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Formative independent evaluation of a digital change programme in the English National Health Service: study protocol for a longitudinal qualitative study

Por: Cresswell · K. · Sheikh · A. · Dean Franklin · B. · Krasuska · M. · Nguyen · H. · Hinder · S. · Lane · W. · Mozaffar · H. · Mason · K. · Eason · S. · Potts · H. · Williams · R.
Introduction

Many countries are launching large-scale, digitally enabled change programmes as part of efforts to improve the quality, safety and efficiency of care. We have been commissioned to conduct an independent evaluation of a major national change programme, the Global Digital Exemplar (GDE) Programme, which aims to develop exemplary digital health solutions and encourage their wider adoption by creating a learning ecosystem across English National Health Service (NHS) provider organisations.

Methods and analysis

This theoretically informed, qualitative, longitudinal formative evaluation comprises five inter-related work packages. We will conduct a combination of 12 in-depth and 24 broader qualitative case studies in GDE sites exploring digital transformation, local learning and mechanisms of spread of knowledge within the Programme and across the wider NHS. Data will be collected through a combination of semistructured interviews with managers, implementation staff (clinical and non-clinical), vendors and policymakers, plus non-participant observations of meetings, site visits, workshops and documentary analysis of strategic local and national plans. Data will be analysed through inductive and deductive methods, beginning with in-depth case study sites and testing the findings against data from the wider sample and national stakeholders.

Ethics and dissemination

This work is commissioned as part of a national change programme and is therefore a service evaluation. We have ethical approval from the University of Edinburgh. Results will be disseminated at six monthly intervals to national policymakers, and made available via our publicly accessible website. We will also identify lessons for the management and evaluation of large-scale evolving digital health change programmes that are of international relevance.

Effect of electronic health interventions on metabolic syndrome: a systematic review and meta-analysis

Por: Chen · D. · Ye · Z. · Shao · J. · Tang · L. · Zhang · H. · Wang · X. · Qiu · R. · Zhang · Q.
Objective

We aimed to examine whether eHealth interventions can effectively improve anthropometric and biochemical indicators of patients with metabolic syndrome (MetS).

Design

Systematic review and meta-analysis.

Methods

PubMed, the Web of Science, Embase, Medline, CINAHL, PsycINFO, the Cochrane Library, the Chinese National Knowledge Infrastructure, the Wanfang and Weipu databases were comprehensively searched for papers that were published from database inception to May 2019. Articles were included if the participants were metabolic syndrome (MetS) patients, the participants received eHealth interventions, the participants in the control group received usual care or were wait listed, the outcomes included anthropometric and biochemical indicators of MetS, and the study was a randomised controlled trial (RCT) or a controlled clinical trial (CCT). The Quality Assessment Tool for Quantitative Studies was used to assess the methodological quality of the included articles. The meta-analysis was conducted using Review Manager V.5.3 software.

Results

In our review, seven RCTs and two CCTs comprising 935 MetS participants met the inclusion criteria. The results of the meta-analysis revealed that eHealth interventions resulted in significant improvements in body mass index (standardised mean difference (SMD)=–0.36, 95% CI (–0.61 to –0.10), p

Conclusions

The results indicated that eHealth interventions were beneficial for improving specific anthropometric outcomes, but did not affect biochemical indicators of MetS. Therefore, whether researchers adopt eHealth interventions should be based on the purpose of the study. More rigorous studies are needed to confirm these findings.

Anxiety levels, precautionary behaviours and public perceptions during the early phase of the COVID-19 outbreak in China: a population-based cross-sectional survey

Por: Qian · M. · Wu · Q. · Wu · P. · Hou · Z. · Liang · Y. · Cowling · B. J. · Yu · H.
Objective

To investigate psychological and behavioural responses to COVID-19 among the Chinese general population.

Design, setting and participants

We conducted a population-based mobile phone survey between 1 February and 10 February 2020 via random digit dialling. A total of 1011 adult residents in Wuhan (n=510), the epicentre and quarantined city, and Shanghai (n=501) were interviewed. Proportional quota sampling and poststratification weighting were used. Multivariable logistic regression models were used to investigate perception factors associated with the public responses.

Primary outcome measures

We measured anxiety levels using the 7-item Generalised Anxiety Disorder Scale (GAD-7) and asked respondents to report their precautionary behaviours before and during the outbreak.

Results

The prevalence of moderate or severe anxiety was significantly higher (p

Conclusions

Prevalence of moderate or severe anxiety and strict personal precautionary behaviours was generally high, regardless of the quarantine status. Our results support efforts for handwashing education programmes with a focus on hygiene procedures in China and timely dissemination of reliable information.

Perioperative patient-controlled regional analgesia versus patient-controlled intravenous analgesia for patients with critical limb ischaemia: a study protocol for a randomised controlled trial

Por: Chen · S. · Xu · Z. · Liu · H. · Zhang · Y. · Zhang · J. · Chen · Y. · Zheng · Y. · Huang · Y.
Introduction

Both regional analgesia and intravenous analgesia are frequently used perioperatively for patients with critical limb ischaemia (CLI). Nevertheless, the comparison of perioperative effect of regional and intravenous analgesia has not yet been thoroughly illustrated. This study will comprehensively compare patient-controlled regional analgesia (PCRA) and patient-controlled intravenous analgesia (PCIA) as two different perioperative analgesia approaches for patients with CLI. It investigates their effects on analgesia, reperfusion and the quality of recovery perioperatively, also aims to provide clinical evidence to those non-surgical patients with non-reconstructable arteries.

Methods and analysis

This trial is a randomised, single-centre, open-label, parallel trial with target sample size of 52 in total. Eligible participants will be randomly allocated to the PCRA group (group R) or the PCIA group (group I) after admission. Participants in group R will receive ultrasound-guided subgluteal sciatic catheterisation, followed by continuous PCRA infusion (0.2% ropivacaine 15 mL as loading dose, 8 mL/hour as background with a patient-controlled bolus of 6 mL). Participants in group I will receive PCIA (morphine is given in boluses of 1 mg as needed, background infusion at 1 mg/hour). Data will be collected at baseline (T0), 2 hours before revascularisation treatment (T1) and 2 hours before discharge (T2). The primary outcomes include the Numerical Rating Scale pain score at T1 and T2. The secondary outcomes include the perioperative transcutaneous oxygen pressure, the Tissue Haemoglobin Index, Hospital Anxiety and Depression Scale at T1 and T2; the Patient Global Impression of Change and patient satisfaction at T1 and T2; the perioperative cumulative morphine consumption, the length of postoperative hospital stay and adverse events.

Ethics and dissemination

This study received authorisation from the Institutional Review Board of Peking Union Medical College Hospital on 21 March 2017 (approval no. ZS-1289X). Study findings will be disseminated through presentations at scientific conferences or publications in peer-reviewed journals.

Trial registration number

Chinese Clinical Trial Registry (ChiCTR2000029298).

Protocol version

V.4CP.B2 (15 June 2020).

Single assessment of delirium severity during postacute intensive care of chronically critically ill patients and its associated factors: post hoc analysis of a prospective cohort study in Germany

Por: Wintermann · G.-B. · Weidner · K. · Strauss · B. · Rosendahl · J.
Objectives

To assess the delirium severity (DS), its risk factors and association with adverse patient outcomes in chronically critically ill (CCI) patients.

Design

A prospective cohort study.

Setting

A tertiary care hospital with postacute intensive care units (ICUs) in Germany.

Participants

N=267 CCI patients with critical illness polyneuropathy and/or critical illness myopathy, aged 18–75 years, who had undergone elective tracheotomy for weaning failure.

Interventions

None.

Measures

Primary outcomes: DS was assessed using the Confusion Assessment Method for the Intensive Care Unit-7 delirium severity score, within 4 weeks (t1) after the transfer to a tertiary care hospital. In post hoc analyses, univariate linear regressions were employed, examining the relationship of DS with clinical, sociodemographic and psychological variables. Secondary outcomes: additionally, correlations of DS with fatigue (using the Multidimensional Fatigue Inventory-20), quality of life (using the Euro-Quality of Life) and institutionalisation/mortality at 3 (t2) and 6 (t3) months follow-up were computed.

Results

Of the N=267 patients analysed, 9.4% showed severe or most severe delirium symptoms. 4.1% had a full-syndromal delirium. DS was significantly associated with the severity of illness (p=0.016, 95% CI –0.1 to –0.3), number of medical comorbidities (p

Conclusions

Illness severity is positively associated with DS during postacute care in CCI patients. An adequate management of delirium is essential in order to mitigate functional and cognitive long-term sequelae following ICU.

Trial registration number

DRKS00003386.

Understanding the importance of non-material factors in retaining community health workers in low-income settings: a qualitative case-study in Ethiopia

Por: Arora · N. · Hanson · K. · Spicer · N. · Estifanos · A. S. · Keraga · D. W. · Welearegay · A. T. · Tela · F. G. · Hussen · Y. A. · Mandefro · Y. S. · Quaife · M.
Objectives

The motivation and retention of community health workers (CHWs) is a challenge and inadequately addressed in research and policy. We sought to identify factors influencing the retention of CHWs in Ethiopia and ways to avert their exit.

Design

A qualitative study was undertaken using in-depth interviews with the study participants. Interviews were audio-recorded, and then simultaneously translated into English and transcribed for analysis. Data were analysed in NVivo 12 using an iterative inductive-deductive approach.

Setting

The study was conducted in two districts each in the Tigray and Southern Nations, Nationalities and People’s Republic (SNNPR) regions in Ethiopia. Respondents were located in a mix of rural and urban settings.

Participants

Leavers of health extension worker (HEW) positions (n=20), active HEWs (n=16) and key informants (n=11) in the form of policymakers were interviewed.

Results

We identified several extrinsic and intrinsic motivational factors affecting the retention and labour market choices of HEWs. While financial incentives in the form of salaries and material incentives in the form of improvements to health facility infrastructure, provision of childcare were reported to be important, non-material factors like HEWs’ self-image, acceptance and validation by the community and their supervisors were found to be critical. A reduction or loss of these non-material factors proved to be the catalyst for many HEWs to leave their jobs.

Conclusion

Our study contributes new empirical evidence to the global debate on factors influencing the motivation and retention of CHWs, by being the first to include job leavers in the analysis. Our findings suggest that policy interventions that appeal to the social needs of CHWs can prove to be more acceptable and potentially cost-effective in improving their retention in the long run. This is important for government policymakers in resource constrained settings like Ethiopia that rely heavily on lay workers for primary healthcare delivery.

Stroke incidence and subtypes in Aboriginal people in remote Australia: a healthcare network population-based study

Por: Balabanski · A. H. · Goldsmith · K. · Giarola · B. · Buxton · D. · Castle · S. · McBride · K. · Brady · S. · Thrift · A. G. · Katzenellenbogen · J. · Brown · A. · Burrow · J. · Donnan · G. A. · Koblar · S. · Kleinig · T. J.
Objectives

We aimed to compare the incidence, subtypes and aetiology of stroke, and in-hospital death due to stroke, between Aboriginal and non-Aboriginal people in Central Australia, a remote region of Australia where a high proportion Aboriginal people reside (40% of the population). We hypothesised that the rates of stroke, particularly in younger adults, would be greater in the Aboriginal population, compared with the non-Aboriginal population; we aimed to elucidate causes for any identified disparities.

Design

A retrospective population-based study of patients hospitalised with stroke within a defined region from 1 January 2011 to 31 December 2014.

Setting

Alice Springs Hospital, the only neuroimaging-capable acute hospital in Central Australia, serving a network of 50 healthcare facilities covering 672 000 km2.

Participants

161 residents (63.4% Aboriginal) of the catchment area admitted to hospital with stroke.

Primary and secondary outcome measures

Rates of first-ever stroke, overall (all events) stroke and in-hospital death.

Results

Of 121 residents with first-ever stroke, 61% identified as Aboriginal. Median onset-age (54 years) was 17 years younger in Aboriginal patients (p

Conclusions

Stroke incidence (both subtypes) and in-hospital deaths for remote Aboriginal Australians are dramatically greater than in non-Aboriginal people, especially in patients aged

Exploring how people with dementia can be best supported to manage long-term conditions: a qualitative study of stakeholder perspectives

Por: Rees · J. L. · Burton · A. · Walters · K. R. · Leverton · M. · Rapaport · P. · Herat Gunaratne · R. · Beresford-Dent · J. · Cooper · C.
Objectives

To explore how the self-management of comorbid long-term conditions is experienced and negotiated by people with dementia and their carers.

Design

Secondary thematic analysis of 82 semi-structured interviews.

Setting

Community settings across the United Kingdom.

Participants

11 people with dementia, 22 family carers, 19 health professionals and 30 homecare staff.

Results

We identified three overarching themes: (1) The process of substituting self-management: stakeholders balanced the wishes of people with dementia to retain autonomy with the risks of lower adherence to medical treatments. The task of helping a person with dementia to take medication was perceived as intermediate between a personal care and a medical activity; rules about which professionals could perform this activity sometimes caused conflict. (2) Communication in the care network: family carers often communicated with services and made decisions about how to implement medical advice. In situations where family carers or homecare workers were not substituting self-management, it could be challenging for general practitioners to identify changes in self-management and decide when to intervene. (3) Impact of physical health on and from dementia: healthcare professionals acknowledged the inter-relatedness of physical health and cognition to adapt care accordingly. Some treatments prescribed for long-term conditions were perceived as unhelpful when not adapted to the context of dementia. Healthcare professionals and homecare workers sometimes felt that family carers were unable to accept that available treatments may not be helpful to people with dementia and that this sometimes led to the continuation of treatments of questionable benefit.

Conclusion

The process of substituting self-management evolves with advancement of dementia symptoms and relies on communication in the care network, while considering the impact on and from dementia to achieve holistic physical health management. Care decisions must consider people with dementia as a whole, and be based on realistic outcomes and best interests.

Acute myocardial infarction incidence and survival in Aboriginal and non-Aboriginal populations: an observational study in the Northern Territory of Australia, 1992-2014

Por: Coffey · C. · Zhao · Y. · Condon · J. R. · Li · S. · Guthridge · S.
Objectives

To examine long-term trends in acute myocardial infarction (AMI) incidence and survival among Aboriginal and non-Aboriginal people.

Design

Retrospective cohort study.

Setting, participants

All first AMI hospital cases and deaths due to ischaemic heart disease in the Northern Territory of Australia (NT), 1992–2014.

Main outcome measures

Age standardised incidence, survival and mortality.

Results

The upward trend in Aboriginal AMI incidence plateaued around 2007 for males and 2001 for females. AMI incidence decreased for non-Aboriginal population, consistent with the national trends. AMI incidence was higher and survival lower for males, for Aboriginal people and in older age groups. In 2014, the age standardised incidence was 881 and 579 per 100 000 for Aboriginal males and females, respectively, compared with 290 and 187 per 100 000 for non-Aboriginal counterparts. The incidence disparity between Aboriginal and non-Aboriginal population was much greater in younger than older age groups. Survival after an AMI improved over time, and more so for Aboriginal than non-Aboriginal patients, because of a decrease in prehospital deaths and improved survival of hospitalised cases.

Conclusions

There was an important breakpoint in increasing trends of Aboriginal AMI incidence between 2001 and 2007. The disparity in AMI survival between the NT Aboriginal and non-Aboriginal populations reduced over time as survival improved for both populations.

Improving substance misuse outcomes in contingency management treatment with adjunctive formal psychotherapy: a systematic review and meta-analysis

Por: Sheridan Rains · L. · Steare · T. · Mason · O. · Johnson · S.
Objectives

Contingency management (CM) is a treatment for substance misuse that involves the provision of incentives. This review examines the hypothesis that adding another formal psychotherapy, such as cognitive–behavioural therapy (CBT) or motivational enhancement therapy (MET), to CM improves substance use outcomes at both treatment end and at post-treatment follow-up compared with CM only.

Data sources

Searches were performed in December 2017 and July 2019 of seven electronic bibliographic databases (MEDLINE, PsycINFO, EMBASE, Scopus, Web of Science, CINAHL, PsycEXTRA), as well as online trial registries and EThoS, and were followed by reference list screening.

Eligibility criteria

Included studies were randomised controlled trials of adults (18–65) who were using illicit substances, alcohol or tobacco. Studies featured an experimental arm delivering CM combined with a structured evidence-based psychotherapeutic intervention and a CM-only arm. Studies published up to July 2019 were included.

Data extraction and synthesis

The primary outcome was biometrically verified point prevalent abstinence (PPA) at treatment end. Secondary outcomes included biometrically verified PPA at post-treatment follow-up and self-reported days of use at treatment end and post-treatment follow-up. Pooled risk ratios for PPA outcomes and standardised mean differences for days of use were calculated using random effects models. Risk of bias was assessed using the Grading of Recommendations Assessment, Development and Evaluation.

Results

12 studies (n=1654) were included. The primary analysis found no evidence of a synergistic effect in PPA at treatment end (relative risk (RR) 0.97, 95% CI 0.85 to 1.09; p=0.57). Sensitivity analysis of studies featuring CBT/MET also found no evidence of an effect (RR 0.92; 95% CI 0.79 to 1.08; p=0.32). None of the secondary outcomes showed any evidence of benefit.

Conclusion

The results of the meta-analyses found no evidence that combining CM with another intervention improves the short-term or long-term effects of CM treatment.

Effects of crowding in the emergency department on the diagnosis and management of suspected acute coronary syndrome using rapid algorithms: an observational study

Por: Stoyanov · K. M. · Biener · M. · Hund · H. · Mueller-Hennessen · M. · Vafaie · M. · Katus · H. A. · Giannitsis · E.
Objectives

Fast diagnostic algorithms using high-sensitivity troponin (hsTn) in suspected acute coronary syndrome (ACS) are regarded as beneficial to expedite diagnosis and safe discharge of patients in crowded emergency departments (ED). This study investigates the effects of crowding on process times related to the diagnostic protocol itself or other time delays, and outcomes.

Design

Prospective single-centre observational study.

Setting

ED (Germany).

Participants

Final study population of 2525 consecutive patients with suspected ACS within 12 months, after exclusion of patients with ST-elevation myocardial infarction, missing blood samples, referral from other hospitals or repeated visits.

Interventions

Use of fast algorithms as per 2015 European Society of Cardiology guidelines.

Main outcome measures

Crowding was defined as mismatch between patient numbers and monitoring capacities, or mean physician time per case, categorised as normal, high and very high crowding. Outcome measures were length of ED stay, direct discharge from ED, laboratory turn around times (TAT), utilisation of fast algorithms, absolute and relative non-laboratory time, as well as mortality.

Results

Crowding was associated with increased length of ED stay (3.75–4.89 hours, p

Conclusions

Process times, and particularly non-laboratory times, are prolonged in a crowded ED diminishing some positive effects of fast diagnostic algorithms in suspected ACS. Higher crowding levels were not significantly associated with higher all-cause mortality rates.

Trial registration number

NCT03111862.

Establishment of sex-specific reference intervals for automated haematology analyser-delivered research parameters in healthy Korean adults: a retrospective database review

Por: Jeon · K. · Kim · M. · Han · J. · Lee · J. · Lee · J.-s. · Kim · H.-S. · Kang · H. J. · Lee · Y. K.
Objectives

Automated haematology analysers measure various parameters of relevance to clinical research along with routine complete blood count (CBC)-related components. We aimed to establish ethnicity-specific and sex-specific reference intervals for 26 research-specific parameters as well as 18 routinely reported components using a large cohort of healthy Korean adults. The necessity of requiring separate sex-specific reference intervals for each parameter was also examined.

Design

A retrospective database review.

Setting

Single tertiary-care hospital of approximately 375 physicians and 530 nurses.

Participants

This study included 1383 reference individuals (840 men and 543 women).

Primary and secondary outcome measures

Following the Clinical and Laboratory Standards Institute guidelines for establishing reference intervals, routine CBCs as well as research parameters were measured using an ADVIA 2120i instrument.

Results

All the routine components except for mean platelet volume and per cent lymphocytes differed significantly between men and women. Most research parameters also differed between the sexes; the exceptions were large platelets, platelet dry mass distribution width, per cent basophil saturation, per cent peroxidase saturation and per cent abnormal peroxidase absorption. Despite these differences, separate reference intervals for men and women were required only for two research-specific parameters: ‘percentage high cellular haemoglobin’ and ‘percentage of hyperchromic red blood cells (RBCs)’.

Conclusion

Even though most parameters showed significant differences between men and women, none of the evaluated parameters except two RBC-related factors required separate reference intervals for each sex.

Changes in the quality of care of colorectal cancer in Estonia: a population-based high-resolution study

Por: Reima · H. · Soplepmann · J. · Elme · A. · Lohmus · M. · Tiigi · R. · Uksov · D. · Innos · K.
Objectives

Large disparities in colorectal cancer (CRC) management and survival have been observed across Europe. Despite recent increases, the survival deficit of Estonian patients with CRC persists, particularly for rectal cancer. The aim of this study was to examine diagnostic, staging and treatment patterns of CRC in Estonia, comparing clinical data from 1997 and 2011.

Design

Nationwide population-based retrospective study.

Setting

Estonia.

Participants

All incident cases of colon and rectal cancer diagnosed in 1997 and 2011 identified from the Estonian Cancer Registry. Clinical data gathered from medical records.

Outcome measures

Differences in diagnostic, staging and treatment patterns; 5-year relative survival ratios.

Results

The number of colon cancer cases was 337 in 1997 and 498 in 2011; for rectal cancer, the respective numbers were 209 and 349. From 1997 to 2011, large increases were seen in the use of colonoscopy and lung and liver imaging. Radical resection rate increased from 48% to 59%, but emergency surgeries showed a rise from 18% to 26% in colon and from 7% to 14% in rectal cancer. The proportion of radically operated patients with ≥12 lymph nodes examined pathologically increased from 2% to 58% in colon cancer and from 2% to 50% in rectal cancer. The use of neoadjuvant radiotherapy increased from 6% to 39% among stage II and from 20% to 50% among patients with stage III rectal cancer. The use of adjuvant chemotherapy in stage III colon cancer increased from 42% to 63%. The 5-year RSR increased from 50% to 58% in colon cancer and from 37% to 64% in patients with rectal cancer.

Conclusions

Major improvements were seen in the diagnostics, staging and treatment of CRC in Estonia contributing to better outcomes. Increase in emergency surgeries highlights possible shortcomings in timely diagnosis and treatment.

Impact of National Drug Pricing Policy 2018 on access to medicines in Lahore division, Pakistan: a pre-post survey study using WHO/HAI methodology

Por: Saeed · A. · Saeed · H. · Saleem · Z. · Yang · C. · Jiang · M. · Zhao · M. · Ji · W. · Aziz · M. M. · Khan · F. U. · Gillani · A. H. · Atif · N. · Fang · Y. · Babar · Z. U. D.
Objective

To evaluate the impact of new National Drug Pricing Policy (NDPP) 2018 on access to medicines in terms of prices, availability and affordability.

Design

Two cross-sectional surveys were undertaken before and after the launch of NDPP 2018, using a modified WHO/Health Action International (WHO/HAI) methodology.

Setting

Four districts of Lahore division, Pakistan.

Participants

16 public sector hospitals and 16 private sector retail pharmacies.

Measures

The pre and post survey data on prices and availability of lowest price generics (LPGs) and originator brands (OBs) of 50 medicines were obtained by visiting the same public and private sector health facilities (n=32). Out of 50, 46 surveyed medicines were from the National Essential Medicines List. Inflation-adjusted median unit prices (MUPs) and median price ratios (MPRs) from 2019 were used for price comparison. Affordability was calculated in terms of number of days’ wages required to get a standard treatment by the lowest paid unskilled government worker.

Results

The overall mean percent availabilities remained poor in both years, that is, far less than 80%. In the public sector, the mean percent availability of OBs improved from 6.8% to 33.1%, whereas, in the case of LPGs, it was reduced from 35.1% to 9%. In the private sector, the mean percent availability of both OBs and LPGs demonstrated slight improvements in 2019, that is, 55.0%–58.3% and 20.3%–32.3%. The adjusted MUPs and MPRs of OBs significantly increased by a median of 4.29% (Wilcoxon test p=0.001, p=0.0001), whereas the adjusted MUPs and MPRs of LPGs increased by a median of 15.7% (p=0.002, p=0.0002). Overall, the affordability of many medicines for common ailments was reduced significantly in 2019.

Conclusions

The availability of medicines slightly improved, except in the case of LPGs, which was reduced in the public sector. The implementation of NDPP 2018 led to increase in drug prices, making the standard treatment for some of the most prevalent ailments unaffordable. So verily, the drug pricing policy must be reviewed to ensure access to essential medicines.

Vedolizumab treatment across antiretroviral treatment interruption in chronic HIV infection: the HAVARTI protocol for a pilot dose-ranging clinical trial to assess safety, tolerance, immunological and virological activity

Por: McGuinty · M. · Angel · J. B. · Cooper · C. L. · Cowan · J. · MacPherson · P. A. · Kumar · A. · Murthy · S. · Sy · R. · Dennehy · M. · Tremblay · N. · Byrareddy · S. N. · Cameron · D. W.
Introduction

Continuous antiretroviral therapy (ART) suppresses HIV plasma viral load (pVL) to very low levels, which allows for some immune recovery. Discontinuation of ART leads to pVL rebound from reservoirs of persistence and latency, and progressive immunodeficiency. One promising but controversial strategy targeting CD4+ T lymphocytes with a monoclonal antibody (mAb) against α4β7 integrin has shown promise through sustained virological remission of pVL (SVR) in SIV239-infected rhesus macaques. We propose to assess the safety and tolerability of vedolizumab, a licensed humanised mAb against human α4β7 integrin, in healthy HIV-infected adults on ART. This study will also assess, by analytical treatment interruption (ATI), whether vedolizumab treatment can induce SVR beyond ART and vedolizumab treatment.

Methods and analysis

The HIV-ART-vedolizumab-ATI (HAVARTI) trial is a single-arm, dose-ranging pilot trial in healthy HIV-positive adult volunteers receiving ART. Twelve consenting persons will be enrolled in sequential groups of 4 to each serial dosing vedolizumab regimen (300 mg, 150 mg, 75 mg). The primary outcomes are: (1) to assess the safety and tolerability of seven serial infusions of vedolizumab at each of three doses; (2) to identify the immunovirological measures, including pVL and T-cell kinetics, that characterise HIV/ART cases before, during, after vedolizumab treatment and ATI; and (3) to seek SVR of pVL after ATI. Secondary outcomes will include immune reconstitution and pVL suppression as well as immune reconstitution and long-term safety following re-initiation of ART in the absence of SVR.

Ethics and dissemination

The study protocol was approved by the Ottawa Health Science Network-REB and by the Health Canada Therapeutic Products Directorate. A Data Safety Monitor will review safety information at regular intervals. The final manuscript will be submitted to an open access journal within a year of study completion.

Trial registration number

ClinicalTrials.gov NCT03147859; https://clinicaltrials.gov/ct2/show/NCT03147859

'Hobsons choice: a qualitative study of consent in acute surgery

Por: Howard · A. · Webster · J. · Quinton · N. · Giannoudis · P. V.
Objectives

The study aimed to understand through qualitative research what patients considered material in their decision to consent to an acute surgical intervention.

Participants, setting and intervention

The patients selected aged between 18 and 90, having been admitted to a major trauma centre to undergo an acute surgical intervention within 14 days of injury, where English was their first language. Data saturation point was reached after 21 patients had been recruited. Data collection and analysis were conducted simultaneously, through interviews undertaken immediately prior to surgery. The data were coded using NVIVO V.12 software.

Results

The key theme that originated from the data analysis was patients were unable to identify any individual risk that would modify their decision-making process around giving consent. The patient’s previous experience and the experience of others around them were a further theme. Patients sensed that there were no non-operative options for their injuries.

Conclusion

This is the first study investigating what patient considered a material risk in the consent process. Patients in this study did attribute significance to past experiences of friends and family as material, prompting us to suggest that the surgeon asks about these experiences as part of the consent process. Concern about functional recovery was important to patients but insufficient to stop them from consenting to surgery, thus could not be classified as material risk.

Development and pilot implementation of a standardised trauma documentation form to inform a national trauma registry in a low-resource setting: lessons from Tanzania

Por: Sawe · H. R. · Reynolds · T. A. · Weber · E. J. · Mfinanga · J. A. · Coats · T. J. · Wallis · L. A.
Objectives

Trauma registries are an integral part of a well-organised trauma system. Tanzania, like many low and middle-income countries, does not have a trauma registry. We describe the development, structure, implementation and impact of a context appropriate standardised trauma form based on the adaptation of the WHO Data Set for Injury (DSI), for clinical documentation and use in a national trauma registry.

Setting

Our study was conducted in emergency units of five regional referral hospitals in Tanzania.

Procedures

Mixed methods participatory action research was employed. After an assessment of baseline trauma documentation, we conducted semi-structured interviews with a purposefully selected sample of 33 healthcare providers from all participating hospitals to understand, develop, pilot and implement a standardised trauma form. We compared the number and types of variables captured before and after the form was implemented.

Outcomes

Change in proportion of variables of DSI captured after implementation of a standardised trauma documentation form.

Results

Piloting and feedback informed the development of a context appropriate standardised trauma documentation paper form with carbonless copy that could be used as both the clinical chart and data capture. Among 721 patients (seen by 21 clinicians) during the initial 30-day pilot, overall variable capture was 86.4% of required variables. After modifications of the form and training of healthcare providers, the form was implemented for 7 months, during which the capture improved to 96.3% among 6302 patients (seen by 31 clinicians). The providers reported the form was user-friendly, resulted in less time documenting, and served as a guide to managing trauma patients.

Conclusions

The development and implementation of a contextually appropriate, standardised trauma form were successful, yielding increased capture rates of injury variables. This system will facilitate expansion of the trauma registry across the country and inform similar initiatives in Sub-Saharan Africa.

Healthcare utilisation in overweight and obese children: a systematic review and meta-analysis

Por: Hasan · T. · Ainscough · T. S. · West · J. · Fraser · L. K.
Objective

This systematic review and meta-analysis aims to systematically analyse the association of overweight and obesity with health service utilisation during childhood.

Data sources

PubMed, MEDLINE, CINAHL, EMBASE and Web of Science.

Methods

Observational studies published up to May 2020 that assessed the impact of overweight and obesity on healthcare utilisation in children and adolescents were included. Studies were eligible for inclusion if the included participants were ≤19 years of age. Findings from all included studies were summarised narratively. In addition, rate ratios (RRs) and 95% CIs were calculated in a meta-analysis on a subgroup of eligible studies.

Outcome measures

Included studies reported association of weight status with healthcare utilisation measures of outpatient visits, emergency department (ED) visits, general practitioner visits, hospital admissions and hospital length of stay.

Results

Thirty-three studies were included in the review. When synthesising the findings from all studies narratively, obesity and overweight were found to be positively associated with increased healthcare utilisation in children for all the outcome measures. Six studies reported sufficient data to meta-analyse association of weight with outpatient visits. Five studies were included in a separate meta-analysis for the outcome measure of ED visits. In comparison with normal-weight children, rates of ED (RR 1.34, 95% CI 1.07 to 1.68) and outpatient visits (RR 1.11, 95% CI 1.02 to 1.20) were significantly higher in obese children. The rates of ED and outpatient visits by overweight children were only slightly higher and non-significant compared with normal-weight children.

Conclusions

Obesity in children is associated with increased healthcare utilisation. Future research should assess the impact of ethnicity and obesity-associated health conditions on increased healthcare utilisation in children with overweight and obesity.

PROSPERO registration number

CRD42018091752

Effectiveness and cost-effectiveness of a progressive, individualised walking and education programme for prevention of low back pain recurrence in adults: study protocol for the WalkBack randomised controlled trial

Por: Pocovi · N. C. · Lin · C.-W. C. · Latimer · J. · Merom · D. · Tiedemann · A. · Maher · C. · van Tulder · M. W. · Macaskill · P. · Clavisi · O. · Tong · S. Y. K. · Hancock · M. J.
Introduction

Low back pain (LBP) is recognised globally as a prevalent, costly and disabling condition. Recurrences are common and contribute to much of the burden of LBP. Current evidence favours exercise and education for prevention of LBP recurrence, but an optimal intervention has not yet been established. Walking is a simple, widely accessible, low-cost intervention that has yet to be evaluated. This randomised controlled trial (RCT) aims to establish the effectiveness and cost-effectiveness of a progressive and individualised walking and education programme (intervention) for the prevention of LBP recurrences in adults compared with no treatment (control).

Methods and analysis

A pragmatic, two-armed RCT comparing walking and education (n=349) with a no treatment control group (n=349). Inclusion criteria are adults recovered from an episode of non-specific LBP within the last 6 months. Those allocated to the intervention group will receive six sessions (three face to face and three telephone delivered) with a trained physiotherapist to facilitate a progressive walking programme and education over a 6-month period. The primary outcome will be days to first recurrence of an episode of activity-limiting LBP. The secondary outcomes include days to recurrence of an episode of LBP, days to recurrence of an episode of LBP leading to care seeking, disability and quality of life measured at 3, 6, 9 and 12 months and costs associated with LBP recurrence. All participants will be followed up monthly for a minimum of 12 months. The primary intention-to-treat analysis will assess difference in survival curves (days to recurrence) using the log-rank statistic. The cost-effectiveness analysis will be conducted from the societal perspective.

Ethics and dissemination

Approved by Macquarie University Human Research Ethics Committee (Reference: 5201949218164, May 2019). Findings will be disseminated through publication in peer-reviewed journals and conference presentations.

Trial registration number

ACTRN12619001134112.

Safety and efficacy of larval therapy on treating leg ulcers: a protocol for systematic review and meta-analysis

Por: Fan · W. · Yang · B. · Hu · X. · Yang · X. · Shi · C. · Liu · G.
Introduction

Leg ulcers (LUs) not only seriously affect life and work of patients, but also bring huge economic burden to the society. As a potential underused biological debridement, larval therapy provides help for the treatment of LUs. The purpose of our research is to assess whether patients with LUs can benefit from larval therapy.

Methods and analysis

The following electronic databases will be searched: PubMed, EMBASE, Web of Science, the Cochrane Library, China National Knowledge Infrastructure Database, Wanfang Database and Chinese Biological Medicine. Randomised controlled trials are eligible for inclusion. There will be no restrictions with respect to language and search date is up to June 2020. Primary outcomes investigated are complete healing rate after treatment, time to ulcer healing, reduction of wound surface area and adverse events. Risk ratios will be used for categorical data; weighted mean difference will be used for measurement data. Subgroup analysis and sensitivity analysis will be considered if heterogeneity exists. The results of data synthesis will be performed by narrative summary and quantitative analysis.

Ethics and dissemination

This systematic review does not require the approval of the ethics committee because individual data on patients are not collected. The results of the study will be disseminated in peer-reviewed journals.

PROSPERO registration number

CRD42020176953.

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