In the last 10 years there has been a significant increase in cycle traffic in the UK, with an associated increase in the overall number of cycling injuries. Despite this, and the significant media, political and public health debate into this issue, there remains an absence of studies from the UK assessing the impact of helmet use on rates of serious injury presenting to the National Health Service (NHS) in cyclists.

The NHS England Trauma Audit and Research Network (TARN) Database was interrogated to identify all adult (≥16 years) patients presenting to hospital with cycling-related major injuries, during a period from 14 March 2012 to 30 September 2017 (the last date for which a validated dataset was available).

11 patients met inclusion criteria. Data on the use of cycling helmets were available in 6621 patients.

TARN injury descriptors were used to compare patterns of injury, care and mortality in helmeted versus non-helmeted cohorts.

Data on cycle helmet use were available for 6621 of the 11 192 cycle-related injuries entered onto the TARN Database in the 66 months of this study (93 excluded as not pedal cyclists). There was a significantly higher crude 30-day mortality in un-helmeted cyclists 5.6% (4.8%–6.6%) versus helmeted cyclists 1.8% (1.4%–2.2%) (p

This study suggests that there is a significant correlation between use of cycle helmets and reduction in adjusted mortality and morbidity associated with TBI and facial injury.

A large proportion of malaria-infected individuals in endemic areas do not experience symptoms that prompt treatment-seeking. These asymptomatically infected individuals may retain their infections for many months during which sexual-stage parasites (gametocytes) are produced that may be transmissible to mosquitoes. Reductions in malaria transmission could be achieved by detecting and treating these infections early. This study assesses the impact of enhanced community case management (CCM) and monthly screening and treatment (MSAT) on the prevalence and transmissibility of malaria infections.

This cluster-randomised trial will take place in Sapone, an area of intense, highly seasonal malaria in Burkina Faso. In total, 180 compounds will be randomised to one of three interventions: arm 1 - current standard of care with passively monitored malaria infections; arm 2 - standard of care plus enhanced CCM, comprising active weekly screening for fever, and detection and treatment of infections in fever positive individuals using conventional rapid diagnostic tests (RDTs); or arm 3 - standard of care and enhanced CCM, plus MSAT using RDTs. The study will be conducted over approximately 18 months covering two high-transmission seasons and the intervening dry season. The recruitment strategy aims to ensure that overall transmission and force of infection is not affected so we are able to continuously evaluate the impact of interventions in the context of ongoing intense malaria transmission. The main objectives of the study are to determine the impact of enhanced CCM and MSAT on the prevalence and density of parasitaemia and gametocytaemia and the transmissibility of infections. This will be achieved by molecular detection of infections in all study participants during start and end season cross-sectional surveys and routine sampling of malaria-positive individuals to assess their infectiousness to mosquitoes.

The study has been reviewed and approved by the London School of Hygiene and Tropical Medicine (LSHTM) (Review number: 14724) and The Centre National de Recherche et de Formation sur le Paludisme institutional review board (IRB) (Deliberation N° 2018/000002/MS/SG/CNRFP/CIB) and Burkina Faso national medical ethics committees (Deliberation N° 2018-01-010).

Findings of the study will be shared with the community via local opinion leaders and community meetings. Results may also be shared through conferences, seminars, reports, theses and peer-reviewed publications; disease occurrence data and study outcomes will be shared with the Ministry of Health. Data will be published in an online digital repository.

NCT03705624.

The aim of this study was to explore perspectives and reasoning of medical staff from Class A tertiary hospitals about the factors hindering and facilitating the uptake and use of clinical practice guidelines (CPGs) during medical procedures.

Mixed-method research study to collect and analyse both quantitative and qualitative data.

Class A tertiary hospitals in China.

The inclusion criteria for the questionnaire survey and qualitative research were (1) medical practitioners and (2) years of practice: above 5 years in a tertiary hospital.

Questionnaires were distributed to medical staff in 11 cities to collect quantitative data. Frequency and ranking of barriers and enablers were analysed. Spearman correlations were computed to explore the correlation between years of practice, professional title ranking and educational background with self-reported guideline adherence. Using a constructivist grounded theory method, qualitative data were generated via in-depth face-to-face interviews with Chinese medical practitioners.

A total of 359 medical practitioners were surveyed and 32 medical practitioners interviewed in 11 cities. Higher frequency and higher ranking of barriers all converged on ‘lack of access’, ‘less convenient’, ‘lack of applicability’ and ‘lack of evidence from Chinese sample’. Higher frequency and higher ranking of enablers converged on ‘Short formats presentation’, ‘Utilisation of various media’, ‘Information visualisation’ and ‘Linking to patient electronic medical records’. There were no relationships between characteristics of respondents with self-reported adherence. This research produced a theoretical understanding of the experience of medical practitioners when using guidelines. Themes identified were as follows: existing intrinsic flaws in guidelines, deficient or incomplete system mechanism and being ambiguous.

Our findings provide a comprehensive and culturally sensitive perspective in understanding guideline implementation in China. Strategies addressing those barriers should be further discussed and researched in the future.

The incidence and prevalence of end-stage renal disease (ESRD) in Taiwan have been ranked the highest worldwide. Therefore, the National Health Insurance Administration has implemented the pre-ESRD pay-for-performance (P4P) programme since November 2006, which had significantly reduced the incidence of dialysis and all-cause mortality. This study aimed to identify the factors associated with the enrolment in the pre-ESRD P4P programme.

Cross-sectional study.

The National Health Insurance research database 2007–2012 in Taiwan.

Patients with prevalent pre-ESRD aged more than 18 years between January 2007 and December 2012 were enrolled. Patient demographics and hospital characteristics between P4P and non-P4P groups were compared. A logistic regression model was used to analyse the factors associated with P4P enrolment, and a generalised estimating equation was used to verify the results.

Enrolment in the pre-ESRD P4P programme.

In total, 82 991 patients were enrolled in the programme, with a 45.6% participation rate. Patients who were males (adjusted OR (AOR)=0.89, 95% CI=0.86 to 0.91) and employed (AOR=0.95, 95% CI=0.92 to 0.97) had a significantly lower probability to be enrolled in the programme. Older patients (66–75 years old, AOR=1.23, 95% CI=1.14 to 1.33) and those with higher Charlson Comorbidities Index (CCI 5+, AOR=4.01, 95% CI=3.55 to 4.53) tended to be enrolled in the programme, while those in the 76+ years age group were not (AOR=1.03, 95% CI=0.95 to 1.13). Hospitals located in the central (AOR=1.48, 95% CI=1.05 to 2.08) and Kao-Ping regions (AOR=1.62, 95% CI=1.18 to 2.22) also tended to enrol patients in the pre-ESRD P4P programme. Enrolment rates increased over time.

Pre-ESRD patients of the female gender, greater age and more comorbidities were more likely to be enrolled in the pre-ESRD P4P programme. Healthcare providers and health authorities should focus attention on patients who are male, younger and with less comorbidities to improve the healthcare quality and equality for all pre-ESRD patients.

Endovascular thrombectomy is the standard of care for anterior circulation acute ischaemic stroke (AIS) secondary to emergent large vessel occlusion in patients who qualify. General anaesthesia (GA) or conscious sedation (CS) is usually required to ensure patient comfort and avoid agitation and movement during thrombectomy. However, the question of whether the use of GA or CS might influence functional outcome remains debated. Indeed, conflicting results exist between observational studies with better outcomes associated with CS and small monocentric randomised controlled trials favouring GA. Therefore, we aim to evaluate the effect of CS versus GA on functional outcome and periprocedural complications in endovascular mechanical thrombectomy for anterior circulation AIS.

Anesthesia Management in Endovascular Therapy for Ischemic Stroke (AMETIS) trial is an investigator initiated, multicentre, prospective, randomised controlled, two-arm trial. AMETIS trial will randomise 270 patients with anterior circulation AIS in a 1:1 ratio, stratified by centre, National Institutes of Health Stroke Scale (≤15 or >15) and association of intravenous thrombolysis or not to receive either CS or GA. The primary outcome is a composite of functional independence at 3 months and absence of perioperative complication occurring by day 7 after endovascular therapy for anterior circulation AIS. Functional independence is defined as a modified Rankin Scale score of 0–2 by day 90. Perioperative complications are defined as intervention-associated arterial perforation or dissection, pneumonia or myocardial infarction or cardiogenic acute pulmonary oedema or malignant stroke evolution occurring by day 7.

The AMETIS trial was approved by an independent ethics committee. Study began in august 2017. Results will be published in an international peer-reviewed medical journal.

NCT03229148.

To quantify the economic and psychological impact of the cancellation of operations due to winter pressures on patients, their families and the economy.

This questionnaire study was designed with the help of patient groups. Data were collected on the economic and financial burden of cancellations. Emotions were also quantified on a 5-point Likert scale.

Five NHS Hospital Trusts in the East Midlands region of England.

We identified 796 participants who had their elective operations cancelled between 1 November 2017 and 31 March 2018 and received responses from 339 (43%) participants.

Participants were posted a modified version of a validated quality of life questionnaire with a prepaid return envelope.

The primary outcome measures were the financial and psychological impact of the cancellation of elective surgery on patients and their families.

Of the 339 respondents, 163 (48%) were aged

The cancellation of elective surgery during the winter had an adverse impact on patients and the economy, including days of work lost and health-related anxiety. We recommend better planning, and provision of more notice and better support to patients.

Diabetes mellitus (DM) and metabolic syndrome (MS) are both associated with heart attack. Evidence regarding which condition—MS or DM—is better associated with heart attack, however, is limited. The purpose of this study is to examine DM and MS, and their comparative associations with heart attack, using the 2015 Behavioral Risk Factor Surveillance System (BRFSS).

Cross-sectional study.

A total of 332 008 subjects aged over 18 years were included in the analysis. All subjects were classified into four groups based on their DM and MS status: neither DM nor MS, DM without MS, MS without DM, and both DM and MS. A weighted hierarchical logistic regression was used to examine the difference between the four groups in their association with the risk of a heart attack.

Differences in weighted frequency distributions of gender, age category (over 45 years or not), smoking status, education, race, physical activity and daily vegetable and fruit consumption were significantly different across the four groups (p

The BRFSS 2015 data indicated that MS without DM and DM without MS had comparable effects on heart attack, and the odds of risk are doubled than US adults with neither DM nor MS.

Services are being encouraged to provide postdiagnostic treatment to those with dementia but the availability of evidence-based interventions following diagnosis has not kept pace with increase in demand. To address this need, the Journeying through Dementia (JtD) intervention was created. A randomised controlled trial (RCT), based on a pilot study, is in progress.

The RCT is a pragmatic, two-arm, parallel group trial designed to test the clinical and cost-effectiveness of JtD compared with usual care. Recruitment will be through NHS services, third sector organisations and Join Dementia Research. The sample size is 486 randomised (243 to usual care and 243 to the intervention usual care). Participants can choose to ask a friend or relative (supporter) to become involved in the study. The primary outcome measure for participants is Dementia-Related Quality of Life (DEMQOL), collected at baseline and at 8 months’ postrandomisation. Secondary outcome measures will be collected from participants and supporters at those visits. Participants will also be followed up at 12 months’ postrandomisation with a reduced set of measures. A process evaluation will be conducted through qualitative and fidelity substudies. Analyses will compare the two arms of the trial on an intention to treat as allocated basis. The primary analyses will compare the mean DEMQOL scores of the participants at 8 months between the two study arms. A cost-effectiveness analysis will consider the incremental cost per Quality Adjusted Life Years of the intervention compared with usual care. Qualitative and fidelity substudies will be analysed through framework analysis and fidelity assessment tools respectively.

REC and HRA approval were obtained. A Data Monitoring and Ethics Committee has been constituted. Dissemination will be via publications, conferences and social media. Intervention materials will be made open access.

ISRCTN17993825.

Cancer care has expanded from a disease-focused, survival-oriented model to an approach that now considers how survivors can live well in the aftermath of intensive therapy, where they may deal with significant changes to their bodies, mental health or emotional well-being. Research evidence supports the benefit of exercise during and following cancer treatments for cancer-related symptoms, physical functioning and fitness, and health-related quality of life. To move this efficacy evidence into practice, we designed and launched a 5-year study to evaluate the relative benefit from implementing a clinic-to-community-based cancer and exercise model of care.

A hybrid effectiveness and implementation trial design is being used to evaluate the effectiveness of delivery of community-based exercise and to collect data on implementation of the programme. The study opened in January 2017, with estimated completion by January 2022. The programme will be delivered in seven cities across the province of Alberta, Canada, with sites including three academic institutions, six YMCA locations, Wellspring Edmonton and Calgary, and six municipal fitness centres. Participants are adult cancer survivors (n=2500) from all tumour groups and stages and at any time point along their cancer treatment trajectory, up to 3 years post treatment completion. Survivors take part in a minimum of 60 min of mild-to-moderate intensity full body exercise twice weekly for a 12-week period. The primary effectiveness outcome is the proportion of participants meeting or exceeding 150 min of moderate intensity exercise per week at 1-year follow-up. The Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework will be utilised to capture individual-level and organizational-level impact of the exercise programme at 12 and 24 weeks and 1-year follow-up. The cohort of survivors participating in the study will allow for long-term (>5-year) evaluation of rates of cancer recurrence and secondary cancers beyond the funding period.

The study was approved by the Health Research Ethics Board of Alberta. The study is funded by Alberta Innovates and the Alberta Cancer Foundation. The study will help to answer critical questions on the effectiveness of cancer-specific community-based exercise programming in both the short-term and the long-term. Collectively, the findings will help to inform the acceptability, adoption, feasibility, reach and sustainability of community-based exercise.

NCT02984163; Pre-results.

A growing interest has emerged on the effects of exercise during gestation. Several systematic reviews and meta-analyses have shown that prenatal exercise could reduce the mothers’ risk for some disorders. Despite this, evidence regarding the risk of caesarean section, birth weight or Apgar score at delivery is still controversial. Furthermore, practitioners are reluctant to recommend exercise to pregnant women suffering from some disorders, such as hypertension, pre-eclampsia or pregnant women with obesity. Moreover, the scarcity of studies addressing the risks and benefits of exercise at higher intensity prevent practitioners from recommending it at higher dosages. Umbrella reviews represent an appropriate design to elucidate the reasons behind the contradictory findings of previous systematic reviews.

This protocol was developed according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols and the Cochrane Collaboration Handbook. Medline, EMBASE, Web of Science, Cochrane database of systematic reviews, Epistemonikos, Prospero register and SPORTDiscuss databases will be searched to identify systematic reviews, meta-analyses and randomised controlled trials that examine the effect of exercise on pregnancy outcomes from inception to August 2019. Searches will be conducted from September to November 2019.

Methodological quality will be evaluated using the AMSTAR 2 tool. The certainty of evidence and strength of recommendations for meta-analyses will be assessed by the Grading of Recommendations Assessment, Development and Evaluation framework. The summary effect sizes will be calculated through the use of random-effects and fixed-effects models. Heterogeneity among studies will be assessed using the I² statistic, and evidence of excess significance bias and evidence of small study effects will also be evaluated.

Ethical approval will not be needed for this review protocol. The results will be disseminated to academic audiences by peer-reviewed publications. Furthermore, results will be disseminated to clinical audiences through professionals’ associations and social networks, and may influence guidelines developers in order to improve outcomes in mothers and offspring.

CRD42019123410.

To examine the analgesic efficacy and safety of ketamine after total knee or hip arthroplasty.

Systematic review and meta-analysis.

PubMed, EMBASE and Cochrane Library from inception to 22 May 2019.

Randomised controlled trials comparing the efficacy and safety of ketamine with placebo for postoperative pain relief in patients undergoing total knee or hip arthroplasty.

Data (ie, pain intensity, morphine consumption, gastrointestinal and psychotic adverse effects) were extracted by two reviewers independently. The Cochrane Collaboration’s recommended tool was used to determine the methodological quality of included studies.

A total of 10 studies were included. One of them was rated as low quality. Compared with placebo, intravenous ketamine was effective for pain relief during 0–8-hour (weighted mean difference (WMD) –1.21, 95% CI –1.45 to –0.98, p

Intravenous administration of ketamine is effective and safe for postoperative pain relief in patients undergoing total knee or hip arthroplasty. Nevertheless, the analgesic efficacy and safety of ketamine in such patients seem to vary by different administration routes and still warrant further studies to explore.

The KERALINK trial tests the hypothesis that corneal cross-linking (CXL) treatment reduces the progression of keratoconus in comparison to standard care in patients under 17 years old. KERALINK is a randomised controlled, observer-masked, multicentre trial in progressive keratoconus comparing epithelium-off CXL with standard care, including spectacles or contact lenses as necessary for best-corrected acuity.

A total of 30 participants will be randomised per group. Eligible participants aged 10–16 years with progressive keratoconus in one or both eyes will be recruited. Following randomisation, participants will be followed up 3-monthly for 18 months. The effect on progression will be determined by K₂ on corneal topography. The primary outcome measure is between-group difference in K₂ at 18 months adjusted for K₂ at baseline examination. Secondary outcomes are the effect of CXL on (1) keratoconus progression, (2) time to keratoconus progression, (3) visual acuity, (4) refraction, (5) apical corneal thickness and (6) adverse events. Patient-reported effects will be explored by questionnaires.

Research Ethics Committee Approval was obtained on 30 June 2016 (ref: 14/LO/1937). Current protocol: V.5.0 (08/11/2017). Study findings will be published in peer-reviewed journals.

European Union clinial trials register (EudraCT) 2016-001460-11

Our aim was to conduct a systematic review of the literature to determine the impact of patient decision aids (PDA) on patients facing treatment decisions for colorectal cancer.

Systematic review.

Sources included Embase, Medline, Web of Science, CINAHL and the Cochrane Library from inception to June, 20, 2019.

We included randomised controlled trials (RCTs), cohort studies, mixed methods and case series in which a PDA for colorectal cancer treatment was used. Qualitative studies were excluded from our review.

Following execution of the search strategy by a medical librarian, two blinded independent reviewers identified articles for inclusion. Two blinded reviewers were also responsible for data extraction, risk of bias and study quality assessments. Any conflict in article inclusion or extraction was resolved by discussion.

Out of 3773 articles identified, three met our inclusion criteria: one RCT, one before-and-after study and one mixed-method study. In these studies, the use of a PDA for colorectal cancer treatment was associated with increased patient knowledge, satisfaction and preparation for making a decision. On quality assessment, two of three studies were judged to be of low quality.

A paucity of evidence exists on the effect of PDA for colorectal cancer treatment with existing evidence being largely of low quality. Further investigation is required to determine the effect of decision aids for colorectal cancer treatment as well as reasons for the lack of PDA development and implementation in this area.

CRD42018095153.

Rigorous evaluation of innovative invasive procedures and medical devices is uncommon and lacks reporting standardisation. Devices may therefore enter routine practice without thorough evaluation, resulting in patient harm. Detailed guidance on how to select and report outcomes at each stage of evaluation is lacking. Development of reporting guidance and core outcome sets (COS) is one strategy to promote safe and transparent evaluation.

A COS, comprising outcome domains applicable to all phases of evaluation of procedure/device introduction and modification and, if necessary, supplementary domains relevant to specific phases or types of innovation (procedure or device), will be developed according to principles outlined by Core Outcome Measures in Effectiveness Trials (COMET) and Core Outcome Set-Standards for Development (COS-STAD) guidelines. Reporting guidance will be developed concurrently. The study will have the following three phases:

1. Generation of a list of relevant outcome domains and reporting items identified from (a) published studies, (b) hospital policy documentation, (c) regulatory body documentation and (d) stakeholder qualitative interviews. Identified items/domains will be categorised using a conceptual framework and formatted into Delphi consensus survey questionnaire items.

2. Key stakeholders, including 50 patients and 150 professionals (surgeons, researchers, device manufacturers, regulatory representatives, journal editors) sampled from multinational sources, will complete a Delphi survey to score the importance of each reporting item and outcome.

3. A consensus meeting with key stakeholders will discuss and agree the final content of the reporting guidance and COS(s).

Ethical approval has been granted by North East-Newcastle and North Tyneside 1 Health Research Authority Research Ethics Committee (18/NE/0378). Dissemination strategies include scientific meeting presentations, peer-reviewed journal publications, development of plain English summaries/materials, patient engagement events, development of a social media identity, workshops and other events.

To examine the oral health conditions and oral health behaviour of high-cost patients and evaluate oral health measures as predictors of future high-cost patients.

A retrospective, population-based cohort study using administrative healthcare records.

The National Health Insurance Service (NHIS) medical check-up database (a.k.a. NHIS—national health screening cohort database) in South Korea.

131 549 individuals who received biennial health check-ups including dental check-ups in 2011 or 2012, aged 49–88.

Current and subsequent year high-cost patient status.

High-cost patients, on average, incur higher dental costs, suffer more from periodontal disease, brush their teeth less and use secondary oral hygiene products less. Some of the self-reported oral health behaviours and oral symptom variables show statistically significant associations with subsequent year high-cost patient indicators, even after adjusting for demographic, socioeconomic, medical conditions, and prior healthcare cost and utilisation.

We demonstrate that oral health measures are associated with an increased risk of becoming a high-cost patient.

Qigong exercise offers a potentially safe, low-cost and effective mind–body rehabilitative intervention for mitigating the problem of gait interruption among patients with Parkinson’s disease (PD) who have frequent freezing of gait (FOG) episodes. However, its clinical effects have not been established. This paper describes the trial protocol of evaluating the clinical efficacy of a newly developed Integrated Qigong in improving gait among patients with PD who have FOG.

A single-blind randomised controlled trial is designed to compare Integrated Qigong and balance training with an attention control. Participants will be patients with mild to moderate PD who experience FOG and are recruited from local communities in Shanghai, China. Participants will be randomly allocated to one of the three groups: Integrated Qigong group, a balance exercise intervention group, or control group. The total number of participants will be 126, and masked assessments will be made at baseline, 12 weeks (end of intervention) and 12-week follow-up. Both Integrated Qigong group and balance training group will receive a group-based exercise intervention that meets three times per week, 60 min in duration, for 12 weeks. The control group will receive a 60 min weekly group session and monthly health education. The primary outcomes are gait parameters (stride length, gait velocity, stride time variability) and occurrence of FOG. The secondary outcomes are postural instability, walking disability, falling, fear of falling and quality of life.

This study has been approved by the Ethics Committee of Shanghai University of Sport and registered at China Clinical Trial Registry. Participants will sign informed consent prior to the participation of the trial. The findings of the study will be published in peer-reviewed academic journals and disseminated to PD support groups, medical community and media.

ChiCTR1800016570.

To explore patients’ and General Practitioners' (GPs) accounts of how responsibility for follow-up was perceived and shared in their experiences of cancer safety netting occurring within the past 6 months.

In-depth interviews were recorded and transcribed verbatim. Data were analysed through an abductive process, exploring anticipated and emergent themes. Conceptualisations of ‘responsibility’ were explored by drawing on a transactional to interdependent continuum drawing from the shared decision-making literature.

A purposive sample of 25 qualified GPs and 23 adult patients in Oxfordshire, UK.

The transactional sharing approach involves responsibility being passed from GP to patient. Patients expected and were willing to accept responsibility in this way as long as they received clear guidance from their GP and had capacity. In interdependent sharing, GPs principally aimed to reach consensus and share responsibility with the patient by explaining their rationale, uncertainty or by stressing the potential seriousness of the situation. Patients sharing this responsibility could be put at risk if no follow-up or timeframe was suggested, they had inadequate information, were falsely reassured or their concerns were not addressed at re-consultation.

GPs and patients exchange and share responsibility using a combination of transactional and interdependent styles, tailoring information based on patient characteristics and each party’s level of concern. Clear action plans (written where necessary) at the end of every consultation would help patients decide when to re-consult. Further research should investigate how responsibility is shared within and outside the consultation, within primary care teams and with specialist services.

Methotrimeprazine is commonly used for the management of nausea but never tested formally against other drugs used in this setting. The aim was to demonstrate superior antiemetic efficacy.

Double-blind, randomised, controlled trial of methotrimeprazine versus haloperidol.

11 palliative care sites in Australia.

Participants were >18 years, had cancer, an average nausea score of ≥3/10 and able to tolerate oral medications. Ineligible patients had acute nausea related to treatment, nausea for which a specific antiemetic was indicated, were about to undergo a procedure or had received either of the study drugs or a change in glucocorticoid dose within the previous 48 hours.

Based on previous studies, haloperidol was used as the control. Participants were randomised to encapsulated methotrimeprazine 6·25 mg or haloperidol 1·5 mg one time or two times per day and assessed every 24 hours for 72 hours.

A ≥two-point reduction in nausea score at 72 hours from baseline. Secondary outcome measures were as follows: complete response at 72 hours (end nausea score less than 3), response at 24 and 48 hours, vomiting episodes, use of rescue antiemetics, harms and global impression of change.

Response to treatment at 72 hours was 75% (44/59) in the haloperidol (H) arm and 63% (36/57) in the methotrimeprazine (M) arm with no difference between groups (intention-to-treat analysis). Complete response rates were 56% (H) and 51% (M). In the per protocol analysis, there was no difference in response rates: (85% (44/52) (H) and 74% (36/49) (M). Complete per protocol response rates were 64% (H) and 59% (M). Toxicity worse than baseline was minimal with a trend towards greater sedation in the methotrimeprazine arm.

This study did not demonstrate any difference in response rate between methotrimeprazine and haloperidol in the control of nausea.

ACTRN 12615000177550.

Cerebral palsy (CP) is a lifelong condition. The CP quality of life (CPQOL) instrument is a frequently used disease-specific instrument to assess health-related quality of life (HRQoL) in people with CP, but it cannot be used to generate quality-adjusted life years (QALY) which are the basis of cost utility analysis (CUA). Generic utility instruments (such as the EQ-5D or SF-6D) that are used to value HRQOL may be insensitive to small but important health changes in children with CP. This study aims to generate a preference-based scoring algorithm for the CP six dimensions (CP-6D), a classification system developed from the CPQOL.

A discrete choice experiment with duration (DCEtto) will be administrated to value health states described by the CP-6D classification system. These health states will be presented to members of Australian general population and parents of children with CP via an online survey. Conditional logit regression will be used to produce the utility algorithm for CP-6D.

The Griffith University Human Research Ethics Committee approved for the study (reference HREC/number 2018/913). The developed algorithm can be applied to previous and future economic evaluation of interventions and treatments targeting people with CP which have used either the CPQOL or CP-6D.