BMJ Open is a medical journal. We consider papers addressing research questions in clinical medicine, public health and epidemiology. We also welcome studies in health services research, health economics, surgery, qualitative research, research methods, medical education, medical publishing and any other field that directly addresses patient outcomes or the practice and delivery of healthcare. Our focus is on research that is relevant to patients and clinicians. We do not publish studies conducted in animals, laboratory studies not linked to patient outcomes, papers reporting solely physiological or biomechanical results from healthy participants, anatomy, cell biology or non-clinical psychology. All research study types are considered, from study protocols through phase I trials to meta-analyses. This includes specialist studies and studies reporting negative results.
Brett P. Dyer, Trishna Rathod‐Mistry, Claire Burton, Daniëlle van der Windt, Miliça Blagojevic‐Bucknall
ObjectiveSummarise longitudinal observational studies to determine whether diabetes (types 1 and 2) is a risk factor for frozen shoulder.DesignSystematic review and meta-analysis.Data sourcesMEDLINE, Embase, AMED, PsycINFO, Web of Science Core Collection, CINAHL, Epistemonikos, Trip, PEDro, OpenGrey and The Grey Literature Report were searched on January 2019 and updated in June 2021. Reference screening and emailing professional contacts were also used.Eligibility criteriaLongitudinal observational studies that estimated the association between diabetes and developing frozen shoulder.Data extraction and synthesisData extraction was completed by one reviewer and independently checked by another using a predefined extraction sheet. Risk of bias was judged using the Quality In Prognosis Studies tool. For studies providing sufficient data, random-effects meta-analysis was used to derive summary estimates of the association between diabetes and the onset of frozen shoulder.ResultsA meta-analysis of six case–control studies including 5388 people estimated the odds of developing frozen shoulder for people with diabetes to be 3.69 (95% CI 2.99 to 4.56) times the odds for people without diabetes. Two cohort studies were identified, both suggesting diabetes was associated with frozen shoulder, with HRs of 1.32 (95% CI 1.22 to 1.42) and 1.67 (95% CI 1.46 to 1.91). Risk of bias was judged as high in seven studies and moderate in one study.ConclusionPeople with diabetes are more likely to develop frozen shoulder. Risk of unmeasured confounding was the main limitation of this systematic review. High-quality studies are needed to confirm the strength of, and understand reasons for, the association.PROSPERO registration numberCRD42019122963.
Michel GCAM Mertens, Mira Meeus, Suzie Noten, Olivier Verborgt, Erik Fransén, Enrique Lluch Girbés, Marta Aguilar Rodríguez, Santiago Navarro-Ledesma, Manuel Fernández-Sánchez, Alejandro Luque-Suárez, Filip Struyf, Lirios Dueñas
IntroductionThere is a large diversity in the clinical presentation of frozen shoulder (FS) and the clinical outcome is not always satisfactory. The aim of the current study was to examine to what extent range of motion (ROM) limitation, metabolic factors (diabetes mellitus and thyroid disorders), autonomic symptoms and pain sensitivity may contribute to the prognosis in terms of shoulder pain and disability and quality of life in patients with FS.MethodsPatients with stage 1 or 2 FS were longitudinally followed-up during 9 months after baseline assessment. They completed six questionnaires and underwent quantitative sensory testing (pressure pain thresholds, temporal summation and conditioned pain modulation) and ROM assessment.ResultsOne hundred and forty-nine patients with FS were initially recruited and 121 completed at least one follow-up measurement. Shoulder pain and disability improved over time and diabetes mellitus was found to be a prognostic factor for final outcome. Several domains of quality of life also improved over time and external rotation ROM, diabetes mellitus, thyroid disorder and autonomic symptoms were found to be prognostic factors for final outcome. These prognostic factors explained 2.5%–6.3% of the final outcome of shoulder pain and disability and quality of life.Discussion and conclusionIn patients with FS, prognostic variables were able to predict different outcomes, indicating that outcomes in this population can be variable-dependent. Other variables not explored in this study might contribute to the prognosis of patients with FS, which should be investigated in future research. In clinical practice, baseline assessment of prognostic factors and focusing on a more holistic approach might be useful to inform healthcare practitioners about progression of patients with FS during a 9-month period.
ObjectiveTo evaluate utility and equivalence of Glasgow Coma Scale (GCS) and the Alert, Voice, Pain, Unresponsive (AVPU) scale in children with head injury.DesignCross sectional study.SettingUK hospital admissions: September 2009–February 2010.Patients<15 years with head injury.InterventionsGCS and/or AVPU at injury scene and in emergency departments (ED).Main outcomeMeasures used, the equivalence of AVPU to GCS, GCS at the scene predicting GCS in ED, CT results by age, hospital type.ResultsLevel of consciousness was recorded in 91% (5168/5700) in ED (43%: GCS/30.5%: GCS+AVPU/17.3%: AVPU) and 66.1% (1190/1801) prehospital (33%: GCS/26%GCS+AVPU/7%: AVPU). Failure to record level of consciousness and the use of AVPU were greatest for infants. Correlation between AVPU and median GCS in 1147 children <5 years: A=15, V=14, P=8, U=3, for 1163 children ≥5 years: A=15, V=13, P=11, U=3. There was no significant difference in the proportion of infants who had a CT whether AVPU=V/P/U or GCS<15. However diagnostic yield of intracranial injury or depressed fracture was significantly greater for V/P/U than GCS<15 :7/7: 100% (95% CI 64.6% to 100%) versus 5/17: 29.4% (95% CI 13.3% to 53.1%). For children >1 year significantly more had a CT scan when GCS<14 was recorded than ‘V/P/U only’ and the diagnostic yield was greater. Prehospital GCS and GCS in the ED were the same for 77.4% (705/911).ConclusionThere was a clear correlation between Alert and GCS=15 and between Unresponsive and GCS=3 but a wider range of GCS scores for responsive to Pain or Voice that varied with age. AVPU was valuable at initial assessment of infants and did not adversely affect the proportion of infants who had head CT or the diagnostic yield.
Qianyu Zhuang, Liyuan Tao, Jin Lin, Jin Jin, Wenwei Qian, Yanyan Bian, Yu-Long Li, Yulei Dong, Xisheng Weng, Ye Li, Yu Fan, Wei Wang, Bin Feng, Na Gao, Tiezheng Sun, Jianhao Lin, Miaofeng Zhang, Shigui Yan, Bin Shen, Fuxing Pei
ObjectivesTo evaluate the morphine-sparing effects of the sequential treatment versus placebo in subjects undergoing total knee arthroplasty (TKA), the effects on pain relief, inflammation control and functional rehabilitation after TKA and safety.DesignDouble-blind, pragmatic, randomised, placebo-controlled trial.SettingFour tertiary hospitals in China.Participants246 consecutive patients who underwent elective unilateral TKA because of osteoarthritis (OA).InterventionsPatients were randomised 1:1 to the parecoxib/celecoxib group or the control group. The patients in the parecoxib/celecoxib group were supplied sequential treatment with intravenous parecoxib 40 mg (every 12 hours) for the first 3 days after surgery, followed by oral celecoxib 200 mg (every 12 hours) for up to 6 weeks. The patients in the control group were supplied with the corresponding placebo under the same instructions.Primary and secondary outcome measuresThe primary endpoint was the cumulative opioid consumption at 2 weeks post operation (intention-to-treat analysis). Secondary endpoints included the Knee Society Score, patient-reported outcomes and the cumulative opioid consumption.ResultsThe cumulative opioid consumption at 2 weeks was significantly smaller in the parecoxib/celecoxib group than in the control group (median difference, 57.31 (95% CI 34.66 to 110.33)). The parecoxib/celecoxib group achieving superior Knee Society Scores and EQ-5D scores and greater Visual Analogue Scale score reduction during 6 weeks. Interleukin 6, erythrocyte sedation rate and C-reactive protein levels were reduced at 72 hours, 2 weeks and 4 weeks and prostaglandin E2 levels were reduced at 48 hours and 72 hours in the parecoxib/celecoxib group compared with the placebo group. The occurrence of adverse events (AEs) was significantly lower in the parecoxib/celecoxib group.ConclusionsThe sequential intravenous parecoxib followed by oral celecoxib regimen reduces morphine consumption, achieves better pain control and functional recovery and leads to less AEs than placebo after TKA for OA.Trial registration numberClinicalTrials.gov (ID:NCT02198924).
Christofer Åström, Hans Orru, Joacim Rocklöv, Gustav Strandberg, Kristie L. Ebi, Bertil Forsberg
ObjectivesRespiratory diseases are ranked second in Europe in terms of mortality, prevalence and costs. Studies have shown that extreme heat has a large impact on mortality and morbidity, with a large relative increase for respiratory diseases. Expected increases in mean temperature and the number of extreme heat events over the coming decades due to climate change raise questions about the possible health impacts. We assess the number of heat-related respiratory hospital admissions in a future with a different climate.DesignA Europe-wide health impact assessment.SettingAn assessment for each of the EU27 countries.MethodsHeat-related hospital admissions under a changing climate are projected using multicity epidemiological exposure–response relationships applied to gridded population data and country-specific baseline respiratory hospital admission rates. Times-series of temperatures are simulated with a regional climate model based on four global climate models, under two greenhouse gas emission scenarios.ResultsBetween a reference period (1981–2010) and a future period (2021–2050), the total number of respiratory hospital admissions attributed to heat is projected to be larger in southern Europe, with three times more heat attributed respiratory hospital admissions in the future period. The smallest change was estimated in Eastern Europe with about a twofold increase. For all of Europe, the number of heat-related respiratory hospital admissions is projected to be 26 000 annually in the future period compared with 11 000 in the reference period.ConclusionsThe results suggest that the projected effects of climate change on temperature and the number of extreme heat events could substantially influence respiratory morbidity across Europe.
Sergio Livigni, Guido Bertolini, Carlotta Rossi, Fiorenza Ferrari, Michele Giardino, Marco Pozzato, Giuseppe Remuzzi
ObjectivesCoupled plasma filtration adsorption (CPFA, Bellco, Italy), to remove inflammatory mediators from blood, has been proposed as a novel treatment for septic shock. This multicenter, randomised, non-blinded trial compared CPFA with standard care in the treatment of critically ill patients with septic shock.DesignProspective, multicenter, randomised, open-label, two parallel group and superiority clinical trial.Setting18 Italian adult, general, intensive care units (ICUs).ParticipantsOf the planned 330 adult patients with septic shock, 192 were randomised to either have CPFA added to the standard care, or not. The external monitoring committee excluded eight ineligible patients who were erroneously included.InterventionsCPFA was to be performed daily for 5 days, lasting at least 10 h/day.Primary and secondary outcome measuresThe primary endpoint was mortality at discharge from the hospital at which the patient last stayed. Secondary endpoints were: 90-day mortality, new organ failures and ICU-free days within 30 days.ResultsThere was no statistical difference in hospital mortality (47.3% controls, 45.1% CPFA; p=0.76), nor in secondary endpoints, namely the occurrence of new organ failures (55.9% vs 56.0%; p=0.99) or free-ICU days during the first 30 days (6.8 vs 7.5; p=0.35). The study was terminated on the grounds of futility. Several patients randomised to CPFA were subsequently found to be undertreated. An a priori planned subgroup analysis showed those receiving a CPFA dose >0.18 L/kg/day had a lower mortality compared with controls (OR 0.36, 95% CI 0.13 to 0.99).ConclusionsCPFA did not reduce mortality in patients with septic shock, nor did it positively affect other important clinical outcomes. A subgroup analysis suggested that CPFA could reduce mortality, when a high volume of plasma is treated. Owing to the inherent potential biases of such a subgroup analysis, this result can only be viewed as a hypothesis generator and should be confirmed in future studies.ClinicalTrials.govNCT00332371;ISRCTN24534559.
Joanne Greenhalgh, Ray Pawson, Judy Wright, Nick Black, José M Valderas, David Meads, Elizabeth Gibbons, Lianne Wood, Charlotte Wood, Chris Mills, Sonia Dalkin
IntroductionThe feedback and public reporting of PROMs data aims to improve the quality of care provided to patients. Existing systematic reviews have found it difficult to draw overall conclusions about the effectiveness of PROMs feedback. We aim to execute a realist synthesis of the evidence to understand by what means and in what circumstances the feedback of PROMs data leads to the intended service improvements.Methods and analysisRealist synthesis involves (stage 1) identifying the ideas, assumptions or ‘programme theories’ which explain how PROMs feedback is supposed to work and in what circumstances and then (stage 2) reviewing the evidence to determine the extent to which these expectations are met in practice. For stage 1, six provisional ‘functions’ of PROMs feedback have been identified to structure our review (screening, monitoring, patient involvement, demand management, quality improvement and patient choice). For each function, we will identify the different programme theories that underlie these different goals and develop a logical map of the respective implementation processes. In stage 2, we will identify studies that will provide empirical tests of each component of the programme theories to evaluate the circumstances in which the potential obstacles can be overcome and whether and how the unintended consequences of PROMs feedback arise. We will synthesise this evidence to (1) identify the implementation processes which support or constrain the successful collation, interpretation and utilisation of PROMs data; (2) identify the implementation processes through which the unintended consequences of PROMs data arise and those where they can be avoided.Ethics and disseminationThe study will not require NHS ethics approval. We have secured ethical approval for the study from the University of Leeds (LTSSP-019). We will disseminate the findings of the review through a briefing paper and dissemination event for National Health Service stakeholders, conferences and peer reviewed publications.
Marco Silano, Carlo Agostoni, Yolanda Sanz, Stefano Guandalini
ObjectiveTo review the evidence for the association of breast feeding, breastfeeding duration or the timing of gluten introduction and the later development of celiac disease (CD).DesignSystematic review.MethodsWe searched MEDLINE, via PubMed, EMBASE and Web of Science, for studies published up to 31 August 2015 investigating the association of breastfeeding duration, breast feeding at the moment of gluten introduction or the timing of gluten introduction and the later development of CD. Prospective studies had to enrol infants/children at high risk of CD. For retrospective studies, participants had to be children or adults with CD. The paper quality was assessed by means of a GRADE score and the bias risk was assessed by the Newcastle-Ottawa Scale (for observational cohort studies) and Cochrane Collaboration's tool (for randomised trials).ResultsOut of 149 retrieved papers, 48 were considered in depth and 16 were included in this review (9 were prospective and 2 were interventional). We found that neither duration of breastfeeding nor breastfeeding at time of gluten introduction nor the delayed introduction of gluten during weaning were effective in preventing later development of CD.ConclusionsCurrently, there is no evidence on the optimal breastfeeding duration or the effects of avoiding early (<4 months of age) or late (≥6 or even at 12 months) gluten introduction in children at risk of CD. Accordingly, no specific general recommendations about gluten introduction or optimal breastfeeding duration can be presently provided on evidence-based criteria in order to prevent CD.
Jayne Cooper, Sarah Steeg, Olive Bennewith, Michael Lowe, David Gunnell, Allan House, Keith Hawton, Navneet Kapur
ObjectivesTo describe the characteristics and management of individuals attending hospital with self-harm and assess changes in management and service quality since an earlier study in 2001, a period in which national guidance has been available.DesignObservational study.SettingA stratified random sample of 32 hospitals in England, UK.Participants:6442 individuals presenting with 7689 episodes of self-harm during a 3-month audit period between 2010 and 2011.OutcomeSelf-harm episodes, key aspects of individual management relating to psychosocial assessment and follow-up, and a 21-item measure of service quality.ResultsOverall, 56% (3583/6442) of individuals were women and 51% (3274/6442) were aged under 35 years. Hospitals varied markedly in their management. The proportion of episodes that received a psychosocial assessment by a mental health professional ranged from 22% to 88% (median 58%, IQR 48–70%); the proportion of episodes resulting in admission to general hospitals varied from 22% to 85% (median 54%, IQR 41–63%); a referral for specialist mental health follow-up was made in 11–64% of episodes (median 28%, IQR 22–38%); a referral to non-statutory services was made in 4–62% of episodes (median 15%, IQR 8–23%); 0–21% of episodes resulted in psychiatric admission (median 7%, QR 4–12%). The specialist assessment rate varied by method of harm; the median rate for self-cutting was 45% (IQR 28–63%) vs 58% (IQR 48–73%) for self-poisoning. Compared with the 2001 study, there was little difference in the proportion of episodes receiving specialist assessment; there was a significant increase in general hospital admission but a decrease in referrals for specialist mental health follow-up. However, scores on the service quality scale had increased from a median of 11.5–14.5 (a 26% increase).ConclusionsServices for the hospital management of self-harm remain variable despite national guidelines and policy initiatives. We found no evidence for increasing levels of assessment over time but markers of service quality may have improved.This paper forms part of the study ‘Variations in self-harm service delivery: an observational study examining outcomes and temporal trends’. The National Institute for Health Research Clinical Research Network (NIHR CRN) Portfolio database registration number: HOMASH 2 (7333). The NIHR Coordinated System for gaining NHS Permission (CSP) registration number: 23226.
ObjectiveThere is sparse data on the prevalence of frailty from rural parts of India. Our aim was to estimate prevalence of frailty among community-dwelling older people in rural South Indian population and explore socio-demographic factors associated with frailty. We further explored the associations between frailty with fear of falling and falls.DesignCommunity based cross-sectional study.SettingFour villages in Thanjavur district of Southern India.ParticipantsRandom sample of adults aged 60 years and above from four villages.MethodsWe sampled community-dwelling older adults from the electoral list of four villages using stratified random sampling. We report prevalence of frailty as defined by physical definition (Fried’s Phenotype), accumulation of deficits (Frailty Index) and multi-domain definition (Tilburg Frailty Indicator). We report proportion of agreement of frailty status between the frailty tools. We used logistic regressions with robust SEs to examine the associations between socio-demographic determinants with frailty and the association between frailty with fear of falling and falls.ResultsAmong the 408 participants, the weighted (non-response and poststratification for sex) prevalence and 95% CI of frailty was 28% (18.9 to 28.1) for physical definition, 59% (53.9 to 64.3) for accumulation of deficits and 63% (57.4 to 67.6) for multi-domain definition. Frailty Index and Tilburg Frailty Indicator had good agreement (80%). Age, female, lower education, lower socioeconomic status, minimum physical activity in routine work were independently associated with frailty irrespective of the frailty definitions. Frail elderly had higher odds of falls as well as fear of falling compared with non-frail, irrespective of the definitions.ConclusionPrevalence of frailty among older people in rural Thanjavur district of South India was high compared with low-income and middle-income countries. Understanding the modifiable determinants of frailty can provide a valuable reference for future prevention and intervention.
Chỉ số ảnh hưởng
Total publication
25
Total citation
1,446
Avg. Citation
57.84
Impact Factor
0
H-index
16
H-index (5 years)
16
i10
20
i10-index (5 years)
3
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