bluuebunny/crossref_metadata_2025_split huggingface dataset:
Referral to Slimming World in UK Stop Smoking Services (SWISSS) versus stop smoking support alone on body weight in quitters: results of a randomised controlled trial
Authors: Lycett Deborah , Aveyard Paul , Farmer Andrew , Lewis Amanda , Munafò Marcus 
Published: April 2023

IntroductionMost people who stop smoking gain weight. Dietary modification may seem an obvious solution, but food restriction may increase cigarette craving and smoking relapse.Trial designAn unblinded parallel randomised controlled trial.MethodsParticipants were adult smokers with a body mass index greater or equal to 23 kg/m2. Setting was National Health Service commissioned Stop Smoking Services, interventions were referral to a commercial weight management programme, plus stop smoking support (treatment group), compared with stop smoking support alone (control group). Objective was to compare weight change between interventions in smoking abstainers and not abstinent rates in all. Primary outcome was change in weight (kg) at 12 weeks. Randomisation sequence was computer generated and concealed until allocation.ResultsSeventy-six participants were recruited, 37 were randomised to the treatment group and 39 to the control group. Change in weight was analysed in long-term abstainers (13 treatment, 14 control) only because the aim was to prevent weight gain associated with smoking cessation. Abstinence was analysed on an intention-to-treat basis (37 treatment, 39 control). At 12 weeks weight gain was less in the treatment than the control group with an adjusted mean difference of −2.3 kg 95% CI (−4.4 to -0.1). Craving scores were lower (Mood and Physical Symptoms Scale craving domain −1.6 (–2.7 to –0.5)) and quit rates were higher in the treatment than the control group (32% vs 21%), although the trial was not powered to superiority in cravings and quit rates. No adverse events or side effects were reported.ConclusionIn people who are obese and want to quit smoking, these data provide modest encouragement that providing weight management at the time of quitting may be helpful. Those who are not obese, but who are informed about potential weight gain during their quit attempt, were uninterested in a weight management programme.Trial registration numberNCT65705512
Risk factors and clinical outcomes of functional decline during hospitalisation in very old patients with acute decompensated heart failure: an observational study
Authors: Yaku Hidenori , Kato Takao , Morimoto Takeshi , Inuzuka Yasutaka , Tamaki Yodo , Ozasa Neiko , Yamamoto Erika , Yoshikawa Yusuke , Kitai Takeshi , Kato Masashi , Ikeda Tomoyuki , Furukawa Yutaka , Nakagawa Yoshihisa , Sato Yukihito , Kuwahara Koichiro , Kimura Takeshi 
Published: April 2023

ObjectiveTo investigate the prevalence and risk factors of functional decline during hospitalisation and its relationship with postdischarge outcomes in very old patients with acute decompensated heart failure (ADHF) hospitalisation.DesignProspective cohort study between 1 October 2014 and 31 March 2016.SettingA physician-initiated, multicentre study of consecutive patients admitted for ADHF in 19 hospitals throughout Japan.ParticipantsAmong 3555 patients hospitalised for ADHF (median age (IQR), 80 (71–86) years; 1572 (44%) women), functional decline during the index hospitalisation occurred in 528 patients (15%).Primary and secondary outcomesThe primary outcome measure was a composite of all-cause death or heart failure (HF) hospitalisation after discharge. The secondary outcome measures were all-cause death, HF hospitalisation, and a composite of all-cause death or all-cause hospitalisation.ResultsThe independent risk factors for functional decline included age ≥80 years (OR 2.71; 95% CI 2.09 to 3.51), female (OR 1.32; 95% CI 1.05 to 1.67), prior stroke (OR 1.67; 95% CI 1.28 to 2.19), dementia (OR 2.26; 95% CI 1.74 to 2.95), ambulatory before admission (OR 1.74; 95% CI 1.29 to 2.35), elevated body temperature (OR 1.91; 95% CI 1.31 to 2.79), New York Heart Association class III or IV on admission (OR 1.54; 95% CI 1.07 to 2.22), decreased albumin levels (OR 1.76; 95% CI 1.32 to 2.34), hyponatraemia (OR 1.49; 95% CI 1.10 to 2.03) and renal dysfunction (OR 1.55; 95% CI 1.22 to 1.98), after multivariable adjustment. The cumulative 1-year incidence of the primary outcome in the functional decline group was significantly higher than that in the no functional decline group (50% vs 31%, log-rank p<0.001). After adjusting for baseline characteristics, the higher risk of the functional decline group relative to the no functional decline group remained significant (adjusted HR 1.46; 95% CI 1.24 to 1.71; p<0.001).ConclusionsIndependent risk factors of functional decline in very old patients with ADHF were related to both frailty and severity of HF. Functional decline during ADHF hospitalisation was associated with unfavourable postdischarge outcomes.Trial registration numberNCT02334891UMIN000015238.
Randomised controlled pilot feasibility trial of an early intervention programme for young infants with neurodevelopmental impairment in Uganda: a study protocol
Authors: Nampijja Margaret , Webb Emily , Nanyunja Carol , Sadoo Samantha , Nalugya Ruth , Nyonyintono James , Muhumuza Anita , Ssekidde Moses , Katumba Kenneth , Magnusson Brooke , Kabugo Daniel , Cowan Frances M , Martinez-Biarge Miriam , Zuurmond Maria , Morgan Cathy , Lester Deborah , Seeley Janet , Tann Cally J 
Published: April 2023

IntroductionEarly intervention programmes (EIPs) for infants with neurodevelopmental impairment have been poorly studied especially in low-income settings. We aim to evaluate the feasibility and acceptability of a group participatory EIP, the ‘ABAaNA EIP’, for young children with neurodevelopmental impairment in Uganda.Methods and analysisWe will conduct a pilot feasibility, single-blinded, randomised controlled trial comparing the EIP with standard care across two study sites (one urban, one rural) in central Uganda. Eligible infants (n=126, age 6–11 completed months) with neurodevelopmental impairment (defined as a developmental quotient <70 on Griffiths Scales of Mental Development, and, or Hammersmith Infant Neurological Examination score <60) will be recruited and randomised to the intervention or standard care arm. Intervention arm families will receive the 10-modular, peer-facilitated, participatory, community-based programme over 6 months. Recruited families will be followed up at 6 and 12 months after recruitment, and assessors will be blinded to the trial allocation. The primary hypothesis is that the ABAaNA EIP is feasible and acceptable when compared with standard care. Primary outcomes of interest are feasibility (number recruited and randomised at baseline) and acceptability (protocol violation of arm allocation and number of sessions attended) and family and child quality of life. Guided by the study aim, the qualitative data analysis will use a data-led thematic framework approach. The findings will inform scalability and sustainability of the programme.Ethics and disseminationThe trial protocol has been approved by the relevant Ugandan and UK ethics committees. Recruited families will give written informed consent and we will follow international codes for ethics and good clinical practice. Dissemination will be through peer-reviewed publications, conference presentations and public engagement.Trial registration numberNCT44380971; protocol version 3.0, 19th February 2018.
Study protocol for the Melbourne Infant Study: BCG for Allergy and Infection Reduction (MIS BAIR), a randomised controlled trial to determine the non-specific effects of neonatal BCG vaccination in a low-mortality setting
Authors: Messina Nicole L , Gardiner Kaya , Donath Susan , Flanagan Katie , Ponsonby Anne-Louise , Shann Frank , Robins-Browne Roy , Freyne Bridget , Abruzzo Veronica , Morison Clare , Cox Lianne , Germano Susie , Zufferey Christel , Zimmermann Petra , Allen Katie J , Vuillermin Peter , South Mike , Casalaz Dan , Curtis Nigel 
Published: April 2023

IntroductionBCG vaccination reduces all-cause infant mortality in high-mortality settings by more than can be attributed to protection against tuberculosis. This is proposed to result from non-specific protection against non-vaccine targeted (‘off-target’) infections. There is also evidence that BCG protects against allergic diseases.Methods and analysisThe Melbourne Infant Study: BCG for Allergy and Infection Reduction is a phase III multicentre, single-blinded, randomised controlled trial. A total of 1438 healthy neonates will be randomised to receive either BCG vaccination or no BCG vaccination in the first 10 days of life. Measures of allergy, eczema, infection and asthma will be obtained from parent-completed questionnaires 3 monthly in the first year and 6 monthly from 1 to 5 years of age, and clinical assessments at 1 and 5 years of age. Biological samples will also be collected for future immunological studies.Analysis primary outcomeThe proportion of participants with measures of allergy and infection (atopic sensitisation, eczema, lower respiratory tract infection) at 1 and 5 years of age, and asthma at 5 years of age. Secondary outcomes: (1) the proportion of participants with additional measures of allergy, eczema, asthma and infections; (2) medication use for eczema and asthma; (3) the severity and age of onset of eczema and asthma; (4) the number of episodes of infection; (5) hospitalisations for infections and (6) laboratory measures of immune responses.Ethics and disseminationThis trial has ethical and governance approval from Mercy Health Human Research Ethics Committee (HREC, No. R12-28) and Royal Children’s Hospital HREC (No. 33025) with additional governance approval from Barwon Health and St John of God, Geelong, Victoria. Results of this trial will be published in peer-reviewed journals and presented at scientific conferences.Trial registration numberNCT01906853
Is fascia iliaca compartment block administered by paramedics for suspected hip fracture acceptable to patients? A qualitative study
Authors: Evans Bridie Angela , Brown Alan , Fegan Greg , Ford Simon , Guy Katy , Jones Jenna , Jones Sian , Keen Leigh , Khanom Ashrafunnesa , Longo Mirella , Pallister Ian , Rees Nigel , Russell Ian T , Seagrove Anne C , Watkins Alan , Snooks Helen 
Published: April 2023

ObjectiveTo explore patients’ experience of receiving pain relief injection for suspected hip fracture from paramedics at the location of the injury.DesignQualitative interviews within a feasibility trial about an alternative to routine prehospital pain management for patients with suspected hip fracture.SettingPatients treated by paramedics in the catchment area of one emergency department in South Wales.ParticipantsSix patients and one carer of a patient who received fascia iliaca compartment block (FICB).InterventionFICB administered to patients with suspected hip fracture by trained paramedics. We randomly allocated eligible patients to FICB—a local anaesthetic injection directly into the hip region—or usual care—most commonly morphine—using audited scratch cards.OutcomesAcceptability and experience of receiving FICB, assessed through interview data. We audio-recorded, with participants’ consent, and conducted thematic analysis of interview transcripts. The analysis team comprised two researchers, one paramedic and one lay member.ResultsPatients had little or no memory of being offered, consenting to or receiving FICB. They recalled the reassuring manner and high quality of care received. They accepted FICB without question. Partial or confused memory characterised experience of subsequent hospital care until surgery. They said their priorities when calling for emergency help were to receive effective care. After hospital treatment, they wanted to regain their health and mobility and resume the quality of life they experienced before their injury.ConclusionsThis study did not raise any concerns about the acceptability of FICB administered at the scene of injury by paramedics to people with suspected hip fracture. It adds to existing evidence about patient and carer experience of on-scene care for people with suspected hip fracture. Further research is needed to assess safety, effectiveness and cost effectiveness of this health technology in a new setting.Trial registration numberNCT60065373.
Family-based habit intervention to promote parent support for child physical activity in Canada: protocol for a randomised trial
Authors: Medd Emily R , Beauchamp Mark R , Blanchard Chris M , Carson Valerie , Gardner Benjamin , Warburton Darren ER , Rhodes Ryan E 
Published: April 2023

IntroductionRegular physical activity (PA) participation has many important physical and psychological health benefits, managing and preventing over 25 chronic conditions. Being more physically active as a child is associated with being more active as an adult, but less than 10% of Canadian children are achieving the recommended PA guidelines of 60 minutes per day of moderate to vigorous PA. Parental support is a predictor of child PA, but parent intention to support child PA does not always predict enacted support. Targeting factors that assist in the sustainability of parent support behaviour of child PA may have an impact on child PA. The purpose of this study is to evaluate an intervention designed to promote habit formation of parental support (HABIT, independent variable) on child PA (dependant variable) compared with a planning and education group (PLANNING) and an education only group (EDUCATION).Methods and analysisThe three conditions will be compared using a 6-month longitudinal randomised trial. Eligible families have at least one child aged 6–12 years who is not meeting the 2011 Canadian PA Guidelines. Intervention materials are delivered at baseline, with check-in sessions at 6 weeks and 3 months. Child’s moderate-to-vigorous PA, measured by accelerometry, is assessed at baseline, 6 weeks, 3 months and 6 months as the primary outcome. At baseline and 6 months, children perform fitness testing. Parents and children complete questionnaires at all timepoints. So far, 123 families have been recruited from the Greater Victoria and surrounding area. Recruitment will be continuing through 2020 with a target of 240 families.Ethics and disseminationThis protocol has been approved by the University of Victoria Human Research Ethics Board (Victoria, Canada). Results will be shared at conferences as presentations and as published manuscripts. Study findings will be made available to interested participants.Trial registration numberNCT03145688
Early Psychosis Intervention-Spreading Evidence-based Treatment (EPI-SET): protocol for an effectiveness-implementation study of a structured model of care for psychosis in youth and emerging adults
Authors: Kozloff Nicole , Foussias George , Durbin Janet , Sockalingam Sanjeev , Addington Jean , Addington Donald , Ampofo Augustina , Anderson Kelly K , Barwick Melanie , Bromley Sarah , Cunningham Jasmyn E A , Dahrouge Simone , Duda Lillian , Ford Catherine , Gallagher Sheila , Haltigan John D , Henderson Joanna , Jaouich Alexia , Miranda Dielle , Mitchell Patrick , Morin Josette , de Oliveira Claire , Primeau Valerie , Serhal Eva , Soklaridis Sophie , Urajnik Diana , Whittard Krista , Zaheer Juveria , Kurdyak Paul , Voineskos Aristotle N 
Published: April 2023

IntroductionWhile early psychosis intervention (EPI) has proliferated in recent years amid evidence of its effectiveness, programmes often struggle to deliver consistent, recovery-based care. NAVIGATE is a manualised model of EPI with demonstrated effectiveness consisting of four components: individualised medication management, individual resiliency training, supported employment and education and family education. We aim to implement NAVIGATE in geographically diverse EPI programmes in Ontario, Canada, evaluating implementation and its effect on fidelity to the EPI model, as well as individual-level outcomes (patient/family member-reported and interviewer-rated), system-level outcomes (captured in provincial administrative databases) and engagement of participants with lived experience.Methods and analysisThis is a multisite, non-randomised pragmatic hybrid effectiveness-implementation type III mixed methods study coordinated at the Centre for Addiction and Mental Health (CAMH) in Toronto. Implementation is supported by the Provincial System Support Program, a CAMH-based programme with provincial offices across Ontario, and Extension of Community Healthcare Outcomes Ontario Mental Health at CAMH and the University of Toronto. The primary outcome is fidelity to the EPI model as measured using the First Episode Psychosis Services—Fidelity Scale. Four hundred participants in the EPI programmes will be recruited and followed using both individual-level assessments and health administrative data for 2 years following NAVIGATE initiation. People with lived experience will be engaged in all aspects of the project, including through youth and family advisory committees.Ethics and disseminationResearch ethics board approval has been obtained from CAMH and institutions overseeing the local EPI programmes. Study findings will be reported in scientific journal articles and shared with key stakeholders including youth, family members, programme staff and policymakers.Trial registration numberNCT03919760.
Foot orthoses for people with rheumatoid arthritis, involving quantitative and qualitative outcomes: protocol for a randomised controlled trial
Authors: Ramos-Petersen Laura , Nester Christoper J , Gijon-Nogueron Gabriel , Ortega-Avila Ana Belen 
Published: April 2023

IntroductionRheumatoid arthritis (RA) involves changes to foot structure and function, and there is an association between RA and foot pain. This pain affects those patient’s physical activity and experience of daily living. While there is clinical evidence for the value of foot orthoses (FO) on foot pain, there is a wide range of FO available and there is little evidence on the relative benefits of one orthoses type over another, especially in terms of their impact on physical activity and associated well-being. The aim of this study is to compare physical activity, general and foot health and foot health experiences in people with RA when wearing three different types of FO.Methods and analysisA randomised controlled trial with three arms will compare the effects of (1) custom FO made using a direct adaptation technique, (2) custom FO made through a digital design and production process and (3) prefabricated orthoses. The primary outcome is physical activity measured using a GENEActiv bracelet. Secondary outcomes will be pain, function and disability and associated foot and general health evaluated using existing questionnaires. Semistructured interviews will identify patients’ experiences of the orthoses and living with RA.Ethics and disseminationThe study has been approved by the Portal de Ética de la Investigación Biomédica de Andalucía ethical committee (SPAR-001). The results will be disseminated regardless of the magnitude or direction of effect.Trial registration numberNCT03170947.
Effect of endotracheal tube plus stylet versus endotracheal tube alone on successful first-attempt tracheal intubation among critically ill patients: the multicentre randomised STYLETO study protocol
Authors: Jaber Samir , Rolle Amélie , Jung Boris , Chanques Gerald , Bertet Helena , Galeazzi David , Chauveton Claire , Molinari Nicolas , De Jong Audrey 
Published: April 2023

IntroductionTracheal intubation is one of the most daily practiced procedures performed in intensive care unit (ICU). It is associated with severe life-threatening complications, which can lead to intubation-related cardiac arrest. Using a preshaped endotracheal tube plus stylet may have potential advantages over endotracheal tube without stylet. The stylet is a rigid but malleable introducer which fits inside the endotracheal tube and allows for manipulation of the tube shape; to facilitate passage of the tube through the laryngeal inlet. However, some complications from stylets have been reported including mucosal bleeding, perforation of the trachea or oesophagus and sore throat. The use of a stylet for first-attempt intubation has never been assessed in ICU and benefit remains to be established.Methods and analysisThe endotracheal tube plus stylet to increase first-attempt success during orotracheal intubation compared with endotracheal tube alone in ICU patients (STYLETO) trial is an investigator-initiated, multicentre, stratified, parallel-group unblinded trial with an electronic system-based randomisation. Patients will be randomly assigned to undergo the initial intubation attempt with endotracheal tube alone (ie,without stylet, control group) or endotracheal tube + stylet (experimental group). The primary outcome is the proportion of patients with successful first-attempt orotracheal intubation. The single, prespecified, secondary outcome is the incidence of complications related to intubation, in the hour following intubation. Other outcomes analysed will include safety, exploratory procedural and clinical outcomes.Ethics and disseminationThe study project has been approved by the appropriate ethics committee ‘Comité-de-Protection-des-Personnes Nord-Ouest3-19.04.26.65808 Cat2 RECHMPL19_0216/STYLETO2019-A01180-57’”. Informed consent is required. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences. If combined use of endotracheal tube plus stylet facilitates tracheal intubation of ICU patients compared with endotracheal tube alone, its use will become standard practice, thereby decreasing first-attempt intubation failure rates and, potentially, the frequency of intubation-related complications.Trial registration detailsClinicalTrials.gov Identifier:NCT04079387.