Risk of death and cardiovascular outcomes with thiazolidinediones: a study with the general practice research database and secondary care data

Objective

To describe the likely extent of confounding in evaluating the risks of cardiovascular (CV) events and mortality in patients using diabetes medication.

Methods

The General Practice Research Database was used to identify inception cohorts of insulin and different oral antidiabetics. An analysis of bias and incidence of mortality, acute coronary syndrome, stroke and heart failure were analysed in GPRD, Hospital Episode Statistics and death certificates.

Results

206,940 patients were identified. The bias analysis showed that past thiazolidinedione users had a lower mortality risk compared to past metformin users. There were no differences between past users of rosiglitazone and pioglitazone (adjusted RR of 1.04; 95% CI 0.93–1.18). Current rosiglitazone users had an increased risk of death (adjusted RR 1.20; 95% CI 1.08–1.34) and of hospitalisation for heart failure (adjusted RR of 1.73; 95% CI 1.19–2.51) compared to current pioglitazone users. Risk of mortality was increased two-fold shortly after starting rosiglitazone. Excess risk of death over 3 years with rosiglitazone was 0.3 per 100 in those aged 50–64 years, 2.0 aged 65–74, 3.0 aged 75–84, and 7.0 aged 85+. The cause of death with rosiglitazone was more likely to be due to a disease of the circulatory system.

Conclusions

Higher risks for death (overall and due to cardiovascular disease) and heart failure were found for rosiglitazone compared to pioglitazone. These excess risks were largest in patients aged 65 years or older. The European regulatory decision to suspend rosiglitazone is supported by this study.     

Health care burden and cost associated with fetal alcohol syndrome: based on official canadian data

Background

Fetal Alcohol Spectrum Disorder (FASD) is a group of disorders caused by prenatal alcohol exposure. From this group, Fetal Alcohol Syndrome (FAS) is the only disorder coded in the International Classification of Diseases, version 10 (ICD-10). This coding was used to gain an understanding on the health care utilization and the mortality rate for individuals diagnosed with FAS, as well as to estimate the associated health care costs in Canada for the most recent available fiscal year (2008–2009).

Methods

Health care utilization data associated with a diagnosis of FAS were directly obtained from the Canadian Institute for Health Information (CIHI). Mortality data associated with a diagnosis of FAS were obtained from Statistics Canada.

Results

The total direct health care cost of acute care, psychiatric care, day surgery, and emergency department services associated with FAS in Canada in 2008–2009, based on the official CIHI data, was about $6.7 million. The vast majority of the most responsible diagnoses, which account for the majority of a patient’s length of stay in hospital, fall within the ICD-10 category Mental and Behavioural Disorders (F00–F99). It was evident that the burden and cost of acute care hospitalizations due to FAS is increasing −1.6 times greater in 2008–2009, compared to 2002–2003. The mortality data due to FAS, obtained from Statistics Canada (2000–2008), may be underreported, and are likely invalid.

Discussion

The official data on the utilization of health care services by individuals diagnosed with FAS are likely to be underreported and therefore, the reported cost figures are most likely underestimated. The quantification of the health care costs associated with FAS is crucial for policy developers and decision makers alike, of the impact of prenatal alcohol exposure, with the ultimate goal of initiating preventive interventions to address FASD.     

Validity of cancer diagnosis in a primary care database compared with linked cancer registrations in England. Population-based cohort study

AimsThe present study aimed to evaluate the validity of cancer diagnoses and death recording in a primary care database compared with cancer registry (CR) data in England.MethodsThe eligible cohort comprised 42,556 participants, registered with English general practices in the General Practice Research Database (GPRD) that consented to CR linkage. CR and primary care records were compared for cancer diagnosis, date of cancer diagnosis and death. Read and ICD cancer code sets were reviewed and agreed by two authors.ResultsThere were 5216 (91% of CR total) cancer events diagnosed in both sources. There were 494 (9%) diagnosed in CR only and 213 (4%) that were diagnosed in GPRD only. The predictive value of a GPRD cancer diagnosis was 96% for lung cancer, 92% for urinary tract cancer, 96% for gastro-oesophageal cancer and 98% for colorectal cancer. ‘False negative’ primary care records were sometimes accounted for by registration end dates being shortly before cancer diagnosis dates. The date of cancer diagnosis was median 11 (interquartile range ?6 to 30) days later in GPRD compared with CR. Death records were consistent for the two sources for 3337/3397 (99%) of cases.ConclusionRecording of cancer diagnosis and mortality in primary care electronic records is generally consistent with CR in England. Linkage studies must pay careful attention to selection of codes to define eligibility and timing of diagnoses in relation to beginning and end of record.     

Needs for care from a demand led community psychiatric service: a study of patients with major mental illness.

OBJECTIVE--To measure needs for care of patients aged 18-65 years with major mental illness. DESIGN. Identification of everyone in one area seen by a health professional within the previous five years because of a psychotic disorder. Interview of a one in three sample of patients and their main carers with the cardinal needs schedule. SETTING--Hamilton, a socially deprived district of Scotland. SUBJECTS--71 subjects were interviewed from the original sample of 263 patients. MAIN OUTCOME MEASURES--"Cardinal problems" in seven clinical and eight social areas of functioning; these are defined as problems requiring action. "Needs"-cardinal problems for which suitable interventions exist but have not been tried recently. RESULTS--High levels of morbidity were found. 30 interviewed patients (42%; 95% confidence interval 31% to 54%) had one or more clinical needs. 35 (49%; 38% to 61%) had one or more social needs. Skills to deal with all but seven needs in the sample were available at the time of investigation. Patients not being seen by the community mental health team were similar in severity and levels of need to those who were on the community team''s caseload. Care was unequivocally and severely inadequate for four patients. Shortcomings in service delivery usually arose from failure to monitor some patients at home. Problems were not due to shortage of acute psychiatric beds nor the absence of an elaborate assertive community care team. CONCLUSIONS--Systematic assessment of needs with research instruments can give valuable insights into the successes and failures of community care of people with major mental illness. Most needs could be dealt with in these patients but in our area (and probably most other parts of the United Kingdom) this would entail diversion of resources from people with less severe disorders.     

Factors associated with practice of colorectal cancer screening among primary care physicians in a Chinese population: A cross-sectional study

Objectives: Primary care physicians (PCPs) are influential in colorectal cancer (CRC) screening uptake in the community. This study aims to evaluate the factors associated with PCPs’ practice of CRC screening among asymptomatic patients in a Chinese population. Methods: A validated postal questionnaire was sent to all practicing PCPs who were members of a community-based network in Hong Kong. Three separate rounds of reminder letters were sent to non-respondents. Binary logistic regression analysis was used with ever-referral for CRC screening in the past 12 months as the outcome variable. Predictor variables include physicians’ gender, clinical experience, types of practice, and attitudes towards CRC screening. Results: Of 428 eligible physicians, 263 (61.4%) responded. A total of 187 physicians (71.1%) had referred patients for CRC screening in the past 1 year. Among all asymptomatic patients aged 50 years or older, physicians reported referring only 3.0% (1.0–10.0%) [median (interquartile range)] of patients. Colonoscopy (57.0%) and fecal occult blood testing (FOBT) (46.4%) were the most commonly recommended tests for these asymptomatic patients. Family history of CRC (58.6%) and patients’ concern about CRC (50.2%) were major reasons for referral. PCPs in private practice (adjusted odds ratio [aOR] 2.60, 95% C.I. 1.21–5.59) and those with positive attitude towards CRC screening (aOR 2.27, 95% C.I. 1.15–4.48) were more likely to recommend CRC screening. Conclusions: PCPs’ attitude towards CRC screening is a significant determinant of its practice. Future studies should identify and strengthen the influencers of PCPs’ attitude to enhance CRC screening rates.     

A Cost-Consequences analysis of the effect of Pregabalin in the treatment of peripheral Neuropathic Pain in routine medical practice in Primary Care settings

Background  

Neuropathic pain (NeP) is a common symptom of a group of a variety of conditions, including diabetic neuropathy, trigeminal neuralgia, or postherpetic neuralgia. Prevalence of NeP has been estimated to range between 5-7.5%, and produces up to 25% of pain clinics consultations. Due to its severity, chronic evolution, and associated co-morbidities, NeP has an important individual and social impact. The objective was to analyze the effect of pregabalin (PGB) on pain alleviation and longitudinal health and non-health resources utilization and derived costs in peripheral refractory NeP in routine medical practice in primary care settings (PCS) in Spain.     

Community occupational therapy for older patients with dementia and their care givers: cost effectiveness study

Objective To assess the cost effectiveness of community based occupational therapy compared with usual care in older patients with dementia and their care givers from a societal viewpoint.Design Cost effectiveness study alongside a single blind randomised controlled trial.Setting Memory clinic, day clinic of a geriatrics department, and participants’ homes.Patients 135 patients aged ≥65 with mild to moderate dementia living in the community and their primary care givers.Intervention 10 sessions of occupational therapy over five weeks, including cognitive and behavioural interventions, to train patients in the use of aids to compensate for cognitive decline and care givers in coping behaviours and supervision.Main outcome measures Incremental cost effectiveness ratio expressed as the difference in mean total care costs per successful treatment (that is, a combined patient and care giver outcome measure of clinically relevant improvement on process, performance, and competence scales) at three months after randomisation. Bootstrap methods used to determine confidence intervals for these measures.Results The intervention cost €1183 (£848, $1738) (95% confidence interval €1128 (£808, $1657) to €1239 (£888, $1820)) per patient and primary care giver unit at three months. Visits to general practitioners and hospital doctors cost the same in both groups but total mean costs were €1748 (£1279, $2621) lower in the intervention group, with the main cost savings in informal care. There was a significant difference in proportions of successful treatments of 36% at three months. The number needed to treat for successful treatment at three months was 2.8 (2.7 to 2.9).Conclusions Community occupational therapy intervention for patients with dementia and their care givers is successful and cost effective, especially in terms of informal care giving.     

Profiling dizziness in older primary care patients: an empirical study

Background

The diagnostic approach to dizzy, older patients is not straightforward as many organ systems can be involved and evidence for diagnostic strategies is lacking. A first differentiation in diagnostic subtypes or profiles may guide the diagnostic process of dizziness and can serve as a classification system in future research. In the literature this has been done, but based on pathophysiological reasoning only.

Objective

To establish a classification of diagnostic profiles of dizziness based on empirical data.

Design

Cross-sectional study.

Participants and Setting

417 consecutive patients of 65 years and older presenting with dizziness to 45 primary care physicians in the Netherlands from July 2006 to January 2008.

Methods

We performed tests, including patient history, and physical and additional examination, previously selected by an international expert panel and based on an earlier systematic review. We used the results of these tests in a principal component analysis for exploration, data-reduction and finally differentiation into diagnostic dizziness profiles.

Results

Demographic data and the results of the tests yielded 221 variables, of which 49 contributed to the classification of dizziness into six diagnostic profiles, that may be named as follows: “frailty”, “psychological”, “cardiovascular”, “presyncope”, “non-specific dizziness” and “ENT”. These explained 32% of the variance.

Conclusions

Empirically identified components classify dizziness into six profiles. This classification takes into account the heterogeneity and multicausality of dizziness and may serve as starting point for research on diagnostic strategies and can be a first step in an evidence based diagnostic approach of dizzy older patients.     

Screening for psychosocial problems among primary care patients: a pilot study.

The symptoms that a patient presents to the doctor are often not the underlying concern that prompted the consultation. The success of consultations involving a hidden diagnosis depends on how well the patient can express his or her concerns to the doctor and on how skilfully the doctor can encourage this. This study tested the feasibility and acceptability of having patients complete a brief health index questionnaire designed to help them describe their underlying concerns to the doctor. In two family medicine centres 996 patients were asked to complete a questionnaire while waiting to see the doctor; 724 (73%) did so. An evaluation of their responses showed the method to be acceptable to most. The doctors judged that it added valuable information in 41% of all consultations and in 73% of consultations in which the patient presented with psychologic complaints. There was, nevertheless, considerable variation among the physicians in their acceptance of the approach. This variability is discussed in the light of alternative models of how, in practical terms, to treat the psychosocial dimensions of a patient''s complaint.     

Postural control deficits in people with fibromyalgia: a pilot study

Introduction  

Postural instability and falls are increasingly recognized problems in patients with fibromyalgia (FM). The purpose of this study was to determine whether FM patients, compared to age-matched healthy controls (HCs), have differences in dynamic posturography, including sensory, motor, and limits of stability. We further sought to determine whether postural instability is associated with strength, proprioception and lower-extremity myofascial trigger points (MTPs); FM symptoms and physical function; dyscognition; balance confidence; and medication use. Last, we evaluated self-reported of falls over the past six months.     

Long-term outcome of patients with neurotic illness in general practice.

OBJECTIVE--To determine the 11 year outcome of neurotic disorder in general practice. DESIGN--Cohort study over 11 years. SETTING--Two general practices in Warwickshire England. SUBJECTS--100 patients selected to be representative of those identified nationally by general practitioners as having neurotic disorders. MAIN OUTCOME MEASURES--Mortality, morbidity, and use of health services. RESULTS--At 11 years 87 subjects were traced. The 11 year standardised mortality ratio was 173 (95% confidence interval 164 to 200). 47 were cases on the general health questionnaire, 32 had a relapsing or chronic psychiatric course, and 49 a relapsing or chronic physical course. Treatment for psychiatric illness was mainly drugs. The mean number of consultations per year was 10.8 (median 8.7). A persistent psychiatric diagnosis at one year follow up was associated with high attendance ( > 12 visits a year for 11 years) at follow up after age, sex, and physical illness were adjusted for. Severity of psychiatric illness (general health questionnaire score) at outset predicted general health questionnaire score at 11 year follow up, course of psychiatric illness, and high consultation rate. CONCLUSION--These data support the view that a neurotic illness can become chronic and is associated with raised mortality from all causes and high use of services. Such patients need effective intervention, particularly those with a more severe illness who do not recover within one year.     

Costs and cost effectiveness of health checks conducted by nurses in primary care: the Oxcheck study.

OBJECTIVE--To measure the costs and cost effectiveness of the Oxcheck cardiovascular risk factor screening and intervention programme. DESIGN--Cost effectiveness analysis of a randomised controlled trial using clinical and economic data taken from the trial. SETTING--Five general practices in Luton and Dunstable, England. SUBJECTS--2205 patients who attended a health check in 1989-90 and were scheduled for re-examination in 1992-3 (intervention group); 1916 patients who attended their initial health check in 1992-3 (control group). Participants were men and women aged 35-64 years. INTERVENTION--Health check conducted by nurse, with health education and follow up according to degree of risk. MAIN OUTCOME MEASURES--Cost of health check programme; cost per 1% reduction in coronary risk. RESULTS--Health check and follow up cost 29.27 pounds per patient. Estimated programme cost per 1% reduction in coronary risk per participant was between 1.46 pounds and 2.25 pounds; it was nearly twice as much for men as women. CONCLUSIONS--The cost to the practice of implementing Oxcheck-style health checks in an average sized practice of 7500 patients would be 47,000 pounds, a proportion of which could be paid for through staff pay reimbursements and Band Three health promotion target payments. This study highlights the considerable difficulties faced when calculating the costs and benefits of a health promotion programme. Economic evaluations should be integrated into the protocols of randomised controlled trials to enable judgments to be made on the relative cost effectiveness of different prevention strategies.     

Rituximab in patients with rheumatoid arthritis in routine practice (GERINIS): six-year results from a prospective,multicentre, non-interventional study in 2,484 patients

Introduction

The aim of this study was to evaluate the safety and efficacy of rituximab (RTX) in a large cohort of patients with rheumatoid arthritis in routine care, and to monitor changes in daily practice since the introduction of RTX therapy.

Methods

This was a multicentre, prospective, non-interventional study conducted under routine practice conditions in Germany. Efficacy was evaluated using Disease Activity Score in 28 joints (DAS28) and Health Assessment Questionnaire-Disability Index (HAQ-DI). Safety was assessed by recording adverse drug reactions (ADRs). Physician and patient global efficacy and tolerability assessments were also evaluated.

Results

Overall, 2,484 patients (76.7% female, mean age 56.4 years, mean disease duration 11.7 years) received RTX treatment (22.7% monotherapy). The total observation period was approximately six-years (median follow-up 14.7 months). RTX treatment led to improvements in DAS28 and HAQ-DI that were sustained over multiple courses. DAS28 improvements positively correlated with higher rheumatoid factor levels up to 50 IU/ml. Response and tolerability were rated good/very good by the majority of physicians and patients. Mean treatment intervals were 10.5 and 6.8 months for the first and last 400 enrolled patients, respectively. Infections were the most frequently reported ADRs (9.1%; 11.39/100 patient-years); approximately 1% of patients per course discontinued therapy due to ADRs.

Conclusions

Prolonged RTX treatment in routine care is associated with good efficacy and tolerability, as measured by conventional parameters and by physicians’ and patients’ global assessments. Rheumatoid factor status served as a distinct and quantitative biomarker of RTX responsiveness. With growing experience, physicians repeated treatments earlier in patients with less severe disease activity.     

Home based care and standard hospital care for patients with severe mental illness: a randomised controlled trial.

OBJECTIVE--To compare the efficacy of home based care with standard hospital care in treating serious mental illness. DESIGN--Randomised controlled trial. SETTING--South Southwark, London. PATIENTS--189 patients aged 18-64 living in catchment area. 92 were randomised to home based care (daily living programme) and 97 to standard hospital care. At three months'' follow up 68 home care and 60 hospital patients were evaluated. MAIN OUTCOME MEASURES--Use of hospital beds, psychiatric diagnosis, social functioning, patients'' and relatives'' satisfaction, and activity of daily living programme staff. RESULTS--Home care reduced hospital stay by 80% (median stay six days in home care group, 53 days in hospital group) and did not increase the number of admissions compared with hospital care. On clinical and social outcome there was a non-significant trend in favour of home care, but both groups showed big improvements. On the global adjustment scale home care patients improved by 26.8 points and the hospital group by 21.6 points (difference 5.2; 95% confidence interval -1.5 to 12). Other rating scales showed similar trends. Home care patients required a wide range of support in areas such as housing, finance, and work. Only three patients dropped out from the programme. CONCLUSIONS--Home based care may offer some slight advantages over hospital based care for patients with serious mental illness and their relatives. The care is intensive, but the low drop out rate suggests appreciation. Changes to traditional training for mental health workers are required.