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author:("baycox, A")
1.  Induction of labour in pre-eclamptic women: a randomised trial comparing the Foley balloon catheter with oral misoprostol 
Between 40,000 and 80,000 pregnant women die annually from pre-eclampsia and eclampsia. Although magnesium sulphate and anti-hypertensive therapies can reduce the morbidity and mortality associated with pre-eclampsia, the only cure comes with delivery. Prompt delivery of the baby, preferably by vaginal route, is vital in order to achieve good maternal and neonatal outcomes. Induction of labour is therefore a critical intervention in order to prevent morbidity to both mother and baby. Two low cost interventions – oral misoprostol tablets and transcervical Foley catheterization – are already used by some in low resource settings, but their relative risks and benefits are not known. The trial will compare the risks, benefits, and trade-offs in efficacy, safety, acceptability and cost of misoprostol and Foley catheter for induction in women with preeclampsia or uncontrolled hypertension.
A total of 602 women with an ongoing pregnancy with a live fetus requiring delivery because of pre-eclampsia or uncontrolled hypertension will be randomly assigned to labor induction with a transcervical Foley catheter or oral misoprostol 25 micrograms. Women will be recruited at two hospitals in Nagpur, India. The misoprostol group will receive oral misoprostol 25 microgram every 2 hours for a maximum of 12 doses or until active labor commences. The Foley group will undergo induction using a Foley catheter (silicone, size 18 F with 30 ml balloon) which will remain until active labor starts, the Foley catheter falls out, or 12 hours have elapsed. The primary outcome will be the attainment of vaginal delivery within 24 hours. Providers administering the treatment and those assessing the outcomes will not be blinded to group assignment.
Trial registration
NCT01801410 (
PMCID: PMC4261642  PMID: 25193157
Preeclampsia; Misoprostol; Foley catheter; Induction of labor
2.  Personalizing health care: feasibility and future implications 
BMC Medicine  2013;11:179.
Considerable variety in how patients respond to treatments, driven by differences in their geno- and/ or phenotypes, calls for a more tailored approach. This is already happening, and will accelerate with developments in personalized medicine. However, its promise has not always translated into improvements in patient care due to the complexities involved. There are also concerns that advice for tests has been reversed, current tests can be costly, there is fragmentation of funding of care, and companies may seek high prices for new targeted drugs. There is a need to integrate current knowledge from a payer’s perspective to provide future guidance. Multiple findings including general considerations; influence of pharmacogenomics on response and toxicity of drug therapies; value of biomarker tests; limitations and costs of tests; and potentially high acquisition costs of new targeted therapies help to give guidance on potential ways forward for all stakeholder groups. Overall, personalized medicine has the potential to revolutionize care. However, current challenges and concerns need to be addressed to enhance its uptake and funding to benefit patients.
PMCID: PMC3750765  PMID: 23941275
Biomarkers; Drug development; Genomics; Genotyping; Healthcare policy; Pharmacogenetics precision medicine; Personalized medicine; Health authorities; Rational use of medicines; Reimbursement; Targeted treatments
3.  Dabigatran – a case history demonstrating the need for comprehensive approaches to optimize the use of new drugs 
Background: There are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are safety and/or budget concerns. Dabigatran, a new oral anticoagulant for the prevention of stroke in patients with non-valvular atrial fibrillation (AF), exemplifies this issue. Whilst new effective treatments are needed, there are issues in the elderly with dabigatran due to variable drug concentrations, no known antidote and dependence on renal elimination. Published studies have shown dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. There are also issues with potentially re-designing anticoagulant services. This has resulted in activities across countries to better manage its use.
Objective: To (i) review authority activities in over 30 countries and regions, (ii) use the findings to develop new models to better manage the entry of new drugs, and (iii) review the implications for all major stakeholder groups.
Methodology: Descriptive review and appraisal of activities regarding dabigatran and the development of guidance for groups through an iterative process.
Results: There has been a plethora of activities among authorities to manage the prescribing of dabigatran including extensive pre-launch activities, risk sharing arrangements, prescribing restrictions, and monitoring of prescribing post-launch. Reimbursement has been denied in some countries due to concerns with its budget impact and/or excessive bleeding. Development of a new model and future guidance is proposed to better manage the entry of new drugs, centering on three pillars of pre-, peri-, and post-launch activities.
Conclusion: Models for introducing new drugs are essential to optimize their prescribing especially where there are concerns. Without such models, new drugs may be withdrawn prematurely and/or struggle for funding.
PMCID: PMC3653065  PMID: 23717279
critical drug evaluation; dabigatran; demand-side measures; drug and therapeutics committees; managed introduction new medicines; pharmacovigilance; registries; risk sharing
4.  The Iranian Health Insurance System; Past Experiences, Present Challenges And Future Strategies 
The Iranian healthcare system is primarily an insurance based system. This structure has an important influence on the efficiency and equity of the provision of healthcare in Iran. This paper reviews the history of the Iranian healthcare system and the impact of the Iranian health insurance system on healthcare performance based on the results of interviews with key opinion leaders and empirical evidence.
This review uses mixed methods: a systematic literature review of electronic databases supplemented by hand searching of books and journals including Government publications and other grey literature. The issues identified were explored through a series of semi-structured interviews with key informants from within the Iranian healthcare system. The interviews were recorded transcribed, coded, classified, and analysed thematically. Empirical evidence was also sought to support or contradict the views expressed in the interviews.
Sixteen interviews with key informants were conducted and presented anonymously. The interviewees raised many issues which were summarised into five main issues: increasing health expenditures, lack of systematic health technology assessment, very limited financial resources, challenging management and regulation, and uncovered population.
A wide range of issues have affected the efficiency, quality and equity of the services provided by the Iranian healthcare system. The initial and most important step toward improving the efficiency, equity and quality of the health insurance system is to focus on evidence-based policy making to generate feasible, reasonable and comprehensive reforms.
PMCID: PMC3494208  PMID: 23193499
Health; Insurance; Strategy; Iran
5.  Health Care Financing In Iran; Is Privatization A Good Solution? 
This paper considers a range of issues related to the financing of health care system and relevant government policies in Iran.
This study used mixed methods. A systematic literature review was undertaken to identify relevant publications. This was supplemented by hand searching in books and journals, including government publications. The issues and uncertainties identified in the literature were explored in detail through semi-structured interviews with key informants. These were triangulated with empirical evidence in the form of the literature, government statistics and independent expert opinions to validate the views expressed in the interviews.
The systematic review of published literature showed that no previous publication has addressed issues relating to the financing of healthcare services in Iran. However, a range of opinion pieces outlined issues to be explored further in the interviews. Such issues summarised into four main categories.
The health care market in Iran has faced a period in which financial issues have enhanced managerial complexity. Privatization of health care services would appear to be a step too far in assisting the system to confront its challenges at the current time. The most important step toward solving such challenges is to focus on a feasible, relevant and comprehensive policy, which optimises the use of health care resources in Iran.
PMCID: PMC3469022  PMID: 23113205
Healthcare; Financing; privatization; Iran
6.  Risk sharing arrangements for pharmaceuticals: potential considerations and recommendations for European payers 
There has been an increase in 'risk sharing' schemes for pharmaceuticals between healthcare institutions and pharmaceutical companies in Europe in recent years as an additional approach to provide continued comprehensive and equitable healthcare. There is though confusion surrounding the terminology as well as concerns with existing schemes.
Aliterature review was undertaken to identify existing schemes supplemented with additional internal documents or web-based references known to the authors. This was combined with the extensive knowledge of health authority personnel from 14 different countries and locations involved with these schemes.
Results and discussion
A large number of 'risk sharing' schemes with pharmaceuticals are in existence incorporating both financial-based models and performance-based/outcomes-based models. In view of this, a new logical definition is proposed. This is "risk sharing' schemes should be considered as agreements concluded by payers and pharmaceutical companies to diminish the impact on payers' budgets for new and existing schemes brought about by uncertainty and/or the need to work within finite budgets". There are a number of concerns with existing schemes. These include potentially high administration costs, lack of transparency, conflicts of interest, and whether health authorities will end up funding an appreciable proportion of a new drug's development costs. In addition, there is a paucity of published evaluations of existing schemes with pharmaceuticals.
We believe there are only a limited number of situations where 'risk sharing' schemes should be considered as well as factors that should be considered by payers in advance of implementation. This includes their objective, appropriateness, the availability of competent staff to fully evaluate proposed schemes as well as access to IT support. This also includes whether systematic evaluations have been built into proposed schemes.
PMCID: PMC2906457  PMID: 20529296
7.  Economic evaluation of an acute paediatric hospital at home clinical trial 
Archives of Disease in Childhood  2002;87(6):489-492.
Aims: To compare the privately borne and NHS costs of hospital at home (HAH) and conventional inpatient care for children with selected acute conditions.
Methods: Prospective economic evaluation using cost minimisation analysis within a randomised controlled trial, in paediatric wards of a district general hospital, and private homes in the local catchment area in Wirral, Merseyside. Subjects were children who fulfilled the criteria for admission to HAH, suffering from breathing difficulties (n = 202), diarrhoea and vomiting (n = 125), or fever (n = 72).
Results: Direct costs borne by families are reduced by 41% for HAH patients (£23.31 v £13.76, p = 0.001). There is no evidence that HAH transfers the burden of care to parents, and there is no difference in absence rates from paid employment. Patients and their carers expressed a strong preference for HAH. Comparison of NHS costs is equivocal, depending on how HAH is implemented alongside the conventional hospital service.
Conclusion: Paediatric HAH schemes are unlikely to reduce NHS costs and do not increase privately borne costs. They will, however, significantly increase patient and carer satisfaction with care provision for sick children with appropriate conditions.
PMCID: PMC1755818  PMID: 12456545
8.  Randomised controlled trial comparing an acute paediatric hospital at home scheme with conventional hospital care 
Archives of Disease in Childhood  2002;87(5):371-375.
Aims: To assess the clinical effectiveness of a paediatric hospital at home service compared to conventional hospital care.
Methods: A total of 399 children suffering from breathing difficulty (n = 202), diarrhoea and vomiting (n = 125), or fever (n = 72) were randomised to Hospital at Home or in-patient paediatric care. Main outcome measures were: comparative clinical effectiveness as measured by readmission rate within three months (used as a proxy for parental coping with illness); and length of stay/care and comparative satisfaction of both patients and carers.
Results: Clinical effectiveness of both services was not significantly different. Length of care was one day longer in the Hospital at Home group; however, most parents and children preferred home care.
Conclusions: Hospital at Home is a clinically acceptable form of care for these groups of acute paediatric illness. Readmission rates within three months failed to show any advantage in terms of parental coping. Parents and patients expressed a strong preference for hospital at home.
PMCID: PMC1763073  PMID: 12390903
9.  Treatment for newly diagnosed hypertension: patterns of prescribing and antihypertensive effectiveness in the UK 
Improved practice in the management of hypertension depends on an understanding of existing patterns of treatment. To describe the management of newly diagnosed hypertension in British general practice and the effectiveness of current prescribing patterns we conducted a retrospective observational study using data from a computerized general practitioner record database (DIN-LINK).
21 024 patients were first treated for newly diagnosed hypertension between January 1993 and December 1997, and were followed for 4 years. Diuretics or beta-blockers were the most widely prescribed first-line treatments, used in 54% of patients. The mean continuation rate for first-line therapy was 69% at 12 months: the continuation rate was highest for angiotensin converting enzyme inhibitors/angiotensin II receptor antagonists. After 12 months of treatment the mean blood pressure reduction was 19/10 mmHg. Blood pressure targets were met in only 14% of patients. After 48 months of treatment 34% of patients had not improved in band of blood pressure severity. Many patients with severe hypertension at 12 months were still being prescribed only one drug.
The lack of aggression in antihypertensive treatment, indicated by the low number of agents prescribed and the failure to achieve targets, is disappointing. Prescribing patterns for first-line therapy corresponded to guidelines. Continuation rates on first-line therapy were higher than often reported. The choice of drug for additions to or switches from first-line therapy had no clear pattern. Routinely collected computerized data could be used to support clinical governance activities in primary care.
PMCID: PMC539623  PMID: 14594958
10.  Systematic review of cost effectiveness studies of telemedicine interventions 
BMJ : British Medical Journal  2002;324(7351):1434-1437.
To systematically review cost benefit studies of telemedicine.
Systematic review of English language, peer reviewed journal articles.
Data sources
Searches of Medline, Embase, ISI citation indexes, and database of Telemedicine Information Exchange.
Studies selected
55 of 612 identified articles that presented actual cost benefit data.
Main outcome measures
Scientific quality of reports assessed by use of an established instrument for adjudicating on the quality of economic analyses.
557 articles without cost data categorised by topic. 55 articles with data initially categorised by cost variables employed in the study and conclusions. Only 24/55 (44%) studies met quality criteria justifying inclusion in a quality review. 20/24 (83%) restricted to simple cost comparisons. No study used cost utility analysis, the conventional means of establishing the “value for money” that a therapeutic intervention represents. Only 7/24 (29%) studies attempted to explore the level of utilisation that would be needed for telemedicine services to compare favourably with traditionally organised health care. None addressed this question in sufficient detail to adequately answer it. 15/24 (62.5%) of articles reviewed here provided no details of sensitivity analysis, a method all economic analyses should incorporate.
There is no good evidence that telemedicine is a cost effective means of delivering health care.
What is already known on this topicThe use of telemedicine has garnered much attention in the past decadeHundreds of articles have been published claiming that telemedicine is cost effectiveHowever, missing from the literature is a synthesis or meta-analysis of these publicationsWhat this study addsA comprehensive literature search of cost related articles on telemedicine identified more than 600 articles, but only 9% contained any cost benefit dataOnly 4% of these articles met quality criteria justifying inclusion in a formalised quality review, and most of these were small scale, short term, pragmatic evaluations with few generalisable conclusionsThere is little published evidence to confirm whether or not telemedicine is a cost effective alternative to standard healthcare delivery
PMCID: PMC115857  PMID: 12065269
11.  Cost effectiveness of treatment for gastro-oesophageal reflux disease 
Gut  1998;43(5):729-730.
PMCID: PMC1727320  PMID: 9917195
12.  Cost effectiveness of treatment for gastro-oesophageal reflux disease in clinical practice: a clinical database analysis 
Gut  1998;42(1):13-16.
Background—Previous evaluations of the cost effectiveness of antireflux medication used in gastro-oesophageal reflux disease (GORD) have been based on results obtained in controlled clinical trials. Unfortunately such an approach does not necessarily identify the therapeutic option which provides the greatest benefit from available resources in real life situations. To make an informed choice requires a recognition that the costs and benefits of therapy in practice may differ from those identified in trials. 
Aims—To evaluate, based on a retrospective prescription database analysis, the cost effectiveness of alternative treatment options for patients with uncomplicated GORD. The analysis assesses health service resource use during the first six months of treatment in three groups of patients initially prescribed cisapride (CIS), ranitidine (RAN), or omeprazole (OME). 
Methods—The MediPlusTM UK database was used to identify all health care resources consumed by patients in the three treatment groups during their first six months of treatment. Patients with more complicated GORD, as indicated by initial referral to a specialist or outpatient hospital visit (<13%), were excluded from the analysis. 
Results—The average cost per patient for the initial six months of treatment for CIS, RAN, and OME based therapies was £136, £177, and £189 per patient, respectively. A major element underlying this cost variation was the acquisition cost and quantity of antireflux medication required by patients. The average number of one month equivalent prescriptions consumed during this six month period was 1.85 (CIS), 2.57 (RAN), and 2.96 (OME) with associated costs of £49 (CIS), £67 (RAN), and £105 (OME). Antacid and alginate/antacid use was higher in the CIS and RAN groups (about 1.0 antacid prescription per patient versus 0.4 for OME), but their contribution to the total cost per patient was less than 2%. The number of general practitioner consultations over the six month period for each treatment group was 2.4 (CIS), 2.9 (RAN), and 2.6 (OME) with associated costs of £60.31 (CIS), £73.06 (RAN), and £65.52 (OME). The average number of non-drug interventions (referrals, outpatient visits, endoscopies, barium meals, or x rays) was 0.34 in the RAN group compared with less than 0.2 in the CIS and OME groups. The costs associated with such interventions were £23.80 (RAN), £9.60 (CIS), and £11.10 (OME) per patient. 
Conclusion—The data indicate that the "step up" approach, starting with a prokinetic or H2 receptor antagonist, represents the most cost effective initial therapeutic strategy for a primary care physician to adopt when faced with a patient with first diagnosis of uncomplicated GORD. 

Keywords: cisapride; ranitidine; omeprazole; gastro-oesophageal reflux disease; cost; outcomes research
PMCID: PMC1726943  PMID: 9505878
15.  Clinical guidelines—the hidden costs 
BMJ : British Medical Journal  1999;318(7180):391-393.
PMCID: PMC1114849  PMID: 9933210

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