Maternal gestational weight gain and offspring's risk of cardiovascular disease and mortality.

OBJECTIVE: To examine the effect of maternal gestational weight gain (GWG) on adult offspring mortality, cardiovascular morbidity and cerebrovascular morbidity. METHODS: The Aberdeen Children of the Nineteen Fifties (ACONF) is a population-based cohort of adults born in Aberdeen, Scotland between 1950 and 1956. GWG of the mothers of cohort members was extracted from original birth records and linked to the data on offspring morbidity and mortality up to 2011 obtained from Scottish national records. HRs for cardiovascular events and mortality in offspring according to maternal weight gain in pregnancy were estimated adjusting for maternal and offspring confounders using a restricted cubic spline model. RESULTS: After exclusions, 3781 members of the original ACONF cohort were analysed. Of these, 103 (2.7%) had died, 169 (4.5%) had suffered at least one cardiovascular event and 73 (1.9%) had had a hospital admission for cerebrovascular disease. Maternal weight gain of 1 kg/week or more was associated with increased risk of cerebrovascular event in the offspring (adjusted HR 2.70 (95% CI 1.19 to 6.12)). There was no association seen between GWG and offspring's all-cause mortality or cardiovascular event. Adult offspring characteristics (smoking, body mass index (BMI) and diabetes) were strongly associated with each outcome. CONCLUSIONS: Maternal GWG above 0.9 kg/week may increase the risk of cerebrovascular disease in the adult offspring, but not all-cause mortality or cardiovascular disease. Health and lifestyle factors such as smoking, BMI and diabetes in the adult offspring had a stronger influence than maternal and birth characteristics on their mortality and morbidity.

Self-reported pain severity is associated with a history of coronary heart disease.

BACKGROUND: Previous studies have found an association between chronic pain and cardiovascular (CV) mortality. OBJECTIVE: To explore the relationship between the severity of pain and non-fatal CV disease. METHODS: A total of 45,994 adults randomly selected from general practice registers in Manchester and Aberdeen were posted a survey, which included a Chronic Pain Grade questionnaire, pain manikin and questions about lifestyle and medical history. A single component measuring pain severity was extracted using factor analysis. Logistic regression was used to test for an association between quintiles of pain severity and a history of CV disease, adjusting for confounders. RESULTS: Of the 15,288 responders, 61% (n = 9357) reported pain for ≥ 1 day in the past month. Compared with the first (lowest) pain severity quintile, the fully adjusted odds ratio for heart attack in the second severity quintile was 1.25 (95% confidence interval 0.68, 2.30); third quintile: 1.65 (0.93, 2.94); fourth quintile: 1.76 (1.00, 3.11) and fifth (highest) quintile 2.47 (1.43, 4.28). Corresponding figures for angina (excluding heart attack) were: 1.79 (0.93, 3.45), 1.91 (1.00, 3.62), 1.03 (0.50, 2.11) and 3.17 (1.71, 5.85). CONCLUSION: A history of CV disease is reported more often in those with severe pain than would be expected by chance, even when adjusting for shared risk factors.

Factors associated with reporting classic menopausal symptoms differ.

OBJECTIVES: To investigate how symptoms experienced in midlife cluster and to identify factors independently associated with hot flushes, night sweats, and vaginal dryness. METHODS: A questionnaire was sent to 8206 women aged 45-54 years, recruited from family practices in north-east Scotland, UK. Using data collected about 23 symptoms, we conducted factor analysis for premenopausal, perimenopausal, postmenopausal and surgically menopausal women. Forward stepwise logistic regression was used to identify sociodemographic, lifestyle and psychological variables independently associated with the classic menopausal symptoms. RESULTS: Overall, 4407 women responded. Hot flushes were experienced by 46.7% (95% confidence interval (CI) 45.2-48.2) of women, night sweats by 46.4% (95% CI 44.9-47.9) and vaginal dryness by 28.2% (95% CI 26.9-29.6). Seven factors including 20 symptoms emerged from factor analysis. Hot flushes were associated with: being perimenopausal or postmenopausal; low education; obesity; low social support; reporting night sweats, musculoskeletal, bloating, menstrual and sexual symptoms; using complementary alternative medicines, lifestyle (e.g. exercising) or psychological management strategies (e.g. talking to family or friends) for menopausal symptoms. Night sweats were associated with: lower body weight; smoking; possible depression; reporting sleep difficulties, hot flushes and sexual symptoms; using lifestyle strategies for menopausal symptoms. Vaginal dryness was associated with: being postmenopausal; high education; high social support; below average physical health, reporting hot flushes, somatic symptoms and decreased sexual interest; using psychological or lifestyle strategies for menopausal symptoms. CONCLUSION: It is important to investigate each classic menopausal symptom separately. Combining menopausal symptoms into categories such as vasomotor symptoms may lead to inaccurate conclusions about variables associated with these symptoms.

The impact and management of symptoms experienced at midlife: a community-based study of women in northeast Scotland.

OBJECTIVES: To determine the frequency and management of menopausal symptoms among community-dwelling women. DESIGN: Cross-sectional study. SETTING: Northeast Scotland. POPULATION: Women aged 45-54 years registered with 16 general practices. METHODS: In 2009, a self-completed questionnaire enquiring about the frequency, associated level of bothersomeness and management of 23 symptoms experienced during the previous month was sent to 8206 women. MAIN OUTCOME MEASURES: The proportion (95% CI) of women reporting each symptom and management strategy. RESULTS: Hot flushes, night sweats and vaginal dryness were reported by 46.7% (95% CI 45.2-48.2), 46.4% (95% CI 44.9-47.9) and 28.2% (95% CI 26.9-29.6) of women, respectively. Two-fifths of women rated these symptoms as quite bothersome or extremely bothersome. More than 60% managed menopausal symptoms using social support by talking to friends and family. Avoidance or alleviating options were common. Herbal remedies were more commonly used than prescription drugs. Current hormone replacement therapy use was highest among surgically menopausal women (21%); 8% of postmenopausal and <2% of perimenopausal women with symptoms were using hormone replacement therapy. Many women had sought information about symptom management. More than one-third of women wanted more support about menopausal symptoms from their general practitioner or practice nurse. CONCLUSION: Following the publication of the Women's Health Initiative trial results, menopausal symptoms remain common and are often bothersome. Many women seek information about menopausal symptoms from healthcare professionals. Future studies should look beyond frequently researched management strategies, to consider other commonly used options, such as social support, strategies to reduce core body temperature and information about managing menopausal symptoms.

Hypertensive disorders of pregnancy and future health and mortality: A record linkage study.

The objective of this register-based cohort study was to examine the relationship between hypertensive disorders of pregnancy and future hospital discharges from specified causes including cardiovascular disease, incident cancer registrations and mortality. From the Aberdeen Maternity and Neonatal Databank we identified 34,854 women who were born on or before 31st December 1967 and who had (i) preeclampsia/eclampsia, (ii) gestational hypertension or (iii) normal blood pressure in their first pregnancy. Hospital discharges from selected causes including cardiovascular disease, cancer registrations and deaths in these women were identified from the Scottish Morbidity Records. There were 2026 women who had preeclampsia, 8891 who had gestational hypertension and 23,937 who were normotensive during their first pregnancy. Compared to normotensive women, women with preeclampsia had a higher mortality from ischaemic heart disease (adj. IRR 1.38, 95% CI 1.03, 1.84) and circulatory disease (adj. IRR 1.30, 95% CI 1.06, 1.60). Similar trends were seen with gestational hypertension. There was no difference in all cause mortality in the three groups. The odds of a hypertensive episode were higher in women with preeclampsia (adj. OR 1.79, 95% CI 1.55, 2.05) and gestational hypertension (adj. OR 1.68, 95% CI 1.55, 1.82) compared to normotensives. Compared to normotensives, women with gestational hypertension (adj. IRR 0.91, 95% CI 0.85, 0.96) or preeclampsia (adj. IRR 0.86, 95% CI 0.77, 0.97) had lower incidences of cancer. Women with pregnancy induced hypertension are at a higher risk of incidence and mortality from ischaemic heart disease and a lower risk of cancer.

Evaluation of patient reporting of adverse drug reactions to the UK 'Yellow Card Scheme': literature review, descriptive and qualitative analyses, and questionnaire surveys.

BACKGROUND: The monitoring of adverse drug reactions (ADRs) through pharmacovigilance is vital to patient safety. Spontaneous reporting of ADRs is one method of pharmacovigilance, and in the UK this is undertaken through the Yellow Card Scheme (YCS). Yellow Card reports are submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) by post, telephone or via the internet. The MHRA electronically records and reviews information submitted so that important safety issues can be detected. While previous studies have shown differences between patient and health-care professional (HCP) reports for the types of drugs and reactions reported, relatively little is known about the pharmacovigilance impact of patient reports. There have also been few studies on the views and experiences of patients/consumers on the reporting of suspected ADRs. OBJECTIVES: To evaluate the pharmacovigilance impact of patient reporting of ADRs by analysing reports of suspected ADRs from the UK YCS and comparing reports from patients and HCPs. To elicit the views and experiences of patients and the public about patient reporting of ADRs. DESIGN: (1) Literature review and survey of international experiences of consumer reporting of ADRs; (2) descriptive analysis of Yellow Card reports; (3) signal generation analysis of Yellow Card reports; (4) qualitative analysis of Yellow Card reports; (5) questionnaire survey of patients reporting on Yellow Cards; (6) qualitative analysis of telephone interviews with patient reporters to the scheme; (7) qualitative analysis of focus groups and usability testing of the patient YCS; and (8) national omnibus telephone survey of public awareness of the YCS. PARTICIPANTS: Patients (n = 5180) and HCPs (n = 20,949) submitting Yellow Card reports from October 2005 to September 2007. Respondents to questionnaire survey (n = 1362). Participants at focus groups and usability testing sessions (n = 40). National omnibus telephone survey (n = 2028). SETTING: The literature review included studies in English from across the world. All other components included populations from the UK; the omnibus survey was restricted to Great Britain. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Characteristics of patient reports: types of drug and suspected ADR reported; seriousness of reports; and content of reports. The relative contributions of patient reports and of HCP reports to signal generation. Views and experiences of patient reporters. Views of members of the public about the YCS, including user-friendliness and usability of different ways of patient reporting. Public awareness of the YCS. Suggestions for improving patient reporting to the YCS. RESULTS: Compared with HCPs, patient reports to the YCS contained a higher median number of suspected ADRs per report, and described reactions in more detail. The proportions of reports categorised as 'serious' were similar; the patterns of drugs and reactions reported differed. Patient reports were richer in their descriptions of reactions than those from HCPs, and more often noted the effects of ADRs on patients' lives. Combining patient and HCP reports generated more potential signals than HCP reports alone; some potential signals in the 'HCP-only' data set were lost when combined with patient reports, but fewer than those gained; the addition of patient reports to HCP reports identified 47 new 'serious' reactions not previously included in 'Summaries of Product Characteristics'. Most patient reporters found it fairly easy to make reports, although improvements to the scheme were suggested, including greater publicity and the redesign of web- and paper-based reporting systems. Among members of the public, 8.5% were aware of the YCS in 2009. CONCLUSIONS: Patient reporting of suspected ADRs has the potential to add value to pharmacovigilance by reporting types of drugs and reactions different from those reported by HCPs; generating new potential signals; and describing suspected ADRs in enough detail to provide useful information on likely causality and impact on patients' lives. These findings suggest that further promotion of patient reporting to the YCS is justified, along with improvements to existing reporting systems. In order of priority, future work should include further investigation of (1) the pharmacovigilance impact of patient reporting in a longer-term study; (2) the optimum approach to signal generation analysis of patient and HCP reports; (3) the burden of ADRs in terms of impact on patients' lives; (4) the knowledge and attitudes of HCPs towards patient reporting of ADRs; (5) the value of using patient reports of ADRs to help other patients and HCPs who are seeking information on patient experiences of ADRs; and (6) the impact of increasing publicity and/or enhancements to reporting systems on the numbers and types of Yellow Card reports from patients. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

The menopause 'It's somewhere between a taboo and a joke'. A focus group study.

OBJECTIVES: To explore the menopause from the perspective of women in the community, with specific emphasis on their experience of menopausal symptoms, management strategies and support post the Women's Health Initiative trial. METHODS: Four focus groups were conducted with 14 middle-aged women living in the Grampian region of Scotland. The groups lasted up to 2 hours and were analyzed using the framework approach. RESULTS: Symptom experience was multifaceted and varied, depending on factors such as embarrassment from symptoms, loss of identity, expectations, social support and effectiveness of management strategies. Lack of support was highlighted as a reason why some participants felt confused about the symptoms that they could attribute to the menopause and the management strategies available to them. A variety of management strategies had been used including hormone replacement therapy, herbal remedies and lifestyle changes, with varying levels of success. Some women who chose not to use hormone replacement therapy (HRT) preferred to use lifestyle changes or felt that their symptoms did not warrant hormonal therapy. Some women felt that they had to persuade their family doctor to prescribe HRT and felt that their doctors were too restrictive in prescribing this treatment. CONCLUSIONS: Although having good social support in general, some respondents felt less supported about the menopause and felt that improved support networks would diminish some of the confusion about symptoms experienced and management strategies available. In spite of the negative publicity surrounding HRT in recent years, a number of women perceived their family doctor as too restrictive when prescribing HRT.

Hormonal contraception and risk of cancer.

BACKGROUND: Fear from increased cancer risk is one of the most significant reasons for low acceptance of reliable contraceptive methods and low compliance. METHODS: In this review, we included all cohort and case-control studies published in English up to December 2008. They were identified through a search of the literature using Pubmed and EMBASE. RESULTS: Data about breast cancer risk indicate a slightly increased risk among current users of oral contraceptives (OC), an effect which disappears 5-10 years after stopping. Combined OC have a significant protective effect on the risk of ovarian cancer, and the protection increases with duration of use (relative risk decreased by 20% for each 5 years of use). The significant risk reduction has been confirmed for BRCA 1 and 2 mutation carriers. The risk of endometrial cancer is reduced by about 50% in ever users, a benefit which is greater with increasing duration of use. An association has been found between increased risk of cervical cancer and long-term OC use. Current OC use has been associated with an excess risk of benign liver tumours and a modest increased risk of liver cancer. None of large prospective cohort studies with prolonged follow-up has observed an increased overall risk of cancer incidence or mortality among ever users of OC, indeed several have suggested important long-term benefits. Specifically, protective effect of OC can be used as chemoprevention in young women who are BRCA mutation carriers. CONCLUSIONS: Women wishing to use combined OC can be reassured that their decision is unlikely to place them at higher risk of developing cancer.

Patient satisfaction with GP-led melanoma follow-up: a randomised controlled trial.

BACKGROUND: There are no universally accepted guidelines for the follow-up of individuals with cutaneous melanoma. Furthermore, to date, there have been no randomised controlled trials of different models of melanoma follow-up care. This randomised controlled trial was conducted to evaluate the effects of GP-led melanoma follow-up on patient satisfaction, follow-up guideline compliance, anxiety and depression, as well as health status. METHODS: A randomised controlled trial of GP-led follow-up of cutaneous melanoma was conducted over a period of 1 year with assessment by self-completed questionnaires and review of general practice-held medical records at baseline and 12 months later. It took place in 35 general practices in North-east Scotland. Subjects were 142 individuals (51.4% women 48.6% men; mean (s.d.) age 59.2 (15.2) years previously treated for cutaneous melanoma and free of recurrent disease. The intervention consisted of protocol-driven melanoma reviews in primary care, conducted by trained GPs and supported by centralised recall, rapid access pathway to secondary care and a patient information booklet. The main outcome measure was patient satisfaction measured by questionnaire. Secondary outcomes were adherence to guidelines, health status measured by Short Form-36 and the Hospital Anxiety and Depression Scale. RESULTS: There were significant improvements in 5 out of 15 aspects of patient satisfaction during the study year in those receiving GP-led melanoma follow-up (all P

Introduction of a new incentive and target-based contract for family physicians in the UK: good for older patients with diabetes but less good for women?

AIMS: To determine whether the recording of diabetes-related health indicators has increased and differences diminished between age, gender and deprivation groups, following the introduction of the new General Medical Services contract (nGMS), an incentive- and target-based contract for UK family physicians. METHODS: A serial cross-sectional study set in 310 primary care practices in Scotland serving a population of 1.5 million registered patients, focussing on diabetic patients. Data were taken immediately before the introduction of the nGMS and after it had been in place for 1 year. RESULTS: One year after the introduction of the nGMS contract, there was a 54.2% relative increase in the number of patients electronically recorded as having diabetes. In addition, measurement of the quality indicators glycated haemoglobin (HbA(1c)), blood pressure, serum creatinine and cholesterol significantly increased (P < 0.05). Women were less likely than men to have HbA(1c)[odds ratio (OR) 0.85, 95% confidence intervals (CI) 0.80-0.91], serum creatinine (OR 0.90, 95% CI 0.84-0.96) and cholesterol recorded (OR 0.83, 95% CI 0.77-0.90) or achieve HbA(1c) (

Evidence for age and sex differences in the secondary prevention of stroke in Scottish primary care.

BACKGROUND AND PURPOSE: Secondary preventive measures play an important role in the reduction of stroke, the third largest cause of death in Scotland. We investigated whether sex, age, or deprivation differences existed in the secondary prevention of stroke in primary care. METHODS: A retrospective cross-sectional study using a computerized database with 61 practices (377,439 patients) to identify group differences in secondary preventive therapy between March 2003 and April 2004 for 10,076 patients with a diagnosis of any stroke. RESULTS: Women with any stroke were more likely than men to be prescribed a thiazide (odds ratios [OR], 1.60; 95% confidence interval [CI], 1.46 to 1.75) but less likely to be prescribed an angiotensin-converting enzyme inhibitor (OR, 0.73; 95% CI, 0.67 to 0.81). Women with ischemic stroke were less likely to receive either an antiplatelet or warfarin (OR, 0.84; 95% CI, 0.75 to 0.94) or statin therapy (OR, 0.82; 95% CI, 0.74 to 0.90) than men. Women with atrial fibrillation received less warfarin (OR, 0.62; 95% CI, 0.48 to 0.81) but more antiplatelet therapy than men (OR, 1.30; 95% CI, 1.00 to 1.68). The oldest patients (older than 75 years) with ischemic stroke received more antiplatelet therapy than the youngest patients (younger than 65 years) (OR, 1.83; 95% CI, 1.64 to 2.06). No significant differences in secondary preventative treatment across deprivation groups were found. CONCLUSIONS: Important sex and age differences exist in the care of patients with stroke and suggest that women and the elderly need to be targeted for secondary prevention therapy.

Evidence for inequalities in the management of coronary heart disease in Scotland.

OBJECTIVES: To investigate whether sex, age, and deprivation inequalities existed in the prescription of secondary preventive treatment for coronary heart disease (CHD) in Scottish general practice and whether these differences altered over time. DESIGN: 6 year cross sectional study based on general practice morbidity and prescribing data. SETTING: 55 primary care practices in Scotland. SUBJECTS: 14,435 patients with diagnosed CHD. MAIN OUTCOME MEASURE: Prescription of various groups of secondary preventive treatment in six study years. RESULTS: The use of all secondary prevention treatments increased over time (63.6% of patients with CHD in 1997 to 87.6% in 2002). After adjustments for age, sex, deprivation, co-morbidities, and practice where appropriate, women received fewer secondary prevention treatments than men, a difference that increased over time (March 1997: adjusted odds ratio (OR) 0.9, 95% confidence interval (CI) 0.8 to 1.0; March 2002: OR 0.6, 95% CI 0.6 to 0.7). Sex differences were observed within each group of treatments studied. The oldest group of patients was less likely than the youngest group to receive any secondary preventive treatment in the year up to March 1997 (OR 0.6, 95% CI 0.5 to 0.7) but were more likely by 2002 (OR 1.3, 95% CI 1.1 to 1.5) to receive secondary prevention. The most affluent patients with CHD were significantly less likely to receive a statin between March 1998 and 2001 (March 1998 OR 0.6, 95% CI 0.5 to 0.9), a finding that disappeared by 2002 (OR 0.9, 95% CI 0.7 to 1.1). CONCLUSION: The results suggest that inequalities exist in the secondary prevention of CHD in Scotland.

Gender, age and deprivation differences in the primary care management of hypertension in Scotland: a cross-sectional database study.

BACKGROUND: Little is known about the community management of cardiovascular disease among different gender, age or deprivation groups, even though much of the long-term treatment takes place within primary care. OBJECTIVES: Our aim was to determine whether important gender, age and deprivation differences exist in the primary care management of hypertension. METHODS: A cross-sectional analysis of computerized general practice data was carried out in 43 practices in Scotland contributing to the Continuous Morbidity Recording project. The main outcome measures were odds ratios of being under GP review; receiving different classes of antihypertensive treatments [thiazides, beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, calcium channel blockers]; and receiving other cardiovascular preventative treatments (statins and/or antiplatelets). RESULTS: Compared with males, female hypertensive patients were more likely to receive a thiazide and less likely to be given an ACE inhibitor, calcium channel blocker or secondary preventative treatment. Elderly hypertensive patients were less likely than the youngest patients to be under GP active review, more likely to be on a thiazide, calcium channel blocker or antiplatelet treatment, and less likely to be on a statin. More deprived hypertensive patients were less likely to be under GP review, or to be on a thiazide or a statin, but were more likely to be on a calcium channel blocker or an antiplatelet drug than the most affluent group. CONCLUSIONS: Important gender, age and deprivation differences exist in three important components of the primary care treatment of hypertension in Scotland.

Pharmacovigilance of over-the-counter products based in community pharmacy: methodological issues from pilot work conducted in Hampshire and Grampian, UK.

PURPOSE: The incidence of serious adverse events from non-prescription medicines remains to be established. The aim of this initial pilot work, using an observational cohort design, was to determine the feasibility of conducting a pharmacovigilance study of a non-prescription medicine, based in community pharmacies. METHOD: Community pharmacists from Grampian, Scotland, and Hampshire, England, recruited user-purchasers of ibuprofen. Exposure data were collected from a series of self-completed questionnaires. Outcome data were any new symptoms, use of concomitant medication and subsequent health-care utilization. RESULTS: A total of 1021 eligible customers were recruited, 6.4% (466/7320) and 48.2% (555/1152) by the Hampshire and Grampian networks respectively. The cohorts differed with regard to age, smoking and socio-economic status, reason for purchase and recommendation, and duration of use. The two cohorts reported different use of concomitant medication (46.0 and 65.5%), asthma (7.2 and 10.5%), stomach/peptic ulcer (3.5 and 2.1%), a higher prevalence of gastrointestinal symptoms post-compared to pre-purchase (12.9 vs. 7.2%, p = 0.0006 and 8.8 vs. 5.8%, p = 0.034), ingestion of doses in excess of the licensed non-prescription dose by 5.1 and 3.9%, and discontinuation of treatment because the medicine upset them by 4.5 and 3.1%, respectively. Most participants did not seek medical advice for their symptoms. CONCLUSION: Greater vigilance is required for adverse events that may be attributable to non-prescription product use. Development of pharmacovigilance models using community pharmacies is one means of systematically collecting information regarding drug safety. Further work is needed to identify a method which maximizes patient recruitment whilst maintaining acceptable follow-up rates.

The course of chronic pain in the community: results of a 4-year follow-up study.

Little is known about the course of chronic pain in the community. Such information is needed for the prevention and management of chronic pain. We undertook a 4-year follow-up study of 2184 individuals living in Grampian, UK to describe patterns and predictors of change in chronic pain over time. In October 2000, participants completed a postal questionnaire including case definition questions, the chronic pain grade questionnaire, the SF-36 and socio-demographic questions. Information from this questionnaire was compared to information collected from a similar questionnaire in 1996. A response rate of 83% was achieved for the follow-up study. The overall prevalence of chronic pain (pain or discomfort present either all the time or on and off for 3 months or longer) increased from 45.5% at baseline to 53.8% at follow-up. Seventy-nine percent of those with chronic pain at baseline still had it at follow-up. The average annual incidence was 8.3% and the average annual recovery rate was 5.4%. Individuals in the study samples who are in lowest quartile of SF-36 domains--physical functioning, social functioning and bodily pain at baseline--were more likely to develop chronic pain at follow-up, and respondents who were retired were less likely to develop chronic pain. Individuals in the study samples in the lowest quartile of SF-36 domains, bodily pain and general health at baseline, were less likely to recover from their chronic pain, as were those aged 45-74 compared with those aged 25-34. We concluded that chronic pain is a common, persistent problem in the community with relatively high incidence and low recovery rates. The lack of association between onset or recovery from chronic pain and most traditional socio-demographic factors, highlights the need to broaden the range of factors included in studies of chronic pain aetiology.

The contribution of cohort studies to prescribing research.

This paper highlights the main issues in the design, analysis and interpretation of cohort studies used in prescribing research.

Long term follow-up studies of users of nonprescription medicines purchased from community pharmacies: some methodological issues.

BACKGROUND: Despite the wider availability of medicines to the general public, little is known about their safety when supplied without prescription. Pilot work has already tested 4 methods of recruiting users of ibuprofen purchased from community pharmacies. This paper describes the piloting of a fifth method (a shortened questionnaire), long term follow-up rates of all methods, consistency of reporting of ibuprofen use, and issues relating to possible comparison groups in pharmacovigilance studies. METHODS: A shortened version of a previously tested recruitment questionnaire was used. Eligible study participants were all users, aged over 17 years, purchasing ibuprofen from a research network of community pharmacies (n = 61) in Grampian, Scotland. Postal questionnaires were sent at I week and 2, 6 and 12 months irrespective of the method of recruitment. The follow-up questionnaires collected information about ibuprofen and other drug usage, symptoms and associated health service utilisation. RESULTS: The shortened form recruited 67% of people issued with a questionnaire. The overall 12-month follow-up rate was 67%, although there were important differences in the rates by method of recruitment. There was reasonable consistency in the reporting of use or non-use of ibuprofen at different follow-up times. In the 12 months after the index purchase, 17% of participants never used any ibuprofen (non-users) and 28% used it for more than 8 weeks in total (long term users). At 12 months, long term users were significantly more likely than short term users (< or =8 weeks total use) or non-users to have experienced dizziness, skin rash, itchy skin and wheeziness in the previous week. CONCLUSIONS: Our pilot work has confirmed the feasibility of recruiting, and following-up over prolonged periods, users of nonprescription medicines. Evidence of long term use of ibuprofen confirms the need for pharmacovigilance studies of this drug, although further work is required to identify a suitable comparison group in order to inform the interpretation of such investigations.

Respiratory illness and healthcare utilization in children: the primary and secondary care interface.

The aim of the present study was to quantify the healthcare utilization of a child population according to level of respiratory illness. A stratified random sample of 713 children was selected from respondents to a postal respiratory questionnaire, carried out in two general practice populations in 1993. Children were stratified into four groups according to the number of positive responses to five key questions. These groups were used as indicators of likelihood of asthma diagnosis. A search was made of these childrens' practice records covering a 2-yr period, to include both primary and secondary healthcare. There was a significant increase across positive response groups in the proportion of children having primary and secondary care based consultations, particularly for respiratory conditions (p = 0.001). There was also a significant increase in prescribing. Of those children considered to be "likely asthmatics" from their questionnaire responses, 8.1% (n = 31) did not receive any primary or secondary care for a respiratory problem over the 2-yr period. As the likelihood of respiratory illness increased in this population, more demand was made upon resources for the treatment of respiratory illness. Quantification of this demand enables evidence based resource allocation decisions to be made. This method of quantification could be applied in other populations.

The impact of chronic pain in the community.

BACKGROUND: Chronic pain is known to be very common in the community. Less is known about the epidemiology of more significant or severe chronic pain. The impact of chronic pain in the community, in terms of general health, employment and interference with daily activity, has not been quantified. OBJECTIVES: The aim of this study was to describe the prevalence and distribution in the community of chronic pain defined as 'significant' and 'severe', and to explore the impact of chronic pain on health and activity. METHODS: A questionnaire survey was carried out of a sample drawn from the general population in the Grampian region of SCOTLAND: Questionnaires were sent to a random sample of 4611 individuals aged 25 years and over, stratified for age and gender, selected from the practice lists of 29 general practices (total practice population 136,383). The study instrument included a case definition questionnaire, from which were identified individuals with 'any chronic pain' (pain of at least 3 months duration). The instrument also included a level of expressed need questionnaire and the chronic pain grade questionnaire, from which were derived definitions for 'significant chronic pain' (based on the reported need for treatment and professional advice) and 'severe chronic pain' (based on reported intensity and pain-related disability). The SF-36 general health questionnaire and demographic questions were also included. RESULTS: Of the sample, 14.1% reported 'significant chronic pain', and this was more prevalent among women and older age groups. A total of 6.3% reported 'severe chronic pain', and this was more common in older age groups. On multiple logistic regression modelling, female gender, housing tenure, employment category and educational attainment were found to be independently associated with both 'significant' and 'severe' chronic pain. The presence of 'any', 'significant' and 'severe' chronic pain had progressively more marked adverse associations with employment, interference with daily activities and all measured dimensions of general health. CONCLUSIONS: Comparison of the epidemiology of 'significant chronic pain' and 'severe chronic pain' with 'any chronic pain' allows an understanding of the more clinically important end of the chronic pain spectrum. These results support the suggestion that chronic pain is multidimensional, both in its aetiology and in its effects, particularly at this end of the spectrum. This must be addressed in management and in further research.