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1.
JAMA ; 2024 May 14.
Article in English | MEDLINE | ID: mdl-38744430

ABSTRACT

Importance: Effective weight loss interventions are needed for men with obesity. Objective: To determine whether an intervention that combined text messaging with financial incentives attained significant weight loss at the 12-month follow-up compared with the control group and whether an intervention of text messaging alone attained significant weight loss at the 12-month follow-up compared with the control group. Design, Setting, and Participants: An assessor-blinded randomized clinical trial conducted in Belfast, Bristol, and Glasgow areas in the UK. A total of 585 men with body mass index (BMI) of 30 or more were enrolled between July 2021 and May 2022. Final follow-up occurred June 2023. Interventions: Participants were randomly assigned to 12 months of behavioral focused text messages combined with financial incentives (n = 196), 12 months of behavioral focused text messages alone (n= 194), or a waiting list (control group; n= 195). The financial incentive consisted of a monetary reward that was lost if weight loss targets were not met. All participants received weight management information and a pedometer at baseline. Main Outcomes and Measures: The 2 primary comparisons were the 12-month comparison of within-participant weight change between the text messaging with financial incentive group and the control group and the comparison between the text messaging alone group and the control group (minimum clinically important difference, 3%). The P value defined for statistical significance was P < .025 for each comparison. Results: Of the 585 men (mean [SD] age, 50.7 [13.3] years; mean weight, 118.5 [19.9] kg; mean BMI, 37.7 [5.7]; 525 [90%] White), 227 (39%) lived in postal code areas with lower socioeconomic status, and 426 (73%) completed the 12-month follow-up. At the 12-month follow-up, compared with the control group, the mean percent weight change was significantly greater in the text messaging with financial incentive group (mean difference, -3.2%; 97.5% CI, -4.6% to -1.9%; P < .001) but was not significantly greater in the text messaging alone group (mean difference, -1.4%; 97.5% CI, -2.9% to 0.0, P = .05). The mean (SD) weight changes were -5.7 (7.4) kg for the text messaging with financial incentives group, -3.0 (7.5) kg for the text messaging alone group, and -1.5 (6.6) kg for the control group. The 12-month mean (SD) percentage weight changes from baseline were -4.8% (6.1%) for the text messaging with financial incentives group, -2.7% (6.3%) for text messaging alone group, and -1.3% (5.5%) for the control group. Of 366 adverse events reported, the most common were infections (83 [23%]). Of the 23 serious adverse events (6.3%), 12 (52%) occurred in the text messaging with financial incentives group, 5 (22%) in the texts messaging alone group, and 6 (26%) in the control group. None were considered related to participating in a trial group. Conclusion and Relevance: Among men with obesity, an intervention with text messaging with financial incentive significantly improved weight loss compared with a control group, whereas text messaging alone was not significantly better than the control condition. These findings support text messaging combined with financial incentives to attain weight loss in men with obesity. Trial Registration: isrctn.org Identifier: ISRCTN91974895.

2.
Health Technol Assess ; 28(5): 1-266, 2024 Jan.
Article in English | MEDLINE | ID: mdl-38343084

ABSTRACT

Background: Up to 30% of children have constipation at some stage in their life. Although often short-lived, in one-third of children it progresses to chronic functional constipation, potentially with overflow incontinence. Optimal management strategies remain unclear. Objective: To determine the most effective interventions, and combinations and sequences of interventions, for childhood chronic functional constipation, and understand how they can best be implemented. Methods: Key stakeholders, comprising two parents of children with chronic functional constipation, two adults who experienced childhood chronic functional constipation and four health professional/continence experts, contributed throughout the research. We conducted pragmatic mixed-method reviews. For all reviews, included studies focused on any interventions/strategies, delivered in any setting, to improve any outcomes in children (0-18 years) with a clinical diagnosis of chronic functional constipation (excluding studies of diagnosis/assessment) included. Dual reviewers applied inclusion criteria and assessed risk of bias. One reviewer extracted data, checked by a second reviewer. Scoping review: We systematically searched electronic databases (including Medical Literature Analysis and Retrieval System Online, Excerpta Medica Database, Cumulative Index to Nursing and Allied Health Literature) (January 2011 to March 2020) and grey literature, including studies (any design) reporting any intervention/strategy. Data were coded, tabulated and mapped. Research quality was not evaluated. Systematic reviews of the evidence of effectiveness: For each different intervention, we included existing systematic reviews judged to be low risk of bias (using the Risk of Bias Assessment Tool for Systematic Reviews), updating any meta-analyses with new randomised controlled trials. Where there was no existing low risk of bias systematic reviews, we included randomised controlled trials and other primary studies. The risk of bias was judged using design-specific tools. Evidence was synthesised narratively, and a process of considered judgement was used to judge certainty in the evidence as high, moderate, low, very low or insufficient evidence. Economic synthesis: Included studies (any design, English-language) detailed intervention-related costs. Studies were categorised as cost-consequence, cost-effectiveness, cost-utility or cost-benefit, and reporting quality evaluated using the consensus health economic criteria checklist. Systematic review of implementation factors: Included studies reported data relating to implementation barriers or facilitators. Using a best-fit framework synthesis approach, factors were synthesised around the consolidated framework for implementation research domains. Results: Stakeholders prioritised outcomes, developed a model which informed evidence synthesis and identified evidence gaps. Scoping review: 651 studies, including 190 randomised controlled trials and 236 primary studies, conservatively reported 48 interventions/intervention combinations. Effectiveness systematic reviews: studies explored service delivery models (n = 15); interventions delivered by families/carers (n = 32), wider children's workforce (n = 21), continence teams (n = 31) and specialist consultant-led teams (n = 42); complementary therapies (n = 15); and psychosocial interventions (n = 4). One intervention (probiotics) had moderate-quality evidence; all others had low to very-low-quality evidence. Thirty-one studies reported evidence relating to cost or resource use; data were insufficient to support generalisable conclusions. One hundred and six studies described implementation barriers and facilitators. Conclusions: Management of childhood chronic functional constipation is complex. The available evidence remains limited, with small, poorly conducted and reported studies. Many evidence gaps were identified. Treatment recommendations within current clinical guidelines remain largely unchanged, but there is a need for research to move away from considering effectiveness of single interventions. Clinical care and future studies must consider the individual characteristics of children. Study registration: This study is registered as PROSPERO CRD42019159008. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 128470) and is published in full in Health Technology Assessment; Vol. 28, No. 5. See the NIHR Funding and Awards website for further award information.


Between 5% and 30% of children experience constipation at some stage. In one-third of these children, this progresses to chronic functional constipation. Chronic functional constipation affects more children with additional needs. We aimed to find and bring together published information about treatments for chronic functional constipation, to help establish best treatments and treatment combinations. We did not cover assessment or diagnosis of chronic functional constipation. This project was guided by a 'stakeholder group', including parents of children with constipation, people who experienced constipation as children, and healthcare professionals/continence experts. We carried out a 'scoping review' and a series of 'systematic reviews'. Our 'scoping review' provides an overall picture of research about treatments, with 651 studies describing 48 treatments. This helps identify important evidence gaps. 'Systematic reviews' are robust methods of bringing together and interpreting research evidence. Our stakeholder group decided to structure our systematic reviews to reflect who delivered the interventions. We brought together evidence about how well treatments worked when delivered by families/carers (32 studies), the wider children's workforce (e.g. general practitioner, health visitor) (21 studies), continence teams (31 studies) or specialist consultant-led teams (42 studies). We also considered complementary therapies (15 studies) and behavioural strategies (4 studies). Care is affected by what is done and how it is done. We brought together evidence about different models of delivering care (15 studies), barriers and facilitators to implementation of treatments (106 studies) and costs (31 studies). Quality of evidence was mainly low to very low. Despite numerous studies, there was often insufficient information to support generalisable conclusions. Our findings generally agreed with current clinical guidelines. Management of childhood chronic functional constipation should be child-centred, multifaceted and adapted according to the individual child, their needs, the situation in which they live and the health-care setting in which they are looked after. Research is needed to address our identified evidence gaps.


Subject(s)
Constipation , Health Personnel , Child , Adult , Humans , Systematic Reviews as Topic , Constipation/therapy
3.
Pilot Feasibility Stud ; 10(1): 3, 2024 Jan 08.
Article in English | MEDLINE | ID: mdl-38191445

ABSTRACT

OBJECTIVES: To determine the feasibility and acceptability of implementing the Mini-AFTERc intervention. DESIGN: Non-randomised cluster-controlled pilot trial. SETTING: Four NHS out-patient breast cancer centres in Scotland. PARTICIPANTS: Ninety-two women who had successfully completed primary treatment for breast cancer were screened for moderate levels of fear of cancer recurrence (FCR). Forty-five were eligible (17 intervention and 28 control) and 34 completed 3-month follow-up (15 intervention and 21 control). INTERVENTION: Mini-AFTERc, a single brief (30 min) structured telephone discussion with a specialist breast cancer nurse (SBCN) trained to target the antecedents of FCR. OUTCOMES: Feasibility and acceptability of Mini-AFTERc and the study design were assessed via recruitment, consent, retention rates, patient outcomes (measured at baseline, 2, 4, and 12 weeks), and post-study interviews with participants and SBCNs, which were guided by Normalisation Process Theory. RESULTS: Mini-AFTERc was acceptable to patients and SBCNs. SBCNs believe the implementation of Mini-AFTERc to be feasible and an extension of discussions that already happen routinely. SBCNs believe delivery, however, at the scale required would be challenging given current competing demands for their time. Recruitment was impacted by variability in the follow-up practices of cancer centres and COVID-19 lockdown. Consent and follow-up procedures worked well, and retention rates were high. CONCLUSIONS: The study provided invaluable information about the potential challenges and solutions for testing the Mini-AFTERc intervention more widely where limiting high FCR levels is an important goal following recovery from primary breast cancer treatment. TRIAL REGISTRATION: ClinicalTrials.gov, NCT0376382 . Registered on 4 December 2018.

4.
Neurooncol Pract ; 10(3): 249-260, 2023 Jun.
Article in English | MEDLINE | ID: mdl-37188163

ABSTRACT

Background: There are no effective treatments for brain tumor-related fatigue. We studied the feasibility of two novel lifestyle coaching interventions in fatigued brain tumor patients. Methods: This phase I/feasibility multi-center RCT recruited patients with a clinically stable primary brain tumor and significant fatigue (mean Brief Fatigue Inventory [BFI] score ≥ 4/10). Participants were randomized in a 1-1-1 allocation ratio to: Control (usual care); Health Coaching ("HC", an eight-week program targeting lifestyle behaviors); or HC plus Activation Coaching ("HC + AC", further targeting self-efficacy). The primary outcome was feasibility of recruitment and retention. Secondary outcomes were intervention acceptability, which was evaluated via qualitative interview, and safety. Exploratory quantitative outcomes were measured at baseline (T0), post-interventions (T1, 10 weeks), and endpoint (T2, 16 weeks). Results: n = 46 fatigued brain tumor patients (T0 BFI mean = 6.8/10) were recruited and 34 were retained to endpoint, establishing feasibility. Engagement with interventions was sustained over time. Qualitative interviews (n = 21) suggested that coaching interventions were broadly acceptable, although mediated by participant outlook and prior lifestyle. Coaching led to significant improvements in fatigue (improvement in BFI versus control at T1: HC=2.2 points [95% CI 0.6, 3.8], HC + AC = 1.8 [0.1, 3.4], Cohen's d [HC] = 1.9; improvement in FACIT-Fatigue: HC = 4.8 points [-3.7, 13.3]; HC + AC = 12 [3.5, 20.5], d [HC and AC] = 0.9). Coaching also improved depressive and mental health outcomes. Modeling suggested a potential limiting effect of higher baseline depressive symptoms. Conclusions: Lifestyle coaching interventions are feasible to deliver to fatigued brain tumor patients. They were manageable, acceptable, and safe, with preliminary evidence of benefit on fatigue and mental health outcomes. Larger trials of efficacy are justified.

5.
BMC Cardiovasc Disord ; 23(1): 19, 2023 01 14.
Article in English | MEDLINE | ID: mdl-36639764

ABSTRACT

BACKGROUND: Prompt, effective CPR greatly increases the chances of survival in out-of-hospital c ardiac arrest. However, it is often not provided, even by people who have previously undertaken training. Psychological and behavioural factors are likely to be important in relation to CPR initiation by lay-people but have not yet been systematically identified. METHODS: Aim: to identify the psychological and behavioural factors associated with CPR initiation amongst lay-people. DESIGN: Systematic review Data sources: Cochrane Library, MEDLINE, EMBASE, CINAHL, PsycInfo and Google Scholar. STUDY ELIGIBILITY CRITERIA: Primary studies reporting psychological or behavioural factors and data on CPR initiation involving lay-people published (inception to 31 Dec 2021). STUDY APPRAISAL AND SYNTHESIS METHODS: Potential studies were screened independently by two reviewers. Study characteristics, psychological and behavioural factors associated with CPR initiation were extracted from included studies, categorised by study type and synthesised narratively. RESULTS: One hundred and five studies (150,820 participants) comprising various designs, populations and of mostly weak quality were identified. The strongest and most ecologically valid studies identified factors associated with CPR initiation: the overwhelming emotion of the situation, perceptions of capability, uncertainty about when CPR is appropriate, feeling unprepared and fear of doing harm. Current evidence comprises mainly atheoretical cross-sectional surveys using unvalidated measures with relatively little formal testing of relationships between proposed variables and CPR initiation. CONCLUSIONS: Preparing people to manage strong emotions and increasing their perceptions of capability are likely important foci for interventions aiming to increase CPR initiation. The literature in this area would benefit from more robust study designs. SYSTEMATIC REVIEW REGISTRATION: PROSPERO: CRD42018117438.


Subject(s)
Cardiopulmonary Resuscitation , Out-of-Hospital Cardiac Arrest , Humans , Cardiopulmonary Resuscitation/adverse effects , Out-of-Hospital Cardiac Arrest/diagnosis , Out-of-Hospital Cardiac Arrest/therapy , Cross-Sectional Studies
6.
Resusc Plus ; 12: 100312, 2022 Dec.
Article in English | MEDLINE | ID: mdl-36238584

ABSTRACT

Background: Prompt, effective cardio-pulmonary resuscitation (CPR) increases survival in out-of-hospital cardiac arrest. However, CPR is often not provided, even by people with training. Low confidence, perceptions of risks and high emotion can prevent initiation of CPR. Behaviour-change techniques may be helpful in increasing CPR rates. Aim: To pilot a text-message behavioural intervention designed to increase intentions to initiate CPR, explore participant responses and pilot methods for future randomised controlled trial of effectiveness. Methods: A 'before and after' pilot study plus qualitative interviews was undertaken. Participants were lay-people who had undertaken CPR training in previous 2 years.Participants were sent an intervention, comprising 35 text-messages containing 14 behaviour-change techniques, to their mobile phone over 4-6 weeks.Primary outcome: intentions to initiate CPR assessed in response to 4 different scenarios.Secondary outcomes: theory-based determinants of intention (attitudes, subjective norms, perceived behavioural control and self-efficacy) and self-rated competence. Results: 20 participants (6 female, 14 male), aged 20-84 provided baseline data. 17 received the full suite of 35 text messages.15 provided follow-up data. Intentions to perform CPR in scenarios where CPR was indicated were high at baseline and increased (18.1 ± 3.2-19.5 ± 1.8/21) after the intervention, as did self-efficacy and self-rated competency. Self-efficacy, attitudes, perceived behavioural control and subjective norms were positively correlated with intentions. Qualitative data suggest the intervention was perceived as useful. Additional options for delivery format and pace were suggested. Conclusions: Pilot-testing suggests a text-message intervention delivered after CPR training is acceptable and may be helpful in increasing/maintaining intentions to perform CPR.

7.
Trials ; 23(1): 582, 2022 Jul 22.
Article in English | MEDLINE | ID: mdl-35869503

ABSTRACT

BACKGROUND: Obesity increases the risk of type 2 diabetes, heart disease, stroke, mobility problems and some cancers, and its prevalence is rising. Men engage less than women in existing weight loss interventions. Game of Stones builds on a successful feasibility study and aims to find out if automated text messages with or without endowment incentives are effective and cost-effective for weight loss at 12 months compared to a waiting list comparator arm in men with obesity. METHODS: A 3-arm, parallel group, assessor-blind superiority randomised controlled trial with process evaluation will recruit 585 adult men with body mass index of 30 kg/m2 or more living in and around three UK centres (Belfast, Bristol, Glasgow), purposively targeting disadvantaged areas. Intervention groups: (i) automated, theory-informed text messages daily for 12 months plus endowment incentives linked to verified weight loss targets at 3, 6 and 12 months; (ii) the same text messages and weight loss assessment protocol; (iii) comparator group: 12 month waiting list, then text messages for 3 months. The primary outcome is percentage weight change at 12 months from baseline. Secondary outcomes at 12 months are as follows: quality of life, wellbeing, mental health, weight stigma, behaviours, satisfaction and confidence. Follow-up includes weight at 24 months. A health economic evaluation will measure cost-effectiveness over the trial and over modelled lifetime: including health service resource-use and quality-adjusted life years. The cost-utility analysis will report incremental cost per quality-adjusted life years gained. Participant and service provider perspectives will be explored via telephone interviews, and exploratory mixed methods process evaluation analyses will focus on mental health, multiple long-term conditions, health inequalities and implementation strategies. DISCUSSION: The trial will report whether text messages (with and without cash incentives) can help men to lose weight over 1 year and maintain this for another year compared to a comparator group; the costs and benefits to the health service; and men's experiences of the interventions. Process analyses with public involvement and service commissioner input will ensure that this open-source digital self-care intervention could be sustainable and scalable by a range of NHS or public services. TRIAL REGISTRATION: ISRCTN 91974895 . Registered on 14/04/2021.


Subject(s)
Diabetes Mellitus, Type 2 , Financial Management , Text Messaging , Adult , Cost-Benefit Analysis , Humans , Male , Motivation , Obesity/diagnosis , Obesity/therapy , Quality of Life , Randomized Controlled Trials as Topic , Weight Loss
8.
Cochrane Database Syst Rev ; 11: CD013779, 2020 11 05.
Article in English | MEDLINE | ID: mdl-33150970

ABSTRACT

BACKGROUND: Evidence from disease epidemics shows that healthcare workers are at risk of developing short- and long-term mental health problems. The World Health Organization (WHO) has warned about the potential negative impact of the COVID-19 crisis on the mental well-being of health and social care professionals. Symptoms of mental health problems commonly include depression, anxiety, stress, and additional cognitive and social problems; these can impact on function in the workplace. The mental health and resilience (ability to cope with the negative effects of stress) of frontline health and social care professionals ('frontline workers' in this review) could be supported during disease epidemics by workplace interventions, interventions to support basic daily needs, psychological support interventions, pharmacological interventions, or a combination of any or all of these. OBJECTIVES: Objective 1: to assess the effects of interventions aimed at supporting the resilience and mental health of frontline health and social care professionals during and after a disease outbreak, epidemic or pandemic. Objective 2: to identify barriers and facilitators that may impact on the implementation of interventions aimed at supporting the resilience and mental health of frontline health and social care professionals during and after a disease outbreak, epidemic or pandemic. SEARCH METHODS: On 28 May 2020 we searched the Cochrane Database of Systematic Reviews, CENTRAL, MEDLINE, Embase, Web of Science, PsycINFO, CINAHL, Global Index Medicus databases and WHO Institutional Repository for Information Sharing. We also searched ongoing trials registers and Google Scholar. We ran all searches from the year 2002 onwards, with no language restrictions. SELECTION CRITERIA: We included studies in which participants were health and social care professionals working at the front line during infectious disease outbreaks, categorised as epidemics or pandemics by WHO, from 2002 onwards. For objective 1 we included quantitative evidence from randomised trials, non-randomised trials, controlled before-after studies and interrupted time series studies, which investigated the effect of any intervention to support mental health or resilience, compared to no intervention, standard care, placebo or attention control intervention, or other active interventions. For objective 2 we included qualitative evidence from studies that described barriers and facilitators to the implementation of interventions. Outcomes critical to this review were general mental health and resilience. Additional outcomes included psychological symptoms of anxiety, depression or stress; burnout; other mental health disorders; workplace staffing; and adverse events arising from interventions. DATA COLLECTION AND ANALYSIS: Pairs of review authors independently applied selection criteria to abstracts and full papers, with disagreements resolved through discussion. One review author systematically extracted data, cross-checked by a second review author. For objective 1, we assessed risk of bias of studies of effectiveness using the Cochrane 'Risk of bias' tool. For objective 2, we assessed methodological limitations using either the CASP (Critical Appraisal Skills Programme) qualitative study tool, for qualitative studies, or WEIRD (Ways of Evaluating Important and Relevant Data) tool, for descriptive studies. We planned meta-analyses of pairwise comparisons for outcomes if direct evidence were available. Two review authors extracted evidence relating to barriers and facilitators to implementation, organised these around the domains of the Consolidated Framework of Implementation Research, and used the GRADE-CERQual approach to assess confidence in each finding. We planned to produce an overarching synthesis, bringing quantitative and qualitative findings together. MAIN RESULTS: We included 16 studies that reported implementation of an intervention aimed at supporting the resilience or mental health of frontline workers during disease outbreaks (severe acute respiratory syndrome (SARS): 2; Ebola: 9; Middle East respiratory syndrome (MERS): 1; COVID-19: 4). Interventions studied included workplace interventions, such as training, structure and communication (6 studies); psychological support interventions, such as counselling and psychology services (8 studies); and multifaceted interventions (2 studies). Objective 1: a mixed-methods study that incorporated a cluster-randomised trial, investigating the effect of a work-based intervention, provided very low-certainty evidence about the effect of training frontline healthcare workers to deliver psychological first aid on a measure of burnout. Objective 2: we included all 16 studies in our qualitative evidence synthesis; we classified seven as qualitative and nine as descriptive studies. We identified 17 key findings from multiple barriers and facilitators reported in studies. We did not have high confidence in any of the findings; we had moderate confidence in six findings and low to very low confidence in 11 findings. We are moderately confident that the following two factors were barriers to intervention implementation: frontline workers, or the organisations in which they worked, not being fully aware of what they needed to support their mental well-being; and a lack of equipment, staff time or skills needed for an intervention. We are moderately confident that the following three factors were facilitators of intervention implementation: interventions that could be adapted for local needs; having effective communication, both formally and socially; and having positive, safe and supportive learning environments for frontline workers. We are moderately confident that the knowledge or beliefs, or both, that people have about an intervention can act as either barriers or facilitators to implementation of the intervention. AUTHORS' CONCLUSIONS: There is a lack of both quantitative and qualitative evidence from studies carried out during or after disease epidemics and pandemics that can inform the selection of interventions that are beneficial to the resilience and mental health of frontline workers. Alternative sources of evidence (e.g. from other healthcare crises, and general evidence about interventions that support mental well-being) could therefore be used to inform decision making. When selecting interventions aimed at supporting frontline workers' mental health, organisational, social, personal, and psychological factors may all be important. Research to determine the effectiveness of interventions is a high priority. The COVID-19 pandemic provides unique opportunities for robust evaluation of interventions. Future studies must be developed with appropriately rigorous planning, including development, peer review and transparent reporting of research protocols, following guidance and standards for best practice, and with appropriate length of follow-up. Factors that may act as barriers and facilitators to implementation of interventions should be considered during the planning of future research and when selecting interventions to deliver within local settings.


Subject(s)
Disease Outbreaks , Health Personnel/psychology , Mental Health , Occupational Health , Resilience, Psychological , Social Workers/psychology , Betacoronavirus , Bias , Burnout, Professional/psychology , COVID-19 , Coronavirus Infections/epidemiology , Coronavirus Infections/therapy , Epidemics , Hemorrhagic Fever, Ebola/epidemiology , Hemorrhagic Fever, Ebola/therapy , Humans , Needs Assessment , Pandemics , Pneumonia, Viral/epidemiology , Pneumonia, Viral/therapy , Psychosocial Support Systems , SARS-CoV-2 , Severe Acute Respiratory Syndrome/epidemiology , Severe Acute Respiratory Syndrome/therapy , Workplace
9.
Article in English | MEDLINE | ID: mdl-32399254

ABSTRACT

BACKGROUND: Fear of cancer recurrence (FCR) is common in people affected by breast cancer. FCR is associated with increased health service and medication use, anxiety, depression and reduced quality of life. Existing interventions for FCR are time and resource intensive, making implementation in a National Health Service (NHS) setting challenging. To effectively manage FCR in current clinical practice, less intensive FCR interventions are required. Mini-AFTERc is a structured 30-min counselling intervention delivered over the telephone and is designed to normalise moderate FCR levels by targeting unhelpful behaviours and misconceptions about cancer recurrence.This multi-centre non-randomised controlled pilot trial will investigate the feasibility of delivering the Mini-AFTERc intervention, its acceptability and usefulness, in relation to specialist breast cancer nurses (SBCNs) and patients. This protocol describes the rationale, methods and analysis plan for this pilot trial of the Mini-AFTERc intervention in everyday practice. METHODS: This study will run in four breast cancer centres in NHS Scotland, two intervention and two control centres. SBCNs at intervention centres will be trained to deliver the Mini-AFTERc intervention. Female patients who have completed primary breast cancer treatment in the previous 6 months will be screened for moderate FCR (FCR4 score: 10­14). Participants at intervention centres will receive the Mini-AFTERc intervention within 2 weeks of recruitment. SBCNs will audio record the intervention telephone discussions with participants. Fidelity of intervention implementation will be assessed from audio recordings. All participants will complete three separate follow-up questionnaires assessing changes in FCR, anxiety, depression and quality of life over 3 months. Normalisation process theory (NPT) will form the framework for semi-structured interviews with 20% of patients and all SBCNs. Interviews will explore participants' experience of the study, acceptability and usefulness of the intervention and factors influencing implementation within clinical practice. The ADePT process will be adopted to systematically problem solve and refine the trial design. DISCUSSION: Findings will provide evidence for the potential effectiveness, fidelity, acceptability and practicality of the Mini-AFTERc intervention, and will inform the design and development of a large randomised controlled trial (RCT). TRIAL REGISTRATION: ClinicalTrials.gov: NCT0376382. Registered 4th December 2018, https://clinicaltrials.gov/ct2/show/NCT03763825.

10.
Int J Nurs Stud ; 104: 103443, 2020 Apr.
Article in English | MEDLINE | ID: mdl-32120089

ABSTRACT

BACKGROUND: Workload and workforce issues in primary care are key drivers for the growing international trend to expand nursing roles. Advanced nurse practitioners are increasingly being appointed to take on activities and roles traditionally carried out by doctors. Successful implementation of any new role within multidisciplinary teams is complex and time-consuming, therefore it is important to understand the factors that may hinder or support implementation of the advanced nurse practitioner role in primary care settings. OBJECTIVES: To identify, appraise and synthesise the barriers and facilitators that impact implementation of advanced practitioner roles in primary care settings. METHODS: A scoping review conducted using the Arksey and O'Malley (2005) framework and reported in accordance with PRISMA-ScR. Eight databases (Cochrane Library, Health Business Elite, Kings Fund Library, HMIC, Medline, CINAHL, SCOPUS and Web of Science) were searched to identify studies published in English between 2002 and 2017. Study selection and methodological assessment were conducted by two independent reviewers. A pre-piloted extraction form was used to extract the following data: study characteristics, context, participants and information describing the advanced nurse practitioner role. Deductive coding for barriers and facilitators was undertaken using a modified Yorkshire Contributory Framework. We used inductive coding for barriers or facilitators that could not be classified using pre-defined codes. Disagreements were addressed through discussion. Descriptive data was tabulated within evidence tables, and key findings for barriers and facilitators were brought together within a narrative synthesis based on the volume of evidence. FINDINGS: Systematic searching identified 5976 potential records, 2852 abstracts were screened, and 122 full texts were retrieved. Fifty-four studies (reported across 76 publications) met the selection criteria. Half of the studies (n = 27) were conducted in North America (n = 27), and 25/54 employed a qualitative design. The advanced nurse practitioner role was diverse, working across the lifespan and with different patient groups. However, there was little agreement about the level of autonomy, or what constituted everyday activities. Team factors were the most frequently reported barrier and facilitator. Individual factors, lines of responsibility and 'other' factors (i.e., funding), were also frequently reported barriers. Facilitators included individual factors, supervision and leadership and 'other' factors (i.e., funding, planning for role integration). CONCLUSION: Building collaborative relationships with other healthcare professionals and negotiating the role are critical to the success of the implementation of the advanced nurse practitioner role. Team consensus about the role and how it integrates into the wider team is also essential.


Subject(s)
Nurse Practitioners/organization & administration , Nurse's Role , Primary Health Care/organization & administration , Health Personnel/organization & administration , Humans , Leadership
11.
Age Ageing ; 48(3): 327-336, 2019 05 01.
Article in English | MEDLINE | ID: mdl-30615052

ABSTRACT

BACKGROUND: foot problems are independent risk factors for falls in older people. Podiatrists diagnose and treat a wide range of problems affecting the feet, ankles and lower limbs. However, the effectiveness of podiatry interventions to prevent falls in older people is unknown. This systematic review examined podiatry interventions for falls prevention delivered in the community and in care homes. METHODS: systematic review and meta-analysis. We searched multiple electronic databases with no language restrictions. Randomised or quasi-randomised-controlled trials documenting podiatry interventions in older people (aged 60+) were included. Two reviewers independently applied selection criteria and assessed methodological quality using the Cochrane Risk of Bias tool. TiDieR guidelines guided data extraction and where suitable statistical summary data were available, we combined the selected outcome data in pooled meta-analyses. RESULTS: from 35,857 titles and 5,201 screened abstracts, nine studies involving 6,502 participants (range 40-3,727) met the inclusion criteria. Interventions were single component podiatry (two studies), multifaceted podiatry (three studies), or multifactorial involving other components and referral to podiatry component (four studies). Seven studies were conducted in the community and two in care homes. Quality assessment showed overall low risk for selection bias, but unclear or high risk of detection bias in 4/9 studies. Combining falls rate data showed significant effects for multifaceted podiatry interventions compared to usual care (falls rate ratio 0.77 [95% CI 0.61, 0.99]); and multifactorial interventions including podiatry (falls rate ratio: 0.73 [95% CI 0.54, 0.98]). Single component podiatry interventions demonstrated no significant effects on falls rate. CONCLUSIONS: multifaceted podiatry interventions and multifactorial interventions involving referral to podiatry produce significant reductions in falls rate. The effect of multi-component podiatry interventions and of podiatry within multifactorial interventions in care homes is unknown and requires further trial data. PROSPERO REGISTRATION NUMBER: CRD42017068300.


Subject(s)
Accidental Falls/prevention & control , Podiatry/methods , Aged , Foot Diseases/therapy , Humans
12.
Int J Nurs Stud ; 86: 36-43, 2018 Oct.
Article in English | MEDLINE | ID: mdl-29960894

ABSTRACT

BACKGROUND: Advances in research and technology coupled with an increased cancer incidence and prevalence have resulted in significant expansion of cancer nurse role, in order to meet the growing demands and expectations of people affected by cancer (PABC). Cancer nurses are also tasked with delivering an increasing number of complex interventions as a result of ongoing clinical trials in cancer research. However much of this innovation is undocumented, and we have little insight about the nature of novel interventions currently being designed or delivered by cancer nurses. OBJECTIVES: To identify and synthesise the available evidence from clinical trials on interventions delivered or facilitated by cancer nurses. DATA SOURCES AND REVIEW METHODS: A systematic review of randomised controlled trials (RCT), quasi-RCTs and controlled before and after studies (CBA) of cancer nursing interventions aimed at improving the experience and outcomes of PABC. Ten electronic databases (CENTRAL, MEDLINE, AMED, CINAHL, EMBASE, Epistemonikos, CDSR, DARE, HTA, WHO ICTRP) were searched between 01 January 2000 and 31 May 2016. No language restrictions were applied. Bibliographies of selected studies and relevant Cochrane reviews were also hand-searched. Interventions delivered by cancer nurses were classified according to the OMAHA System. Heat maps were used to highlight the volume of evidence available for different cancer groups, intervention types and stage of cancer care continuum. RESULTS: The search identified 22,450 records; we screened 16,169 abstracts and considered 925 full papers, of which 214 studies (247,550 participants) were included in the evidence synthesis. The majority of studies were conducted in Europe (n = 79) and USA (n = 74). Interventions were delivered across the cancer continuum from prevention and risk reduction to survivorship, with the majority of interventions delivered during the treatment phase (n = 137). Most studies (131/214) had a teaching, guidance or counselling component. Cancer nurse interventions were targeted at primarily breast, prostate or multiple cancers. No studies were conducted in brain, sarcoma or other rare cancer types. The majority of the studies (n = 153) were nurse-led and delivered by specialist cancer nurses (n = 74) or advanced cancer nurses (n = 29), although the quality of reporting was poor. CONCLUSIONS: To the best of our knowledge, this is the first review to synthesise evidence from intervention studies across the entire cancer spectrum. As such, this work provides new insights into the nature of the contribution that cancer nurses have made to evidence-based innovations, as well as highlighting areas in which cancer nursing trials can be developed in the future.


Subject(s)
Neoplasms/nursing , Randomized Controlled Trials as Topic , Cost-Benefit Analysis , Humans
13.
J Adv Nurs ; 73(12): 3144-3153, 2017 Dec.
Article in English | MEDLINE | ID: mdl-28702945

ABSTRACT

AIM: To identify, appraise and synthesize the available evidence relating to the value and impact of cancer nursing on patient experience and outcomes. BACKGROUND: There is a growing body of literature that recognizes the importance and contribution of cancer nurses, however, a comprehensive review examining how cancer nurses have an impact on care quality, patient outcomes and overall experience of cancer, as well as cost of services across the entire cancer spectrum is lacking. DESIGN: A systematic review and meta-analysis using Cochrane methods. METHODS: We will systematically search 10 electronic databases from 2000, with pre-determined search terms. No language restrictions will be applied. We will include all randomized and controlled before-and-after studies that compare cancer nursing interventions to a standard care or no intervention. Two reviewers will independently assess the eligibility of the studies and appraise methodological quality using the Cochrane Risk of Bias tool. Disagreements will be resolved by discussion and may involve a third reviewer if necessary. Data from included studies will be extracted in accordance with the Template for intervention Description and Replication reporting guidelines. Missing data will be actively sought from all trialists. Data will be synthesized in evidence tables and narrative to answer three key questions. If sufficient data are available, we will perform meta-analyses. DISCUSSION: This review will allow us to systematically assess the impact of cancer nursing on patient care and experience. This evidence will be used to determine implications for clinical practice and used to inform future programme and policy decisions in Europe.


Subject(s)
Evidence-Based Nursing , Oncology Nursing , Europe , Humans , Nurse-Patient Relations , Societies, Nursing , Systematic Reviews as Topic
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