The Perspectives of Lagos Healthcare Leaders on Faith-Institution Involvement in Hypertension Health.

BACKGROUND: Hypertension is an important challenge for the Nigerian healthcare system and multiple stakeholder mitigation is imperative. Faith institution mitigation is evolving but the opinion of healthcare leaders on their involvement in hypertension remains an important gap. OBJECTIVE: To explore the perspectives of a cross-section of leaders of healthcare institutions in Lagos (Nigeria) on faith institution-facilitated hyper tension inter vention against the background of current practice. METHODS: Attempts were made to recruit 152 healthcare institution leaders who were contacted using electronic mails, telephone conversations, institutional social media communication, institutions' web-mails and other contacts. The views of consenting leaders were gathered using an exploratory questionnaire survey, and analysed. RESULTS: The views of 23 leaders from the variety of institutions were that most (60%) hypertension cases were diagnosed during emergency presentations; and the public's hypertension health knowledge remains generally inadequate. Hypertension information dissemination was mostly verbal rather than in written/print form. Basic resources are deployed in hypertension management. There was majority support for collaboration in hypertension health promotion (90.0%), blood pressure screening (95.7%) and hypertension referral (95.5%). Fewer institutions had the resources to support hypertension health promotion (55.0%) and blood pressure screening (42.1%) compared to hypertension referral (90.9%). CONCLUSION: There is good support for faith institution involvement in hypertension health, with a particular interest in and capacity for health system referral. Deploying scarce resources to collaborate may be challenging. However, collaboration and better resources could improve hypertension prevention and management. Further work is needed for context specific innovation so faith institutions can contribute to hypertension health.

CONTEXTE: L'hypertension représente un défi majeur pour le système de santé nigérian, et une atténuation impliquant plusieurs parties prenantes est impérative. L'atténuation par les institutions religieuses est en évolution, mais l'opinion des leaders de la santé sur leur implication dans l'hypertension reste une lacune importante. OBJECTIF: Explorer les perspectives d'un échantillon de leaders d'institutions de santé à Lagos, Nigeria, sur l'intervention contre l'hypertension facilitée par les institutions religieuses, dans le contexte de la pratique actuelle. MÉTHODES: Des tentatives ont été faites pour recruter 152 dirigeants d'établissements de santé qui ont été contactés par courriels électroniques, conversations téléphoniques, communication sur les médias sociaux institutionnels, courriers électroniques des établissements et autres contacts. Les points de vue des dirigeants consentants ont été recueillis à l'aide d'une enquête par questionnaire exploratoire, puis analysés. RÉSULTATS: Les opinions de 23 dirigeants provenant de divers établissements indiquaient que la plupart des cas d'hypertension (60%) étaient diagnostiqués lors de présentations aux urgences; et les connaissances du public sur la santé liée à l'hypertension demeurent généralement insuffisantes. La diffusion d'informations sur l'hypertension se faisait principalement de manière verbale plutôt que sous forme écrite/imprimée. Des ressources de base sont utilisées dans la gestion de l'hypertension. Une majorité soutenait la collaboration dans la promotion de la santé liée à l'hypertension (90,0%), le dépistage de la tension artérielle (95,7%) et l'orientation des patients atteints d'hypertension (95,5%). Moins d'institutions avaient les ressources pour soutenir la promotion de la santé liée à l'hypertension (55,0 %) et le dépistage de la pression artérielle (42,1 %) par rapport à l'orientation vers l'hypertension (90,9 %). CONCLUSION: Il existe un soutien significatif pour l'implication des institutions religieuses dans la santé liée à l'hypertension, avec un intérêt particulier et une capacité à orienter vers le système de santé. Le déploiement de ressources limitées pour la collaboration peut présenter des défis. Cependant, la collaboration et de meilleures ressources pourraient améliorer la prévention et la gestion de l'hypertension. Des travaux supplémentaires sont nécessaires pour des innovations spécifiques au contexte afin que les institutions religieuses puissent contribuer à la santé liée à l'hypertension. MOTS- CLÉS: Hypertension, Lagos, Institutions religieuses, Responsables de la santé, Intervention.

Social media and COVID-19 vaccination hesitancy during pregnancy: a mixed methods analysis.

OBJECTIVE: To evaluate the reasons for COVID-19 vaccine hesitancy during pregnancy. DESIGN: We used regular expressions to identify publicly available social media posts from pregnant people expressing at least one reason for their decision not to accept COVID-19 vaccine. SETTING: Two social media platforms - WhatToExpect and Twitter. SAMPLE: A total of 945 pregnant people in WhatToExpect (1017 posts) and 345 pregnant people in Twitter (435 tweets). METHODS: Two annotators manually coded posts according to the Scientific Advisory Group for Emergencies (SAGE) working group's 3Cs vaccine hesitancy model (confidence, complacency and convenience barriers). Within each 3Cs we created subthemes that emerged from the data. MAIN OUTCOME MEASURES: Subthemes were derived according to the people's posting own words. RESULTS: Safety concerns were most common and largely linked to the perceived speed at which the vaccine was created and the lack of data about its safety in pregnancy. This led to a preference to wait until after the baby was born or to take other precautions instead. Complacency surrounded a belief that they are young and healthy or already had COVID-19. Misinformation led to false safety and efficacy allegations, or even conspiracy theories, and fed into creating confidence and complacency barriers. Convenience barriers (such as availability) were uncommon. CONCLUSION: The information in this study can be used to highlight the questions, fears and hesitations pregnant people have about the COVID-19 vaccine. Highlighting these hesitations can help public health campaigns and improve communication between healthcare professionals and patients.

Double-endoscope assisted endoscopic submucosal dissection for treating tumors in rectum and distal colon by expert endoscopists: a feasibility study.

BACKGROUND: Colorectal endoscopic submucosal dissection (ESD) is an effective but challenging procedure. To facilitate ESD, several methods that apply traction are available; however, the optimal one remains to be established. The aim of this study was to evaluate the feasibility and safety of the double-endoscope assisted ESD (DEA-ESD) by improving traction to treat complex colorectal lesions. METHODS: Naïve or previously treated lesions in the rectum and sigmoid colon were included. A grasping forceps advanced through a small-caliber endoscope (GIF-XP190N, Olympus Medical Systems, Tokyo, Japan, 5.4 mm outer diameter) was used to apply traction to the mucosal flap. Lesions were deemed complex when they exceeded a total of nine points on the SMSA scoring system (size, morphology, site, and access) and recurrent when they were previously treated with endoscopic mucosal resection (EMR). Outcome measures included procedural success, total procedure time, complications, and recurrence rate at 3-month follow-up. RESULTS: Nine patients (mean age 62.3 ± 14.5 years) were included; five had rectal and four had tumors in the sigmoid colon. The median SMSA score was 14 (SMSA Level IV-complex polyp), while three patients were pre-treated with EMR. DEA-ESD was technically feasible in all cases. En bloc resection and R0 resection rates were 100%, respectively, with a mean procedure time of 128.4 ± 54.1 min. No immediate or delayed complications occurred. CONCLUSIONS: DEA-ESD is a feasible and safe method for treating complex or recurrent tumors in the rectum and distal colon.

[Improvement of cost allocation in gastroenterology by introduction of a novel service catalogue covering the complete spectrum of endoscopic procedures]. / Verbesserung der Kostenkalkulation in der Gastroenterologie durch Einführung eines neuen Leistungskatalogs für alle endoskopischen Prozeduren.

BACKGROUND: The German hospital reimbursement system (G-DRG) is incomplete for endoscopic interventions and fails to differentiate between complex and simple procedures. This is caused by outdated methods of personnel-cost allocation. METHODS: To establish an up-to-date service catalogue 50 hospitals made their anonymized expense-budget data available to the German-Society-of-Gastroenterology (DGVS). 2.499.900 patient-datasets (2011-2013) were used to classify operation-and-procedure codes (OPS) into procedure-tiers (e.g. colonoscopy with biopsy/colonoscopy with stent-insertion). An expert panel ranked these tiers according to complexity and assigned estimates of physician time. From June to November 2014 exact time tracking data for a total 38.288 individual procedures were collected in 119 hospitals to validate this service catalogue. RESULTS: In this three-step process a catalogue of 97 procedure-tiers was established that covers 99% of endoscopic interventions performed in German hospitals and assigned validated mean personnel-costs using gastroscopy as standard. Previously, diagnostic colonoscopy had a relative personnel-cost value of 1.13 (compared to gastroscopy 1.0) and rose to 2.16, whereas diagnostic ERCP increased from 1.7 to 3.62, more appropriately reflecting complexity. Complex procedures previously not catalogued were now included (e.g. gastric endoscopic submucosal dissection: 16.74). DISCUSSION: This novel service catalogue for GI-endoscopy almost completely covers all endoscopic procedures performed in German hospitals and assigns relative personnel-cost values based on actual physician time logs. It is to be included in the national coding recommendation and should replace all prior inventories for cost distribution. The catalogue will contribute to a more objective cost allocation and hospital reimbursement - at least until time tracking for endoscopy becomes mandatory.

Dexamethasone and haemorrhage risk in paediatric tonsillectomy: a systematic review and meta-analysis.

Summary In children undergoing tonsillectomy, dexamethasone is recommended to reduce the risk of postoperative nausea and vomiting while non-steroidal anti-inflammatory drugs (NSAIDs) are used for pain relief. We aimed to determine whether children who receive dexamethasone or dexamethasone with NSAID are more likely to experience haemorrhage post-tonsillectomy. Randomized and non-randomized studies in which children undergoing tonsillectomy received dexamethasone or dexamethasone and NSAID were sought within bibliographic databases and selected tertiary sources. The risk of bias assessment and evaluation of haemorrhage rate data collection and reporting were assessed using the Cochrane Risk of Bias Tool and McHarm tool. Synthesis methods comprised pooled estimate of the effect of dexamethasone on the risk of haemorrhage rate using the Peto odds ratio (OR) method. The pooled estimate for haemorrhage rate in children who received dexamethasone was 6.2%, OR 1.41 (95% confidence interval 0.89-2.25, P=0.15). There was risk of bias and inconsistent data collection and reporting rates of haemorrhage in many of the included studies. Clinical heterogeneity was observed between studies. The pooled analysis did not demonstrate a statistically significant increase in the risk of post-tonsillectomy haemorrhage with dexamethasone with/without NSAID use in children. However, the majority of the included studies were not designed to investigate this endpoint, and thus large studies which are specifically designed to collect data on haemorrhage rate are needed.

[Chronic renal insufficiency with hypercalcemia in a 60-year-old patient]. / Chronische Niereninsuffizienz mit Hyperkalzämie bei einem 60-jährigen Patienten.

A 60-year-old man developed stomach pains and early morning vomiting as well as fatigue over the last few months. Severe hypercalcemia was found in combination with a significantly reduced renal function. Laboratory tests as well as histological findings from the kidneys led to the working diagnosis of sarcoidosis with renal and possible osseous manifestations. After 14 days of oral medication with steroids the symptoms were significantly improved and renal parameters normalized.

The commercial promotion of electronic cigarettes on social media and its influence on positive perceptions of vaping and vaping behaviours in Anglophone countries: A scoping review.

There is ongoing scientific and policy debate about the role e-cigarettes play in tobacco control, with concerns centring around unknown long-term effects, and the potential industry co-option of harm reduction efforts, including marketing to youths. There is substantial evidence of the influence of conventional cigarette promotion on smoking behaviours in Anglophone countries, and the popularity of social networking sites, as well as the lack of marketing regulations on the commercial promotion of electronic cigarettes online, suggest an urgent need to explore this topic further. This scoping review aims to map the existing evidence related to the influence of e-cigarette commercial promotion on social media on positive perceptions of vaping and vaping behaviours in core Anglophone countries. Searches were conducted in CENTRAL, Cochrane Database of Systematic Reviews (CDSR), Embase, Epistemonikos, MEDLINE, PsycINFO and Science Citation Index, on the 21st of July 2022. From 1,385 studies, 11 articles were included in the final review, using diverse study designs, including focus groups, content analysis, cross-sectional studies, and experiments. The studies were primarily based in the U.S. and evidenced the association between the commercial promotion of e-cigarettes on social media with positive perceptions of vaping and vaping behaviours, particularly among young people, addressing diverse themes including celebrities' sponsorship, e-liquid appeal (including flavours and nicotine levels), users' engagement with ads, and other marketing strategies. Further, social networking sites commercially promoting e-cigarettes might increase positive attitudes towards vaping and vaping behaviours, particularly among youths. Future research should be conducted in broader settings, incorporate larger and diverse sample sizes, ensure research transparency, cover multiple social networking sites, emphasize ecological validity, and foment longitudinal studies.

Extending A Chronological and Geographical Analysis of Personal Reports of COVID-19 on Twitter to England, UK.

The rapidly evolving COVID-19 pandemic presents challenges for actively monitoring its transmission. In this study, we extend a social media mining approach used in the US to automatically identify personal reports of COVID-19 on Twitter in England, UK. The findings indicate that natural language processing and machine learning framework could help provide an early indication of the chronological and geographical distribution of COVID-19 in England.

Irinotecan plus gemcitabine and 5-fluorouracil in advanced pancreatic cancer: a phase II study.

AIMS: The aim of the present study was to evaluate the 6-month survival rate of patients with inoperable or metastatic pancreatic cancer treated with irinotecan and gemcitabine plus 5-fluorouracil. Secondary efficacy end points included response rate, time to progression (TTP), overall survival (OS) and toxicity. PATIENTS AND METHODS: 30 patients with histologically proven pancreatic carcinoma and at least one bidimensionally measurable lesion were enrolled. Of the patients, 83% had metastatic and 17% locally advanced disease. One cycle, lasting 21 days, comprised treatment on days 1 and 8 consisting of 75 mg/m(2) irinotecan i.v. for 90 min, 1,000 mg/m(2) gemcitabine i.v. for 30 min and 2,000 mg/m(2) fluorouracil (5-FU) for 24 h. A total of six cycles was planned for each patient. RESULTS: 28 patients competed at least one treatment cycle and were therefore assessable for efficacy, and 75% of them achieved the primary end point of the study (survival after 6 months). One-year survival was 25%. Stabilization (partial response and stable disease) was observed in 35.7% (10/28) and partial remission in 7.1% (2/28). The objective response rate was 7.1% (2/28) after completion of the six cycles. Median TTP was 3.4 months (1.2-11.5), and median OS was 8.3 months (2.1-36.2). Regarding severe hematological toxicities, only neutropenia was observed (grade 3 20.7%, 6/29, and grade 4 3.5%, 1/29). In spite of anti-emetic supportive care, nausea affected most of the patients: 79.3% (23/29). Grade 3 vomiting was observed in 4 of the 29 patients (13.8%) and grade 4 in 1 patient (3.5%). Only 1 patient experienced diarrhea grade 3 (3.5%) and 1 patient (3.5%) suffered from a grade 3 peroneal nerve enervation. CONCLUSIONS: A combination of irinotecan, gemcitabine and 5-FU is feasible and shows considerable efficacy in patients with inoperable or metastatic pancreatic cancer. Due to its low toxicity, this combination might be an interesting cytotoxic regimen in addition to targeted therapies.

Detection Rate and Clinical Relevance of Ink Tattooing during Balloon-Assisted Enteroscopy.

BACKGROUND AND AIMS: Balloon-assisted enteroscopy (BAE) is a well-established tool in the diagnosis and therapy of small bowel diseases. Ink tattooing of the small bowel is used to mark pathologic lesions or the depth of small bowel insertion. The purpose of this study was to determine the safety, the detection rate, and the clinical relevance of ink tattooing during BAE. METHODS: We performed a retrospective analysis of all 81 patients who received an ink tattooing during BAE between 2010 and 2015. RESULTS: In all patients, ink tattooing was performed with no complications. 26 patients received a capsule endoscopy after BAE. The tattoo could be detected via capsule endoscopy in 19 of these 26 patients. The tattoo of the previous BAE could be detected via opposite BAE in 2 of 11 patients. In 9 patients, ink tattooing influenced the choice of approach for reenteroscopy. In 7 patients, the tattoo was used for intraoperative localization and in 3 patients for intraoperative localization as well as for reenteroscopy. The intraoperative detection rate of the tattoo was 100%. CONCLUSION: Ink tattooing of the small intestine is a safe endoscopic procedure to mark the depth of scope insertion or a pathologic lesion during balloon-assisted enteroscopy.

A systematic review and economic model of the effectiveness and cost-effectiveness of methylphenidate, dexamfetamine and atomoxetine for the treatment of attention deficit hyperactivity disorder in children and adolescents.

OBJECTIVES: To assess the clinical and cost-effectiveness of oral methylphenidate hydrochloride (MPH), dexamfetaminesulphate (DEX) and atomoxetine (ATX) in children and adolescents (<18 years of age) diagnosed with attention deficit hyperactivity disorder (ADHD) (including hyperkinetic disorder). DATA SOURCES: Electronic databases covering 1999--July 2004 for MPH, 1997--July 2004 for DEX and 1981--July 2004 for ATX. REVIEW METHODS: Selected studies were assessed using modified criteria based on CRD Report No. 4. Clinical effectiveness data were reported separately for each drug and by the type of comparison. Data for MPH were also analysed separately based on whether it was administered as an immediate release (IR) or extended release (ER) formulation. For all drugs, the data were examined by dose. Data for the core outcomes of hyperactivity (using any scale), Clinical Global Impression [as a proxy of quality of life (QoL)] and adverse events were reported. For crossover studies, the mean and standard deviation (SD) for each outcome were data extracted for end of trial data (i.e. baseline data were not considered). For parallel studies, change scores were reported where given, otherwise means and SDs were presented for end of trial data. In addition, mean differences with 95% confidence intervals were calculated for each study. For adverse events, self-ratings were reported when used, otherwise, parent reports were utilised. Percentages of participants reporting adverse events were used to calculate numbers of events in each treatment arm. All the clinical effectiveness data and economic evaluations (including accompanying models) included in the company submissions were assessed. A new model was developed to assess the cost-effectiveness of the alternative treatments in terms of cost per quality-adjusted life-year. To achieve this, a mixed treatment comparison model was used to estimate the differential mean response rates. Monte Carlo simulation was used to reflect uncertainty in the cost-effectiveness results. RESULTS: In total, 65 papers met the inclusion criteria. The results suggest that MPH and DEX are effective at reducing hyperactivity and improving QoL (as determined by Clinical Global Impression) in children, although the reliability of the MPH study results is not known and there were only a small number of DEX studies. There was consistent evidence that ATX was superior to placebo for hyperactivity and Clinical Global Impression. Studies on ATX more often reported the study methodology well, and the results were likely to be reliable. Very few studies made direct head-to-head comparisons between the drugs or examined a non-drug intervention in combination with MPH, DEX or ATX. Adequate and informative data regarding the potential adverse effects of the drugs were also lacking. The results of the economic evaluation clearly identified an optimal treatment strategy of DEX first-line, followed by IR-MPH for treatment failures, followed by ATX for repeat treatment failures. Where DEX is unsuitable as a first-line therapy, the optimal strategy is IR-MPH first-line, followed by DEX and then ATX. For patients contraindicated to stimulants, ATX is preferred to no treatment. For patients in whom a midday dose of medication is unworkable, ER-MPH is preferred to ATX, and ER-MPH12 appears more cost-effective than ER-MPH8. As identified in the clinical effectiveness review, the reporting of studies was poor, therefore this should be borne in mind when interpreting the model results. CONCLUSIONS: Drug therapy seems to be superior to no drug therapy, no significant differences between the various drugs in terms of efficacy or side effects were found, mainly owing to lack of evidence, and the additional benefits from behavioural therapy (in combination with drug therapy) are uncertain. Given the lack of evidence for any differences in effectiveness between the drugs, the economic model tended to be driven by drug costs, which differed considerably. Future trials examining MPH, DEX and ATX should include the assessment of tolerability and safety as a priority. Longer term follow-up of individuals participating in trials could further inform policy makers and health professionals. Such data could potentially distinguish between these drugs in a clinically useful way. In addition, research examining whether somatic complaints are actually related to drug treatment or to the disorder itself would be informative.

A series of systematic reviews to inform a decision analysis for sampling and treating infected diabetic foot ulcers.

OBJECTIVES: To review systematically the evidence on the performance of diagnostic tests used to identify infection in diabetic foot ulcers (DFUs) and of interventions to treat infected DFUs. To use estimates derived from the systematic reviews to create a decision analytic model in order to identify the most effective method of diagnosing and treating infection and to identify areas of research that would lead to large reductions in clinical uncertainty. DATA SOURCES: Electronic databases covering period from inception of the database to November 2002. REVIEW METHODS: Selected studies were assessed against validated criteria and described in a narrative review. The structure of a decision analytic model was derived for two groups of patients in whom diagnostic tests were likely to be used. RESULTS: Three studies that investigated the performance of diagnostic tests for infection on populations including people with DFUs found that there was no evidence that single items on a clinical examination checklist were reliable in identifying infection in DFUs, that wound swabs perform poorly against wound biopsies, and that semi-quantitative analysis of wound swabs may be a useful alternative to quantitative analysis. However, few people with DFUs were included, so it was not possible to tell whether diagnostic performance differs for DFUs relative to wounds of other aetiologies. Twenty-three studies investigated the effectiveness (n = 23) or cost-effectiveness (n = 2) of antimicrobial agents for DFUs. Eight studied intravenous antibiotics, five oral antibiotics, four different topical agents such as dressings, four subcutaneous granulocyte colony stimulating factor (G-CSF), one evaluated oral and topical Ayurvedic preparations and one compared topical sugar versus antibiotics versus standard care. The majority of trials were underpowered and were too dissimilar to be pooled. There was no strong evidence for recommending any particular antimicrobial agent for the prevention of amputation, resolution of infection or ulcer healing. Topical pexiganan cream may be as effective as oral antibiotic treatment with ofloxacin for the resolution of local infection. Ampicillin and sulbactam were less costly than imipenem and cilastatin, a growth factor (G-CSF) was less costly than standard care and cadexomer iodine dressings may be less costly than daily dressings. A decision analytic model was derived for two groups of people, those for whom diagnostic testing would inform treatment--people with ulcers which do not appear infected but whose ulcer is not progressing despite optimal concurrent treatment--and those in whom a first course of antibiotics (prescribed empirically) have failed. There was insufficient information from the systematic reviews or interviews with experts to populate the model with transition probabilities for the sensitivity and specificity of diagnosis of infection in DFUs. Similarly, there was insufficient information on the probabilities of healing, amputation or death in the intervention studies for the two populations of interest. Therefore, we were unable to run the model to inform the most effective diagnostic and treatment strategy. CONCLUSIONS: The available evidence is too weak to be able to draw reliable implications for practice. This means that, in terms of diagnosis, infection in DFUs cannot be reliably identified using clinical assessment. This has implications for determining which patients need formal diagnostic testing for infection, on whether empirical treatment with antibiotics (before the results of diagnostic tests are available) leads to better outcomes, and on identifying the optimal methods of diagnostic testing. With respect to treatment, it is not known whether treatment with systemic or local antibiotics leads to better outcomes or whether any particular agent is more effective. Limited evidence suggests that both G-CSF and cadexomer iodine dressings may be less expensive than 'standard' care, that ampicillin/sulbactam may be less costly than imipenem/cilastatin, and that an unlicensed cream (pexiganan) may be as effective as oral ofloxacin. Further research is needed to ascertain the characteristics of infection in people with DFUs that influence healing and amputation outcomes, to determine whether detecting infection prior to treatment offers any benefit over empirical therapy, and to establish the most effective and cost-effective methods for detecting infection, as well as the relative effectiveness and cost-effectiveness of antimicrobial interventions for DFU infection.

Clinical Experience with the PillCam Patency Capsule prior to Video Capsule Endoscopy: A Real-World Experience.

Background. In patients with known or suspected risk factors for gastrointestinal stenosis, the PillCam patency capsule (PC) is given before a video capsule endoscopy (VCE) in order to minimize the risk of capsule retention (CR). CR is considered unlikely upon excretion of the PC within 30 hours, excretion in an undamaged state after 30 hours, or radiological projection to the colon. Methods. We performed a retrospective analysis of 38 patients with risk factors for CR, who received a PC from 02/2013 to 04/2015 at Klinikum Augsburg. Results. Sixteen of our 38 patients observed a natural excretion after a mean time of 34 hours past ingestion. However, only 8 patients observed excretion within 30 hours, as recommended by the company. In 20 patients passage of the PC into the colon was shown via RFID-scan or radiological imaging (after 33 and 45 hours, resp.). Only 2 patients showed a pathologic PC result. In consequence, 32 patients received the VCE; no CR was observed. Conclusion. Our data indicates that a VCE could safely be performed even if the PC excretion time is longer than 30 hours and the excreted PC was not screened for damage.

Clinical effectiveness, tolerability and cost-effectiveness of newer drugs for epilepsy in adults: a systematic review and economic evaluation.

OBJECTIVES: To examine the clinical effectiveness, tolerability and cost-effectiveness of gabapentin (GBP), lamotrigine (LTG), levetiracetam (LEV), oxcarbazepine (OXC), tiagabine (TGB), topiramate (TPM) and vigabatrin (VGB) for epilepsy in adults. DATA SOURCES: Electronic databases. Internet resources. Pharmaceutical company submissions. REVIEW METHODS: Selected studies were screened and quality assessed. Separate analyses assessed clinical effectiveness, serious, rare and long-term adverse events and cost-effectiveness. An integrated economic analysis incorporating information on costs and effects of newer and older antiepileptic drugs (AEDs) was performed to give direct comparisons of long-term costs and benefits. RESULTS: A total of 212 studies were included in the review. All included systematic reviews were Cochrane reviews and of good quality. The quality of randomised controlled trials (RCTs) was variable. Assessment was hampered by poor reporting of methods of randomisation, allocation concealment and blinding. Few of the non-randomised studies were of good quality. The main weakness of the economic evaluations was inappropriate use of the cost-minimisation design. The included systematic reviews reported that newer AEDs were effective as adjunctive therapy compared to placebo. For newer versus older drugs, data were available for all three monotherapy AEDs, although data for OXC and TPM were limited. There was limited, poor-quality evidence of a significant improvement in cognitive function with LTG and OXC compared with older AEDs. However, there were no consistent statistically significant differences in other clinical outcomes, including proportion of seizure-free patients. No studies assessed effectiveness of AEDs in people with intellectual disabilities or in pregnant women. There was very little evidence to assess the effectiveness of AEDs in the elderly; no significant differences were found between LTG and carbamazepine monotherapy. Sixty-seven RCTs compared adjunctive therapy with placebo, older AEDs or other newer AEDs. For newer AEDs versus placebo, a trend was observed in favour of newer drugs, and there was evidence of statistically significant differences in proportion of responders favouring newer drugs. However, it was not possible to assess long-term effectiveness. Most trials were conducted in patients with partial seizures. For newer AEDs versus older drugs, there was no evidence to assess the effectiveness of LEV, LTG or OXC, and evidence for other newer drugs was limited to single studies. Trials only included patients with partial seizures and follow-up was relatively short. There was no evidence to assess effectiveness of adjunctive LEV, OXC or TPM versus other newer drugs, and there were no time to event or cognitive data. No studies assessed the effectiveness of adjunctive AEDs in the elderly or pregnant women. There was some evidence from one study (GBP versus LTG) that both drugs have some beneficial effect on behaviour in people with learning disabilities. Eighty RCTs reported the incidence of adverse events. There was no consistent or convincing evidence to draw any conclusions concerning relative safety and tolerability of newer AEDs compared with each other, older AEDs or placebo. The integrated economic analysis for monotherapy for newly diagnosed patients with partial seizures showed that older AEDs were more likely to be cost-effective, although there was considerable uncertainty in these results. The integrated analysis suggested that newer AEDs used as adjunctive therapy for refractory patients with partial seizures were more effective and more costly than continuing with existing treatment alone. Combination therapy, involving new AEDs, may be cost-effective at a threshold willingness to pay per quality-adjusted life year (QALY) greater than 20,000 pounds, depending on patients' previous treatment history. There was, again, considerable uncertainty in these results. There were few data available to determine effectiveness of treatments for patients with generalised seizures. LTG and VPA showed similar health benefits when used as monotherapy. VPA was less costly and was likely to be cost-effective. The analysis indicated that TPM might be cost-effective when used as an adjunctive therapy, with an estimated incremental cost-effectiveness ratio of 34,500 pounds compared with continuing current treatment alone. CONCLUSIONS: There was little good-quality evidence from clinical trials to support the use of newer monotherapy or adjunctive therapy AEDs over older drugs, or to support the use of one newer AED in preference to another. In general, data relating to clinical effectiveness, safety and tolerability failed to demonstrate consistent and statistically significant differences between the drugs. The exception was comparisons between newer adjunctive AEDs and placebo, where significant differences favoured newer AEDs. However, trials often had relatively short-term treatment durations and often failed to limit recruitment to either partial or generalised onset seizures, thus limiting the applicability of the data. Newer AEDs, used as monotherapy, may be cost-effective for the treatment of patients who have experienced adverse events with older AEDs, who have failed to respond to the older drugs, or where such drugs are contraindicated. The integrated economic analysis also suggested that newer AEDs used as adjunctive therapy may be cost-effective compared with the continuing current treatment alone given a QALY of about 20,000 pounds. There is a need for more direct comparisons of the different AEDs within clinical trials, considering different treatment sequences within both monotherapy and adjunctive therapy. Length of follow-up also needs to be considered. Trials are needed that recruit patients with either partial or generalised seizures; that investigate effectiveness and cost-effectiveness in patients with generalised onset seizures and that investigate effectiveness in specific populations of epilepsy patients, as well as studies evaluating cognitive outcomes to use more stringent testing protocols and to adopt a more consistent approach in assessing outcomes. Further research is also required to assess the quality of life within trials of epilepsy therapy using preference-based measures of outcomes that generate cost-effectiveness data. Future RCTs should use CONSORT guidelines; and observational data to provide information on the use of AEDs in actual practice, including details of treatment sequences and doses.

Cost-effectiveness of alternative strategies for the initial medical management of non-ST elevation acute coronary syndrome: systematic review and decision-analytical modelling.

OBJECTIVES: To identify and prioritise key areas of clinical uncertainty regarding the medical management of non-ST elevation acute coronary syndrome (ACS) in current UK practice. DATA SOURCES: Electronic databases. Consultations with clinical advisors. Postal survey of cardiologists. REVIEW METHODS: Potential areas of important uncertainty were identified and 'decision problems' prioritised. A systematic literature review was carried out using standard methods. The constructed decision model consisted of a short-term phase that applied the results of the systematic review and a long-term phase that included relevant information from a UK observational study to extrapolate estimated costs and effects. Sensitivity analyses were undertaken to examine the dependence of the results on baseline parameters, using alternative data sources. Expected value of information analysis was undertaken to estimate the expected value of perfect information associated with the decision problem. This provided an upper bound on the monetary value associated with additional research in the area. RESULTS: Seven current areas of clinical uncertainty (decision problems) in the drug treatment of unstable angina patients were identified. The agents concerned were clopidogrel, low molecular weight heparin, hirudin and intravenous glycoprotein antagonists (GPAs). Twelve published clinical guidelines for unstable angina or non-ST elevation ACS were identified, but few contained recommendations about the specified decision problems. The postal survey of clinicians showed that the greatest disagreement existed for the use of small molecule GPAs, and the greatest uncertainty existed for decisions relating to the use of abciximab (a large molecule GPA). Overall, decision problems concerning the GPA class of drugs were considered to be the highest priority for further study. Selected papers describing the clinical efficacy of treatment were divided into three groups, each representing an alternative strategy. The strategy involving the use of GPAs as part of the initial medical management of all non-ST elevation ACS was the optimal choice, with an incremental cost-effectiveness ratio (ICER) of 5738 pounds per quality-adjusted life-year (QALY) compared with no use of GPAs. Stochastic analysis showed that if the health service is willing to pay 10,000 pounds per additional QALY, the probability of this strategy being cost-effective was around 82%, increasing to 95% at a threshold of 50,000 pounds per QALY. A sensitivity analysis including an additional strategy of using GPAs as part of initial medical management only in patients at particular high risk (as defined by age, ST depression or diabetes) showed that this additional strategy was yet more cost-effective, with an ICER of 3996 pounds per QALY compared with no treatment with GPA. Value of information analysis suggested that there was considerable merit in additional research to reduce the level of uncertainty in the optimal decision. At a threshold of 10,000 pounds per QALY, the maximum potential value of such research in the base case was calculated as 12.7 million pounds per annum for the UK as a whole. Taking account of the greater uncertainty in the sensitivity analyses including clopidogrel, this figure was increased to approximately 50 million pounds. CONCLUSIONS: This study suggests the use of GPAs in all non-ST elevation ACS patients as part of their initial medical management. Sensitivity analysis showed that virtually all of the benefit could be realised by treating only high-risk patients. Further clarification of the optimum role of GPAs in the UK NHS depends on the availability of further high-quality observational and trial data. Value of information analysis derived from the model suggests that a relatively large investment in such research may be worthwhile. Further research should focus on the identification of the characteristics of patients who benefit most from GPAs as part of medical management, the comparison of GPAs with clopidogrel as an adjunct to standard care, follow-up cohort studies of the costs and outcomes of high-risk non-ST elevation ACS over several years, and exploring how clinicians' decisions combine a normative evidence-based decision model with their own personal behavioural perspective.

[Endoscopic management of lower gastrointestinal bleeding]. / Endoskopische Therapie der unteren gastrointestinalen Blutung.

Endoscopic hemostasis is the daily challenge that must be mastered by gastroenterologists. An emergency colonoscopy is the procedure of choice for lower gastrointestinal bleeding because of the diagnostic and therapeutic potential. Colonoscopy should be performed after oral preparation with 4-6 l polyethylene glycol solution within 12 h. In the case of massive hematochezia, colonoscopy without oral preparation employinga mechanical pump is possible and is not associated with a higher rate of complications. Many different endoscopic techniques are available (injection therapy, hemoclips, thermal coagulation, topical hemostatic substances). The suitable and most effective method must be chosen depending on the source of bleeding.

The effectiveness and cost-effectiveness of prophylactic removal of wisdom teeth.

BACKGROUND: Removal of wisdom teeth is one of the most common surgical procedures performed in the UK. Little controversy surrounds the removal of impacted third molars when they are associated with pathological changes such as infection, non-restorable carious lesions, cysts, tumours, and destruction of adjacent teeth and bone. However, the justification for prophylactic removal of impacted third molars is less certain and has been debated for many years. OBJECTIVES: To provide a summary of existing evidence on prophylactic removal of impacted wisdom teeth, in terms of the incidence of surgical complications associated with prophylactic removal, and the morbidity associated with retention. METHODS: A systematic review of the research literature was undertaken. METHODS - DATA SOURCES: An existing review formed the basis of this report, and additional literature searches were undertaken, including searches of electronic databases (MEDLINE, 1984-99; EMBASE, 1984-99; Science Citation Index, Cochrane Controlled Trials Register, National Research Register; Database of Abstracts of Reviews of Effectiveness), paper sources (including Clinical Evidence), and web-based resources. Relevant organisations and professional bodies were contacted for further information. METHODS - STUDY SELECTION: Studies were selected for inclusion if they met the following criteria: (1) design - randomised controlled trials (RCTs), literature reviews, or decision analyses; (2) participants - people with unerupted or impacted third molars, or those undergoing surgical removal of third molars either as prophylaxis or due to associated pathological changes; (3) reported outcomes - either the pathological changes associated with retention of third molars, or post-operative complications following extraction. There were no language restrictions on study selection. METHODS - DATA EXTRACTION AND SYNTHESIS: Data from included studies were extracted into structured tables and individual study validity was assessed against methodological checklists. Data were summarised descriptively. Decisions relating to study selection, data extraction and validity assessment were made by two independent reviewers, and disagreements were resolved by discussion. For non-English papers, translators were recruited to assist with study selection and data extraction. RESULTS: Forty studies were included in the review: two RCTs, 34 literature reviews, and four decision analysis studies. One RCT in the UK focused on the effects of retained third molars on incisor crowding (predominantly a cosmetic problem) in patients who had previously undergone orthodontic treatment. The results of this trial suggested that the removal of third molars to prevent late incisor crowding cannot be justified. Another on-going RCT in Denmark compares the effects and costs of prophylactic removal of third molars with removal according to morbidity. So far, this trial has recruited 200 participants, and preliminary results indicate that watchful waiting may be a promising strategy. However, more data and longer follow-up of patients are needed to conclude which treatment strategy is the most cost-effective. It is also known that a trial is on-going in the USA but no results are available so far. The methodological quality of the literature reviews was generally poor, and none of the reviews was systematic. Conclusions from nine reviews on anterior crowding suggested that there was only a weak association between retention of third molars and crowding. Six out of 21 reviews with a more general scope also concluded that the prophylactic removal of third molars was unjustified. Twelve general reviews did not conclude with a clear message about the management of third molars. Three reviews suggested that prophylactic removal of third molars is appropriate, but these reviews were of poorer methodological quality than the majority of other reviews. Three out of four papers focusing on surgical management expressed

Review of guidelines for good practice in decision-analytic modelling in health technology assessment.

OBJECTIVES: To identify existing guidelines and develop a synthesised guideline plus accompanying checklist. In addition to provide guidance on key theoretical, methodological and practical issues and consider the implications of this research for what might be expected of future decision-analytic models. DATA SOURCES: Electronic databases. REVIEW METHODS: A systematic review of existing good practice guidelines was undertaken to identify and summarise guidelines currently available for assessing the quality of decision-analytic models that have been undertaken for health technology assessment. A synthesised good practice guidance and accompanying checklist was developed. Two specific methods areas in decision modelling were considered. The first method's topic is the identification of parameter estimates from published literature. Parameter searches were developed and piloted using a case-study model. The second topic relates to bias in parameter estimates; that is, how to adjust estimates of treatment effect from observational studies where there are risks of selection bias. A systematic literature review was conducted to identify those studies looking at quantification of bias in parameter estimates and the implication of this bias. RESULTS: Fifteen studies met the inclusion criteria and were reviewed and consolidated into a single set of brief statements of good practice. From this, a checklist was developed and applied to three independent decision-analytic models. Although the checklist provided excellent guidance on some key issues for model evaluation, it was too general to pick up on the specific nuances of each model. The searches that were developed helped to identify important data for inclusion in the model. However, the quality of life searches proved to be problematic: the published search filters did not focus on those measures specific to cost-effectiveness analysis and although the strategies developed as part of this project were more successful few data were found. Of the 11 studies meeting the criteria on the effect of selection bias, five concluded that a non-randomised trial design is associated with bias and six studies found 'similar' estimates of treatment effects from observational studies or non-randomised clinical trials and randomised controlled trials (RCTs). One purpose of developing the synthesised guideline and checklist was to provide a framework for critical appraisal by the various parties involved in the health technology assessment process. First, the guideline and checklist can be used by groups that are reviewing other analysts' models and, secondly, the guideline and checklist could be used by the various analysts as they develop their models (to use it as a check on how they are developing and reporting their analyses). The Expert Advisory Group (EAG) that was convened to discuss the potential role of the guidance and checklist felt that, in general, the guidance and checklist would be a useful tool, although the checklist is not meant to be used exclusively to determine a model's quality, and so should not be used as a substitute for critical appraisal. CONCLUSIONS: The review of current guidelines showed that although authors may provide a consistent message regarding some aspects of modelling, in other areas conflicting attributes are presented in different guidelines. In general, the checklist appears to perform well, in terms of identifying those aspects of the model that should be of particular concern to the reader. The checklist cannot, however, provide answers to the appropriateness of the model structure and structural assumptions, as these may be seen as a general problem with generic checklists and do not reflect any shortcoming with the synthesised guidance and checklist developed here. The assessment of the checklist, as well as feedback from the EAG, indicated the importance of its use in conjunction with a more general checklist or guidelines on economic evaluation. Further methods research into the following areas would be valuable: the quantification of selection bias in non-controlled studies and in controlled observational studies; the level of bias in the different non-RCT study designs; a comparison of results from RCTs with those from other non-randomised studies; assessment of the strengths and weaknesses of alternative ways to adjust for bias in a decision model; and how to prioritise searching for parameter estimates.

Generalisability in economic evaluation studies in healthcare: a review and case studies.

OBJECTIVES: To review, and to develop further, the methods used to assess and to increase the generalisability of economic evaluation studies. DATA SOURCES: Electronic databases. REVIEW METHODS: Methodological studies relating to economic evaluation in healthcare were searched. This included electronic searches of a range of databases, including PREMEDLINE, MEDLINE, EMBASE and EconLit, and manual searches of key journals. The case studies of a decision analytic model involved highlighting specific features of previously published economic studies related to generalisability and location-related variability. The case-study involving the secondary analysis of cost-effectiveness analyses was based on the secondary analysis of three economic studies using data from randomised trials. RESULTS: The factor most frequently cited as generating variability in economic results between locations was the unit costs associated with particular resources. In the context of studies based on the analysis of patient-level data, regression analysis has been advocated as a means of looking at variability in economic results across locations. These methods have generally accepted that some components of resource use and outcomes are exchangeable across locations. Recent studies have also explored, in cost-effectiveness analysis, the use of tests of heterogeneity similar to those used in clinical evaluation in trials. The decision analytic model has been the main means by which cost-effectiveness has been adapted from trial to non-trial locations. Most models have focused on changes to the cost side of the analysis, but it is clear that the effectiveness side may also need to be adapted between locations. There have been weaknesses in some aspects of the reporting in applied cost-effectiveness studies. These may limit decision-makers' ability to judge the relevance of a study to their specific situations. The case study demonstrated the potential value of multilevel modelling (MLM). Where clustering exists by location (e.g. centre or country), MLM can facilitate correct estimates of the uncertainty in cost-effectiveness results, and also a means of estimating location-specific cost-effectiveness. The review of applied economic studies based on decision analytic models showed that few studies were explicit about their target decision-maker(s)/jurisdictions. The studies in the review generally made more effort to ensure that their cost inputs were specific to their target jurisdiction than their effectiveness parameters. Standard sensitivity analysis was the main way of dealing with uncertainty in the models, although few studies looked explicitly at variability between locations. The modelling case study illustrated how effectiveness and cost data can be made location-specific. In particular, on the effectiveness side, the example showed the separation of location-specific baseline events and pooled estimates of relative treatment effect, where the latter are assumed exchangeable across locations. CONCLUSIONS: A large number of factors are mentioned in the literature that might be expected to generate variation in the cost-effectiveness of healthcare interventions across locations. Several papers have demonstrated differences in the volume and cost of resource use between locations, but few studies have looked at variability in outcomes. In applied trial-based cost-effectiveness studies, few studies provide sufficient evidence for decision-makers to establish the relevance or to adjust the results of the study to their location of interest. Very few studies utilised statistical methods formally to assess the variability in results between locations. In applied economic studies based on decision models, most studies either stated their target decision-maker/jurisdiction or provided sufficient information from which this could be inferred. There was a greater tendency to ensure that cost inputs were specific to the target jurisdiction than clinical parameters. Methods to assess generalisability and variability in economic evaluation studies have been discussed extensively in the literature relating to both trial-based and modelling studies. Regression-based methods are likely to offer a systematic approach to quantifying variability in patient-level data. In particular, MLM has the potential to facilitate estimates of cost-effectiveness, which both reflect the variation in costs and outcomes between locations and also enable the consistency of cost-effectiveness estimates between locations to be assessed directly. Decision analytic models will retain an important role in adapting the results of cost-effectiveness studies between locations. Recommendations for further research include: the development of methods of evidence synthesis which model the exchangeability of data across locations and allow for the additional uncertainty in this process; assessment of alternative approaches to specifying multilevel models to the analysis of cost-effectiveness data alongside multilocation randomised trials; identification of a range of appropriate covariates relating to locations (e.g. hospitals) in multilevel models; and further assessment of the role of econometric methods (e.g. selection models) for cost-effectiveness analysis alongside observational datasets, and to increase the generalisability of randomised trials.