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1.  Implementing the NICE osteoarthritis guidelines: a mixed methods study and cluster randomised trial of a model osteoarthritis consultation in primary care - the Management of OsteoArthritis In Consultations (MOSAICS) study protocol 
There is as yet no evidence on the feasibility of implementing recommendations from the National Institute of Health and Care Excellence (NICE) osteoarthritis (OA) guidelines in primary care, or of the effect these recommendations have on the condition. The primary aim of this study is to determine the clinical and cost effectiveness of a model OA consultation (MOAC), implementing the core recommendations from the NICE OA guidelines in primary care. Secondary aims are to investigate the impact, feasibility and acceptability of the MOAC intervention; to develop and evaluate a training package for management of OA by general practitioners (GPs) and practice nurses; test the feasibility of deriving ‘quality markers’ of OA management using a new consultation template and medical record review; and describe the uptake of core NICE OA recommendations in participants aged 45 years and over with joint pain.
A mixed methods study with a nested cluster randomised controlled trial.
This study was developed according to a defined theoretical framework (the Whole System Informing Self-management Engagement). An overarching model (the Normalisation Process Theory) will be employed to undertake a comprehensive ‘whole-system’ evaluation of the processes and outcomes of implementing the MOAC intervention. The primary outcome is general physical health (Short Form-12 Physical component score [PCS]) (Ware 1996). The impact, acceptability and feasibility of the MOAC intervention at practice level will be assessed by comparing intervention and control practices using a Quality Indicators template and medical record review. Impact and acceptability of the intervention for patients will be assessed via self-completed outcome measures and semi-structured interviews. The impact, acceptability and feasibility of the MOAC intervention and training for GPs and practice nurses will be evaluated using a variety of methods including questionnaires, semi-structured interviews, and observations.
The main output from the study will be to determine whether the MOAC intervention is clinically and cost effective. Additional outputs will be the development of the MOAC for patients consulting with joint pain in primary care, training and educational materials, and resources for patients and professionals regarding supported self-management and uptake of NICE guidance.
Trial registration
ISRCTN number: ISRCTN06984617.
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-014-0095-y) contains supplementary material, which is available to authorized users.
PMCID: PMC4176866  PMID: 25209897
Osteoarthritis; General practice; Implementation; Primary care; NICE guidelines; Self-management
2.  The clinical course of low back pain: a meta-analysis comparing outcomes in randomised clinical trials (RCTs) and observational studies 
Evidence suggests that the course of low back pain (LBP) symptoms in randomised clinical trials (RCTs) follows a pattern of large improvement regardless of the type of treatment. A similar pattern was independently observed in observational studies. However, there is an assumption that the clinical course of symptoms is particularly influenced in RCTs by mere participation in the trials. To test this assumption, the aim of our study was to compare the course of LBP in RCTs and observational studies.
Source of studies CENTRAL database for RCTs and MEDLINE, CINAHL, EMBASE and hand search of systematic reviews for cohort studies. Studies include individuals aged 18 or over, and concern non-specific LBP. Trials had to concern primary care treatments. Data were extracted on pain intensity. Meta-regression analysis was used to compare the pooled within-group change in pain in RCTs with that in cohort studies calculated as the standardised mean change (SMC).
70 RCTs and 19 cohort studies were included, out of 1134 and 653 identified respectively. LBP symptoms followed a similar course in RCTs and cohort studies: a rapid improvement in the first 6 weeks followed by a smaller further improvement until 52 weeks. There was no statistically significant difference in pooled SMC between RCTs and cohort studies at any time point:- 6 weeks: RCTs: SMC 1.0 (95% CI 0.9 to 1.0) and cohorts 1.2 (0.7to 1.7); 13 weeks: RCTs 1.2 (1.1 to 1.3) and cohorts 1.0 (0.8 to 1.3); 27 weeks: RCTs 1.1 (1.0 to 1.2) and cohorts 1.2 (0.8 to 1.7); 52 weeks: RCTs 0.9 (0.8 to 1.0) and cohorts 1.1 (0.8 to 1.6).
The clinical course of LBP symptoms followed a pattern that was similar in RCTs and cohort observational studies. In addition to a shared ‘natural history’, enrolment of LBP patients in clinical studies is likely to provoke responses that reflect the nonspecific effects of seeking and receiving care, independent of the study design.
PMCID: PMC4007531  PMID: 24607083
3.  Does Attrition during Follow-Up of a Population Cohort Study Inevitably Lead to Biased Estimates of Health Status? 
PLoS ONE  2013;8(12):e83948.
Attrition is a potential source of bias in cohort studies. Although attrition may be inevitable in cohort studies of older people, there is little empirical evidence as to whether bias due to such attrition is also inevitable. Anonymised primary care data, routinely collected in clinical practice and independent of any cohort research study, represents an ideal unselected comparison dataset with which to compare primary care data from consenting responders to a cohort study. Our objective was to use this method as a novel means to assess if (i) responders at follow-up stages in a cohort study remain representative of responders at baseline and (ii) attrition biases estimates of longitudinal associations. We compared primary care consultation morbidities and prescription prevalences among circa 32,000 patients aged 50+ who contribute to an anonymised general practice database (Consultations in Primary Care Archive (CiPCA)) with those from patients aged 50+ in the North Staffordshire Osteoarthritis Project (NorStOP) cohort, United Kingdom (2002–2008; n = 16,159). 8,197 (51%) persons responded to the NorStOP baseline survey and consented to medical record review. 5,121 and 3,311 responded at 3- and 6-year follow-ups. Differences in consulting prevalence of non-musculoskeletal morbidities between NorStOP responders and CiPCA comparison population did not increase over the two follow-up points except for ischaemic heart disease. Differences observed at baseline for osteoarthritis-related consultations were generally unchanged at the two follow-ups (standardised prevalence ratios for osteoarthritis (1.09–1.13) and joint pain (1.12–1.23)). Age and gender adjusted associations between baseline consultation for chronic morbidity and future new osteoarthritis and related consultations were similar in CiPCA (adjusted Hazard Ratio: 1.40; 95% Confidence Interval: 1.34,1.47) and NorStOP 6-year responders (1.32; 1.15,1.51). There was little evidence that responders at follow-ups represented any further selection bias to that present at baseline. Attrition in cohort studies of older people does not inevitably indicate bias.
PMCID: PMC3875525  PMID: 24386313
4.  Taking responsibility for the early assessment and treatment of patients with musculoskeletal pain: a review and critical analysis 
Musculoskeletal pain is common across all populations and costly in terms of impact on the individual and, more generally, on society. In most health-care systems, the first person to see the patient with a musculoskeletal problem such as back pain is the general practitioner, and access to other professionals such as physiotherapists, chiropractors, or osteopaths is still either largely controlled by a traditional medical model of referral or left to self-referral by the patient. In this paper, we examine the arguments for the general practitioner-led model and consider the arguments, and underpinning evidence, for reconsidering who should take responsibility for the early assessment and treatment of patients with musculoskeletal problems.
PMCID: PMC3392833  PMID: 22404958
5.  Does life course socio-economic position influence chronic disabling pain in older adults? A general population study 
Background: Chronic pain is the leading cause of disability in developed countries. Prevalence is linked with socio-economic position (SEP), but little is known about the influence of SEP on disabling pain over the life course. We have investigated the influence of different life course trajectories of SEP on disabling pain (‘pain interference’) in postal surveys of adults aged ≥50 years sampled from the general population of adults registered with three UK general practices. Methods: Current pain interference was measured using the dichotomized 36-item Short-Form (SF-36) health survey. Three recalled SEP measures (age left school, longest job and current/most recent job) were dichotomized into low SEP (left school at or before minimum school leaving age; reported routine or manual occupations) and high SEP, from which eight life course SEP trajectories were constructed. Associations of (i) eight SEP trajectories and (ii) three individual SEP measures adjusted for each other, with pain interference, adjusted for potential confounders, were calculated using logistic regression. Results: A total of 2533 individuals provided data on all three SEP measures. A consistently low life course SEP trajectory was significantly associated with current pain interference compared with a high trajectory [odds ratio (OR) = 2.76, 95% confidence interval (CI): 2.19–3.47], even after adjustment for age and gender. Further adjustment reduced the association but it remained significant (OR = 2.04; 95% CI: 1.55–2.68). In the model with individual measures, low age left school (OR = 1.45; 95% CI: 1.15–1.82) and manual longest job (OR = 1.47; 95% CI: 1.13–1.91) were independently associated with pain interference. Conclusions: Our results highlight the potential for reducing chronic disabling pain in later life by addressing inequalities in both childhood education and adult occupational opportunities.
PMCID: PMC3719471  PMID: 22874735
6.  Validity of two simple measures for estimating life-course socio-economic position in cross-sectional postal survey data in an older population: results from the North Staffordshire Osteoarthritis Project (NorStOP) 
Since few cohorts encompass the whole life-course, many studies that measure socio-economic position (SEP) across the life-course rely on participant recall of SEP measures from cross-sectional postal or interview surveys. It is also particularly important that SEP measures should be appropriate for the age of the population studied, as the level of missing data has been shown to increase in older people. The aim of this study was to investigate the accuracy of recall of two SEP measures in older adults, age left school and longest job, by examining their validity in a general population postal survey in North Staffordshire, UK.
Sets of questions on education and longest job were included in a questionnaire at different stages of the study. All patients aged 50+ registered with three general practices were sent a baseline Health Questionnaire. 6 years later, 3410 responders were mailed a follow-up Health Questionnaire; a sub-sample of these participants took part in independent qualitative interviews. Validity was assessed by: percentage completion; internal percentage agreement within each set of questions; percentage agreement of qualitative and quantitative data for age left school and longest job; comparing recall of age left school with historical change in legal school leaving age; comparing frequency of pottery job titles with those in 1981 Census data for Stoke-on-Trent.
The adjusted response to different stages of the study was 71–85%. Completion of questions was 83–98%. Internal agreement was 84–97% (education) and 95–100% (longest job). Comparison of survey and interview data showed 86% agreement (± 1 year) for age left school and 91% agreement for longest job. The change in age left school data concurred with the historical shift in legal school leaving age. 11% of job titles were pottery in NorStOP data and 15% in Stoke-on-Trent Census data.
The results from this study provide evidence for the accuracy of recall of two simple measures of SEP (age left school and longest job) in a postal survey of older adults. Consistency with evidence from external datasets indicated the potential validity of these measures for studying life-course SEP in population surveys.
PMCID: PMC3438121  PMID: 22738317
7.  Contributions of prognostic factors for poor outcome in primary care low back pain patients 
Back pain is common and some sufferers consult GPs, yet many sufferers develop persistent problems. Combining information on risk of persistence and prognostic indicator prevalence provides more information on potential intervention targets than risk estimates alone.
To determine the proportion of primary care back pain patients with persistent problems whose outcome is related to measurable prognostic factors.
Prospective cohort study of back pain patients (30–59 years) at five general practices in Staffordshire, UK (n = 389). Baseline factors (demographic; episode duration; symptom severity; pain widespreadness; anxiety; depression; catastrophising; fear-avoidance; self-rated health) were assessed for their association with disabling and limiting pain after 12-months. The proportion of those with persistent problems whose outcome was related to each factor was calculated.
Prevalence of prognostic factors ranged from 23% to 87%. Strongest predictors were unemployment (adjusted relative risk (RR) 4.2; 95% CI 2.0, 8.5) and high pain intensity (4.1; 1.7, 9.9). The largest proportions of persistent problems were related to high pain intensity (68%; 95% CI 27, 87%) and unemployment (64%; 33, 82%). Combining these indicated that 85% of poor back pain outcome is related to these two factors. Poor self-rated health, functional disability, upper body pain and pain bothersomeness were related with outcome for over 40% of those with persistent problems.
Several factors increased risk of poor outcome in back pain patients, notably high pain and unemployment. These risks in combination with high prevalence of risk factors in this population distinguish factors that can help identify targets or sub-groups for intervention.
PMCID: PMC3062783  PMID: 20728385
Back pain; Epidemiology; Cohort study; Primary health care; Targeting
8.  The search for stable prognostic models in multiple imputed data sets 
In prognostic studies model instability and missing data can be troubling factors. Proposed methods for handling these situations are bootstrapping (B) and Multiple imputation (MI). The authors examined the influence of these methods on model composition.
Models were constructed using a cohort of 587 patients consulting between January 2001 and January 2003 with a shoulder problem in general practice in the Netherlands (the Dutch Shoulder Study). Outcome measures were persistent shoulder disability and persistent shoulder pain. Potential predictors included socio-demographic variables, characteristics of the pain problem, physical activity and psychosocial factors. Model composition and performance (calibration and discrimination) were assessed for models using a complete case analysis, MI, bootstrapping or both MI and bootstrapping.
Results showed that model composition varied between models as a result of how missing data was handled and that bootstrapping provided additional information on the stability of the selected prognostic model.
In prognostic modeling missing data needs to be handled by MI and bootstrap model selection is advised in order to provide information on model stability.
PMCID: PMC2954918  PMID: 20846460
9.  Musculoskeletal foot problems in primary care: what influences older people to consult? 
Rheumatology (Oxford, England)  2010;49(11):2109-2116.
Objective. To estimate the incidence of, and factors associated with, consultation for musculoskeletal foot problems in primary care.
Methods. Survey data from 13 986 people aged ≥50 years who took part in the North Staffordshire Osteoarthritis Project were linked to a database of primary care consultations. Foot problems were defined as responding affirmatively to the questions: ‘Have you had any problems with your feet over the last year?’ or ‘Have you had pain in the last year in and around the foot?’. The main outcome measure was a record of a musculoskeletal foot-related consultation within 18 months following the survey.
Results. Of the 3858 participants with foot problems who had not consulted before the survey, 350 (9.1%) consulted in the 18 months following the survey. Age, sex, education, general health and pain in other regions were not associated with future consultation. However, those who consulted were more likely to have reported foot pain [adjusted odds ratio (OR) 2.04; 95% CI 1.22, 3.42) and to consider treatments to be effective in controlling disease (OR 1.54; 95% CI 1.07, 2.21) in the baseline survey, and to have been a frequent consulter in the 18 months before the survey (OR 1.65; 95% CI 1.30, 2.09).
Conclusions. Only a minority of older people with musculoskeletal foot problems consult their general practitioner about them. Foot pain, frequent consultation for other problems and positive perceptions of treatment efficacy appear to be the strongest factors influencing future consultation.
PMCID: PMC2954366  PMID: 20660499
Foot deformities; Osteoarthritis; Pain; Consultation
10.  Characteristics of primary care consultations for musculoskeletal foot and ankle problems in the UK 
Rheumatology (Oxford, England)  2010;49(7):1391-1398.
Objective. Foot and ankle problems are highly prevalent in the general population; however, little is known about the characteristics of those seeking medical assessment for these problems. The objective of this study was to explore the extent and types of musculoskeletal foot and ankle problems in primary care.
Methods. Consultation data related to musculoskeletal foot and ankle problems in 2006 were extracted from the Consultations in Primary Care Archive (CiPCA), which covers consultations in 12 general practices in North Staffordshire. Data were cross-tabulated by age and gender, and annual consultation prevalence per 10 000 registered persons was calculated.
Results. Of the 55 033 musculoskeletal consultations documented in CiPCA in 2006, 4500 (8%) related to foot and ankle problems. The most commonly documented Read term was ‘foot pain’ (1281 consultations; 28%), followed by ‘ankle pain’ [451 (10%)]. Most consultations [3538 (79%)] involved non-traumatic conditions. Females accounted for slightly more consultations than males (55 vs 45%), and the highest proportion of consultations involved people aged 45–64 years (36%). The number of consultations per patient ranged from 1 to 11. Annual consultation prevalence was 290 per 10 000 registered persons and increased with age, reaching a peak in the 65- to 74-year age group (411 per 10 000 registered persons).
Conclusion. Foot and ankle problems account for a substantial number of consultations in primary care, and most frequently involve non-traumatic conditions. Further research is required to evaluate the factors that influence consultation for foot problems and strategies that general practitioners use to manage these conditions.
PMCID: PMC2886311  PMID: 20403912
Foot deformities; Osteoarthritis; Pain; Consultation
11.  The discordance between clinical and radiographic knee osteoarthritis: A systematic search and summary of the literature 
Studies have suggested that the symptoms of knee osteoarthritis (OA) are rather weakly associated with radiographic findings and vice versa. Our objectives were to identify estimates of the prevalence of radiographic knee OA in adults with knee pain and of knee pain in adults with radiographic knee OA, and determine if the definitions of x ray osteoarthritis and symptoms, and variation in demographic factors influence these estimates.
A systematic literature search identifying population studies which combined x rays, diagnosis, clinical signs and symptoms in knee OA. Estimates of the prevalence of radiographic OA in people with knee pain were determined and vice versa. In addition the effects of influencing factors were scrutinised.
The proportion of those with knee pain found to have radiographic osteoarthritis ranged from 15–76%, and in those with radiographic knee OA the proportion with pain ranged from 15% – 81%. Considerable variation occurred with x ray view, pain definition, OA grading and demographic factors
Knee pain is an imprecise marker of radiographic knee osteoarthritis but this depends on the extent of radiographic views used. Radiographic knee osteoarthritis is likewise an imprecise guide to the likelihood that knee pain or disability will be present. Both associations are affected by the definition of pain used and the nature of the study group. The results of knee x rays should not be used in isolation when assessing individual patients with knee pain.
PMCID: PMC2542996  PMID: 18764949
12.  Prognostic factors for musculoskeletal pain in primary care: a systematic review 
Estimating the future course of musculoskeletal pain is an important consideration in the primary care consultation for patients and healthcare professionals. Studies of prognostic indicators tend to have been viewed in relation to each site separately, however, an alternative view is that some prognostic indicators may be common across different sites of musculoskeletal pain.
To identify generic prognostic indicators for patients with musculoskeletal pain in primary care.
Design of study
Systematic review.
Observational cohort studies in primary care.
MEDLINE, EMBASE, PsychINFO and CINAHL electronic databases were searched from inception to April 2006. Inclusion criteria were that the study was a primary care-based cohort, published in English and contained information on prognostic indicators for musculoskeletal conditions.
Forty-five studies were included. Eleven factors, assessed at baseline, were found to be associated with poor outcome at follow up for at least two different regional pain complaints: higher pain severity at baseline, longer pain duration, multiple-site pain, previous pain episodes, anxiety and/or depression, higher somatic perceptions and/or distress, adverse coping strategies, low social support, older age, higher baseline disability, and greater movement restriction.
Despite substantial heterogeneity in the design and analysis of original studies, this review has identified potential generic prognostic indicators that may be useful when assessing any regional musculoskeletal pain complaint. However, Its unclear whether these indicators, used alone, or in combination, can correctly estimate the likely course of individual patients' problems. Further research is needed, particularly in peripheral joint pain and using assessment methods feasible for routine practice.
PMCID: PMC2099673  PMID: 17688762
general practice; musculoskeletal; primary care; prognosis; rheumatology; systematic review
13.  Chest pain and subsequent consultation for coronary heart disease: a prospective cohort study 
Chest pain may not be reported to general practice but could be an important first sign of coronary heart disease (CHD).
To determine whether self-reported chest pain predicts future consultation for CHD in those with no history of consultation for CHD.
Design of study
Population-based study, with 7 year's follow up by GP record linkage.
General practice in North Staffordshire.
A survey, including the Rose angina questionnaire, was mailed to 4002 adults. Linked GP records used to identify responders with no record of CHD (G3 Read code or British National Formulary code for nitrate use) in the 32 months before the survey to form the sample for a 7-year prospective study. ‘Survival’ was compared in those with and without self-reported chest pain up to the earliest date of GP diagnosis of CHD, death, or end of the study period.
The survey response was 65% and 2348 participants gave permission to access their GP records. Of these, 2229 had no prior consultation for CHD. From the questionnaire, 558 reported chest pain of which 186 reported exertional pain and 103 met the criteria for angina. When followed prospectively, incidence of CHD consultations was higher in those with any chest pain definition, compared with no pain, and continued to be so for 7 years subsequently. Although these associations were strongly age related, self-reported symptoms were found to be an independent risk factor for future consultation for CHD.
This study highlighted that self-reported chest pain is a marker of future CHD. The usefulness of early identification of people with this symptom remains to be established.
PMCID: PMC2032699  PMID: 17244423
angina; chest pain; coronary disease; epidemiology; referral and consultation; screening
14.  A cross sectional study of requests for knee radiographs from primary care 
Knee pain is the commonest pain complaint amongst older adults in general practice. General Practitioners (GPs) may use x rays when managing knee pain, but little information exists regarding this process. Our objectives, therefore, were to describe the information GPs provide when ordering knee radiographs in older people, to assess the association between a clinical diagnosis of osteoarthritis (OA) and the presence of radiographic knee OA, and to investigate the clinical content of the corresponding radiologists' report.
A cross sectional study of GP requests for knee radiographs and their matched radiologists' reports from a local radiology department. Cases, aged over 40, were identified during an 11-week period. The clinical content of the GPs' requests and radiologists' reports was analysed. Associations of radiologists' reporting of i) osteoarthritis, ii) degenerative disease and iii) individual radiographic features of OA, with patient characteristics and clinical details on the GPs' requests, were assessed.
The study identified 136 cases with x ray requests from 79 GPs and 11 reporting radiologists. OA was identified clinically in 19 (14%) of the requests, and queried in another 31 (23%). The main clinical descriptor was pain in 119 cases (88%). Radiologists' reported OA in 22% of cases, and the features of OA were mentioned in 63%. Variation in reporting existed between radiologists. The commonest description was joint space narrowing in 52 reports (38%). There was an apparent although non significant increase in the reporting of knee OA when the GP had diagnosed or queried it (OR 1.95; 95% CI 0.76, 5.00).
The features of radiographic OA are commonly reported in those patients over 40 whom GPs send for x ray. If OA is clinically suspected, radiologists appear to be more likely to report its presence. Further research into alternative models of referral and reporting might identify a more appropriate imaging policy in knee disorders for primary care.
PMCID: PMC1963327  PMID: 17683606
15.  A systematic review of postcoital bleeding and risk of cervical cancer 
Postcoital bleeding may be a symptom of cervical cancer. Guidance to aid a GP in determining whom to investigate or refer exists but recommendations vary. Women need to be involved in decisions about their care and this involves communicating risk and an exploration of the implications of the risk. Risk estimates of postcoital bleeding for cervical cancer are not available.
To provide an estimate of the positive predictive values of postcoital bleeding for cervical cancer to aid decision making in primary care about whom to investigate for cervical cancer.
Design of study
A systematic review.
Community, primary and secondary care.
Six electronic databases were searched from the beginning of each of their time frames. Inclusion criteria were that the study was published in English and reported or contained enough data to calculate the prevalence or incidence of postcoital bleeding within the study population. No studies were excluded on issues of methodological quality.
The search strategy identified 910 unique articles. The point prevalence of postcoital bleeding in the community ranged from 0.7 to 9% among women. One study reported an annual cumulative incidence of 6% of menstruating women. The prevalence of postcoital bleeding in women with cervical cancer ranged from 0.7 to 39%. Calculation of risk that a woman in the community developing postcoital bleeding has cervical cancer ranges from 1 in 44 000 at age 20–24 years to 1 in 2 400 aged 45–54 years. There was no information allowing the direct calculation of risk in women presenting to primary care.
The evidence base for management strategies of postcoital bleeding and calculations of risk for cervical cancer in women with postcoital bleeding are poor. Recommendations for clinical practice are made on the current evidence.
PMCID: PMC1839021  PMID: 16762128
cervical cancer; postcoital bleeding; uterine neoplasms
16.  The assessment of the prognosis of musculoskeletal conditions in older adults presenting to general practice: a research protocol 
Musculoskeletal conditions represent a common reason for consulting general practice yet with the exception of low back pain, relatively little is known about the prognosis of these disorders. Recent evidence suggests that common 'generic' factors may be of value when assessing prognosis, irrespective of the location of the pain. This study will test a generic assessment tool used as part of the general practice consultation to determine prognosis of musculoskeletal complaints.
Older adults (aged 50 years and over) presenting to six general practices with musculoskeletal complaints will be assessed as part of the routine consultation using a generic assessment of prognosis. Participants will receive a self-completion questionnaire at baseline, three, six and 12 months post consultation to gather further data on pain, disability and psychological status. The primary outcome measure is participant's global rating of change.
Prognosis is considered to be a fundamental component of scientific medicine yet prognostic research in primary care settings is currently neglected and prognostic enquiry is disappearing from general medical textbooks. This study aims to address this issue by examining the use of generic prognostic factors in a general practice setting.
PMCID: PMC1647277  PMID: 17096846
17.  An epidemiological survey of symptoms of menstrual loss in the community 
Background: For the early detection of gynaecological malignancy, guidance based on presenting symptoms exists to aid a general practitioner (GP) in determining who to investigate or refer. The evidence for this advice is based on the prevalence of symptoms in women with gynaecological malignancy or within specialist clinics. There are no studies on the incidence of symptoms within the community.
Aim: To provide an estimate of the incidence of self-reported symptoms of menstrual loss in the community population of a single general practice.
Design of study: A prospective population-based cohort study of women identified through a baseline postal survey and followed 6 and 12 months later.
Setting: An urban general practice with four partners and 10 000 registered patients.
Method: A postal baseline survey was undertaken on all women aged 18–54 years on the practice age–sex register. Responders who consented to follow-up were sent further questionnaires at 6 and 12 months. All questionnaires enquired about the presence or absence of symptoms related to vaginal bleeding. Twelve-month cumulative incidence rates were calculated using responders to the baseline, 6-month and 12-month questionnaires.
Results: A total of 2435 questionnaires were initially sent out at baseline and 1513 (62%) women replied to all three questionnaires. The 12–month cumulative incidence of symptoms in menstruating women was: menorrhagia 25% (95% confidence interval [CI] = 22 to 29); periods heavier than usual, 21% (95% CI = 18 to 23); change in pattern of cycle, 29% (95% CI = 26 to 32); short cycle 21% (95% CI = 19 to 24); long cycle 15% (95% CI = 13 to 18); intermenstrual bleeding 17% (95% CI = 14 to 19); postcoital bleeding 6% (95% CI = 5 to 8); prolonged period 9% (95% CI = 7 to 11).
Conclusion: The development of symptoms of menstrual loss among women in the community is common, in contrast to the rarity of gynaecological malignancy. This raises concern about the usefulness of current guidelines, based on symptoms, advising women when to consult, and for the early detection of gynaecological malignancy in the community and primary care.
PMCID: PMC1266170  PMID: 15113519
cohort studies; guidelines; gynaecological malignancy; menorrhagia; menstrual cycle; menstruation; questionnaires
18.  What influences participants' treatment preference and can it influence outcome? Results from a primary care-based randomised trial for shoulder pain. 
BACKGROUND: In randomised clinical trials (RCTs), outcome may be influenced by the opinions of the participants about the efficacy of treatments. AIM: To examine how initial treatment preferences of participants in a shoulder pain trial affected functional outcome and future treatment preferences. DESIGN OF STUDY: Observational cohort study nested within a multicentre, pragmatic RCT of steroid injection versus physiotherapy for unilateral shoulder pain. SETTING: Nine general practices in north Staffordshire. METHOD: Two hundred and seven adults were randomised in the trial. Disability scores and preferences of the participants for the trial treatments were elicited at two points: prior to randomisation and 6 months post-randomisation. A good functional outcome was defined as at least a halving in the disability score at the 6 months follow-up point. RESULTS: Pre-randomisation preferences were: 40% for injection and 20% for physiotherapy, and 40% gave no preference. A good outcome was achieved in a higher percentage of participants who gave a pre-randomisation treatment preference compared with those who did not (62% compared with 48% percentage difference = 14%; 95% confidence interval [CI] = -1 to 27%) with similar percentages in each preferred treatment group. However, receiving the preferred treatment did not confer any additional benefit in those who expressed a preference (receiving preferred treatment = 56%; not receiving preferred treatment = 69%). At 6 months post-randomisation, participants with a good, as opposed to poor, outcome were more likely to report as their preferred treatment the one to which they had been randomised, irrespective of pre-randomisation preference and whether the preferred treatment was received. CONCLUSION: This analysis suggests that preferences prior to treatment can affect outcome, but that treatment outcome is a stronger influence on post-treatment preferences. We present some empirical evidence to support the statement that treatment preferences can have important effects on the results of RCTs.
PMCID: PMC1314800  PMID: 14965386
19.  Predictors of hip joint replacement in new attenders in primary care with hip pain. 
BACKGROUND: Studies investigating the factors associated with need for total hip replacement should ideally be based on prospective investigation of new attenders in primary care. AIM: To determine the incidence of listing for total hip replacement, and its predictors, among attenders in primary care with a new episode of hip pain. DESIGN OF STUDY: Prospective multicentre cohort study. SETTING: One hundred and ninety-five patients (mean age = 63 years, 68% female) with new episode of hip pain, attending primary care between November 1994 and October 1997. At the first visit, patients were evaluated for indices of pain and disability, range of hip movement, and radiographic changes of osteoarthritis. METHOD: General practitioner participants were recruited from the membership of the Primary Care Rheumatology Society to recruit all consecutive attenders with a new episode of hip pain. Annual follow-up was carried out to determine which patients were being 'put on a waiting list' for total hip replacement. RESULTS: Seven per cent of patients were put on a waiting list for total hip replacement within 12 months and 23% of patients within four years. At presentation, pain duration, pain severity, (including the need to use a stick) and restriction of internal rotation were the major clinical predictors of being put on a waiting list. Radiographic predictors of osteoarthritis performed similarly to the clinical measures. A simple scoring system based on both radiographic severity and two of the clinical measures was derived that identified groups at high likelihood of being put on a waiting list (sensitivity = 76%) with a low false-positive rate (specificity = 95%). CONCLUSION: New primary care attenders with pain are frequently accepted for total hip replacement soon after their first attendance--a decision that can be predicted by simple clinical measures.
PMCID: PMC1314488  PMID: 12564273
20.  The effect of diabetic control on the incidence of, and changes in, retinopathy in type 2 non-insulin dependent diabetic patients. 
The purpose of this study was to investigate the association between retinopathy and the levels of diabetic control found in type 2 non-insulin dependent diabetic patients. The study covered a four-year period and used retrospective, routinely recorded general practice and optometry records from 260 patients; those with retinopathy (n = 38) and those without retinopathy (n = 222). The study demonstrated a strong relationship between the presence of retinopathy and long-term diabetic control as measured by glycosylated HbA1c, disease duration and, to a lesser extent, the level of urine microalbumin. Blood pressure, cholesterol, body-mass index, and smoking status showed little association with the presence of retinopathy. We conclude that retinopathy, assessed by community optometrists, is a significant correlate of poor diabetic control.
PMCID: PMC1314242  PMID: 12030665
21.  Why women consult with increased vaginal bleeding: a case-control study. 
BACKGROUND: Many women with heavy periods and irregular bleeding do not consult about them. It has been suggested that some of these symptoms are associated with psychological distress and that this influences consultation behaviour which may account for why some women present with a menstrual disturbance and others with apparently the same problem do not. AIM: To explore the relationship between symptom severity, psychological distress, and the seeking of medical help in primary care among women aged 54 years or less with increased vaginal bleeding. DESIGN OF STUDY: Case control. SETTING: An urban four-partner general practice of 10,000 patients. METHOD: Questionnaires were sent to women who were consulting with new episodes of 'increased vaginal bleeding' and two groups of controls: consulting controls with 'acute respiratory tract infection' (RTI) or 'other illness' as identified by weekly computerised searches, and community controls, selected from the practice age-sex register. RESULTS: Nine hundred and forty-three questionnaires were sent out to 108 cases and 835 controls with an 80% response rate. Of these, 60.9% of the cases, 47.0% of the consulting controls, and 39.7% of the community controls were subjects with probable psychological distress on the General Health Questionnaire (chi2 test, P = 0.002). Cases were more likely than community controls to have heavy periods (odds ratio [OR] = 2.86, 95% confidence interval [CI] = 1.53-5.35) and heavy periods interfering with life (OR = 3.69, 95% CI = 2.02-6.75). After controlling for heaviness of periods, cases were still more likely to have psychological distress (OR = 1.80, 95% CI = 1.00-3.24). The same relationships prevailed when comparing cases and consulting controls. CONCLUSION: Interference in life caused by heaviness of periods appears to be a powerful initiator of consultation with increased vaginal bleeding. Perceived heavy periods and psychological disturbance are weaker predictors. Women presenting to primary care with increased vaginal bleeding are more likey to have a psychological disturbance than women from the community or those consulting with another illness.
PMCID: PMC1314217  PMID: 11885820
22.  Predicting who develops chronic low back pain in primary care: a prospective study 
BMJ : British Medical Journal  1999;318(7199):1662-1667.
To quantify the relative contribution of premorbid and episode specific factors in determining the long term persistence of disabling symptoms of low back pain.
Prospective cohort study.
Two general practices in the south Manchester area.
180 patients, who previously participated in a cross sectional population survey, who consulted because of low back pain during the study period. They were followed at 1 week and 3 and 12 months after consultation.
Main outcome measure
Persistent disabling low back pain in the 12 months after the consultation.
Disabling low back pain persisted in one third of participants after consultation and was more common with increasing age, among those with a history of low back pain, and in women. Persistence of symptoms was associated with “premorbid” factors (high levels of psychological distress (odds ratio 3.3; 95% confidence interval 1.5 to 7.2), poor self rated health (3.6; 1.9 to 6.8), low levels of physical activity (2.8; 1.4 to 5.6), smoking (2.1; 1.0 to 4.3), dissatisfaction with employment (2.4; 1.3 to 4.5)) and factors related to the episode of low back pain (duration of symptoms, pain radiating to the leg (2.6; 1.3 to 5.1), widespread pain (6.4; 2.7 to 15), and restriction in spinal mobility). A multivariate model based on six factors identified groups whose likelihood of persistent symptoms ranged from 6% to 70%.
The presence of persistent low back pain is determined not only by clinical factors associated with pain but also by the premorbid state.
Key messagesAlthough many episodes of acute low back pain will resolve rapidly, around 30% result in persistent disabling symptomsThe presence of persistent low back pain is not only determined by clinical factors at the time of onset but also by the “premorbid” statePatients with these adverse prognostic factors represent a group in which effective interventions may result in substantially reduced morbidity and healthcare costs
PMCID: PMC28145  PMID: 10373170
23.  Outcome of low back pain in general practice: a prospective study 
BMJ : British Medical Journal  1998;316(7141):1356-1359.
Objectives: To investigate the claim that 90% of episodes of low back pain that present to general practice have resolved within one month.
Design: Prospective study of all adults consulting in general practice because of low back pain over 12 months with follow up at 1 week, 3 months, and 12 months after consultation.
Setting: Two general practices in south Manchester.
Subjects: 490 subjects (203 men, 287 women) aged 18-75 years.
Main outcome measures: Proportion of patients who have ceased to consult with low back pain after 3 months; proportion of patients who are free of pain and back related disability at 3 and 12 months.
Results: Annual cumulative consultation rate among adults in the practices was 6.4%. Of the 463 patients who consulted with a new episode of low back pain, 275 (59%) had only a single consultation, and 150 (32%) had repeat consultations confined to the 3 months after initial consultation. However, of those interviewed at 3 and 12 months follow up, only 39/188 (21%) and 42/170 (25%) respectively had completely recovered in terms of pain and disability.
Conclusions: The results are consistent with the interpretation that 90% of patients with low back pain in primary care will have stopped consulting with symptoms within three months. However most will still be experiencing low back pain and related disability one year after consultation.
Key messages It is widely believed that 90% of episodes of low back pain seen in general practice resolve within one month In a large population based study we examined the outcome of episodes of low back pain in general practice with respect to both consultation behaviour and self reported pain and disability While 90% of subjects consulting general practice with low back pain ceased to consult about the symptoms within three months, most still had substantial low back pain and related disability Only 25% of the patients who consulted about low back pain had fully recovered 12 months later Since most consulters continue to have long term low back pain and disability, effective early treatment could reduce the burden of these symptoms and their social, economic, and medical impact
PMCID: PMC28536  PMID: 9563990
24.  Incidence of acute otitis media in infants in a general practice 
A 12-month study of the incidence of acute otitis media in children under three years of age in an urban practice of 10 000 patients showed that acute otitis media accounted for one in 10 of all episodes of illness presented. In contrast to findings in Scandinavia and the USA the incidence of acute otitis media in the first year of life (11.5%) was lower than in the second year (28.6%). The study included a number of children in their third year and the incidence in this group was higher still (30.8%).
The problems of defining acceptable diagnostic criteria for acute otitis media, and the relation of these diagnostic criteria to the differences in our results compared with previous studies are discussed.
PMCID: PMC1711282  PMID: 3204570

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