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1.
BJOG ; 128(13): 2180-2189, 2021 12.
Article in English | MEDLINE | ID: mdl-34473896

ABSTRACT

OBJECTIVE: To report complication rates following prolapse surgery using polypropylene mesh inlay, polypropylene mesh kit, biological collagen xenografts and native tissue repairs. DESIGN: Secondary analysis of the PROSPECT randomised controlled trial and cohort study. SETTING: Thirty-five UK hospitals. POPULATION: A total of 2632 women undergoing anterior and/or posterior vaginal prolapse repair. METHODS: Event rates were calculated for all complications. Analysis was by treatment received. MAIN OUTCOME MEASURES: IUGA/ICS classification of complications and validated patient reported outcome measures. RESULTS: At baseline, 8.4% of women had 'generic' pain/discomfort; at 2 years following surgery, there was an improvement in all four groups; however, 3.0% of women developed de novo extreme generic pain. At 24 months de novo vaginal tightness occurred in 1.6% of native tissue, 1.2% of biological xenograft, 0.3% of mesh inlay and 3.6% of mesh kit. Severe dyspareunia occurred in 4.8% of native tissue, 4.2% of biological xenograft, 3.4% of mesh inlay repairs and 13.0% of mesh kits. De novo severe dyspareunia occurred in 3.5% of native tissue, 3.5% of biological xenograft, 1.4% of mesh inlays and 4.8% of mesh kits. Complications requiring re-admission to hospital, unrelated to mesh, affected 1 in 24 women; the most common reasons for re-admission were vaginal adhesions, urinary retention, infection and constipation. CONCLUSIONS: This is the first study to address the complications of vaginal mesh used for prolapse surgery alongside data from both native tissue and biological xenograft. It demonstrates the complexity of assessing pain and that all types of prolapse surgery have low surgical morbidity and a low rate of severe complications. TWEETABLE ABSTRACT: A prospective study of 2362 women undergoing vaginal mesh, xenograft or native tissue repair found low surgical morbidity and low rates of severe complications.


Subject(s)
Collagen , Gynecologic Surgical Procedures/methods , Heterografts , Pelvic Organ Prolapse/surgery , Plastic Surgery Procedures/methods , Polypropylenes , Uterine Prolapse/surgery , Adult , Cohort Studies , Collagen/therapeutic use , Female , Heterografts/transplantation , Humans , Middle Aged , Patient Satisfaction , Polypropylenes/therapeutic use , Postoperative Complications , Prospective Studies , Surgical Mesh , Treatment Outcome
2.
BJOG ; 127(8): 1002-1013, 2020 07.
Article in English | MEDLINE | ID: mdl-32141709

ABSTRACT

OBJECTIVE: To compare standard (native tissue) repair with synthetic mesh inlays or mesh kits. DESIGN: Randomised controlled trial. SETTING: Thirty-three UK hospitals. POPULATION: Women having surgery for recurrent prolapse. METHODS: Women recruited using remote randomisation. MAIN OUTCOME MEASURES: Prolapse symptoms, condition-specific quality-of-life and serious adverse effects. RESULTS: A Mean Pelvic Organ Prolapse Symptom Score at 1 year was similar for each comparison (standard 6.6 versus mesh inlay 6.1, mean difference [MD] -0.41, 95% CI -2.92 to 2.11: standard 6.6 versus mesh kit 5.9, MD -1.21 , 95% CI -4.13 to 1.72) but the confidence intervals did not exclude a minimally important clinical difference. There was no evidence of difference in any other outcome measure at 1 or 2 years. Serious adverse events, excluding mesh exposure, were similar at 1 year (standard 7/55 [13%] versus mesh inlay 5/52 [10%], risk ratio [RR] 1.05 [0.66-1.68]: standard 3/25 [12%] versus mesh kit 3/46 [7%], RR 0.49 [0.11-2.16]). Cumulative mesh exposure rates over 2 years were 7/52 (13%) in the mesh inlay arm, of whom four women required surgical revision; and 4/46 in the mesh kit arm (9%), of whom two required surgical revision. CONCLUSIONS: We did not find evidence of a difference in terms of prolapse symptoms from the use of mesh inlays or mesh kits in women undergoing repeat prolapse surgery. Although the sample size was too small to be conclusive, the results provide a substantive contribution to future meta-analysis. TWEETABLE ABSTRACT: There is not enough evidence to support use of synthetic mesh inlay or mesh kits for repeat prolapse surgery.


Subject(s)
Gynecologic Surgical Procedures/methods , Patient Satisfaction/statistics & numerical data , Pelvic Organ Prolapse/surgery , Surgical Mesh , Urinary Incontinence/surgery , Uterine Prolapse/surgery , Adult , Coitus , Female , Follow-Up Studies , Gynecologic Surgical Procedures/instrumentation , Humans , Middle Aged , Pelvic Organ Prolapse/physiopathology , Pelvic Organ Prolapse/psychology , Quality of Life , Reoperation/statistics & numerical data , Treatment Outcome , Urinary Incontinence/physiopathology , Urinary Incontinence/psychology , Uterine Prolapse/physiopathology , Uterine Prolapse/psychology
4.
Br J Surg ; 101(12): 1532-40, 2014 Nov.
Article in English | MEDLINE | ID: mdl-25274220

ABSTRACT

BACKGROUND: The treatment of patients with varicose veins constitutes a considerable workload and financial burden to the National Health Service. This study aimed to assess the cost-effectiveness of ultrasound-guided foam sclerotherapy (UGFS) and endovenous laser ablation (EVLA) compared with conventional surgery as treatment for primary varicose veins. METHODS: Participant cost and utility data were collected alongside the UK CLASS multicentre randomized clinical trial, which compared EVLA, surgery and UGFS. Regression methods were used to estimate the effects of the alternative treatments on costs to the health service and quality-adjusted life-years (QALYs) at 6 months. A Markov model, incorporating available evidence on clinical recurrence rates, was developed to extrapolate the trial data over a 5-year time horizon. RESULTS: Compared with surgery at 6 months, UGFS and EVLA reduced mean costs to the health service by £655 and £160 respectively. When additional overhead costs associated with theatre use were included, these cost savings increased to £902 and £392 respectively. UGFS produced 0·005 fewer QALYs, whereas EVLA produced 0·011 additional QALYs. Extrapolating to 5 years, EVLA was associated with increased costs and QALYs compared with UGFS (costing £3640 per QALY gained), and generated a cost saving (£206-439) and QALY gain (0·078) compared with surgery. Applying a ceiling willingness-to-pay ratio of £20 000 per QALY gained, EVLA had the highest probability (78·7 per cent) of being cost-effective. CONCLUSION: The results suggest, for patients considered eligible for all three treatment options, that EVLA has the highest probability of being cost-effective at accepted thresholds of willingness to pay per QALY.


Subject(s)
Laser Therapy/economics , Sclerotherapy/economics , Varicose Veins/economics , Adult , Aged , Combined Modality Therapy/economics , Combined Modality Therapy/methods , Cost-Benefit Analysis , Endovascular Procedures/economics , Endovascular Procedures/methods , Humans , Laser Therapy/methods , Middle Aged , Quality-Adjusted Life Years , Sclerotherapy/methods , Treatment Outcome , Varicose Veins/therapy
5.
Eye (Lond) ; 28(12): 1399-406, 2014 Dec.
Article in English | MEDLINE | ID: mdl-25233820

ABSTRACT

UNLABELLED: The purpose is to study the diagnostic performance of optical coherence tomography (OCT) and alternative diagnostic tests for neovascular age-related macular degeneration (nAMD). Methods employed are as follows:systematic review and meta-analysis; INDEX TEST: OCT including time-domain (TD-OCT) and the most recently developed spectral domain (SD-OCT); comparator tests: visual acuity, clinical evaluation (slit lamp), Amsler chart, colour fundus photographs, infra-red reflectance, red-free images/blue reflectance, fundus autofluorescence imaging (FAF), indocyanine green angiography (ICGA), preferential hyperacuity perimetry (PHP), and microperimetry; reference standard: fundus fluorescein angiography. Databases searched included MEDLINE, MEDLINE In Process, EMBASE, Biosis, SCI, the Cochrane Library, DARE, MEDION, and HTA database. Last literature searches: March 2013. Risk of bias assessed using QUADAS-2. Meta-analysis models were fitted using hierarchical summary receiver operating characteristic (HSROC) curves. Twenty-two studies (2 abstracts and 20 articles) enrolling 2124 participants were identified, reporting TD-OCT (12 studies), SD-OCT (1 study), ICGA (8 studies), PHP (3 studies), Amsler grid, colour fundus photography and FAF (1 study each). Most studies were considered to have a high risk of bias in the patient selection (55%, 11/20), and flow and timing (40%, 8/20) domains. In a meta-analysis of TD-OCT studies, sensitivity and specificity (95% CI) were 88% (46-98%) and 78% (64-88%), respectively. There was insufficient information to undertake meta-analysis for other tests. TD-OCT is a sensitive test for detecting nAMD, although specificity was only moderate. Data on SD-OCT are sparse. Diagnosis of nAMD should not rely solely on OCT.


Subject(s)
Diagnostic Techniques, Ophthalmological , Tomography, Optical Coherence/methods , Wet Macular Degeneration/diagnosis , Coloring Agents , Fluorescein Angiography , Humans , Indocyanine Green , Sensitivity and Specificity , Visual Acuity/physiology
6.
BJOG ; 121(6): 747-53; discussion 754, 2014 May.
Article in English | MEDLINE | ID: mdl-24506529

ABSTRACT

OBJECTIVE: To compare long-term outcomes following microwave endometrial ablation (MEA™) and thermal balloon ablation (TBall). DESIGN: Follow up of a prospective, double-blind randomised controlled trial at 5 years. SETTING: A teaching hospital in the UK. POPULATION: A total of 320 women eligible for and requesting endometrial ablation. METHODS: Eligible women were randomised in a 1:1 ratio to undergo MEA or Tball. Postal questionnaires were sent to participants at a minimum of 5 years postoperatively to determine satisfaction with outcome, menstrual status, bleeding scores and quality of life measurement. Subsequent surgery was ascertained from the women and the hospital operative database. MAIN OUTCOME MEASURES: The primary outcome measure was overall satisfaction with treatment. Secondary outcomes included evaluation of menstrual loss, change in quality of life scores and subsequent surgery. RESULTS: Of the women originally randomised 217/314 (69.1%) returned questionnaires. Nonresponders were assumed to be treatment failures for data analysis. The primary outcome of satisfaction was similar in both groups (58% for MEA™ versus 53% for TBall, difference 5%; 95% CI -6 to 16%). Amenorrhoea rates were high following both techniques (51% versus 45%, difference 6%; 95% CI -5 to 17%). There was no significant difference in the hysterectomy rates between the two arms (9% versus 7%, difference 2%; 95% CI -5 to 9%). CONCLUSIONS: At 5 years post-treatment there were no significant clinical differences in patient satisfaction, menstrual status, quality of life scores or hysterectomy rates between MEA™ and Thermachoice 3, thermal balloon ablation.


Subject(s)
Amenorrhea/therapy , Endometrial Ablation Techniques/methods , Microwaves/therapeutic use , Adult , Amenorrhea/surgery , Double-Blind Method , Female , Follow-Up Studies , Humans , Hysterectomy/statistics & numerical data , Patient Satisfaction , Prospective Studies , Quality of Life , Surveys and Questionnaires , Treatment Outcome , United Kingdom/epidemiology
7.
BJOG ; 121(1): 112-20, 2014 Jan.
Article in English | MEDLINE | ID: mdl-24148807

ABSTRACT

OBJECTIVE: To determine the long-term (12-year) effects of a conservative nurse-led intervention for postnatal urinary incontinence. DESIGN: Follow-up of a randomised controlled trial. SETTING: Community-based intervention in three centres (in the UK and New Zealand). POPULATION: A cohort of 747 women with urinary incontinence at 3 months after childbirth, of whom 471 (63%) were followed up after 12 years. METHODS: Women were randomly allocated to active conservative treatment after delivery (pelvic floor muscle training and bladder training), or to a control group receiving standard care. MAIN OUTCOME MEASURES: Prevalence of urinary incontinence (primary outcome) and faecal incontinence, symptoms and signs of prolapse, and performance of pelvic floor muscle training at 12 years. RESULTS: The significant improvements relative to controls that had been found in urinary incontinence (60 versus 69%; risk difference, RD, -9.1%; 95% confidence interval, 95% CI, -17.3 to -1.0%) and faecal incontinence (4 versus 11%; RD -6.1%; 95% CI -10.8 to -1.6%) at 1 year did not persist for urinary incontinence (83 versus 80%; RD 2.1%; 95% CI -4.9 to 9.1%) or faecal incontinence (19 versus 15%; RD 4.3%; 95% CI -2.5 to 11.0%) at the 12-year follow up, irrespective of incontinence severity at trial entry. The prevalence of prolapse symptoms or objectively measured pelvic organ prolapse also did not differ between the groups. In the short term the intervention motivated more women to perform pelvic floor muscle training (83 versus 55%), but this fell in both groups by 12 years (52 versus 49%). CONCLUSIONS: The moderate short-term benefits of a brief nurse-led conservative treatment for postnatal urinary incontinence did not persist. About four-fifths of women with urinary incontinence 3 months after childbirth still had this problem 12 years later.


Subject(s)
Exercise Therapy/methods , Fecal Incontinence/rehabilitation , Pelvic Organ Prolapse/prevention & control , Postpartum Period , Urinary Incontinence/rehabilitation , Adult , Delivery, Obstetric , Female , Humans , Longitudinal Studies , Practice Patterns, Nurses' , Treatment Outcome , Young Adult
8.
Health Technol Assess ; 17(29): 1-386, 2013 Jul.
Article in English | MEDLINE | ID: mdl-23870108

ABSTRACT

BACKGROUND: Denosumab offers an alternative, or additional, treatment for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumours. OBJECTIVES: The aim of this review was to assess the clinical effectiveness and cost-effectiveness of denosumab, within its licensed indication, for the prevention of SREs in patients with bone metastases from solid tumours. DATA SOURCES: Databases searched were MEDLINE (1948 to April 2011), EMBASE (1980 to March 2011), The Cochrane Library (all sections; Issue 1, 2011) and Web of Science with Conference Proceedings (1970 to May 2011). REVIEW METHODS: Only randomised controlled trials (RCTs) assessing denosumab, bisphosphonates (BPs) or best supportive care (BSC) in patients with bone metastases were included. Systematic reviews and observational studies were used for safety and quality-of-life assessments. Study quality was assessed using the Cochrane risk of bias tool. Studies suitable for meta-analysis were synthesised using network meta-analysis (NMA). A systematic review was conducted for cost, quality-of-life and cost-effectiveness studies. The results of this informed the cost-utility modelling. This principally estimated the cost-effectiveness of denosumab relative to zoledronic acid for when BPs are currently recommended and relative to BSC when BPs are not recommended or are contraindicated. RESULTS: A literature search identified 39 studies (eight suitable for NMA). Denosumab was effective in delaying time to first SRE and reducing the risk of multiple SREs compared with zoledronic acid. Generally speaking, denosumab was similar to zoledronic acid for quality of life, pain, overall survival and safety. The NMA demonstrated that denosumab was more effective in delaying SREs than placebo, but was limited by numerous uncertainties. Cost-utility modelling results for denosumab relative to zoledronic acid were driven by the availability of the patient access scheme (PAS) for denosumab. Without this, denosumab was not estimated to be cost-effective compared with zoledronic acid. With it, the cost-effectiveness ranged between dominance for breast and prostate cancer, to between £5400 and £15,300 per quality-adjusted life-year (QALY) for other solid tumours (OSTs) including non-small cell lung cancer (NSCLC) and £12,700 per QALY for NSCLC. Owing to small patient gains estimated, the cost-effectiveness of denosumab was very sensitive to the zoledronic acid price. Denosumab was not estimated to be cost-effective compared with BSC. LIMITATIONS: Only subgroup data were available for denosumab for NSCLC, and OSTs excluding NSCLC. The NMA was subject to numerous uncertainties. Owing to small patient gains estimated, the cost-effectiveness of denosumab was very sensitive to the zoledronic acid price. CONCLUSION: Denosumab, compared with zoledronic acid and placebo, is effective in delaying SREs, but is similar with regard to quality of life and pain. Cost-effectiveness showed that without the PAS denosumab was not estimated to be cost-effective relative to either zoledronic acid or BSC. With the PAS, denosumab was estimated to be cost-effective relative to zoledronic acid but not BSC. STUDY REGISTRATION: PROSPERO number CRD42011001418. FUNDING: The National Institute for Health Research Health Technology Assessment programme.


Subject(s)
Antibodies, Monoclonal, Humanized/economics , Antibodies, Monoclonal, Humanized/therapeutic use , Bone Neoplasms/metabolism , Bone Density Conservation Agents/economics , Bone Density Conservation Agents/therapeutic use , Breast Neoplasms/pathology , Cost-Benefit Analysis , Denosumab , Female , Humans , Lung Neoplasms/pathology , Male , Models, Economic , Prostatic Neoplasms/pathology , Quality-Adjusted Life Years , Randomized Controlled Trials as Topic
9.
BJOG ; 120(2): 161-168, 2013 Jan.
Article in English | MEDLINE | ID: mdl-23190018

ABSTRACT

OBJECTIVES: To investigate prolapse symptoms and objectively measured pelvic organ prolapse, 12 years after childbirth, and association with delivery mode history. DESIGN: Twelve-year longitudinal study. SETTING: Maternity units in Aberdeen, Birmingham and Dunedin. POPULATION: Women dwelling in the community. METHODS: Data from women were collected 12 years after an index birth and women were invited for examination. Logistic regression investigated associations between risk factors and prolapse symptoms and signs. MAIN OUTCOME MEASURES: Prolapse symptom score (POP-SS); objectively measured prolapse (POP-Q). RESULTS: Of 7725 continuing women, 3763 (49%) returned questionnaires at 12 years. The median POP-SS score was 2 (IQR 0-4). One or more forceps deliveries (OR 1.20, 95% CI 1.04-1.38) and a body mass index (BMI) over 25 were associated with higher (worse) POP-SS scores, but age over 25 years at first delivery was associated with lower (better) scores. There was no protective effect if all deliveries were by caesarean section (OR 0.84, 95% CI 0.69-1.02). Objective prolapse was found in 182/762 (24%) women. Women aged over 30 years when having their first baby and parity were significantly associated with prolapse. Compared with women whose births were all spontaneous vaginal deliveries, women who had all births by caesarean section were the least likely to have prolapse (OR 0.11, 95% CI 0.03-0.38), and there was a reduced risk after forceps or a mixture of spontaneous vaginal delivery and caesarean section. CONCLUSIONS: These findings are at odds with each other, suggesting that prolapse symptoms and objective prolapse may not be in concordance, or are associated with different antecedent factors. Further follow-up is planned.


Subject(s)
Delivery, Obstetric , Parturition , Pelvic Organ Prolapse/diagnosis , Adult , Cesarean Section , Delivery, Obstetric/adverse effects , Delivery, Obstetric/methods , Extraction, Obstetrical/adverse effects , Female , Health Surveys , Humans , Logistic Models , Longitudinal Studies , Middle Aged , New Zealand/epidemiology , Pelvic Organ Prolapse/epidemiology , Pelvic Organ Prolapse/etiology , Pregnancy , Risk Factors , Surveys and Questionnaires , United Kingdom/epidemiology
10.
Health Technol Assess ; 16(29): 1-271, iii-iv, 2012 Jun.
Article in English | MEDLINE | ID: mdl-22687263

ABSTRACT

OBJECTIVES: To determine effective and efficient monitoring criteria for ocular hypertension [raised intraocular pressure (IOP)] through (i) identification and validation of glaucoma risk prediction models; and (ii) development of models to determine optimal surveillance pathways. DESIGN: A discrete event simulation economic modelling evaluation. Data from systematic reviews of risk prediction models and agreement between tonometers, secondary analyses of existing datasets (to validate identified risk models and determine optimal monitoring criteria) and public preferences were used to structure and populate the economic model. SETTING: Primary and secondary care. PARTICIPANTS: Adults with ocular hypertension (IOP > 21 mmHg) and the public (surveillance preferences). INTERVENTIONS: We compared five pathways: two based on National Institute for Health and Clinical Excellence (NICE) guidelines with monitoring interval and treatment depending on initial risk stratification, 'NICE intensive' (4-monthly to annual monitoring) and 'NICE conservative' (6-monthly to biennial monitoring); two pathways, differing in location (hospital and community), with monitoring biennially and treatment initiated for a ≥ 6% 5-year glaucoma risk; and a 'treat all' pathway involving treatment with a prostaglandin analogue if IOP > 21 mmHg and IOP measured annually in the community. MAIN OUTCOME MEASURES: Glaucoma cases detected; tonometer agreement; public preferences; costs; willingness to pay and quality-adjusted life-years (QALYs). RESULTS: The best available glaucoma risk prediction model estimated the 5-year risk based on age and ocular predictors (IOP, central corneal thickness, optic nerve damage and index of visual field status). Taking the average of two IOP readings, by tonometry, true change was detected at two years. Sizeable measurement variability was noted between tonometers. There was a general public preference for monitoring; good communication and understanding of the process predicted service value. 'Treat all' was the least costly and 'NICE intensive' the most costly pathway. Biennial monitoring reduced the number of cases of glaucoma conversion compared with a 'treat all' pathway and provided more QALYs, but the incremental cost-effectiveness ratio (ICER) was considerably more than £30,000. The 'NICE intensive' pathway also avoided glaucoma conversion, but NICE-based pathways were either dominated (more costly and less effective) by biennial hospital monitoring or had a ICERs > £30,000. Results were not sensitive to the risk threshold for initiating surveillance but were sensitive to the risk threshold for initiating treatment, NHS costs and treatment adherence. LIMITATIONS: Optimal monitoring intervals were based on IOP data. There were insufficient data to determine the optimal frequency of measurement of the visual field or optic nerve head for identification of glaucoma. The economic modelling took a 20-year time horizon which may be insufficient to capture long-term benefits. Sensitivity analyses may not fully capture the uncertainty surrounding parameter estimates. CONCLUSIONS: For confirmed ocular hypertension, findings suggest that there is no clear benefit from intensive monitoring. Consideration of the patient experience is important. A cohort study is recommended to provide data to refine the glaucoma risk prediction model, determine the optimum type and frequency of serial glaucoma tests and estimate costs and patient preferences for monitoring and treatment. FUNDING: The National Institute for Health Research Health Technology Assessment Programme.


Subject(s)
Antihypertensive Agents/economics , Antihypertensive Agents/therapeutic use , Glaucoma, Open-Angle/prevention & control , Ocular Hypertension/drug therapy , Ocular Hypertension/economics , Administration, Ophthalmic , Age Factors , Antihypertensive Agents/administration & dosage , Cohort Studies , Cost-Benefit Analysis , Humans , Intraocular Pressure , Mass Screening , Models, Theoretical , Ocular Hypertension/epidemiology , Quality-Adjusted Life Years , Randomized Controlled Trials as Topic , Risk Assessment
11.
Health Technol Assess ; 15(25): 1-178, 2011 Jun.
Article in English | MEDLINE | ID: mdl-21689502

ABSTRACT

BACKGROUND: Imatinib dose escalation is advocated for gastrointestinal stromal tumour (GIST) treatment, but its effectiveness compared with sunitinib and best supportive care (BSC) after failure at the 400 mg/day dose is unknown. OBJECTIVES: To assess the effectiveness and cost-effectiveness of imatinib at escalated doses of 600 or 800 mg/day for patients with unresectable and/or metastatic GISTs whose disease had progressed on 400 mg/day. DATA SOURCES: Electronic databases, including MEDLlNE, MEDLINE In-Process, EMBASE, BIOSIS, Science Citation Index, Health Management Information Consortium and the Cochrane Controlled Trials Register, were searched until September 2009. REVIEW METHODS: A systematic review of the literature was carried out according to standard methods. An economic model was constructed to assess the cost-effectiveness of seven alternative pathways for treating patients with unresectable and/or metastatic GISTs. RESULTS: Five primary studies involving 669 people were included for clinical effectiveness; four reported imatinib and one reported sunitinib. The data were essentially observational as none of the studies was designed to specifically assess treatment of patients whose disease had progressed on 400 mg/day imatinib. For 600 mg/day imatinib, between 26% and 42% of patients showed either a partial response (PR) or stable disease (SD). Median time to progression was 1.7 months (range 0.7-24.9 months). For 800 mg/day imatinib, between 29% and 33% of patients showed either a PR or SD. Median overall survival (OS) was 19 months [95% confidence interval (CI) 13 to 23 months]. Progression-free survival ranged from 81 days to 5 months (95% CI 2 to 10 months). Median duration of response was 153 days (range 37-574 days). Treatment progression led to 88% discontinuations but between 16% and 31% of patients required a dose reduction, and 23% required a dose delay. There was a statistically significant increase in the severity of fatigue (p < 0.001) and anaemia (p = 0.015) following dose escalation. For sunitinib, median OS was 90 weeks (95% CI 73 to 106 weeks). For the cost-effectiveness review, only one full-text study and one abstract were identified, comparing imatinib at an escalated dose, sunitinib and BSC, although neither was based on a UK context. The definition of BSC was not consistent across the studies, and the pattern of resources (including drugs for treatment) and measures of effectiveness also varied. Within the model, BSC (assumed to include continuing medication to prevent tumour flare) was the least costly and least effective. It would be the care pathway most likely to be cost-effective when the cost per quality-adjusted life-year threshold was < £25,000. Imatinib at 600 mg/day was most likely to be cost-effective at a threshold between £25,000 and £45,000. Imatinib at 600 mg/day followed by further escalation followed by sunitinib was most likely to be cost-effective at a threshold > £45,000. LIMITATIONS: The evidence base was sparse, data were non-randomised and potentially biased. The economic model results are surrounded by a considerable degree of uncertainty and open to biases of unknown magnitude and direction. CONCLUSIONS: Around one-third of patients with unresectable and/or metastatic GIST, who fail on 400 mg/day of imatinib, may show response or SD with escalated doses. Between a threshold of £25,000 and £45,000, provision of an escalated dose of imatinib would be most likely to be cost-effective. However, these results should be interpreted with caution owing to the limited evidence available on outcomes following imatinib dose escalation or sunitinib for this group of patients. FUNDING: The National Institute for Health Research Health Technology Assessment programme.


Subject(s)
Antineoplastic Agents/economics , Gastrointestinal Stromal Tumors/drug therapy , Piperazines/economics , Pyrimidines/economics , Antineoplastic Agents/administration & dosage , Antineoplastic Agents/therapeutic use , Benzamides , Confidence Intervals , Cost-Benefit Analysis , Disease Progression , Gastrointestinal Stromal Tumors/economics , Gastrointestinal Stromal Tumors/pathology , Humans , Imatinib Mesylate , Incidence , Models, Economic , Piperazines/administration & dosage , Piperazines/therapeutic use , Pyrimidines/administration & dosage , Pyrimidines/therapeutic use , Quality-Adjusted Life Years , Survival Analysis , Time Factors , Treatment Outcome , Uncertainty , United States
12.
Public Health ; 123(2): 134-7, 2009 Feb.
Article in English | MEDLINE | ID: mdl-19185887

ABSTRACT

OBJECTIVES: To identify factors influencing hospital re-admission with self-poisoning. STUDY DESIGN: Retrospective cohort follow-up study using national linked hospital discharge data. METHODS: All Scottish adult hospital episodes with self-poisoning admissions were captured using NHS Scotland Information Services Division data, and first-time 'index' admissions between 1996 and 2002 were identified. Re-admission rate was defined as the proportion of index admissions who went on to have one or more further self-poisoning admissions within 2 years. The effects of various potential risk factors for re-admission were examined using logistic regression. RESULTS: In total, 50,891 index admissions were identified; of these, 8278 patients were re-admitted. The 1-year re-admission rate was 12.2%. Older patients (>65 years) were least likely to be re-admitted [odds ratio (OR) 0.40, P<0.01, compared with patients aged 15-24 years]. No differences were found between males and females. Previous psychiatric hospital admission was associated with an increased re-admission rate (OR 2.85, P<0.01), with a diagnosis of personality disorder associated with the highest rate of re-admission (OR 4.59, P<0.01). Other factors predicting re-admission were: increased deprivation (quintile 3: OR 1.16, P<0.01; quintile 5: OR 1.15, P<0.01, compared with quintile 1); taking medicines for chronic disease, drug dependency (OR 1.6 and 1.19, P < or = 0.02) or antidepressants (OR 1.11, P=0.01) (compared with paracetamol); and co-ingestion of three or more agents (OR 1.37, P<0.01). CONCLUSION: Younger age, higher deprivation, ingestion of certain drug groups or multiple drug types, and prior psychiatric hospital admission are all risk factors for re-admission with self-poisoning. Personality disorder carried the greatest risk of re-admission. These findings may provide a basis to develop policies to reduce re-admission rates in the future.


Subject(s)
Patient Readmission/statistics & numerical data , Poisoning/epidemiology , Poisoning/psychology , Suicide, Attempted/statistics & numerical data , Adolescent , Adult , Aged , Female , Humans , Logistic Models , Male , Middle Aged , Retrospective Studies , Risk Factors , Scotland/epidemiology
13.
J Public Health (Oxf) ; 29(4): 405-12, 2007 Dec.
Article in English | MEDLINE | ID: mdl-17916551

ABSTRACT

OBJECTIVE: To determine the association between risk factors and hospital admission. METHODS: The 1998 Scottish Health Survey was linked to the Scottish hospital admission database. FINDINGS: Smoking was the most important behavioural risk factor (hazard ratio: 1.90, 95% CI: 1.59-2.27). Other behavioural risk factors yielded small but largely anticipated results. Hazard ratios for biological risks increased predictably but with some exceptions (blood pressure and total cholesterol). The top quintile for C-reactive protein showed almost double the risk of admission compared with the bottom quintile (hazard ratio: 1.93, 95% CI: 1.52-2.46). Elevated body mass index (BMI) increased the risk of serious admission (hazard ratio: 1.23, 95% CI: 1.03-1.47) and raised gamma-GT increased this risk by 20% (hazard ratio: 1.20, 95% CI: 1.04-1.38). Forced expiratory volume was the 'biological' factor with the largest risk (hazard ratio for lowest category: 1.82, 95% CI: 1.49-2.22). All the measures of social position showed variable effects on the risk of hospital admission. Large effects on risk were associated with self assessed health, longstanding illness and previous admission. CONCLUSION: The linkage of national surveys with a prospective hospitalization database will develop into an increasingly powerful tool.


Subject(s)
Hospitalization/statistics & numerical data , Risk-Taking , Social Class , Adolescent , Adult , Aged , Databases as Topic , Female , Health Status Indicators , Health Surveys , Humans , Interviews as Topic , Male , Middle Aged , Proportional Hazards Models , Risk Factors , Scotland/epidemiology
14.
Aliment Pharmacol Ther ; 24(1): 65-79, 2006 Jul 01.
Article in English | MEDLINE | ID: mdl-16803604

ABSTRACT

BACKGROUND: While overall hospital admission rates for peptic ulcer declined in England in the 1990 s, they increased among the elderly, especially for complicated ulcer. However, peptic ulcer admissions fell for all age groups in the United States. AIM: To examine time trends in the incidence of hospital admissions, mortality and operations because of peptic ulcer in Scotland from 1982 to 2002, and the use of various drugs relevant to the aetiology and treatment of peptic ulcer from 1992 to 2002. RESULTS: There was a general decrease in admission rates, especially for younger individuals. For individuals aged above 74 years, admission rates actually increased for gastric ulcer with haemorrhage among men, and for duodenal ulcer haemorrhage between both sexes. The number of operations fell dramatically, especially for younger patients. Mortality rates generally declined. Case fatality rates were greater for women than men, and declined over the study period for gastric ulcer, but increased for duodenal ulcer. The use of low-dose aspirin, oral anticoagulants, selective serotonin reuptake inhibitors and proton-pump inhibitors increased while those of non-steroidal anti-inflammatory drugs and histamine-2 antagonists declined. CONCLUSIONS: Admission rates for peptic ulcer generally fell for younger individuals, but increased for older people with haemorrhage.


Subject(s)
Hospitalization/statistics & numerical data , Peptic Ulcer/mortality , Adult , Aged , Female , Humans , Male , Middle Aged , Mortality/trends , Peptic Ulcer/drug therapy , Practice Patterns, Physicians'/statistics & numerical data , Scotland/epidemiology
15.
Eur J Obstet Gynecol Reprod Biol ; 37(1): 95-8, 1990 Oct.
Article in English | MEDLINE | ID: mdl-2376283

ABSTRACT

An eclamptic primigravid patient is presented in whom central monitoring by a Swan-Ganz pulmonary artery catheter led to a series of complications, including the Mendelson's syndrome of necrotisizing pneumonia, resulting in severe maternal morbidity and in fetal mortality.


Subject(s)
Catheterization, Swan-Ganz/adverse effects , Eclampsia/diagnosis , Fetal Death/etiology , Pneumonia, Aspiration/etiology , Tachycardia/etiology , Adult , Female , Humans , Pregnancy , Pulmonary Edema/etiology , Pulmonary Edema/therapy , Pulmonary Embolism/etiology , Pulmonary Embolism/therapy , Tracheostomy/adverse effects
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