Single intraoperative intravenous Co-Amoxiclav versus postoperative full oral course in prevention of postadenotonsillectomy morbidity: a randomised clinical trial

<p>Abstract</p> <p>Background</p> <p>Adenotonsillectomy results in postoperative morbidity which otolaryngologists attempt to reduce by use of antibiotics. The regimes used as quite varied with some opting for a full oral course postoperatively while others prefer prophylactic doses. This randomised clinical trial done in Kenyatta National Hospital, Kenya had the aim of comparing the efficacy of Co-Amoxiclav given as a single intravenous dose with a full oral course in the prevention of post adenotonsillectomy morbidity.</p> <p>Methods</p> <p>126 patients below 12 years scheduled to undergo adenotonsillectomy were randomised into two groups. 63 were given a single intravenous dose of Enhancin [Co-Amoxiclav] at induction while the remaining half received a five days oral course of the same postoperatively. All received oral Pacimol [Paracetamol] in the postoperative period. Analysis was done and comparison made between the two groups with regards to pain, fever and diet tolerated in the postoperative period with a follow up period of seven days.</p> <p>Results</p> <p>There was no statistical significant difference between the two groups with regards to postoperative pain, fever and diet tolerated. All had a P-value > 0.2. Postoperative pain was highest in the first postoperative day and reduced progressively to the lowest level on the 7^thpostoperative day. As pain reduced, patients were able to tolerate a more solid diet with all but 6 tolerating their usual diet. 4 patients developed fever in the 1^stpostoperative day which did not progress to the next day. One patient had fever on the 4^thand 7^thpostoperative day and was admitted in the paediatrics' ward with a chest infection. All these patients with history of fever were in the group that was on oral postoperative Co-Amoxiclav.</p> <p>Conclusion</p> <p>A single intraoperative dose of Co-Amoxiclav given intravenously at induction was found to be just as effective as a full oral course of the same given postoperatively in the prevention of post adenotonsillectomy morbidity. The prophylactic dose is favoured over the later as it is cheaper, ensures compliance and relieves off the need for refrigeration of the oral suspension as not all have access to refrigeration in low economy countries as ours.</p> <p>Trial registration</p> <p>ClinicalTrials.gov: <a href="http://www.clinicaltrials.gov/ct2/show/NCT01267942">NCT01267942</a></p

Recent trends in the incidence of anxiety and prescription of anxiolytics and hypnotics in children and young people: An e-cohort study

AbstractBackgroundLittle is known regarding the recognition of anxiety in children and young people (CYP) in primary care. This study examined trends in the presentation, recognition and recording of anxiety and of anxiolytic and hypnotic prescriptions for CYP in primary care.MethodA population-based retrospective electronic cohort of individuals aged 6–18 years between 2003 and 2011 within the Secure Anonymised Information Linkage (SAIL) Databank primary care database was created. Incidence rates were calculated using person years at risk (PYAR) as a denominator accounting for deprivation, age and gender.ResultsWe identified a cohort of 311,343 registered individuals providing a total of 1,546,489 person years of follow up. The incidence of anxiety symptoms more than tripled over the study period (Incidence Rate Ratio (IRR)=3.55, 95% CI 2.65–4.77) whilst that of diagnosis has remained stable. Anxiolytic/hypnotic prescriptions for the cohort as a whole did not change significantly over time; however there was a significant increase in anxiolytic prescriptions for the 15–18 year age group (IRR 1.62, 95% CI 1.30–2.02).LimitationsThere was a lack of reliable information regarding other interventions available or received at a primary, secondary or tertiary level such as psychological treatments.ConclusionsThere appears to be a preference over time for the recording of general symptoms over diagnosis for anxiety in CYP. The increase in anxiolytic prescriptions for 15–18 year olds is discrepant with current prescribing guidelines. Specific guidance is required for the assessment and management of CYP presenting with anxiety to primary care, particularly older adolescents

Are chiropractors in the uk primary healthcare or primary contact practitioners?: a mixed methods study

<p>Abstract</p> <p>Background</p> <p>One of the debates regarding the role of chiropractors is whether or not they should be considered as primary healthcare practitioners. Primary care is often used to describe chiropractic but without any definition of what is meant by the term. Primary healthcare itself has many definitions and this adds to the problem. Existing research literature, based mostly in the USA, suggests that the use of the title "primary healthcare professional" by chiropractors is central to the identity of the profession. It has also been suggested that the concept of primary care is misused by chiropractors because they have not examined the concept in detail and thus do not understand it. For the sake of quality of patient care and for the legitimacy of the profession, chiropractors in the UK need to agree on their healthcare role. This study aimed to examine the opinions of chiropractors towards the use of the term primary healthcare when applied to chiropractic practice within the UK.</p> <p>Methods</p> <p>A sequential study of exploratory design was used; this model is characterised by an initial phase of qualitative data collection and analysis that precedes and informs the quantitative phase of data collection and analysis. In this study, interviews with members of chiropractic teaching faculty were used to inform the development of a questionnaire used to survey the opinions of chiropractors in the UK.</p> <p>Results</p> <p>There was a general consensus of opinion that chiropractors are primary contact practitioners, who work in a primary healthcare setting and that to be able to fulfil this healthcare role, chiropractors must be able to diagnose patients and refer when required. Participants did not feel that chiropractors are able to treat all of the most common medical conditions that present in a primary healthcare setting.</p> <p>Conclusions</p> <p>The findings of this study suggest that chiropractors in the UK view their role as one of a primary contact healthcare practitioner and that this view is held irrespective of the country in which they were educated or the length of time in practice.</p> <p>Further research needs to be developed to evaluate the findings of the current study within a wider healthcare context. In particular the opinions of other healthcare professionals towards the role of chiropractors in healthcare, need to be examined in more detail.</p

Maintenance Cognitive Stimulation Therapy: An Economic Evaluation Within a Randomized Controlled Trial

Background Cognitive Stimulation Therapy (CST) is effective and cost-effective for people with mild-to-moderate dementia when delivered biweekly over 7 weeks. Aims To examine whether longer-term (maintenance) CST is cost-effective when added to usual care. Methods Cost-effectiveness analysis within multicenter, single-blind, pragmatic randomized controlled trial; subgroup analysis for people taking acetylcholinesterase inhibitors (ACHEIs). A total of 236 participants with mild-to-moderate dementia received CST for 7 weeks. They were randomized to either weekly maintenance CST added to usual care or usual care alone for 24 weeks. Results Although outcome gains were modest over 6 months, maintenance CST appeared cost-effective when looking at self-rated quality of life as primary outcome, and cognition (MMSE) and proxy-rated quality-adjusted life years as secondary outcomes. CST in combination with ACHEIs offered cost-effectiveness gains when outcome was measured as cognition. Conclusions Continuation of CST is likely to be cost-effective for people with mild-to-moderate dementia

Cost-effectiveness of magnetic resonance-guided focused ultrasound surgery for treatment of uterine fibroids

OBJECTIVE: To estimate the cost-effectiveness of a treatment strategy for symptomatic uterine fibroids, which starts with Magnetic Resonance-guided Focused Ultrasound Surgery (MRgFUS) as compared with current practice comprising uterine artery embolisation, myomectomy and hysterectomy. DESIGN: Cost-utility analysis based on a Markov model. SETTING: National Health Service (NHS) Trusts in England and Wales. POPULATION: Women for whom surgical treatment for uterine fibroids is being considered. METHODS: The parameters of the Markov model of the treatment of uterine fibroids are drawn from a series of clinical studies of MRgFUS, and from the clinical effectiveness literature. Health-related quality of life is measured using the 6D. Costs are estimated from the perspective of the NHS. The impact of uncertainty is examined using deterministic and probabilistic sensitivity analysis. MAIN OUTCOME MEASURES: Incremental cost-effectiveness measured by cost per quality-adjusted life-year (QALY) gained. RESULTS: The base-case results imply a cost saving and a small QALY gain per woman as a result of an MRgFUS treatment strategy. The cost per QALY gained is sensitive to cost of MRgFUS relative to other treatments, the age of the woman and the nonperfused volume relative to the total fibroids volume. CONCLUSIONS: A treatment strategy for symptomatic uterine fibroids starting with MRgFUS is likely to be cost-effective

Folate Augmentation of Treatment – Evaluation for Depression (FolATED): protocol of a randomised controlled trial

<p>Abstract</p> <p>Background</p> <p>Clinical depression is common, debilitating and treatable; one in four people experience it during their lives. The majority of sufferers are treated in primary care and only half respond well to active treatment. Evidence suggests that folate may be a useful adjunct to antidepressant treatment: 1) patients with depression often have a functional folate deficiency; 2) the severity of such deficiency, indicated by elevated homocysteine, correlates with depression severity, 3) low folate is associated with poor antidepressant response, and 4) folate is required for the synthesis of neurotransmitters implicated in the pathogenesis and treatment of depression.</p> <p>Methods/Design</p> <p>The primary objective of this trial is to estimate the effect of folate augmentation in new or continuing treatment of depressive disorder in primary and secondary care. Secondary objectives are to evaluate the cost-effectiveness of folate augmentation of antidepressant treatment, investigate how the response to antidepressant treatment depends on genetic polymorphisms relevant to folate metabolism and antidepressant response, and explore whether baseline folate status can predict response to antidepressant treatment.</p> <p>Seven hundred and thirty patients will be recruited from North East Wales, North West Wales and Swansea. Patients with moderate to severe depression will be referred to the trial by their GP or Psychiatrist. If patients consent they will be assessed for eligibility and baseline measures will be undertaken.</p> <p>Blood samples will be taken to exclude patients with folate and B12 deficiency. Some of the blood taken will be used to measure homocysteine levels and for genetic analysis (with additional consent). Eligible participants will be randomised to receive 5 mg of folic acid or placebo. Patients with B12 deficiency or folate deficiency will be given appropriate treatment and will be monitored in the 'comprehensive cohort study'. Assessments will be at screening, randomisation and 3 subsequent follow-ups.</p> <p>Discussion</p> <p>If folic acid is shown to improve the efficacy of antidepressants, then it will provide a safe, simple and cheap way of improving the treatment of depression in primary and secondary care.</p> <p>Trial registration</p> <p>Current controlled trials ISRCTN37558856</p

Results of the First Steps study: a randomised controlled trial and economic evaluation of the Group Family Nurse Partnership (gFNP) programme compared with usual care in improving outcomes for high-risk mothers and their children and preventing abuse

Background: Family Nurse Partnership (FNP) is a home-based nurse home-visiting programme to support vulnerable parents. Group Family Nurse Partnership (gFNP) has similar aims and materials and was demonstrated to be feasible in implementation evaluations. Objectives: To determine whether or not gFNP, compared with usual care, could reduce risk factors for maltreatment in a vulnerable group and be cost-effective. Design: A multisite randomised controlled parallel-group trial and prospective economic evaluation, with eligible women allocated (minimised by site and maternal age group) to gFNP or usual care. Setting: Community locations in the UK. Participants: Expectant mothers aged < 20 years with one or more previous live births, or expectant mothers aged 20–24 years with no previous live births and with low educational qualifications (defined as General Certificate of Education at grade C or higher in neither mathematics nor English language or, if they had both, no more than four General Certificates of Education at grade C or higher). Intervention: Forty-four sessions of gFNP (14 during pregnancy and 30 in the first 12 months after birth) were offered to groups of between 8 and 12 women with similar expected delivery dates (the difference between the earliest and latest expected delivery date ranged from 8 to 10 weeks depending on the group) by two family nurses (FNs), one of whom had notified her intention to practise as a midwife. Main outcome measures: Parenting was assessed by a self-report measure of parenting opinions, the Adult Adolescent Parenting Inventory Version 2 (AAPI-2), and an objective measure of maternal sensitivity, the CARE-Index. Cost-effectiveness was primarily expressed in terms of incremental cost per quality-adjusted life-year (QALY) gained. Data sources: Interviews with participants at baseline and when infants were aged 2, 6 and 12 months. Cost information from nurse weekly logs and other service delivery data. Results: In total, 166 women were enrolled (99 to the intervention group and 67 to the control group). Adjusting for site and maternal age group, the intention-to-treat analysis found no effect of gFNP on either of the primary outcomes. AAPI-2 total was 7.5/10 [standard error (SE) 0.1] in both arms [difference also adjusted for baseline 0.08, 95% confidence interval (CI) –0.15 to 0.28; p = 0.50]. CARE-Index maternal sensitivity mean: intervention 4.0 (SE 0.3); control 4.7 (SE 0.4) (difference –0.76, 95% CI –1.67 to 0.13; p = 0.21). The sensitivity analyses supported the primary analyses. The probability that the gFNP intervention was cost-effective based on the QALY measure did not exceed 3%. However, in terms of change in AAPI-2 score (baseline to 12 months), the probability that gFNP was cost-effective reached 25.1%. A separate discrete choice experiment highlighted the value placed by both pregnant women and members of the general population on non-health outcomes that were not included in the QALY metric. Limitations: Slow recruitment resulted in smaller than ideal group sizes. In some cases, few or no sessions took place owing to low initial group size, and small groups may have contributed to attrition from the intervention. Exposure to gFNP sessions was below maximum for most group members, with only 58 of the 97 intervention participants receiving any sessions; FNs were experienced with FNP but were mainly new to delivering gFNP. Conclusions: The trial does not support the delivery of gFNP as a means of reducing the risk of child abuse or neglect in this population. Future work: A randomised controlled trial with modified eligibility to enable first-time mothers aged < 20 years to be included, and a modified recruitment strategy to enable faster identification of potential participants from antenatal medical records