Evaluating follow-up and complexity in cancer clinical trials (EFACCT): an eDelphi study of research professionals' perspectives.

OBJECTIVES: To evaluate patient follow-up and complexity in cancer clinical trial delivery, using consensus methods to: (1) identify research professionals' priorities, (2) understand localised challenges, (3) define study complexity and workloads supporting the development of a trial rating and complexity assessment tool (TRACAT). DESIGN: A classic eDelphi completed in three rounds, conducted as the launch study to a multiphase national project (evaluating follow-up and complexity in cancer clinical trials). SETTING: Multicentre online survey involving professionals at National Health Service secondary care hospital sites in Scotland and England varied in scale, geographical location and patient populations. PARTICIPANTS: Principal investigators at 13 hospitals across nine clinical research networks recruited 33 participants using pre-defined eligibility criteria to form a multidisciplinary panel. MAIN OUTCOME MEASURES: Statements achieving a consensus level of 70% on a 7-point Likert-type scale and ranked trial rating indicators (TRIs) developed by research professionals. RESULTS: The panel developed 75 consensus statements illustrating factors contributing to complexity, follow-up intensity and operational performance in trial delivery, and specified 14 ranked TRIs. Seven open questions in the first qualitative round generated 531 individual statements. Iterative survey rounds returned rates of 82%, 82% and 93%. CONCLUSIONS: Clinical trials operate within a dynamic, complex healthcare and innovation system where rapid scientific advances present opportunities and challenges for delivery organisations and professionals. Panellists highlighted cultural and organisational factors limiting the profession's potential to support growing trial complexity and patient follow-up. Enhanced communication, interoperability, funding and capacity have emerged as key priorities. Future operational models should test dialectic Singerian-based approaches respecting open dialogue and shared values. Research capacity building should prioritise innovative, collaborative approaches embedding validated review and evaluation models to understand changing operational needs and challenges. TRACAT provides a mechanism for continual knowledge assimilation to improve decision-making.

Effectiveness of non-pharmacological interventions for insomnia in children with Autism Spectrum Disorder: A systematic review and meta-analysis.

BACKGROUND: Autism spectrum disorders (ASD) are a set of neurodevelopmental disorders characterised by behavioural, communication and social impairments. The prevalence of sleep disturbances in children with ASD is 40-80%, with significant effects on quality of life for the children and carers. This systematic review aimed to synthesise evidence of the effects of behavioural interventions to improve sleep among children with ASD. METHODS: Databases (MEDLINE, PsycINFO, CINAHL, ScienceDirect, Autism Data, CENTRAL, ClinicalTrials.gov and Current Controlled Trials) were searched for published, unpublished and ongoing randomised controlled trials evaluating the effect of non-pharmacological interventions for insomnia in children with autism spectrum conditions. RESULTS: Three studies met the inclusion criteria, one provided actigraphy data, one Children's Sleep Habits Questionnaire (CSHQ) data, and one both actigraphy and CSHQ data for use in meta-analyses. There were significant differences between the behavioural intervention and comparison groups (actigraphy data) for total sleep time (24.41 minutes, 95% CI 5.71, 43.11, P = 0.01), sleep latency (-18.31 minutes, 95% CI -30.84, -5.77, P = 0.004) and sleep efficiency (5.59%, 95% CI 0.87, 10.31, P = 0.02). There was also a favourable intervention effect evident for the subjective CSHQ data (-4.71, 95% CI -6.70, -2.73, P<0.00001). Risk of bias was low across several key domains (randomisation, allocation concealment and reporting), with some studies being unclear due to poor reporting. CONCLUSIONS: There are very few high quality randomised controlled trials in this area. Here we provide initial synthesised quantitative evidence of the effectiveness of behavioural interventions for treating sleep problems in children with ASD. TRIAL REGISTRATION: Protocol was registered (CRD42017081784) on the International Prospective Register of Systematic Reviews (http://www.crd.york.ac.uk/PROSPERO).

Facilitators and barriers to physical activity following pulmonary rehabilitation in COPD: a systematic review of qualitative studies.

Pulmonary rehabilitation has short-term benefits on dyspnea, exercise capacity and quality of life in COPD, but evidence suggests these do not always translate to increased daily physical activity on a patient level. This is attributed to a limited understanding of the determinants of physical activity maintenance following pulmonary rehabilitation. This systematic review of qualitative research was conducted to understand COPD patients' perceived facilitators and barriers to physical activity following pulmonary rehabilitation. Electronic databases of published data, non-published data, and trial registers were searched to identify qualitative studies (interviews, focus groups) reporting the facilitators and barriers to physical activity following pulmonary rehabilitation for people with COPD. Thematic synthesis of qualitative data was adopted involving line-by-line coding of the findings of the included studies, development of descriptive themes, and generation of analytical themes. Fourteen studies including 167 COPD patients met the inclusion criteria. Seven sub-themes were identified as influential to physical activity following pulmonary rehabilitation. These included: intentions, self-efficacy, feedback of capabilities and improvements, relationship with health care professionals, peer interaction, opportunities following pulmonary rehabilitation and routine. These encapsulated the facilitators and barriers to physical activity following pulmonary rehabilitation and were identified as sub-themes within the three analytical themes, which were beliefs, social support, and the environment. The findings highlight the challenge of promoting physical activity following pulmonary rehabilitation in COPD and provide complementary evidence to aid evaluations of interventions already attempted in this area, but also adds insight into future development of interventions targeting physical activity maintenance in COPD.

Efficacy of supervised maintenance exercise following pulmonary rehabilitation on health care use: a systematic review and meta-analysis.

Introduction: The clinical benefit of continued supervised maintenance exercise programs following pulmonary rehabilitation in COPD remains unclear. This systematic review aimed to synthesize the available evidence on the efficacy of supervised maintenance exercise programs compared to usual care following pulmonary rehabilitation completion on health care use and mortality. Methods: Electronic databases (MEDLINE, Embase, CINAHL, Cochrane Central Register of Controlled Trials, Web of Science, and PEDro) and trial registers (ClinicalTrials.gov and Current Controlled Trials) were searched for randomized trials comparing supervised maintenance exercise programs with usual care following pulmonary rehabilitation completion. Primary outcomes were respiratory-cause hospital admissions, exacerbations requiring treatment with antibiotics and/or systemic corticosteroids, and mortality. Results: Eight trials (790 COPD patients) met the inclusion criteria, six providing data for meta-analysis. Continued supervised maintenance exercise compared to usual care following pulmonary rehabilitation completion significantly reduced the risk of experiencing at least one respiratory-cause hospital admission (risk ratio 0.62, 95% confidence interval [CI] 0.47-0.81, P<0.001). Meta-analyses also suggested that supervised maintenance exercise leads to a clinically important reduction in the rate of respiratory-cause hospital admissions (rate ratio 0.72, 95% CI 0.50-1.05, P=0.09), overall risk of an exacerbation (risk ratio 0.79, 95% CI 0.52-1.19, P=0.25), and mortality (risk ratio 0.57, 95% CI 0.17-1.92, P=0.37). Conclusion: In the first systematic review of the area, current evidence demonstrates that continued supervised maintenance exercise compared to usual care following pulmonary rehabilitation reduces health care use in COPD. The variance in the quality of the evidence included in this review highlights the need for this evidence to be followed up with further high-quality randomized trials.

Prevalence and predictive factors of psychological morbidity following facial injury: a prospective study of patients attending a maxillofacial outpatient clinic within a major UK city.

Adults presenting to maxillofacial surgery services are at high risk of psychological morbidity. This study examined the prevalence of depression, post-traumatic stress disorder (PTSD), anxiety, drug and alcohol use, and appearance-related distress among maxillofacial trauma outpatients over medium-term follow-up. It also explored socio-demographic and injury-related variables associated with psychological distress to inform targeted psychological screening protocols for maxillofacial trauma services. Significant associations were found between level of distress at time of injury and number of traumatic life events with levels of depression at 3 months. No significant associations were found between predictor variables and PTSD at 3 months, or with any psychiatric diagnosis at 6 months. The lack of evidence for an identifiable subgroup of patients who were at higher risk of psychological distress indicated that routine screening of all maxillofacial trauma outpatients should be offered in order to best respond to their mental health needs. The feasibility of the medical team facilitating this is challenging and should ideally be undertaken by psychologists integrated within the MDT. This study led to the funding of a clinical psychologist to provide collaborative care with the maxillofacial surgeons, resulting in brief assessment and treatment to over 600 patients in the first year of the service.

Los adultos que consultan en los servicios de cirugía máxilo-facial tienen un alto riesgo de presentar morbilidad psicológica. Este estudio examinó la prevalencia de depresión, trastorno por estrés postraumático (TEPT), ansiedad, uso de alcohol y drogas, y distrés relacionado con la apariencia entre los pacientes con trauma máxilofacial en un seguimiento ambulatorio de mediano plazo. También se exploraron variables socio-demográficas y otras relacionadas con las lesiones que se asocian con distrés psicológico para contar con protocolos de evaluación psicológica orientados a los servicios de trauma máxilo-facial. Se encontraron asociaciones significativas entre el nivel de distrés al momento de la lesión y el número de acontecimientos traumáticos con los niveles de depresión a los tres meses. En cambio, no hubo asociaciones significativas entre las variables predictoras y el TEPT a los tres meses, o con algún diagnóstico psiquiátrico a los seis meses. La falta de evidencia de un subgrupo identificable de pacientes que estuvieron en alto riesgo de distrés psicológico indicaron que se debe ofrecer la evaluación de rutina a todos los pacientes ambulatorios con trauma máxilo-facial para responder mejor a sus necesidades de salud mental. Constituye un desafío configurar un equipo médico que permita esto y lo ideal es que se forme un equipo multidisciplinario en que estén integrados psicólogos. Este estudio permitió el financiamiento de un psicólogo clínico, quien aportó atención en colaboración con los cirujanos máxilo-faciales, lo que se tradujo en una evaluación breve y el tratamiento de más de 600 pacientes durante el primer año de funcionamiento del servicio.

Les adultes hospitalisés des services de chirurgie maxillo-faciale sont à risque élevé de morbidité psychologique. Cette étude analyse la prévalence de la dépression, du syndrome de stress post-traumatique (SSPT), de l'anxiété, de la consommation de drogues et d'alcool ainsi que de la détresse liée à l'apparence chez des patients ayant subi un traumatisme maxillo-facial, avec un suivi à moyen terme en ambulatoire. Les variables socio-démographiques et liées à la lésion ainsi que la détresse psychologique sont également examinées afin de renseigner des protocoles ciblés de dépistage psychologique pour les services de chirurgie maxillo-faciale. Le niveau de détresse au moment de la lésion et le nombre d'événements traumatiques de la vie sont significativement associés aux niveaux de dépression à 3 mois. Aucune association significative n'a été trouvée entre les variables prédictives et le SSPT à 3 mois ou un diagnostic psychiatrique quel qu'il soit à 6 mois. L'identification d'un sous-groupe de patients à risque élevé de détresse psychologique est difficile : le dépistage de routine de tous les patients suivis en ambulatoire après chirurgie maxillo-faciale devrait donc être proposé afin de mieux répondre à leurs besoins en santé mentale. Créer l'équipe médicale qui le permettrait est compliqué ; idéalement, cette tâche devrait être confiée à des psychologues au sein d'une équipe pluridisciplinaire. Grâce à l'étude, le poste d'un psychologue clinicien a été financé, qui travaille en collaboration avec les chirurgiens maxillo-faciaux. C'est ainsi que plus de 600 patients ont été évalués et traités au cours de la première année.

Systematic review of interventions to improve patient uptake and completion of pulmonary rehabilitation in COPD.

Pulmonary rehabilitation is considered a key management strategy for chronic obstructive pulmonary disease (COPD), but its effectiveness is undermined by poor patient uptake and completion. The aim of this review was to identify, select and synthesise the available evidence on interventions for improving uptake and completion of pulmonary rehabilitation in COPD. Electronic databases and trial registers were searched for randomised trials evaluating the effect of an intervention compared with a concurrent control group on patient uptake and completion. The primary outcomes were the number of participants who attended a baseline assessment and at least one session of pulmonary rehabilitation (uptake), and the number of participants who received a discharge assessment (completion). Only one quasi-randomised study (n=115) (of 2468 records identified) met the review inclusion criteria and was assessed as having a high risk of bias. The point estimate of effect did, however, indicate greater programme completion and attendance rates in participants allocated to pulmonary rehabilitation plus a tablet computer (enabled with support for exercise training) compared with controls (pulmonary rehabilitation only). There is insufficient evidence to guide clinical practice on interventions for improving patient uptake and completion of pulmonary rehabilitation in COPD. Despite increasing awareness of patient barriers to pulmonary rehabilitation, our review highlights the existing under-appreciation of interventional trials in this area. This knowledge gap should be viewed as an area of research priority due to its likely impact in undermining wider implementation of pulmonary rehabilitation and restricting patient access to a treatment considered the cornerstone of COPD.

Bovine colostrum supplementation and upper respiratory symptoms during exercise training: a systematic review and meta-analysis of randomised controlled trials.

BACKGROUND: Bovine colostrum is proposed as a nutritional countermeasure to the risk of upper respiratory symptoms (URS) during exercise training. The aim of this systematic review and meta-analysis was to estimate the size of the effect of bovine colostrum supplementation on URS. METHODS: Databases (CDSR, CENTRAL, Cinahl, ClinicalTrials.gov, Current Controlled Trials, DARE, EMBASE, Medline, PROSPERO and Web of Science) of published, unpublished and ongoing studies were searched for randomised controlled trials of healthy adults (≥18 years), evaluating the effect of oral bovine colostrum supplementation compared to a concurrent control group on URS. RESULTS: Five trials (152 participants) met the inclusion criteria, all of which involved individuals involved in regular exercise training. Over an 8-12 week follow-up period, bovine colostrum supplementation when compared to placebo significantly reduced the incidence rate of URS days (rate ratio 0.56, 95 % confidence intervals 0.43 to 0.72, P value < 0.001) and URS episodes (0.62, 0.40 to 0.99, P value = 0.04) by 44 and 38 % respectively. There were limited data and considerable variation in results of included studies for duration of URS episodes hence a meta-analysis of this outcome was deemed inappropriate. The risk of bias assessment in this review was hindered by poor reporting practices of included studies. Due to incomplete reporting of study methods, four of the five studies were judged to have a moderate or high risk of overall bias. Our findings must be interpreted in relation to quantity and quality of the available evidence. CONCLUSIONS: The present systematic review and meta-analysis provides evidence that bovine colostrum supplementation may be effective in preventing the incidence of URS days and episodes in adults engaged in exercise training. The fact that the majority of included studies did not report significant effects on URS outcomes mitigates concerns about publication bias. The point estimates of the random-effects meta-analyses are greater than the smallest clinically important difference, but the low precision of the individual study estimates means the evidence presented in this review needs to be followed up with an appropriately designed and adequately powered, randomised control trial. TRIAL REGISTRATION: Protocol was registered (CRD42015014925) on the International Prospective Register of Systematic Reviews (http://www.crd.york.ac.uk/PROSPERO/).

The 100 Most Cited Articles in Facial Trauma: A Bibliometric Analysis.

PURPOSE: The number of citations an article receives has been used as a marker of its influence within a surgical specialty. Currently, there is limited citation analysis in oral and maxillofacial trauma surgery. The purpose of this study was to determine the 100 most cited articles in facial trauma surgery and their characteristics. MATERIALS AND METHODS: Articles were identified from the Science Citation Index of the Institute for Scientific Information using the Thomson Reuters Web of Science search engine. All articles until 2015 were included. Then, the 100 most cited articles were assessed for title, author, journal, country of origin, and number of citations. A citation index (number of citations received per year) also was calculated. RESULTS: The 100 most cited articles in facial trauma received 9,933 citations (range, 66 to 297). They were published from 1942 through 2008, with 1990 through 1999 being the commonest decade. Articles were cited on average 4.6 times per year. Articles were published in 28 different journals, with impact factors ranging from 0.94 to 35.3. Most articles were observational research studies. CONCLUSION: These findings reflect the attention that articles have received during the past half century in oral and maxillofacial trauma research, shedding light on often-read articles in this field. In addition to current bibliometric indices, it could provide a useful evidence base for facial surgeons, represent key educational material for aspiring trainees, and be used to help guide future research efforts.

Singly-qualified medical senior house officer in oral and maxillofacial surgery: perspectives from a unit.

Despite constituting a minority of senior house officers (SHO) in oral and maxillofacial surgery (OMFS), the number of singly-qualified medical trainees is growing. We describe the experience of a singly qualified medical trainee in OMFS and the unique benefits and opportunities for potential trainees and the department. Overall, the advantages of synergistic training outweigh any deficiencies in knowledge, and in our experience, having both medical and dental trainees in our unit has maximised training opportunities and provided a more holistic approach to patient care. Increased exposure to conditions in the head and neck also benefits trainees who wish to pursue careers in other specialties such as ear, nose, and throat (ENT), neurosurgery, ophthalmology, and plastic surgery.

Effect of exercise on depression severity in older people: systematic review and meta-analysis of randomised controlled trials.

BACKGROUND: The prevalence of depression in older people is high, treatment is inadequate, it creates a substantial burden and is a public health priority for which exercise has been proposed as a therapeutic strategy. AIMS: To estimate the effect of exercise on depressive symptoms among older people, and assess whether treatment effect varies depending on the depression criteria used to determine participant eligibility. METHOD: Systematic review and meta-analysis of randomised controlled trials of exercise for depression in older people. RESULTS: Nine trials met the inclusion criteria and seven were meta-analysed. Exercise was associated with significantly lower depression severity (standardised mean difference (SMD) = -0.34, 95% CI -0.52 to -0.17), irrespective of whether participant eligibility was determined by clinical diagnosis (SMD = -0.38, 95% CI -0.67 to -0.10) or symptom checklist (SMD = -0.34, 95% CI -0.62 to -0.06). Results remained significant in sensitivity analyses. CONCLUSIONS: Our findings suggest that, for older people who present with clinically meaningful symptoms of depression, prescribing structured exercise tailored to individual ability will reduce depression severity.

Trial protocol and preliminary results for a cluster randomised trial of behavioural support versus brief advice for smoking cessation in adolescents.

BACKGROUND: Many young people report they want to stop smoking and have tried to do so, but most of their quit attempts fail. For adult smokers, there is strong evidence that group behavioural support enhances quit rates. However, it is uncertain whether group behavioural support enhances abstinence in young smokers trying to quit. FINDINGS: A cluster randomised trial for young people trying to stop smoking to compare the efficacy of a school-based 9 week intensive group behavioural support course versus a school-based 7 week brief advice only course. Participants were assessed for evidence of tobacco addiction and nicotine replacement therapy (NRT) was used if it was deemed appropriate by the therapist. Both types of course aimed to recruit approximately one hundred participants from approximately ten schools.The primary outcome was successful quitting at 4 weeks after quit day judged according to the Russell standard. Had the trial been completed, abstinence at 6 months after quit day and the relationships between successful quit attempts and 1) psychological assessments of dependence prior to quitting 2) salivary cotinine concentration prior to quitting and 3) sociodemographic characteristics would also have been assessed. The proportion of participants who stopped smoking in each arm of the trial were compared using Chi square tests.The trial was stopped shortly after it had started because funding to support the therapists running the stop smoking group behavioural support programme was withdrawn. Only three stop smoking courses were completed (two group support courses and one brief advice pharmacotherapy course). Seventeen participants in total entered the trial. At the end of the courses, one participant (10%) attending the group support programme had stopped smoking and no participant attending the brief advice programme had stopped smoking. DISCUSSION: The trial was stopped so we were unable to determine whether group support helped more young people to stop smoking than brief advice. Engagement and recruitment of participants proved much more difficult than had been anticipated. Fifteen of the seventeen participants reported that quitting smoking was either pretty important or very important to them. Thus, the stop smoking success rate could, nevertheless, be considered disappointing. TRIAL REGISTRATION: Current Controlled Trials ISRCTN25181936.

Mediated, moderated and direct effects of country of residence, age, and gender on the cognitive and social determinants of adolescent smoking in Spain and the UK: a cross-sectional study.

BACKGROUND: European trans-national adolescent smoking prevention interventions based on social influences approaches have had limited success. The attitudes-social influences-efficacy (ASE) model is a social cognition model that states smoking behaviour is determined by smoking intention which, in turn, is predicted by seven ASE determinants; disadvantages, advantages, social acceptance, social norms, modelling, perceived pressure, self-efficacy. Distal factors such as country of residence, age and gender are external to the model. The ASE model is, thus, closely related to the Theory of Planned Behaviour. This study assessed the utility of the ASE model using cross-sectional data from Spanish and UK adolescents. METHODS: In 1997, questionnaires were simultaneously administered to Spanish (n = 3716) and UK adolescents (n = 3715) who were considered at high risk of smoking. Participants' age, gender, smoking intentions and ASE determinant scores were identified and linear regression analysis was used to examine the mediated, moderated and direct effects of country of residence, age and gender on participants' smoking intentions. RESULTS: All UK participants were aged 12 or 13 and most Spanish participants were aged between 12 and 14 (range 12-16 years). Amongst 12 and 13 year olds, regular smoking was more common in Spain. Almost half the participants were female (47.2% in Spain; 49.9% in the UK). Gender did not vary significantly according to age. The distribution of ASE determinant scores varied by country and predicted intention. The influence of each ASE determinant on intention was moderated by country. Country had a large direct influence on intention (1.72 points on a 7 point scale) but the effects of age and gender were mediated by the ASE determinants. The findings suggest resisting peer pressure interventions could potentially influence smoking amongst UK adolescents but not Spanish adolescents. Interventions that promote self-efficacy, on the other hand, would possibly have a greater influence on smoking amongst Spanish adolescents. CONCLUSION: The ASE model may not capture important cultural factors related to adolescent smoking and the relative contribution of particular ASE determinants to adolescent smoking intentions may differ between countries. Future European trans-national adolescent smoking prevention programmes may benefit from greater understanding of country-level cultural norms.

Value-added education and smoking uptake in schools: a cohort study.

AIM: To show that schools achieving higher examination pass and lower truancy rates than expected, given that their pupil populations (high value-added schools) are associated with a lower incidence of smoking among pupils (13-14 years). DESIGN: Value-added scores for schools were derived from standardized residuals of two regression equations predicting separately the proportion of pupils passing high school diplomas and the half-days lost to truancy from the socio-economic and ethnic profiles of pupils. The risk of regular smoking at 1- and 2-year follow-up was examined in relation to the value-added score in a cohort of 8352 UK pupils. Random-effects logistic regression was used to adjust for baseline smoking status and other adolescent smoking risk factors. SETTING: A total of 52 schools, West Midlands, UK. PARTICIPANTS: Year 9 pupils aged 13-14 years (n = 8352) were followed-up after 1 year (n = 7444; 89.1% of original cohort) and 2 years (n = 6819; 84.6% of original cohort excluding pupils from two schools that dropped out). MEASUREMENTS: Regular smoking (at least one cigarette per week). FINDINGS: Schools with high value-added scores occurred throughout the socio-demographic spectrum. The odds ratio (95% confidence interval) for regular smoking for a 1 standard deviation increase in the value-added measure was 0.85 (0.73-0.99) at 1-year and 0.80 (0.71-0.91) at 2-year follow-ups. Baseline smoking status did not moderate this. CONCLUSIONS: Schools with high value-added scores are associated with lower incidence of smoking. Some schools appear to break the strong link between deprivation and smoking. Understanding the mechanisms could be of great public health significance.

Systematic review of the effectiveness of stage based interventions to promote smoking cessation.

OBJECTIVE: To evaluate the effectiveness of interventions using a stage based approach in bringing about positive changes in smoking behaviour. DESIGN: Systematic review. DATA SOURCES: 35 electronic databases, catalogues, and internet resources (from inception to July 2002). Bibliographies of retrieved references were scanned for other relevant publications, and authors were contacted if necessary. RESULTS: 23 randomised controlled trials were reviewed; two reported details of an economic evaluation. Eight trials reported effects in favour of stage based interventions, three trials showed mixed results, and 12 trials found no statistically significant differences between a stage based intervention and a non-stage based intervention or no intervention. Eleven trials compared a stage based intervention with a non-stage based intervention, and one reported statistically significant effects in favour of the stage based intervention. Two studies reported mixed effects, and eight trials reported no statistically significant differences between groups. The methodological quality of the trials was mixed, and few reported any validation of the instrument used to assess participants' stage of change. Overall, the evidence suggests that stage based interventions are no more effective than non-stage based interventions or no intervention in changing smoking behaviour. CONCLUSIONS: Limited evidence exists for the effectiveness of stage based interventions in changing smoking behaviour.