The Economic Impact of the Introduction of Biosimilars in Inflammatory Bowel Disease.

OBJECTIVE: Inflammatory bowel disease [IBD] entails a high economic burden to society. We aimed to estimate the current and future impact of the introduction of biosimilars for infliximab on IBD-related health care costs. METHODS: We designed a stochastic economic model to simulate the introduction of biosimilars in IBD, using a 5-year time horizon, based on the Dutch situation. Prevalence data on ulcerative colitis [UC] and Crohn's disease [CD] and IBD-related health care costs data were used as input. Assumptions were made on price reductions of anti-tumour necrosis factor [TNF] therapy, increase of anti-TNF prescription rate, and development of hospitalization costs. The base case scenario included a gradual decrease in prices of biosimilars up to 60%, a gradual decrease in prices of original anti-TNF compounds up to 50%, and an annual increase of anti-TNF prescription rate of 1%, and this was compared with no introduction of biosimilars. Sensitivity analyses were performed. RESULTS: For the base case, cost savings over the total of 5 years were on average €9,850 per CD patient and €2,250 per UC patient, yielding in €493 million total cost savings [a reduction of 28%] for The Netherlands. Results were predominantly determined by price reduction of anti-TNF therapy, threshold price reduction at which physicians switch patients towards biosimilars and the extent to which switching will take place. CONCLUSIONS: The introduction of biosimilars for infliximab can be expected to have a major impact on the cost profile of IBD. The economic impact will depend on local pricing, procurement policies and the physician's willingness to switch patients to biosimilars.

Smoking is Associated with Higher Disease-related Costs and Lower Health-related Quality of Life in Inflammatory Bowel Disease.

BACKGROUND AND AIMS: Smoking affects the course of inflammatory bowel disease [IBD]. We aimed to study the impact of smoking on IBD-specific costs and health-related quality-of-life [HrQoL] among adults with Crohn's disease [CD] and ulcerative colitis [UC]. METHODS: A large cohort of IBD patients was prospectively followed during 1 year using 3-monthly questionnaires on smoking status, health resources, disease activity and HrQoL. Costs were calculated by multiplying used resources with corresponding unit prices. Healthcare costs, patient costs, productivity losses, disease course items and HrQoL were compared between smokers, never-smokers and ex-smokers, adjusted for potential confounders. RESULTS: In total, 3030 patients [1558 CD, 1054 UC, 418 IBD-unknown] were enrolled; 16% smoked at baseline. In CD, disease course was more severe among smokers. Smoking was associated with > 30% higher annual societal costs in IBD (€7,905 [95% confidence interval €6,234 - €9,864] vs €6,017 [€5,186 - €6,946] in never-smokers and €5,710 [€4,687 - €6,878] in ex-smokers, p = 0.06 and p = 0.04, respectively). In CD, smoking patients generated the highest societal costs, primarily driven by the use of anti-tumour necrosis factor compounds. In UC, societal costs of smoking patients were comparable to those of non-smokers. Societal costs of IBD patients who quitted smoking > 5 years before inclusion were lower than in patients who quitted within the past 5 years (€ 5,135 [95% CI €4,122 - €6,303] vs €9,342 [€6,010 - €12,788], p = 0.01). In both CD and UC, smoking was associated with a lower HrQoL. CONCLUSIONS: Smoking is associated with higher societal costs and lower HrQoL in IBD patients. Smoking cessation may result in considerably lower societal costs.

The Impact of Ethnicity and Country of Birth on Inflammatory Bowel Disease Phenotype: a Prospective Cohort Study.

BACKGROUND AND AIMS: The number of patients with inflammatory bowel disease [IBD], of non-Caucasian descent in Western Europe, is increasing. We aimed to explore the impact of ethnicity and country of birth on IBD phenotype. METHODS: IBD patients treated in the eight University Medical Centers in The Netherlands [Dutch IBD Biobank] were divided into two groups according to their ethnicity: 1] Caucasian patients of Western and Central European descent [CEU]; and 2] patients of non-Caucasian descent [non-CEU]. The non-CEU group was subdivided according to country of birth, into: born in The Netherlands or Western Europe [non-CEU European born]; or born outside Western-Europe who migrated to The Netherlands [non-CEU non-European born]. Both comparisons were analysed for phenotype differences [by chi-square test]. RESULTS: The Dutch IBD Biobank included 2921 CEU patients and 233 non-CEU patients. Non-CEU Crohn's disease [CD] patients more often had upper gastro-intestinal disease [16% vs 8%, p = 0.001] and anal stenosis [10% vs 4%, p = 0.002] than CEU CD patients. The use of anti-tumour necrosis factor [TNF] agents and immunomodulators was higher in non-CEU IBD patients than in CEU IBD patients [45% vs 38%, p = 0.042] and [77% vs 66%, p = 0.001], respectively. Non-CEU IBD patients born in Europe [n = 116] were diagnosed at a lower age than non-CEU IBD patients born outside Europe [n = 115] [at 22.7 vs 28.9 years old, p < 0.001]. CONCLUSION: Non-Caucasians had more severe disease behaviour than Caucasians. Non-CEU patients born in Europe were diagnosed at a lower age with IBD than those born outside Europe who migrated to The Netherlands.

Smoking is Associated With Extra-intestinal Manifestations in Inflammatory Bowel Disease.

BACKGROUND AND AIMS: Smoking affects the course of disease in patients with ulcerative colitis (UC) and Crohn's disease (CD). We aimed to study the association between smoking and extra-intestinal manifestations (EIMs) in inflammatory bowel disease (IBD). METHODS: We cross-sectionally explored the association between smoking and EIMs in IBD in three cohort studies: (1) the COIN study, designed to estimate healthcare expenditures in IBD; (2) the Groningen study, focused on cigarette smoke exposure and disease behaviour in IBD; and (3) the JOINT study, evaluating joint and back manifestations in IBD. RESULTS: In the COIN, Groningen and JOINT cohorts, 3030, 797 and 225 patients were enrolled, of whom 16, 24 and 23.5% were current smokers, respectively. Chronic skin disorders and joint manifestations were more prevalent in smoking IBD patients than in non-smokers (COIN, 39.1 vs 29.8%, p <0.01; Groningen, 41.7 vs 30.0%, p <0.01) in both CD and UC. In the JOINT cohort, smoking was more prevalent in IBD patients with joint manifestations than in those without (30.3 vs 13.0%, p <0.01). EIMs appeared to be more prevalent in high- than in low-exposure smokers (56.0 vs 37.1%, p = 0.10). After smoking cessation, the prevalence of EIMs in IBD patients rapidly decreased towards levels found in never smokers (lag time: COIN cohort, 1-2 years; Groningen cohort, within 1 year). CONCLUSIONS: There is a robust dose-dependent association between active smoking and EIMs in both CD and UC patients. Smoking cessation was found to result in a rapid reduction of EIM prevalence to levels encountered in never smokers.

Care home versus hospital and own home environments for rehabilitation of older people.

BACKGROUND: Rehabilitation for older people has acquired an increasingly important profile for both policy-makers and service providers within health and social care agencies. This growing demand for rehabilitation services has generated an increased interest in the use of alternative care environments, for example care home environments, for older persons' rehabilitation. At a time when there is pressure for policy decision-makers and service providers to explore the use of such care settings for the provision of rehabilitation for older people, there appears limited evidence on which to base decisions. OBJECTIVES: The objective of this review is to compare the effects of care home environments (e.g. nursing home, residential care home and nursing facilities) versus hospital environments and own home environments in the rehabilitation of older people. SEARCH STRATEGY: The following databases were searched. The Cochrane Effective Practice and Organisation of Care Specialised Register, the Cochrane Rehabilitation Specialist Register; Cochrane Controlled Trials Register (CCTR); MEDLINE (1966-2000); EMBASE (1980-2000), Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1982-2000): Science Citation Index (1982-2000); Social Science Citation Index (1982-2000); Best Evidence (1991-2000); HMIC (1979-2000); PsycINFO(1967-2000); ASSIA (1987-2000); Ageline (1978-2000); AgeInfo (1971-2000); Sociological Abstracts (1963-2000); System for Information on Grey Literature (SIGLE) (1980-2000); UK National Research Registers Project Database( Issue 1 2001); Architecture Publication Index (1977-2000). The following Journals were hand searched: Disability and Rehabilitation (1992-2000); Disability and Society (1986-2000); Archives of Physical Medicine and Rehabilitation (1985-2000); Journal of the American Geriatric Society (1980-2000); International Journal of Rehabilitation Research (1980-2000); American Journal of Physical Medicine and Rehabilitation (1980-2000) and: Clinical Rehabilitation (1992-2000). The reviewers also consulted subject area experts and obtained full text review articles and forward tracked any references from these sources. SELECTION CRITERIA: Randomised controlled trials (RCTs), controlled clinical trials (CCTs), controlled before and after studies (CBAs) and interrupted time series (ITS) that compared rehabilitation outcomes for persons 60 years or older who received rehabilitation whilst residing in a care home with those for persons 60 years or older who received rehabilitation in hospital or own home environments. Primary outcomes included functional outcomes using activities of daily living measurement (both personal and instrumental). Secondary outcomes included subjective health status; quality of life measures; return to place of usual residency; all cause mortality; adverse effects; readmission to an acute care facility; patient and carer satisfaction; number of days in facility and number of days receiving rehabilitation. DATA COLLECTION AND ANALYSIS: One reviewer (DW) completed the initial search and identified potential papers for inclusion. Abstracts for these papers were independently scrutinised by two reviewers (DW/MS) to assess their eligibility. Full text versions of potentially eligible papers were independently assessed by two reviewers (DW/MS). Papers that fulfilled the comparison inclusion criteria were then independently scrutinised by all reviewers to assess whether they met EPOC methodological criteria for inclusion. MAIN RESULTS: The total yield from the initial search strategy was 19,457. A total of 1,247 abstracts were independently scrutinised by two reviewers (DW/MS) to assess their eligibility. Full text papers for 99 studies were obtained to assess if they fulfilled the review's comparison inclusion criteria. This process resulted in 12 papers being assessed further for methodological validity. However, none of these studies met the inclusion criteria. REVIEWER'S CONCLUSIONS: There is insufficient evidence to compare the effects of care home environments, hospital environments and own home environments on older persons rehabilitation outcomes. Although the authors acknowledge that absence of effect is not no effect. There are three main reasons; the first is that the description and specification of the environment is often not clear; secondly, the components of the rehabilitation system within the given environments are not adequately specified and; thirdly, when the components are clearly specified they demonstrate that the control and intervention sites are not comparable with respect to the methodological criteria specified by Cochrane EPOC group (Cochrane 1998). The combined effect of these factors resulted in the comparability between intervention and control groups being very weak. For example, there were differences in the services provided in the intervention and control arms, due possibly to differences in dominant remuneration systems, nature of the rehabilitation transformation, patient characteristics, skill mix and academic status of the care environment.

Audiovisual distraction as an adjunct to pain and anxiety relief during minor surgery.

BACKGROUND: Minor surgery for ingrown toenails can provoke anxiety and the anaesthetic injection can be acutely painful. Distraction techniques may reduce the associated pain and anxiety. OBJECTIVE: To investigate an audiovisual distraction (Bedscapes) on pain and anxiety during minor surgery for the correction of ingrown toenail. METHOD: In a randomised controlled trial, patients (N=152) with ingrown toenails requiring surgical correction under local anaesthesia were allocated to receive Bedscapes+standard care or standard care alone. Pain levels due to local anaesthetic injection were assessed post-procedure, and anxiety levels were assessed pre- and post-procedure in both groups. Follow-up focus groups were conducted with 14 patients allocated to the Bedscapes group, and one-to-one interviews were held with four podiatrists. RESULTS: Participants with high pre-procedure anxiety scores experienced greater pain on injection, and older patients reported lower pain than younger patients, regardless of group allocation. Bedscapes did not reduce pain or anxiety, and was apparently no more effective than interpersonal interaction between podiatry staff and the patient. CONCLUSIONS: Pain of injected anaesthesia correlates closely with pre-operative anxiety. Formal audiovisual distraction has no added benefit over interpersonal interaction in the alleviation of pain and anxiety in patients undergoing nail surgery.

Complex service evaluation.

Services represent the practical manifestation of the synthesis of research knowledge and real world factors. In order to develop the evaluation of complex services, there needs to be a consensus about what a complex service is. I suggest that it is a system for the supplying of a public need. Whilst there is strong academic and policy support for a systems-based approach, there is only limited understanding in the clinical and managerial community and limited skills within the health and social care research community on systems methodologies. Evaluation of complex systems will probably need an integration of existing evaluative methods with a soft systems approach.

A study of appropriateness of acute geriatric admissions and an assessment of the Appropriateness Evaluation Protocol.

We studied the appropriateness of admissions to our acute geriatric unit to determine whether they were clinically indicated and to test the Appropriateness Evaluation Protocol (AEP), an instrument previously validated for general hospital admissions. An admission is appropriate according to the AEP if at least 1 of its 16 criteria is met. At the next ward round, a consultant would judge, given the clinical details available on admission, whether the admission was appropriate, regardless of the AEP. All emergency admissions during a three week period were eligible. Of 186 admissions, 146 (78.5%) were available for analysis. The rates of inappropriateness according to consultants and AEP were 13% and 11% respectively. The AEP had a sensitivity of 97%, specificity of 63%, positive and negative predictive values of 95% and 75% respectively. The overall agreement between consultants and AEP was 92% (kappa = 0.62). There are no data on the optimal level of appropriateness but our rate of 87% (89% using the AEP) appears favourable. This study also shows the AEP to be a suitable tool to monitor the appropriateness of acute geriatric admissions.

A hospital palliative care ward for elderly people.

In order to improve inpatient facilities for terminal care for elderly people, a special ward has been opened to maximize the quality of remaining life and to achieve 'death with dignity'. The ward is based within a geriatric department and in a District General Hospital. The work of the first year is described. It is considered to have been successful.

The junior doctor handover: current practices and future expectations.

Restructuring junior doctors' patterns of work has led to several changes, including the increasing implementation of shift and partial-shift rotas. These changes heighten the necessity for good communication between the doctors responsible at different times for the patients. We sent a questionnaire to all junior doctors in two district general hospitals; the results showed that existing handover systems are frequently not as good as doctors would wish. In our opinion, the lack of advice and guidance on the structure of handover has impeded good practice, and a standard of professional practice needs to be set. Opportunities exist within the NHS to utilise information systems to obtain the necessary information and to improve the format of the handover.

An inpatient bed for acute nursing home admissions.

BACKGROUND: Some older patients are admitted directly to nursing homes without a comprehensive assessment. OBJECTIVE: To determine whether a hospital assessment bed might provide better assessment, treatment and a more appropriate placement for selected older people. Setting a single bed in an elderly care unit of a district general hospital. SUBJECTS: Older people who general practitioners thought needed nursing home care but whose social workers felt might benefit from inpatient assessment. MAIN OUTCOME MEASURES: Type of treatment needed (acute care, rehabilitation, palliation, long-term care) and placement (home, nursing home, residential home or hospital). RESULTS: of 34 patients assessed, 22 (65%) needed further clinical assessment or care and 26 (75%) left hospital for places other than nursing homes. CONCLUSIONS: Inpatient assessment is a successful way of assessing the needs of some older people who would otherwise have been admitted directly from their homes to nursing homes.

Collecting, communicating and using information: the educational issues. A report from the Royal College of Physicians Committee on Medical Information Technology.

Few of the major advances in information science and technology have yet been successfully introduced in health care. Their implementation could improve both quality of care and the working environment of clinicians, but this will not be achieved by investing in hardware and software alone. Investment in education is also required.