-analyses that we could perform.For two of our primary outcomes - hospital admission and serious adverse events - events were too infrequent to permit conclusions about the superiority of one treatment over the other, or their equivalence. Researchers in the included studies reported asthma symptoms in different ways and rarely used validated scales, again limiting our conclusions. Secondary outcome meta-analysis was similarly hampered by heterogeneity among interventions and outcome measures used. Overall, we found no convincing evidence of differences in outcomes between a higher dose or longer course and a lower dose or shorter course of prednisolone or dexamethasone, or between prednisolone and dexamethasone.Included studies were generally of reasonable methodological quality. Review authors assessed most outcomes in the review as having low or very low quality, meaning we are not confident in the effect estimates. The predominant reason for downgrading was imprecision, but indirectness and risk of bias also reduced our confidence in some estimates. Evidence is not strong enough to reveal whether shorter or lower-dose regimens are generally less effective than longer or higher-dose regimens, or indeed that the latter are associated with more adverse events. Any changes recommended for current practice should be supported by data from larger, well-designed trials. Varied study design and outcome measures limited the number of meta-analyses that we could perform. Greater emphasis on palatability and on whether some regimens might be easier to adhere to than others could better inform clinical decisions for individual patients.

Efficacy and acceptability of very low energy diets in overweight and obese people with Type 2 diabetes mellitus: a systematic review with meta-analyses.

To explore the efficacy and acceptability of very low energy diets in overweight or obese adults with Type 2 diabetes. Controlled trials and qualitative studies of individuals with Type 2 diabetes that compared very low energy diets with standard care, minimal interventions, other weight loss interventions, less intensive very low energy diet interventions and very low energy diets with additional components were eligible for inclusion. Meta-analyses of changes in weight, blood glucose levels and attrition rates were performed. Acceptability of very low energy diets was assessed by attrition rates, number and severity of side effects, and by qualitative evaluations of the interventions. Four randomized, five non-randomized controlled trials and no qualitative studies (21 references, 9 studies, 346 participants) were identified. Meta-analyses showed that very low energy diets induced greater weight losses than minimal interventions, standard care or low energy diets at 3 and 6 months. No conclusive evidence for differences in outcomes between very low energy diets and Roux-en-Y gastric bypass surgery was found. Greater differences in energy prescription between intervention and comparator arms were associated with greater differences in weight loss and fasting blood glucose levels at 3 months. Attrition rates did not differ between the very low energy diets and the comparator arms at any measurement point. Very low energy diets are effective in substantial weight loss among people with Type 2 diabetes. Levels of adherence to very low energy diets in controlled studies appear to be high, although details about behaviour support provided are usually poorly described.

Rehabilitative treatments for chronic fatigue syndrome: long-term follow-up from the PACE trial

The PACE trial found that, when added to specialist medical care (SMC), cognitive behavioural therapy (CBT), or graded exercise therapy (GET) were superior to adaptive pacing therapy (APT) or SMC alone in improving fatigue and physical functioning in people with chronic fatigue syndrome 1 year after randomisation. In this pre-specified follow-up study, we aimed to assess additional treatments received after the trial and investigate long-term outcomes (at least 2 years after randomisation) within and between original treatment groups in those originally included in the PACE trial. The PACE trial was a parallel-group randomised controlled trial of patients meeting Oxford criteria for chronic fatigue syndrome who were recruited from six secondary care clinics in the UK between March 18, 2005, and Nov 28, 2008. Participants were randomly allocated to receive SMC alone or plus APT, CBT, or GET. Primary outcomes (were fatigue measured with Chalder fatigue questionnaire score and physical functioning with short form-36 subscale score, assessed 1 year after randomisation. In this long-term follow-up, we sent postal questionnaires to assess treatment received after the trial and outcomes a minimum of 2 years after randomisation. We assessed long-term differences in outcomes within and between originally randomised groups. The PACE trial is registered at http://isrctn.org, number ISRCTN54285094. Between May 8, 2008, and April 26, 2011, 481 (75%) participants from the PACE trial returned questionnaires. Median time from randomisation to return of long-term follow-up assessment was 31 months (IQR 30-32; range 24-53). 210 (44%) participants received additional treatment (mostly CBT or GET) after the trial; with participants originally assigned to SMC alone (73 [63%] of 115) or APT (60 [50%] of 119) more likely to seek treatment than those originally assigned to GET (41 [32%] of 127) or CBT (36 [31%] of 118; p<0·0001). Improvements in fatigue and physical functioning reported by participants originally assigned to CBT and GET were maintained (within-group comparison of fatigue and physical functioning, respectively, at long-term follow-up as compared with 1 year: CBT -2·2 [95% CI -3·7 to -0·6], 3·3 [0·02 to 6·7]; GET -1·3 [-2·7 to 0·1], 0·5 [-2·7 to 3·6]). Participants allocated to APT and to SMC alone in the trial improved over the follow-up period compared with 1 year (fatigue and physical functioning, respectively: APT -3·0 [-4·4 to -1·6], 8·5 [4·5 to 12·5]; SMC -3·9 [-5·3 to -2·6], 7·1 [4·0 to 10·3]). There was little evidence of differences in outcomes between the randomised treatment groups at long-term follow-up. The beneficial effects of CBT and GET seen at 1 year were maintained at long-term follow-up a median of 2·5 years after randomisation. Outcomes with SMC alone or APT improved from the 1 year outcome and were similar to CBT and GET at long-term follow-up, but these data should be interpreted in the context of additional therapies having being given according to physician choice and patient preference after the 1 year trial final assessment. Future research should identify predictors of response to CBT and GET and also develop better treatments for those who respond to neither. UK Medical Research Council, Department of Health for England, Scottish Chief Scientist Office, Department for Work and Pensions, National Institute for Health Research (NIHR), NIHR Biomedical Research Centre for Mental Health at South London and Maudsley NHS Foundation Trust, King's College London.

Improving complete EMR of colorectal neoplasia: a randomized trial comparing snares and injectate in the resection of large sessile colon polyps

There are few randomized studies examining efficacy of snares and agents in EMR. To compare the use of a combined needle and snare unit with injectate versus a spiral wire and injectate (primary); saline solution versus hydroxypropyl methylcellulose (secondary). Prospective, randomized, factorial, single center. Tertiary-care academic medical center. A total of 140 patients with large (>15mm), sessile, colorectal polyps. Polyps randomized to either 1 of 2 snare types and 1 of 2 injectates. Primary-the Sydney resection quotient (SRQ), defined as the size of the polyp divided by the number of pieces resected and the amount of tissue per snare attempt. Secondary-procedure time, adverse events, residual neoplasia at follow-up. The SRQ was higher with the combined unit (median 13.8mm vs 7.1mm; P= .019); additionally, procedure time was less (median 6 vs 11 minutes; P< .001). Resection was considered complete after the EMR in 62% (42/68) with the combined needle and snare unit versus 51% (37/72; P= .22) with the spiral wire. Rates of adverse events were similar. Residual neoplasia was found at follow-up in 22% (10/46) with the combined needle and snare unit versus 21% (10/48; P= .89) with the spiral wire. There was no evidence of differences in outcomes by lifting agent. The SRQ is only a surrogate marker. This study provides evidence that the integrated needle-snare may be superior to the snare alonefor the removal of large, flat polyps. Additionally, the type of injectate appears to have no impact on outcome.

Therapist and client race/ethnicity match: An examination of treatment outcome and process with rural older adults in the deep south

This study investigated the effects of race/ethnicity (r/e) match in cognitive-behavioral therapy with rural older adults. Races/ethnicities represented in this study were African-American and White. Treatment followed a CBT treatment protocol and was provided by MSWs to clients in their homes. Results indicated little evidence of differences in outcome and process for matched and non-matched dyads for number of sessions attended, changes in quality of life and psychological symptoms, overall quality of therapy sessions, or the number of sessions considered of unsatisfactory quality. Our findings are consistent with recent research on r/e matching and extend these findings to a sample of rural older adults.

Subacromial impingement syndrome

Subacromial impingement syndrome (SAIS) represents a spectrum of pathology ranging from subacromial bursitis to rotator cuff tendinopathy and full-thickness rotator cuff tears. The relationship between subacromial impingement and rotator cuff disease in the etiology of rotator cuff injury is a matter of debate. However, the etiology is multi-factorial, and it has been attributed to both extrinsic and intrinsic mechanisms. Management includes physical therapy, injections, and, for some patients, surgery. No high-quality randomized controlled trials are available so far to provide possible evidence for differences in outcome of different treatment strategies. There remains a need for high-quality clinical research on the diagnosis and treatment of SAIS.

Use of evidence from systematic reviews to inform commissioning decisions: a case study

Systematic reviews provide high-level evidence but there are barriers to their use by policy makers. This paper reports the preparation and evaluation of an evidence briefing, using systematic reviews and other existing sources of synthesised evidence, to support a possible reorganisation of services for young people with eating disorders in an English primary care trust. There was no evidence of differences in outcomes between community, outpatient and specialist inpatient treatment. The provision of specialist outpatient services appeared most cost-effective. The commissioning group agreed to move towards providing services on an outpatient basis. This work suggests that evidence briefings based on systematic reviews warrant further methodological development and evaluation.

Efficacy of a School‐Based Childhood Obesity Intervention Program in a Rural Southern Community: TEAM Mississippi Project

A healthy lifestyle school-based obesity intervention was evaluated in a rural southern community where the rate of obesity ranks as the highest. School-age children (N = 450) ranging from 6 to 10 years of age (Mage = 8.34) participated in monthly physical activity and nutritional events during a 9-month academic year. The children's nutritional knowledge, number of different physical activities, fitness level, dietary habits, waist circumference, BMI percentile, and percentage body fat were measured pre- and postintervention. Changes on these measures were compared to students in a school employing the school system's standard health curriculum. Regression analyses with residualized change scores revealed that the intervention school showed statistically significant improvement in percentage body fat, physical activity, performance on fitness tests, and dietary habits compared to the control school. There was no evidence of differences in outcomes based on gender or ethnicity/race. With rates of obesity and overweight reaching 50% in southern rural communities, intervening early in development may offer the best outcome because of the difficulties with changing lifestyle behaviors later in adulthood. A population-based approach is recommended over a targeted approach to cultivate a culture of healthy lifestyle behaviors when children are developing their health-care habits. Evidence suggests that both boys and girls, and African-American and white children can benefit equally from such interventions.

Conservative or surgical treatment for subacromial impingement syndrome? A systematic review

Patients with subacromial impingement syndrome are often operated on when conservative treatments fail. But does surgery really lead to better results than nonoperative measures? This systematic review compared effects of conservative and surgical treatment for subacromial impingement syndrome in terms of improvement of shoulder function and reduction of pain. A literature search for randomized controlled trials (RCTs) in PubMed, EMBASE, PEDro, and the Cochrane Central Register of Controlled Trials was conducted. Two reviewers assessed the methodological quality of the selected studies. A best-evidence synthesis was used to summarize the results. Four RCTs were included in this review. Two RCTs had a medium methodological quality, and 2 RCTS had a low methodological quality. No differences in outcome between the treatment groups were reported for any of the studies, irrespective of quality. No high-quality RCTs are available so far to provide possible evidence for differences in outcome; therefore, no confident conclusion can be made. According to the best-evidence synthesis, however, there is no evidence from the available RCTs for differences in outcome in pain and shoulder function between conservatively and surgically treated patients with SIS. Review.

Expanding Agoraphobics' Horizons: An Investigation Of The Effectiveness Of A Personal Construct Psychotherapy Intervention

This article investigated whether a personal construct group intervention would enhance the effectiveness of graduated exposure therapy for agoraphobia more than a supportive group intervention. Fifty-four clients were randomly allocated to the treatment conditions. Personal construct and supportive therapy sessions were differentiated on process measures. Although clients in the personal construct psychotherapy plus exposure condition improved more on some outcome measures during treatment than while on the waiting list, there was no evidence of difference in outcome between the two conditions. However, correlations between repertory grid scores and questionnaire measures, and changes in grid scores during therapy, provided support for the personal construct model of agoraphobia.

Direct comparative trials of the efficacy of proton pump inhibitors in the management of gastro-oesophageal reflux disease and peptic ulcer disease.

Five proton pump inhibitors are now available for use in North America. Claims of differences in the clinical efficacy of different strengths and/or agents have been made. To identify any consistent evidence of differences in outcomes between agents or doses within this class of drugs. A search of the medical literature was performed in two electronic databases, and randomized controlled trials of higher quality were included in the assessment. Thirty-two trials met our criteria. No convincing data were found to indicate that low doses of proton pump inhibitors are as effective as standard doses of proton pump inhibitors in the healing of erosive oesophagitis or in the relief of symptoms of gastro-oesophageal reflux disease; however, they may be as effective as maintenance therapy for gastro-oesophageal reflux disease and peptic ulcer disease. Differences were found between the standard doses of proton pump inhibitors with regard to the onset of symptom relief in gastro-oesophageal reflux disease (lansoprazole was faster than omeprazole, and esomeprazole was faster than both lansoprazole and omeprazole) and the healing of oesophagitis (esomeprazole was superior to both omeprazole and lansoprazole). Despite these differences, there are as yet insufficient data to establish the superiority of any one agent over all others across all disease states treated with these agents.

Using DSM axis II information to predict outcome in short-term individual psychotherapy.

The present study considered three methods of using DSM Axis II information to examine the effect of personality disorder on outcome in two forms of short-term, individual psychotherapy (interpretive and supportive). The first method involved examining whether the presence of any personality disorder influenced treatment outcome. The second method involved examining the effect of the number of personality disorders on outcome. The third involved examining outcome for specific personality disorders. The study found that a diagnosis of any personality disorder did not influence the outcome of therapy. In contrast, the number of personality disorders was significantly related to outcome at post-therapy and at 12-month follow-up. The findings indicated that a greater number of personality disorders was associated with less favorable outcome across both forms of therapy. This supports the notion that personality pathology is more severe when it involves a greater number of personality disorders. In an exploratory set of analyses, the study also found some evidence of differences in outcome for specific personality disorders.

Patient knowledge and the content of the consultation in general practice.

Summary The relationship between verbal exchange in doctor-patient consultations and patients’ comprehension has been measured by means of audiotape recordings. The results provide objective evidence of differences in outcomes for similar presenting illnesses in different social groups, and these results tend to support the hypothesis that people from lower socio-economic classes may not derive as much benefit from medical advice as do those of middle and upper classes. The author identified deficiencies in clinical relationship which if corrected will improve doctor-patient communication in consultations in general practice. If patient comprehension and compliance are viewed as essential, communicative as well as clinical skills have to be accepted as part of the general practitioner's training.