‘Acute Flare-Ups’ In Patients With, Or At High Risk Of, Knee Osteoarthritis: A Daily Diary Study With Case-Crossover Analysis

Objective To determine the natural history of flare-ups in knee osteoarthritis and their relation to physical exposures. Design Adults aged ≥45 years with a recent primary care consultation for knee OA/arthralgia completed a daily pen-and-paper diary for up to 3 months, including questions on average knee pain intensity, pain descriptors, other symptoms, activity interference, and selected physical exposures (prolonged kneeling, squatting, climbing stairs, ladders, and moving/lifting heavy objects). Informed by a systematic review, flare-ups were defined a priori. We calculated the rate of flare-ups in the sample, described their nature and duration, and estimated their association with physical exposures in the prior 48 hours. Results 67 participants completed at least one month of diaries,37 (55%) were female, mean age 62 years (SD 10.6) with a mean body mass index of 24.6 kg/m2 (SD 5.1). 30 participants experienced a total of 54 flare-ups (incidence density 1.09 flare-ups/person-days). The median duration of flare-ups was 8 days (range: 2-30). During a flare-up participants were more likely to report sharp, throbbing, stabbing, burning pain, swelling, limping, stiffness, being woken by pain, taking more analgesia, and stopping usual activities. Exposure to one or more physical exposure increased the risk of a flare-up in the subsequent 48 hours (odds ratio 2.19 (95%CI: 1.22, 4.05)). Conclusions Our study with intensive longitudinal data collection suggests acute flare-ups may be experienced by a substantial number of patients. These episodes often last a week or longer, are disruptive, prompt changes in self-management, and may be triggered by high-loading physical activities

Maternal tetanus toxoid vaccination and neonatal mortality in rural North India

Objectives: Preventable neonatal mortality due to tetanus infection remains common. We aimed to examine antenatal vaccination impact in a context of continuing high neonatal mortality in rural northern India. Methods and Findings: Using the third round of the Indian National Family Health Survey (NFHS) 2005-06, mortality of most recent singleton births was analysed in discrete-time logistic model with maternal tetanus vaccination, together with antenatal care utilisation and supplementation with iron and folic acid. 59% of mothers reported receiving antenatal care, 48% reported receiving iron and folic acid supplementation and 68% reported receiving two or more doses of tetanus toxoid (TT) vaccination. The odds of all-cause neonatal death were reduced following one or more antenatal dose of TT with odds ratios (OR) of 0.46 (95% CI 0.26 to 0.78) after one dose and 0.45 (95% CI 0.31 to 0.66) after two or more doses. Reported utilisation of antenatal care and iron-folic acid supplementation did not influence neonatal mortality. In the statistical model, 16% (95% CI 5% to 27%) of neonatal deaths could be attributed to a lack of at least two doses of TT vaccination during pregnancy, representing an estimated 78,632 neonatal deaths in absolute terms. Conclusions: Substantial gains in newborn survival could be achieved in rural North India through increased coverage of antenatal TT vaccination. The apparent substantial protective effect of a single antenatal dose of TT requires further study. It may reflect greater population vaccination coverage and indicates that health programming should prioritise universal antenatal coverage with at least one dose

Human resource inequalities at the base of India's public health care system

This paper examines the extent of inequalities in human resource provision at India's Heath Sub-Centres (HSC) - first level of service provision in the public health system. ‘Within state' inequality explained about 71% and ‘between state’ inequality explained the remaining 29% of the overall inter-HSC inequality. The Northern states had a lower health worker share relative to the extent of their HSC provision. Contextual factors that contributed to ‘between’ and ‘within’ district inequalities were the percentages of villages connected with all-weather roads and having primary schools. Analysis demonstrates a policy and programming need to address ‘within State’ inequalities as a priority

Pilot cluster randomised controlled trial of flooring to reduce injuries from falls in wards for older people

Background: falls disproportionately affect older people, who are at increased risk of falls and injury. This pilot study investigates shock-absorbing flooring for fall-related injuries in wards for frail older people.Methods: we conducted a non-blinded cluster randomised trial in eight hospitals in England between April 2010 and August 2011. Each site allocated one bay as the ‘study area’, which was randomised via computer to intervention (8.3-mm thick Tarkett Omnisports EXCEL) or control (2-mm standard in situ flooring). Sites had an intervention period of 1 year. Anybody admitted to the study area was eligible. The primary outcome was the fall-related injury rate. Secondary outcomes were injury severity, fall rate and adverse events.Results: during the intervention period, 226 participants were recruited to each group (219 and 223 were analysed in the intervention and control group, respectively). Of 35 falls (31 fallers) in the intervention group, 22.9% were injurious, compared with 42.4% of 33 falls (22 fallers) in the control group [injury incident rate ratio (IRR) = 0.58, 95% CI = 0.18–1.91]. There were no moderate or major injuries in the intervention group and six in the control group. The fall IRR was 1.07 (95% CI = 0.64–1.81). Staff at intervention sites raised concerns about pushing equipment, documenting one pulled back.Conclusions: future research should assess shock-absorbing flooring with better ‘push/pull’ properties and explore increased faller risk. We estimate a future trial will need 33,480–52,840 person bed-days per arm.Trial registration: ClinicalTrials.gov (ID: NCT00817869); UKCRN (ID: 5735)

What is the impact of contraceptive methods and mixes of contraceptive methods on contraceptive prevalence, unmet need for family planning, and unwanted and unintended pregnancies?

Background - In many low-and middle-income countries, there is high maternal, infant and child mortality due in part to low contraceptive use and high unmet need for family planning. The aim of this overview of systematic reviews is to synthesise the findings of systematic reviews conducted in this area to assess the impact of various contraceptive methods and mixes of contraceptive methods on contraceptive prevalence, unwanted and unintended pregnancies, and unmet need (a desire to limit the number of children but not currently using any contraception) for family planning in developing countries/regions.Methods - Eight databases (Bioline international, The Cochrane Library, Latin American and Caribbean Health Sciences Literature - LILACS, Popline, PubMed, Turning Research Into Practice, World Health Organisation Reproductive Health Library and Zetoc) were searched from 28 October 2010 to 08 December 2010. Cochrane and non-Cochrane systematic reviews were included. Eligible reviews included studies whose participants were sexually active women or men from countries classified as ‘developing’, ‘low-income’ or ‘middle-income’. Systematic reviews of any intervention (or combination of interventions) designed to increase contraceptive prevalence, reduce fertility or both were eligible. Data were extracted and synthesised narratively. A Measurement Tool to Assess Systematic Reviews, AMSTAR, was used to evaluate the quality of the included systematic reviews, and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) was used to evaluate the quality of the body of evidence for each comparison. To aid the interpretation of the findings for a variety of settings, relevant contextual information was presented where possible.Results - There were 22 systematic reviews included in this overview of reviews. The overview examined a range of contraceptive methods, including modern (terminal and spacing) and traditional methods (such as withdrawal and periodic abstinence which do not require contraceptive substances or devices and also do not require clinical procedures). However, the systematic reviews included did not address all the objectives of the overview.The results of the review are summarised below according to the objectives.Objective 1: To assess the impact of various contraceptive methods and mixes ofcontraceptive methods on contraceptive prevalence in developing countries/regions. There was no systematic review that met this objective.Objective 2: To assess the impact of various contraceptive methods and mixes ofcontraceptive methods on unwanted and unintended pregnancies in developingcountries/regions.The body of evidence for the relative efficacy or effectiveness of a variety ofcontraceptive methods to prevent pregnancy in developing countries was generally rated as of low or moderate quality. There was, however, a number of comparisons (between different derivatives of the same contraceptive methods) for which the evidence was rated as of high or moderate quality. Evidence from systematic reviews is lacking on the acceptability of contraceptive methods and their impact on prevalence and on unmet needs for family planning. The evidence for the relative effectiveness of a variety of contraceptive methods to prevent pregnancy in developing countries is generally of low quality. There is some high-quality evidence comparing different derivatives of the same contraceptive methods, although this is more often evidence of efficacy than evidence of effectiveness.Objective 3: To assess the impact of various contraceptive methods and mixes ofcontraceptive methods on unmet need for family planning in developing countries/regions.There was no systematic review that met this objective

Prevalence, Characteristics and Clinical Course of Neuropathic Pain in Primary Care Patients Consulting with Low Back-related Leg Pain.

OBJECTIVES: Little is known about the epidemiology of neuropathic pain in primary care patients consulting with low back-related leg pain. We aimed to describe prevalence, characteristics and clinical course of low back-related leg pain patients with and without neuropathic pain, consulting with their family doctor in the UK. METHODS: This was a prospective cohort study. Data were collected using a standardised baseline clinical examination and self-report questionnaires at baseline, 4, 12 and 36-months. We identified cases of neuropathic pain using three definitions: two based on clinical diagnosis (sciatica, with and without evidence of nerve root compression on MRI), one on the self-report version of Leeds Assessment for Neurological Symptoms and Signs (S-LANSS). Differences between patients with and without neuropathic pain were analysed comparing each definition. Clinical course (mean pain intensity measured as the highest of leg or back pain intensity: mean of three Numerical Rating Scales, each 0-10) was investigated using linear mixed models over 36-months. RESULTS: Prevalence of neuropathic pain varied from 48% to 74% according to definition used. At baseline, patients with neuropathic pain had more severe leg pain intensity, lower pain self-efficacy, more patients had sensory loss than those without. Distinct profiles were apparent depending on neuropathic pain definition. Mean pain intensity reduced after 4-months (6.1 to 3.9 (sciatica)), most rapidly in cases defined by clinical diagnosis. DISCUSSION: This research provides new information on the clinical course of neuropathic pain and a better understanding of neuropathic pain in low back-related leg pain patients consulting in primary care

Responsiveness and Minimal Important Change for Pain and Disability Outcome Measures in Pregnancy-Related Low Back and Pelvic Girdle Pain.

BACKGROUND: Pregnancy-related low back pain and pelvic girdle pain (LBP/PGP) are common and negatively impact the lives of many pregnant women. Several patient-based outcome instruments measure treatment effect but there is no consensus about which measure to use with women who have these pain presentations. OBJECTIVE: The objective was to compare the responsiveness of 3 outcome measures in LBP/PGP: Oswestry Disability Index-version 2.0 (ODI), Pelvic Girdle Questionnaire (PGQ), and 0-10 numerical rating scale for pain severity (NRS); and to estimate a minimal important change (MIC) for these measures in pregnancy-related LBP/PGP. DESIGN: This was a methodology study using data from a pilot randomised trial (RCT). METHODS: Women (n = 124) with pregnancy-related LBP/PGP were recruited to a pilot RCT evaluating the benefit of adding acupuncture to standard care and 90 completed 8-weeks follow-up. Responsiveness was evaluated by examining correlation between change score and the external anchor (6-point global perceived effect scale) and by using receiver operating characteristic (ROC) curve analysis. MIC was estimated using anchor-based methods. RESULTS: All measures showed good responsiveness, with areas under ROC curve ranging from 0.77 to 0.90. The estimated MICs were 3.1, 11.0, 9.4, 13.3, and 1.3 for ODI, PGQ-total, PGQ-activity, PGQ-symptoms, and NRS, respectively. All the measures, apart from ODI, had MICs larger than the measurement error. LIMITATIONS: Lack of optimal "gold standard" or external criterion for assessing responsiveness and MIC was a limitation of this study. CONCLUSION: All 3 outcome measures demonstrated good responsiveness. MICs were derived for each instrument. The PGQ at 8 weeks post-randomisation was identified as an appropriate outcome measure for pregnancy-related LBP/PGP since it is specific to these pain presentations and assesses both activity limitations and symptoms. The NRS is an efficient, shorter alternative

Characteristics of patients with low back and leg pain seeking treatment in primary care: baseline results from the ATLAS cohort study.

BackgroundPatients with back pain radiating to the leg(s) report worse symptoms and poorer recovery than those with back pain alone. Robust evidence regarding their epidemiological profile is lacking from primary care, the setting where most of these patients will present and be managed. Our objective was to describe the characteristics of patients with back and leg pain, including sciatica, seeking treatment in primary care.MethodsAdults visiting their general practitioner with back and leg pain, of any duration and severity, were invited to participate. Participants completed questionnaires, underwent clinical assessments and received MRI scans. Characteristics of the sample are described, and differences between patients diagnosed with referred leg pain and those with sciatica are analysed.ResultsSix hundred nine patients participated; 62.6 % were female, mean (SD) age 50.2 (13.9). 67.5 % reported pain below the knee, 60.7 % were in paid employment with 39.7 % reporting time off work. Mean disability (RMDQ) was 12.7 (5.7) and mean pain intensity was 5.6 (2.2) and 5.2 (2.4) for back and leg respectively. Mean sciatica bothersomeness index (SBI) was 14.9 (5.1). Three quarters (74.2 %) were clinically diagnosed as having sciatica. In the sciatica group, leg pain intensity, neuropathic pain, pain below the knee, leg pain worse than back pain, SBI and positive MRI findings were significantly higher as compared to patients with referred leg pain.ConclusionsThis primary care cohort reported high levels of disability and pain. This is the first epidemiological study of unselected primary care patients seeking healthcare for back and leg pain. Follow-up of this cohort will investigate the prognostic value of their baseline characteristics. This new information will contribute to our understanding of the characteristics and clinical features of this population, and will underpin future research aimed at defining prognostic subgroups to enable better targeting of health care provision

Factors associated with costs and health outcomes in patients with Back and leg pain in primary care: a prospective cohort analysis

Background There is limited research on the economic burden of low back-related leg pain, including sciatica. The aim of this study was to describe healthcare resource utilisation and factors associated with cost and health outcomes in primary care patients consulting with symptoms of low back-related leg pain including sciatica. Methods This study is a prospective cohort of 609 adults visiting their family doctor with low back-related leg pain, with or without sciatica in a United Kingdom (UK) Setting. Participants completed questionnaires, underwent clinical assessments, received an MRI scan, and were followed-up for 12-months. The economic analysis outcome was the quality-adjusted life year (QALY) calculated from the EQ-5D-3 L data obtained at baseline, 4 and 12-months. Costs were measured based on patient self-reported information on resource use due to back-related leg pain and results are presented from a UK National Health Service (NHS) and Societal perspective. Factors associated with costs and outcomes were obtained using a generalised linear model. Results Base-case results showed improved health outcomes over 12-months for the whole cohort and slightly higher QALYs for patients in the sciatica group. NHS resource use was highest for physiotherapy and GP visits, and work-related productivity loss highest from a societal perspective. The sciatica group was associated with significantly higher work-related productivity costs. Cost was significantly associated with factors such as self-rated general health and care received as part of the study, while quality of life was significantly predicted by self-rated general health, and pain intensity, depression, and disability scores. Conclusions Our results contribute to understanding the economics of low back- related leg pain and sciatica and may provide guidance for future actions on cost reduction and health care improvement strategies. Trial registration 13/09/2011 Retrospectively registered; ISRCTN62880786

Stratified care versus usual care for management of patients presenting with sciatica in primary care (SCOPiC): a randomised controlled trial

Background Sciatica has a substantial impact on individuals and society. Stratified care has been shown to lead to better outcomes among patients with non-specific low back pain, but it has not been tested for sciatica. We aimed to investigate the clinical and cost-effectiveness of stratified care versus non-stratified usual care for patients presenting with sciatica in primary care. Methods We did a two-parallel arm, pragmatic, randomised controlled trial across three centres in the UK (North Staffordshire, North Shropshire/Wales, and Cheshire). Eligible patients were aged 18 years or older, had a clinical diagnosis of sciatica, access to a mobile phone or landline number, were not pregnant, were not currently receiving treatment for the same problem, and had no previous spinal surgery. Patients were recruited from general practices and randomly assigned (1:1) by a remote web-based service to stratified care or usual care, stratified by centre and stratification group allocation. In the stratified care arm, a combination of prognostic and clinical criteria associated with referral to spinal specialist services were used to allocate patients to one of three groups for matched care pathways. Group 1 was offered brief advice and support in up to two physiotherapy sessions; group 2 was offered up to six physiotherapy sessions; and group 3 was fast-tracked to MRI and spinal specialist assessment within 4 weeks of randomisation. The primary outcome was self-reported time to first resolution of sciatica symptoms, defined as “completely recovered” or “much better” on a 6-point ordinal scale, collected via text messages or telephone calls. Analyses were by intention to treat. Health-care costs and cost-effectiveness were also assessed. This trial is registered on the ISRCTN registry, ISRCTN75449581. Findings Between May 28, 2015, and July 18, 2017, 476 patients from 42 general practices around three UK centres were randomly assigned to stratified care or usual care (238 in each arm). For the primary outcome, the overall response rate was 89% (9467 of 10 601 text messages sent; 4688 [88%] of 5310 in the stratified care arm and 4779 [90%] of 5291 in the usual care arm). Median time to symptom resolution was 10 weeks (95% CI 6·4–13·6) in the stratified care arm and 12 weeks (9·4–14·6) in the usual care arm, with the survival analysis showing no significant difference between the arms (hazard ratio 1·14 [95% CI 0·89–1·46]). Stratified care was not cost-effective compared to usual care. Interpretation The stratified care model for patients with sciatica consulting in primary care was not better than usual care for either clinical or health economic outcomes. These results do not support a transition to this stratified care model for patients with sciatica