bluuebunny/crossref_metadata_2025_split huggingface dataset:
Mobile phone text messages for improving adherence to antiretroviral therapy (ART): a protocol for an individual patient data meta-analysis of randomised trials
Authors: Mbuagbaw Lawrence , van der Kop Mia L , Lester Richard T , Thirumurthy Harsha , Pop-Eleches Cristian , Smieja Marek , Dolovich Lisa , Mills Edward J , Thabane Lehana 
Published: June 2013

IntroductionMobile phone text messaging is emerging as an important tool in the care of people living with HIV; however, reports diverge on its efficacy in improving adherence to antiretroviral therapy (ART), and little is known about which patient groups may benefit most from phone-based adherence interventions. We will conduct an individual patient data meta-analysis to investigate the overall and subgroup effects of text messaging in three recently published text-messaging randomised controlled trials.Methods and analysisData from two Kenyan and one Cameroonian trial will be verified, reformatted and merged. We will determine pooled effect sizes for text messaging versus standard care for improving adherence to ART using individual patient random-effects meta-analysis. We will test for the interaction effects of age, gender, level of education and duration on ART. Sensitivity analyses will be conducted with regard to thresholds for adherence, methods of handling missing data and fixed-effects meta-analysis. Only anonymised data will be collected from the individual studies.Ethics and disseminationEthical approval was obtained for the individual studies. The results of this paper will be disseminated as peer-reviewed publications, at conferences and as part of a doctoral thesis. This individual patient data meta-analysis may provide important insights into the effects of text messaging on ART adherence in different subpopulations, with important implications for programme implementation involving such interventions and future research.
Evidence of overtesting for vitamin D in Australia: an analysis of 4.5 years of Medicare Benefits Schedule (MBS) data
Authors: Bilinski Kellie , Boyages Steve 
Published: June 2013

ObjectiveTo comprehensively examine pathology test utilisation of 25-hydroxyvitamin D (25(OH)D) testing in each state of Australia to determine the cost impact and value and to add evidence to enable the development of vitamin D testing guidelines.DesignLongitudinal analysis of all 25(OH)D pathology tests in Australia.SettingPrimary and Tertiary Care.MeasurementsThe frequency of 25(OH)D testing between 1 April 2006 and 30 October 2010 coded for each individual by provider, state and month between 2006 and 2010. Rate of tests per 100 000 individuals and benefit for 25(OH)D, full blood count (FBC) and bone densitometry by state and quarter between 2000 and 2010.Results4.5 million tests were performed between 1 April 2006 and 30 October 2010. 42.9% of individuals had more than one test with some individuals having up to 79 tests in that period. Of these tests, 80% were ordered by general practitioners and 20% by specialists. The rate of 25(OH)D testing increased 94-fold from 2000 to 2010. Rate varied by state whereby the most southern state represented the highest increase and northern state the lowest increase. In contrast, the rate of a universal pathology test such as FBC remained relatively stable increasing 2.5-fold. Of concern, a 0.5-fold (50%) increase in bone densitometry was seen.ConclusionsThe marked variation in the frequency of testing for vitamin D deficiency indicates that large sums of potentially unnecessary funds are being expended. The rate of 25(OH)D testing increased exponentially at an unsustainable rate. Consequences of such findings are widespread in terms of cost and effectiveness. Further research is required to determine the drivers and cost benefit of such expenditure. Our data indicate that adoption of specific guidelines may improve efficiency and effectiveness of 25(OH)D testing.
Home telemonitoring study for Japanese patients with heart failure (HOMES-HF): protocol for a multicentre randomised controlled trial
Authors: Kotooka Norihiko , Asaka Machiko , Sato Yasunori , Kinugasa Yoshiharu , Nochioka Kotaro , Mizuno Atsushi , Nagatomo Daisuke , Mine Daigo , Yamada Yoko , Eguchi Kazuo , Hanaoka Hideki , Inomata Takayuki , Fukumoto Yoshihiro , Yamamoto Kazuhiro , Tsutsui Hiroyuki , Masuyama Tohru , Kitakaze Masafumi , Inoue Teruo , Shimokawa Hiroaki , Momomura Shin-ichi , Seino Yoshihiko , Node Koichi ,   on behalf of the HOMES-HF study investigators
Published: June 2013

IntroductionDespite the encouraging results from several randomised controlled trials (RCTs) and meta-analyses, the ability of home telemonitoring for heart failure (HF) to improve patient outcomes remains controversial as a consequence of the two recent large-scale RCTs. However, it has been suggested that there is a subgroup of patients with HF who may benefit from telemonitoring. The aim of the present study was to investigate whether an HF management programme using telemonitoring could improve outcomes in patients with HF under the Japanese healthcare system.Methods and analysisThe Home Telemonitoring Study for Japanese Patients with Heart Failure (HOMES-HF) study is a prospective, multicentre RCT to investigate the effectiveness of home telemonitoring on the primary composite endpoint of all-cause death and rehospitalisation due to worsening HF in recently admitted HF patients (aged 20 and older, New York Heart Association classes II–III). The telemonitoring system is an automated physiological monitoring system including body weight, blood pressure and pulse rate by full-time nurses 7 days a week. Additionally, the system was designed to make it a high priority to support patient's self-care instead of an early detection of HF decompensation. A total sample size of 420 patients is planned according to the Schoenfeld and Richter method. Eligible patients are randomly assigned via a website to either the telemonitoring group or the usual care group by using a minimisation method with biased-coin assignment balancing on age, left ventricular ejection fraction and a history of ischaemic heart disease. Participants will be enrolled until August 2013 and followed until August 2014. Time to events will be estimated using the Kaplan-Meier method, and HRs and 95% CIs will be calculated using the Cox proportional hazards models with stratification factors.Trial Registration:The study is registered at UMIN Clinical Trials Registry (UMIN000006839).
Characteristics of paid malpractice claims settled in and out of court in the USA: a retrospective analysis
Authors: Rubin Jessica B , Bishop Tara F 
Published: June 2013

ObjectiveAn analysis of paid malpractice claims judged in court compared with those settled out of court may help explain perceptions of malpractice risk.DesignA retrospective analysis and cross-sectional comparison of malpractice claims. Evaluated trends in the number and proportion of paid claims, and mean payment amount by resolution type; identified patient, physician and claim characteristics associated with each resolution type. Examined the effects of resolution type on payment amount and time to claim resolution.SettingClaims paid on behalf of US physicians reported in the National Practitioner Data Bank (NPDB) from 2005 to 2009.Main outcome measuresType of resolution, claim characteristics, payment amount and time to resolution.ResultsBetween 2005 and 2009, there were 58 667 claims paid on behalf of US physicians. Of these paid claims, 56 850 (96.9%) were settled outside court, and 1817 (3.1%) were judged in court. There was no significant change in the proportion of paid claims resolved by settlement versus judgement over time (p=0.83); nor was there a significant change in the mean payment amount in either resolution group (settlement, p=0.94; judgement, p=0.36). The claims in which the physicians were under 50, had prior malpractice reports, which were paid by a state malpractice programme, for adverse events to a fetus, and for surgical or obstetric error were more likely to be judged in court. The mean payment amount (US$592 283 vs US$317 447, p<0.01), per cent of payments over US$1 million (41.82% vs 15.43%, p<0.01), and time to decision (6.50 years vs 4.93 years, p<0.01) were significantly higher in judged claims.ConclusionsAlthough only a very small percentage of paid malpractice claims in the USA are judged in court, a number of characteristics differ between settled and judged claims. Such differences may influence perceptions of malpractice risk and future reform efforts.
Are there sleep-specific phenotypes in patients with chronic fatigue syndrome? A cross-sectional polysomnography analysis
Authors: Gotts Zoe M , Deary Vincent , Newton Julia , Van der Dussen Donna , De Roy Pierre , Ellis Jason G 
Published: June 2013

ObjectivesDespite sleep disturbances being a central complaint in patients with chronic fatigue syndrome (CFS), evidence of objective sleep abnormalities from over 30 studies is inconsistent. The present study aimed to identify whether sleep-specific phenotypes exist in CFS and explore objective characteristics that could differentiate phenotypes, while also being relevant to routine clinical practice.DesignA cross-sectional, single-site study.SettingA fatigue clinic in the Netherlands.ParticipantsA consecutive series of 343 patients meeting the criteria for CFS, according to the Fukuda definition.MeasuresPatients underwent a single night of polysomnography (all-night recording of EEG, electromyography, electrooculography, ECG and respiration) that was hand-scored by a researcher blind to diagnosis and patient history.ResultsOf the 343 patients, 104 (30.3%) were identified with a Primary Sleep Disorder explaining their diagnosis. A hierarchical cluster analysis on the remaining 239 patients resulted in four sleep phenotypes being identified at saturation. Of the 239 patients, 89.1% met quantitative criteria for at least one objective sleep problem. A one-way analysis of variance confirmed distinct sleep profiles for each sleep phenotype. Relatively longer sleep onset latencies, longer Rapid Eye Movement (REM) latencies and smaller percentages of both stage 2 and REM characterised the first phenotype. The second phenotype was characterised by more frequent arousals per hour. The third phenotype was characterised by a longer Total Sleep Time, shorter REM Latencies, and a higher percentage of REM and lower percentage of wake time. The final phenotype had the shortest Total Sleep Time and the highest percentage of wake time and wake after sleep onset.ConclusionsThe results highlight the need to routinely screen for Primary Sleep Disorders in clinical practice and tailor sleep interventions, based on phenotype, to patients presenting with CFS. The results are discussed in terms of matching patients’ self-reported sleep to these phenotypes in clinical practice.
Prognostication of recovery time after acute peripheral facial palsy: a prospective cohort study
Authors: Volk Gerd Fabian , Klingner Carsten , Finkensieper Mira , Witte Otto W , Guntinas-Lichius Orlando 
Published: June 2013

ObjectiveOwing to a lack of prospective studies, our aim was to evaluate diagnostic factors, in particular, motor and non-motor function tests, for prognostication of recovery time in patients with acute facial palsy (AFP).DesignProspective cohort study.SettingUniversity hospital.Participants259 patients with AFP.MeasurementsClinical data, facial grading, electrophysiological motor function tests and other non-motor function tests were assessed for their contribution to recovery time.ResultsThe predominant origin of AFP was idiopathic (59%) and traumatic (21%). At baseline, the House-Brackmann scale (HB) was >III in 46% of patients. Follow-up time was 5.6±9.8 months with a complete recovery rate of 49%. The median recovery time was 3.5 months (95% CI 2.2 to 4.7 months). The following variables were associated with faster recovery: Interval between onset of AFP and treatment <6 days versus ≥6 days (median recovery time in months 2.1 vs 6.5; p<0.0001); HB ≤III vs >III (2.2 vs 4.6; p=0.001); no versus presence of pathological spontaneous activity in first electromyography (EMG; 2.8 vs probability of recovery <50%; p<0.0001); no versus voluntary activity in EMG (probability of recovery <50% vs 3.1; p<0.0001); normal versus pathological ipsilateral electroneurography (1.9 vs 6.5; p=0.008), normal versus pathological stapedius reflexes (1.6 vs 3.3; p=0.003).ConclusionsStart of treatment and grading, but most importantly EMG evaluated for pathological spontaneous activity and the stapedius reflex test are powerful prognosticators for estimating the recovery time from AFP. These results need confirmation in larger datasets.
An observational study of the hand hygiene initiative: a comparison of preintervention and postintervention outcomes
Authors: Mukerji Amit , Narciso Janet , Moore Christine , McGeer Allison , Kelly Edmond , Shah Vibhuti 
Published: June 2013

ObjectivesTo evaluate the impact of implementing a simple, user-friendly eLearning module on hand hygiene (HH) compliance and infection rates.DesignPreintervention and postintervention observational study.ParticipantsAll neonates admitted to the neonatal intensive care unit (NICU) over the study period were eligible for participation and were included in the analyses. A total of 3422 patients were admitted over a 36-month span (July 2009 to June 2012).InterventionsIn the preintervention and postintervention periods (phases I and II), all healthcare providers were trained on HH practices using an eLearning module. The principles of the ‘4 moments of HH’ and definition of ‘baby space’ were incorporated using interactive tools. The intervention then extended into a long-term sustainability programme (phase III), including the requirement of an annual recertification of the module and introduction of posters and screensavers throughout the NICU.Primary and secondary outcome measuresThe primary outcome was HH compliance rates among healthcare providers in the three phases. The secondary outcome was healthcare-associated infection rates in the NICU.ResultsHH compliance rates declined initially in phase II then improved in phase III with the addition of a long-term sustainability programme (76%, 67% and 76% in phases I, II and III, respectively (p<0.01). Infection rates showed an opposing, but concomitant trend in the overall population as well as in infants <1500 g and were 4%, 6% and 4% (p=0.02), and 11%, 21% and 16% (p<0.01), respectively, during the three phases.ConclusionsInterventions to improve HH compliance are challenging to implement and sustain with the need for ongoing reinforcement and education.
Protocol for a longitudinal qualitative interview study: maintaining psychological well-being in advanced cancer—what can we learn from patients’ and carers’ own coping strategies?
Authors: Roberts Diane , Appleton Lynda , Calman Lynn , Large Paul , Grande Gunn , Lloyd-Williams Mari , Walshe Catherine 
Published: June 2013

IntroductionPeople with advanced cancer and their carers experience stress and uncertainty which affects the quality of life and physical and mental health. This study aims to understand how patients and carers recover or maintain psychological well-being by exploring the strategies employed to self-manage stress and uncertainty.Methods and analysisA longitudinal qualitative interview approach with 30 patients with advanced cancer and 30 associated family or informal carers allows the exploration of contexts, mechanisms and outcomes at an individual level. Two interviews, 4–12 weeks apart, will not only enable the exploration of individuals’ evolving coping strategies in response to changing contexts but also how patients’ and carers’ strategies inter-relate. Patient and Carer focus groups will then consider how the findings may be used in developing an intervention. Recruiting through two major tertiary cancer centres in the North West and using deliberately broad and inclusive criteria will enable the sample to capture demographic and experiential breadth.Ethics and disseminationThe research team will draw on their considerable experience to ensure that the study is sensitive to a patient and carer group, which may be considered vulnerable but still values being able to contribute its views. Public and patient involvement (PPI) is integral to the design and is evidenced by: a research advisory group incorporating patient and carers, prestudy consultations with the PPI group at one of the study sites and a user as the named applicant. The study team will use multiple methods to disseminate the findings to clinical, policy and academic audiences. A key element will be engaging health professionals in patient and carer ideas for promoting self-management of psychological well-being. The study has ethical approval from the North West Research Ethics Committee and the appropriate NHS governance clearance.RegistrationNational Institute for Health Research (NIHR) Clinical Studies Portfolio, UK Clinical Research Network (UKCRN) Study number 11725.
Clinical implementation of a new antibiotic prophylaxis regimen for percutaneous endoscopic gastrostomy
Authors: Lagergren Jesper , Mattsson Fredrik , Lagergren Pernilla 
Published: June 2013

ObjectivesThis study was undertaken to test the extent to which a new antibiotic prophylaxis regimen for percutaneous endoscopic gastrostomy (PEG), identified as a justified and simpler alternative to conventional regimen in a randomised clinical trial, has been adopted in clinical practice.DesignA Swedish nationwide implementation survey, conducted in February 2013, assessed the level of clinical implementation of a 20 ml dose of oral solution of sulfamethoxazole and trimethoprim deposited in the PEG catheter immediately after insertion. All hospitals inserting at least five PEGs annually were identified from the Swedish Patient Registry. A clinician involved in the PEG insertions at each hospital participated in a structured telephone interview addressing their routine use of antibiotic prophylaxis.SettingAll Swedish hospitals inserting PEGs (n=60).ParticipantsRepresentatives of PEG insertions at each of the 60 eligible hospitals participated (100% participation).Main outcome measuresUse of routine antibiotic prophylaxis for PEG.ResultsA total of 32 (53%) of the 60 hospitals had adopted the new regimen. It was more frequently adopted in university hospitals (67%) than in community hospitals (41%). An annual total of 1813 (70%) of 2573 patients received the new regimen. Higher annual hospital volume was associated with a higher level of adoption of the new regimen (80% in the highest vs 31% in the lowest).ConclusionsThe clinical implementation of the new antibiotic prophylaxis regimen for PEG was high and rapid (70% of all patients within 3 years), particularly in large hospitals.
Would increasing centre volumes improve patient outcomes in peritoneal dialysis? A registry-based cohort and Monte Carlo simulation study
Authors: Evans David , Lobbedez Thierry , Verger Christian , Flahault Antoine 
Published: June 2013

ObjectiveTo estimate the association between centre volume and patient outcomes in peritoneal dialysis, explore robustness to residual confounding and predict the impact of policies to increase centre volumes.DesignRegistry-based cohort study with probabilistic sensitivity analysis and Monte Carlo simulation of (hypothetical) intervention effects.Setting112 secondary-care centres in France.Participants9602 adult patients initiating peritoneal dialysis.Main outcome measuresTechnique failure (ie, permanent transfer to haemodialysis), renal transplantation and death while on peritoneal dialysis within 5 years of initiating treatment. Associations with underlying risk measured by cause-specific HRs (cs-HRs) and with cumulative incidence by subdistribution HRs (sd-HRs). Intervention effects measured by predicted mean change in cumulative incidences.ResultsHigher volume centres had more patients with diabetes and were more frequently academic centres or associative groupings of private physicians. Patients in higher volume centres had a reduced risk of technique failure (>60 patients vs 0–10 patients: adjusted cs-HR 0.46; 95% CI 0.43 to 0.69), with no changed risk of death or transplantation. Sensitivity analyses mitigated the cs-HRs without changing the findings. In higher volume centres, the cumulative incidence was reduced for technique failure (>60 patients vs 0–10 patients: adjusted sd-HR 0.49; 95% CI 0.29 to 0.85) but was increased for transplantation and death (>60 patients vs 0–10 patients: transplantation—adjusted sd-HR 1.53; 95% CI 1.04 to 2.24; death—adjusted sd-HR 1.28; 95% CI 1.00 to 1.63). The predicted reduction in cumulative incidence of technique failure was largest under a scenario of shifting all patients to the two highest volume centre groups (0.091 reduction) but lower for three more realistic interventions (around 0.06 reduction).ConclusionsPatients initiating peritoneal dialysis in high-volume centres had a considerably reduced risk of technique failure but simulations of interventions to increase exposure to high-volume centres yielded only modest improvements.
What is the best strategy for investigating abnormal liver function tests in primary care? Implications from a prospective study
Authors: Lilford Richard J , Bentham Louise M , Armstrong Matthew J , Neuberger James , Girling Alan J 
Published: June 2013

ObjectiveEvaluation of predictive value of liver function tests (LFTs) for the detection of liver-related disease in primary care.DesignA prospective observational study.Setting11 UK primary care practices.ParticipantsPatients (n=1290) with an abnormal eight-panel LFT (but no previously diagnosed liver disease).Main outcome measuresPatients were investigated by recording clinical features, and repeating LFTs, specific tests for individual liver diseases, and abdominal ultrasound scan. Patients were characterised as having: hepatocellular disease; biliary disease; tumours of the hepato-biliary system and none of the above. The relationship between LFT results and disease categories was evaluated by stepwise regression and logistic discrimination, with adjustment for demographic and clinical factors. True and False Positives generated by all possible LFT combinations were compared with a view towards optimising the choice of analytes in the routine LFT panel.ResultsRegression methods showed that alanine aminotransferase (ALT) was associated with hepatocellular disease (32 patients), while alkaline phosphatase (ALP) was associated with biliary disease (12 patients) and tumours of the hepatobiliary system (9 patients). A restricted panel of ALT and ALP was an efficient choice of analytes, comparing favourably with the complete panel of eight analytes, provided that 48 False Positives can be tolerated to obtain one additional True Positive. Repeating a complete panel in response to an abnormal reading is not the optimal strategy.ConclusionsThe LFT panel can be restricted to ALT and ALP when the purpose of testing is to exclude liver disease in primary care.