Development and early validation of questionnaires to assess system level factors affecting male partners' attendance at childbirth in LMICs.

BACKGROUND: There is evidence that a woman who receives continuous labour support from a chosen companion can have shorter labour duration, is more likely to give birth without medical interventions, and report a satisfying childbirth experience. These outcomes result from the beneficial effects of emotional and practical support from the woman's chosen companion, and care provided by health providers. When a woman's chosen companion is her male partner, in addition to the above benefits, his presence can promote his bonding with the baby, and shared parenthood. However, there may be healthcare system barriers, including organisational, management and individual (staff) factors, that inhibit or restrict women's choice of companion. There are currently no suitable survey tools that can be used to assess the system level factors affecting the implementation of male partners' attendance at childbirth in low- and middle- income countries (LMICs). METHODS: We designed two questionnaires to help to address that gap: the Male Partners' Attendance at Childbirth-Questionnaire for Heads of Maternity Units (MPAC-QHMUs); and the Male Partners' Attendance at Childbirth-Questionnaire for Maternity Staff (MPAC-QMS). We carried out an extensive review to generate initial items of the two questionnaires. We assessed the content and face validity of the two questionnaires in a three-round modified Delphi study. RESULTS: The Male Partners' Attendance at Childbirth-Questionnaire for Heads of Maternity Units (MPAC-QHMUs) focused on organisational and management factors. The Male Partners' Attendance at Childbirth-Questionnaire of Maternity Staff (MPAC-QMS) focused on individual staff factors. The final MPAC-QHMUs and MPAC-QMS included items which garnered over 80% content relevance according to the experts' rating. After all three consensus rounds of the Delphi study, 43 items were retained for the MPAC-QHMUs and 61 items were retained for the MPAC-QMS. CONCLUSIONS: The MPAC-QHMUs and the MPAC-QMS may help understanding of barriers affecting male partners' attendance at childbirth in LMICs in order to devise implementation strategies to enable wider availability and to maximize women's choices during labour and childbirth. The MPAC-QHMUs and the MPAC-QMS as newly-developed questionnaires require further validation of their acceptability and feasibility in different cultural contexts, and languages.

Perceived impact of formulating, implementing and enacting national mental health policies recommendations in practice: An exploratory qualitative study within child and adolescent mental health services in Scotland.

OBJECTIVE: To understand the process of formulating, implementing and enacting national recommendations into practice, by exploring the interactions between government policymakers and national and local organisations supporting and delivering policy implementation within a Child and Adolescent Mental Health Service (CAMHS) context in Scotland. METHODS: Data collection involved 16 semi-structured individual and four focus group interviews with a purposeful sample of policymakers, national health and social care stakeholders and local outpatient and inpatient CAMHS teams representing three NHS health boards in Scotland. RESULTS: Study participants highlighted the challenges of navigating through evolving and often conflicting policy agendas, seen to not acknowledging the current evidence base or experiential learning from services and prior evaluations. Accounts of transformation fatigue often emerged from increased expectations for staff to adopt new approaches to accommodate constantly changing recommendations. Participants also reported a lack of integration and implementation support from national health and social care organisations, leading to duplication of effort and gaps in provision or waste. Policy recommendations were perceived as sometimes vague, lacking clarity about how to deliver service transformation using a whole-system approach. The collective narratives reflected increased tension between the need for local autonomy to innovate and the limitations created vertically by the relative inflexibility of policy recommendations, and horizontally by the proliferation of national organisations delivering the same transformation aims using different approaches in a resource-constrained environment. CONCLUSION: The findings contribute to the wider literature by offering an exploration of importance of evaluation and evidence uptake in policy formulation; the roles and remits in supporting the implementation of policy recommendations; and how the dynamics of central control and local autonomy might impact on the local enactment of policy recommendations.

Understanding the Impacts of Novel Coronavirus Outbreaks on People Who Use Drugs: A Systematic Review to Inform Practice and Drug Policy Responses to COVID-19.

People who use drugs (PWUD) experience many social and health harms and are considered at greater risk of acquiring COVID-19. Little research has examined the impact of coronaviruses either on PWUD, or on services targeted to PWUD. We report the findings of a systematic review of empirical evidence from studies which have examined the impact of coronaviruses (Severe Acute Respiratory Syndrome (SARS-CoV-1) and Middle Eastern Respiratory Syndrome (MERS-CoV) and COVID-19) on PWUD or on service responses to them. Five databases were searched (MEDLINE, PsycINFO, CINAHL, ASSIA and EMBASE) as well as COVID-19 specific databases. Inclusion criteria were studies reporting any impact of SARS, MERS or COVID-19 or any service responses to those, published between January 2000 and October 2020. Weight of Evidence judgements and quality assessment were undertaken. In total, 27 primary studies were included and grouped by seven main themes: treatment/recovery services; emergency medical settings; low-threshold services; prison setting, PWUD/substance use disorder (SUD) diagnosis; people with SUD and HIV; 'Sexual minority' men. Overall, research in the area was scant, and of average/poor quality. More robust research is required to inform on-going and future responses to coronavirus epidemics for PWUD.

Testing and implementing video consulting for outpatient appointments: using quality improvement system thinking and codesign principles.

Increasing demand for outpatient appointments (OPA) is a global challenge for healthcare providers. Non-attendance rates are high, not least because of the challenges of attending hospital OPAs due to transport difficulties, cost, poor health, caring and work responsibilities. Digital solutions may help ameliorate these challenges. This project aimed to implement codesigned outpatient video consultations across National Health Service (NHS) Highland using system-wide quality improvement approaches to implementation, involving patients, carers, clinical and non-clinical staff, national and local strategic leads. System mapping; an intensive codesign process involving extensive stakeholder engagement and real-time testing; Plan, Do, Study, Act cycles; and collection of clinician and patient feedback were used to optimise the service. Standardised processes were developed and implemented, which made video consulting easy to use for patients, embedded video into routine health service systems for clinicians and non-clinical staff, and automated much of the administrative burden. All clinicians and staff are using the system and both groups identified benefits in terms of travel time and costs saved. Transferable lessons for other services are identified, providing a practical blueprint for others to adapt and use in their own contexts to help implement and sustain video consultation services now and in the future.

Multi-method evaluation of a national clinical fellowship programme to build leadership capacity for quality improvement.

BACKGROUND: This paper reports the results of the evaluation of the Scottish Quality and Safety Fellowship (SQSF)-a 10-month, lead-level international educational programme established in 2008 with the overarching aim of developing clinicians with advanced quality improvement knowledge, technical ability and essential leadership skills. The evaluation explores four levels of educational and practice outcomes associated with (1) the reaction of fellows to SQSF participation, (2) learning gained, (3) subsequent behaviour changes and (4) the overall impact on national and international level capability and capacity building. METHODS: A theory-informed multi-method design was applied using (1) a search and review of the SQSF organisational database to tabulate personal, professional and demographic characteristics; (2) semi-structured telephone interviews with 16 participants using purposive and self-selected sampling; and (3) a cross-sectional online evaluation survey across all 10 cohorts involving 222 fellows RESULTS: SQSF was positively perceived as a high-quality learning experience containing a well-balanced mix of theory and practice, with a majority of respondents reporting career changing benefits. Most participants reported improved social, behavioural and emotional skills, knowledge and attitudes and, with sustained support of their host organisations, were able to apply and share learning in their workplace. The impact of the SQSF on a wider national and international level capability and capacity was both mediated and moderated by a wide range of interrelated contextual factors. CONCLUSIONS: This multi-method evaluation demonstrates that SQSF has achieved significant positive outcomes for the great majority of participants. Some tentative recommendations are provided with the aim of further enhancing fellowship content, delivery, transfer and future evaluations of wider impacts at regional, national and international health system levels.

The influence of contextual factors on healthcare quality improvement initiatives: a realist review.

BACKGROUND: Recognising the influence of context and the context-sensitive nature of quality improvement (QI) interventions is crucial to implementing effective improvements and successfully replicating them in new settings, yet context is still poorly understood. To address this challenge, it is necessary to capture generalisable knowledge, first to understand which aspects of context are most important to QI and why, and secondly, to explore how these factors can be managed to support healthcare improvement, in terms of implementing successful improvement initiatives, achieving sustainability and scaling interventions. The research question was how and why does context influence quality improvement initiatives in healthcare? METHODS: A realist review explored the contextual conditions that influence healthcare improvement. Realist methodology integrates theoretical understanding and stakeholder input with empirical research findings. The review aimed to identify and understand the role of context during the improvement cycle, i.e. planning, implementation, sustainability and transferability; and distil new knowledge to inform the design and development of context-sensitive QI initiatives. We developed a preliminary theory of the influence of context to arrive at a conceptual and theoretical framework. RESULTS: Thirty-five studies were included in the review, demonstrating the interaction of key contextual factors across healthcare system levels during the improvement cycle. An evidence-based explanatory theoretical model is proposed to illustrate the interaction between contextual factors, system levels (macro, meso, micro) and the stages of the improvement journey. Findings indicate that the consideration of these contextual factors would enhance the design and delivery of improvement initiatives, across a range of improvement settings. CONCLUSIONS: This is the first realist review of context in QI and contributes to a deeper understanding of how context influences quality improvement initiatives. The distillation of key contextual factors offers the potential to inform the design and development of context-sensitive interventions to enhance improvement initiatives and address the challenge of spread and sustainability. Future research should explore the application of our conceptual model to enhance improvement-planning processes. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42017062135.

Pharmacist and Data-Driven Quality Improvement in Primary Care (P-DQIP): a qualitative study of anticipated implementation factors informed by the Theoretical Domains Framework.

OBJECTIVES: The quality and safety of drug therapy in primary care are global concerns. The Pharmacist and Data-Driven Quality Improvement in Primary Care (P-DQIP) intervention aims to improve prescribing safety via an informatics tool, which facilitates proactive management of drug therapy risks (DTRs) by health-board employed pharmacists with established roles in general practices. Study objectives were (1) to identify and prioritise factors that could influence P-DQIP implementation from the perspective of practice pharmacists and (2) to identify potentially effective, acceptable and feasible strategies to support P-DQIP implementation. DESIGN: Semistructured face-to-face interviews using a Theoretical Domains Framework informed topic guide. The framework method was used for data analysis. Identified implementation factors were prioritised for intervention based on research team consensus. Candidate intervention functions, behavioural change techniques (BCTs) and policies targeting these were identified from the behavioural change wheel. The final intervention content and modes of delivery were agreed with local senior pharmacists. SETTING: General practices from three Health and Social Care Partnerships in National Health Service (NHS) Tayside. PARTICIPANTS: 14 NHS employed practice pharmacists. RESULTS: Identified implementation factors were linked to thirteen theoretical domains (all except intentions) and six (skill, memory/attention/decision making, behavioural regulation, reinforcement, environmental context/resources, social influences) were prioritised. Three intervention functions (training, enablement and environmental restructuring) were relevant and were served by two policy categories (guidelines, communication/marketing) and eight BCTs (instructions on how to perform a behaviour, problem solving, action planning, prompt/cues, goal setting, self-monitoring, feedback and restructuring the social environment). Intervention components encompass an informatics tool, written educational material, a workshop for pharmacists, promotional activities and small financial incentives. CONCLUSIONS: This study explored pharmacists' perceptions of implementation factors which could influence management of DTRs in general practices to inform implementation of P-DQIP, which will initially be implemented in one Scottish health board with parallel evaluation of effectiveness and implementation.

A balanced approach to identifying, prioritising and evaluating all potential consequences of quality improvement: modified Delphi study.

OBJECTIVES: Healthcare is a complex system, so quality improvement will commonly lead to unintended consequences which are rarely evaluated. In previous qualitative work, we proposed a framework for considering the range of these potential consequences, in terms of their desirability and the extent to which they were predictable or expected during planning. This paper elaborates on the previous findings, using consensus methods to examine what consequences should be identified, why and how to prioritise, evaluate and interpret all identified consequences, and what stakeholders should be involved throughout this process. DESIGN: Two-round modified Delphi consensus study. SETTING AND PARTICIPANTS: Both rounds were completed by 60 panellists from an academic, clinical or management background and experience in designing, implementing or evaluating quality improvement programmes. RESULTS: Panellists agreed that trade-offs (expected undesirable consequences) and unpleasant surprises (unexpected undesirable consequences) should be actively considered. Measurement of harmful consequences for patients, and those with high workload or financial impact was prioritised, and their evaluation could also involve the use of qualitative methods. Clinical teams were agreed as important to involve at all stages, from identifying potential consequences, prioritising which of those to systematically evaluate, undertaking appropriate evaluation and interpreting the findings. Patients were necessary in identifying consequences, managers in identifying and prioritising, and improvement advisors in interpreting the data. CONCLUSION: There was consensus that a balanced approach to considering all the consequences of improvement can be achieved by carefully considering predictable trade-offs from the outset and deliberately pausing after implementation to identify any unexpected surprises and make an informed decision as to whether quantitative or qualitative evaluation is needed and feasible. Stakeholders' roles in in the process of identifying, prioritising, evaluating and interpreting potential consequences should be explicitly addressed within planning and revisited during and after implementation.

Balancing measures or a balanced accounting of improvement impact: a qualitative analysis of individual and focus group interviews with improvement experts in Scotland.

BACKGROUND: As quality improvement (QI) programmes have become progressively larger scale, the risks of implementation having unintended consequences are increasingly recognised. More routine use of balancing measures to monitor unintended consequences has been proposed to evaluate overall effectiveness, but in practice published improvement interventions hardly ever report identification or measurement of consequences other than intended goals of improvement. METHODS: We conducted 15 semistructured interviews and two focus groups with 24 improvement experts to explore the current understanding of balancing measures in QI and inform a more balanced accounting of the overall impact of improvement interventions. Data were analysed iteratively using the framework approach. RESULTS: Participants described the consequences of improvement in terms of desirability/undesirability and the extent to which they were expected/unexpected when planning improvement. Four types of consequences were defined: expected desirable consequences (goals); expected undesirable consequences (trade-offs); unexpected undesirable consequences (unpleasant surprises); and unexpected desirable consequences (pleasant surprises). Unexpected consequences were considered important but rarely measured in existing programmes, and an improvement pause to take stock after implementation would allow these to be more actively identified and managed. A balanced accounting of all consequences of improvement interventions can facilitate staff engagement and reduce resistance to change, but has to be offset against the cost of additional data collection. CONCLUSION: Improvement measurement is usually focused on measuring intended goals, with minimal use of balancing measures which when used, typically monitor trade-offs expected before implementation. This paper proposes that improvers and leaders should seek a balanced accounting of all consequences of improvement across the life of an improvement programme, including deliberately pausing after implementation to identify and quantitatively or qualitatively evaluate any pleasant or unpleasant surprises.

The influence of contextual factors on healthcare quality improvement initiatives: what works, for whom and in what setting? Protocol for a realist review.

BACKGROUND: Context shapes the effectiveness of knowledge implementation and influences health improvement. Successful healthcare quality improvement (QI) initiatives frequently fail to transfer to different settings, with local contextual factors often cited as the cause. Understanding and overcoming contextual barriers is therefore crucial to implementing effective improvement; yet context is still poorly understood. There is a paucity of information on the mechanisms underlying how and why QI projects succeed or fail in given settings. A realist review of empirical studies of healthcare QI initiatives will be undertaken to examine the influence and impact of contextual factors on quality improvement in healthcare settings and explore whether QI initiatives can work in all contexts. METHODS: The review will explore which contextual factors are important, and how, why, when and for whom they are important, within varied settings. The dynamic nature of context and change over time will be explored by examining which aspects of context impact at key points in the improvement trajectory. The review will also consider the influence of context on improvement outcomes (provider- and patient-level), spread and sustainability. The review process will follow five iterative steps: (1) clarify scope, (2) search for evidence, (3) appraise primary studies and extract data, (4) synthesise evidence and draw conclusions and (5) disseminate findings. The reviewers will consult with experts and stakeholders in the early stages to focus the review and develop a programme theory consisting of explanatory 'context-mechanism-outcome' configurations. Searches for primary evidence will be conducted iteratively. Data will be extracted and tested against the programme theory. A review advisory group will oversee the review process. Review findings will follow RAMESES guidelines and will be disseminated via a report, presentations and peer-reviewed publications. DISCUSSION: The review will update and consolidate evidence on the contextual conditions for effective improvement and distil new knowledge to inform the design and development of context-sensitive QI initiatives. This review ties in with the study of improvement programmes as vehicles of change and the development of an evidence base around healthcare improvement by addressing whether QI initiatives can work in all contexts. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42017062135.

Promotion of physical activity interventions for community dwelling older adults: A systematic review of reviews.

OBJECTIVES: While there is strong evidence that regular participation in physical activity (PA) brings numerous health benefits to older adults, and interventions to effectively promote PA are being developed and tested, the characteristics and components of the most effective interventions remain unclear. This systematically conducted review of systematic reviews evaluated the effects and characteristics of PA promotion interventions aimed at community dwelling people over 50 years old. METHODS: Major databases were searched for reviews from January 1990 to May 2015. TIDieR guidelines aided data extraction and the ROBIS tool was used to assess the risk of bias. Primary outcomes were objective and self-reported levels of PA. Indicators of psychological wellbeing and participation rates were secondary outcomes. RESULTS: Of 1284 records identified, 19 reviews met inclusion criteria and eight included meta-analyses. Interventions typically incorporated behaviour change techniques (BCTs) and were delivered as face-to-face, remote, group, individual or as combined interventions. Despite their heterogeneity, interventions often resulted in sustained improvements in PA over the study period, typically at 12 months, and led to improvements in general wellbeing. However, ways to ensure effective maintenance beyond one year are unclear. Certain intervention components were more clearly associated with positive effects (e.g. tailoring promotion strategy with combination of cognitive and behavioural elements, low to moderate intensity activity recommended). We found no evidence that certain other intervention characteristics were superior in achieving positive outcomes (e.g. mode of delivery, setting, professional background of the intervention provider, type of PA recommended). CONCLUSION: The evidence suggests that interventions to promote PA among older adults are generally effective but there is uncertainty around the most beneficial intervention components. There are indications that purely cognitive strategies and BCTs might be less suitable for older adults than motivators more meaningful to them, including social and environmental support, and enjoyment coming from being physically active. A whole system-oriented approach is required that is tailored to meet the needs of older adults and aligned with social, individual and environmental factors.

Long-Term Worries after Colposcopy: Which Women Are at Increased Risk?

BACKGROUND: A colposcopy examination is the main management option for women with an abnormal cervical screening test result. Although some women experience adverse psychological effects after colposcopy, those at greatest risk are unknown. We investigated predictors of worries about cervical cancer, sex, future fertility and general health during 12 to 30 months after colposcopy. METHODS: We invited 1,515 women, aged 20 to 59 years with low-grade cervical cytology who attended colposcopy to complete questionnaires at recruitment (∼8 weeks after cytology result) and after 12, 18, 24, and 30 months of follow up. Outcomes were worries about having cervical cancer, having sex, future fertility, and general health at any time during follow-up. Factors significantly associated with each outcome were identified using multiple logistic regression. RESULTS: At one or more time points during follow-up, 40% of women reported worries about having cervical cancer, 26% about having sex, 24% about future fertility, and 60% about general health. For all outcomes except sex, worries reported at recruitment were associated with significantly increased risk of worries during follow-up. Significant anxiety at recruitment was associated with all worries during follow-up. Women diagnosed with CIN2+ had significantly higher risks of worries about cervical cancer and future fertility. Management received was associated significantly with worries about cervical cancer and having sex. Younger women significantly more often reported worries about future fertility, whereas women who had children had reduced risk of future fertility worries but increased risk of cervical cancer worries. CONCLUSION: Clinical, sociodemographic, lifestyle, and psychological factors predicted risk of reporting worries after colposcopy.

The unintended consequences of cervical screening: distress in women undergoing cytologic surveillance.

OBJECTIVE: It is well known that receipt of an initial abnormal cervical cytology test can trigger considerable anxiety among women. Less is known about the impact of follow-up by repeat cytology tests. We quantified prevalence, and identified predictors, of distress after repeat cytologic testing in women with a single low-grade test. METHODS: Within the framework of the TOMBOLA randomized controlled trial of alternative managements, 844 women aged 20 to 59 years with a single routine cytology test showing borderline nuclear abnormalities (BNA; broadly equivalent to atypical squamous cells of undetermined significance) were assigned to follow-up by repeat cytology in primary care (the first test was due 6 months after the initial BNA result). Women completed sociodemographic and psychosocial questionnaires at recruitment and the Impact of Event Scale (IES) 6 weeks after their first follow-up cytology test. Factors associated with significant psychologic distress (IES ≥ 9) were identified using logistic regression. RESULTS: The response rate was 74% (n = 621/844). Of all the respondents, 39% scored in the range for significant distress. Distress varied by follow-up cytology result: negative, 36%; BNA or mild dyskaryosis, 42%; other (including high grade and inadequate), 55%. After adjusting for the cytology result, risk of distress was significantly raised in women who had significant anxiety at recruitment, reported experiencing pain after the follow-up cytology, had children, or were dissatisfied with support they had received after their initial BNA test. CONCLUSIONS: Substantial proportions of women experience surveillance-related psychologic distress after a follow-up cytology test, even when the result is negative. This is an important, albeit unintended, consequence of cervical screening. Strategies to alleviate this distress merit attention.

Predictors of anxiety and depression in people with colorectal cancer.

BACKGROUND: People living with colorectal cancer are at risk of anxiety and depression. We investigated what factors were most highly associated with these. METHODS: Four hundred and ninety-six people with colorectal cancer completed the Hospital Anxiety and Depression Scale (HADS). Data on functioning, symptoms, illness perceptions and social difficulties were collected by questionnaire. Case-note-identified disease, treatment and co-morbidity data were recorded. Multiple logistic regression identified factors independently predictive of anxiety and depression caseness. RESULTS: Self-reported history of anxiety/depression predicted anxiety but not depression caseness. Depression caseness predicted anxiety caseness (p = 0.043), as did poorer self-reported cognitive functioning (p = 0.001), dyspnoea (p = 0.015) or diarrhoea (p = 0.021), reporting a high negative life and emotional impact (p < 0.001) and having difficulties with finance (p = 0.007). Having neo-adjuvant radiotherapy increased the odds of depression caseness (p = 0.007), as did poorer physical (p = 0.007), cognitive (p < 0.001) and social (p < 0.001) functioning, having constipation (p = 0.011), reporting a high negative life and emotional impact (p < 0.001), having difficulties with personal care (p = 0.022) and communicating with others (p = 0.014). CONCLUSION: Levels of anxiety caseness were similar to those of non-clinical samples, but depression caseness was higher, particularly in those who had received neo-adjuvant radiotherapy. Most factors associated with possible or probable depression may be modified with appropriate intervention.

Measuring the psychosocial burden in women with low-grade abnormal cervical cytology in the TOMBOLA trial: psychometric properties of the Process and Outcome Specific Measure (POSM).

Background: There is a need for an instrument to measure the psychosocial burden of receiving an abnormal cervical cytology result which can be used regardless of the clinical management women receive.Methods: 3331 women completed the POSM as part of baseline psychosocial assessment in a trial of management of low grade cervical cytological abnormalities. Factor analysis and reliability assessment of the POSM were conducted.Results: Two factors were extracted from the POSM: Factor 1, containing items related to worry; and Factor 2 containing items relating to satisfaction with information and support received and change in the way women felt about themselves. Factor 1 had good reliability (Cronbach's alpha 0.769), however reliability of the Factor 2 was poorer(0.482). Data collected at four subsequent time points demonstrated that the factor structure was stable over time.Conclusion: This study demonstrates the presence and reliability of a scale measuring worries within the POSM. This analysis will inform its future use in this population and in other related contexts.

Case management vocational rehabilitation for women with breast cancer after surgery: a feasibility study incorporating a pilot randomised controlled trial.

BACKGROUND: There is a paucity of methodologically robust vocational rehabilitation (VR) intervention trials. This study assessed the feasibility and acceptability of a VR trial of women with breast cancer to inform the development of a larger interventional study. METHODS: Women were recruited in Scotland and randomised to either a case management VR service or to usual care. Data were collected on eligibility, recruitment and attrition rates to assess trial feasibility, and interviews conducted to determine trial acceptability. Sick leave days (primary outcome) were self-reported via postal questionnaire every 4 weeks during the first 6 months post-surgery and at 12 months. Secondary outcome measures were change in employment pattern, quality of life and fatigue. RESULTS: Of the 1,114 women assessed for eligibility, 163 (15%) were eligible. The main reason for ineligibility was age (>65 years, n = 637, 67%). Of those eligible, 111 (68%) received study information, of which 23 (21%) consented to participate in the study. Data for 18 (78%) women were analysed (intervention: n = 7; control: n = 11). Participants in the intervention group reported, on average, 53 fewer days of sick leave over the first 6 months post-surgery than those in the control group; however, this difference was not statistically significant (p = 0.122; 95% confidence interval -15.8, 122.0). No statistically significant differences were found for secondary outcomes. Interviews with trial participants indicated that trial procedures, including recruitment, randomisation and research instruments, were acceptable. CONCLUSIONS: Conducting a pragmatic trial of effectiveness of a VR intervention among cancer survivors is both feasible and acceptable, but more research about the exact components of a VR intervention and choice of outcomes to measure effectiveness is required. VR to assist breast cancer patients in the return to work process is an important component of cancer survivorship plans. TRIAL REGISTRATION: ISRCTN29666484.

Developing a community-based intervention to improve quality of life in people with colorectal cancer: a complex intervention development study.

OBJECTIVES: To develop and pilot a theory and evidence-based intervention to improve quality of life (QoL) in people with colorectal cancer. DESIGN: A complex intervention development study. SETTING: North East Scotland and Glasgow. PARTICIPANTS: Semistructured interviews with people with colorectal cancer (n=28), cancer specialists (n=16) and primary care health professionals (n=14) and pilot testing with patients (n=12). INTERVENTIONS: A single, 1 h nurse home visit 6-12 weeks after diagnosis, and telephone follow-up 1 week later (with a view to ongoing follow-up in future). PRIMARY AND SECONDARY OUTCOME MEASURES: Qualitative assessment of intervention feasibility and acceptability. RESULTS: Modifiable predictors of QoL identified previously were symptoms (fatigue, pain, diarrhoea, shortness of breath, insomnia, anorexia/cachexia, poor psychological well-being, sexual problems) and impaired activities. To modify these symptoms and activities, an intervention based on Control Theory was developed to help participants identify personally important symptoms and activities; set appropriate goals; use action planning to progress towards goals; self-monitor progress and identify (and tackle) barriers limiting progress. Interview responses were generally favourable and included recommendations about timing and style of delivery that were incorporated into the intervention. The pilot study demonstrated the feasibility of intervention delivery. CONCLUSIONS: Through multidisciplinary collaboration, a theory-based, acceptable and feasible intervention to improve QoL in colorectal cancer patients was developed, and can now be evaluated.

Impact of alternative management policies on health-related quality of life in women with low-grade abnormal cervical cytology referred for colposcopy.

OBJECTIVE: To assess the health-related quality of life (HRQoL) over 30 months among women who received colposcopy following low-grade abnormal cervical cytology. DESIGN: 751 women with low-grade abnormal cytology were seen for colposcopy. Of these, 350 additionally underwent either immediate treatment by large loop excision of the transformation zone (LLETZ) or investigation by punch biopsy followed by treatment of high-grade cervical intraepithelial neoplasia if present. The HRQoL of the women was assessed on seven separate occasions over 30 months by means of the EQ-5D instrument. Outcomes for women receiving colposcopy only, colposcopy with biopsy and colposcopy with LLETZ were compared. RESULTS: Women experienced modest short-term increases in HRQoL, statistically significant for the colposcopy only and biopsy groups but not for the LLETZ group. HRQoL in all three groups thereafter fell until 12 months following recruitment, significantly so for the LLETZ group. Changes in EQ-5D index score arose primarily from changes in severities in the "pain and discomfort" and "anxiety and depression" domains. Changes in the visual analogue scale (VAS) representations of quality of life corresponded closely to those of the index scores and most of the VAS scores themselves did not differ from VAS population norms. All inter-assessment changes in index scores were smaller than the minimum important difference for the instrument. Beyond 18 months from recruitment, HRQoL stabilised in all three groups. CONCLUSION: Women referred to colposcopy following a low-grade abnormal smear test result experienced a short-term improvement in their health-related quality of life, but the long-term effect was insubstantial. HRQoL over the post-recruitment follow-up period did not vary by intervention.

Psychosocial impact of alternative management policies for low-grade cervical abnormalities: results from the TOMBOLA randomised controlled trial.

BACKGROUND: Large numbers of women who participate in cervical screening require follow-up for minor cytological abnormalities. Little is known about the psychological consequences of alternative management policies for these women. We compared, over 30-months, psychosocial outcomes of two policies: cytological surveillance (repeat cervical cytology tests in primary care) and a hospital-based colposcopy examination. METHODS: Women attending for a routine cytology test within the UK NHS Cervical Screening Programmes were eligible to participate. 3399 women, aged 20-59 years, with low-grade abnormal cytology, were randomised to cytological surveillance (six-monthly tests; n = 1703) or initial colposcopy with biopsies and/or subsequent treatment based on colposcopic and histological findings (n = 1696). At 12, 18, 24 and 30-months post-recruitment, women completed the Hospital Anxiety and Depression Scale (HADS). A subgroup (n = 2354) completed the Impact of Event Scale (IES) six weeks after the colposcopy episode or first surveillance cytology test. Primary outcomes were percentages over the entire follow-up period of significant depression (≥ 8) and significant anxiety (≥ 11; "30-month percentages"). Secondary outcomes were point prevalences of significant depression, significant anxiety and procedure-related distress (≥ 9). Outcomes were compared between arms by calculating fully-adjusted odds ratios (ORs) for initial colposcopy versus cytological surveillance. RESULTS: There was no significant difference in 30-month percentages of significant depression (OR = 0.99, 95% CI 0.80-1.21) or anxiety (OR = 0.97, 95% CI 0.81-1.16) between arms. At the six-week assessment, anxiety and distress, but not depression, were significantly less common in the initial colposcopy arm (anxiety: 7.9% vs 13.4%; OR = 0.55, 95% CI 0.38-0.81; distress: 30.6% vs 39.3%, OR = 0.67 95% CI 0.54-0.84). Neither anxiety nor depression differed between arms at subsequent time-points. CONCLUSIONS: There was no difference in the longer-term psychosocial impact of management policies based on cytological surveillance or initial colposcopy. Policy-makers, clinicians, and women themselves can be reassured that neither management policy has a significantly greater psychosocial cost. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN 34841617.

Human papillomavirus infection and anxiety: analyses in women with low-grade cervical cytological abnormalities unaware of their infection status.

BACKGROUND: Women testing positive for human papillomavirus (HPV) infection experience increased levels of anxiety that have been attributed to fears of stigmatization and developing cervical cancer. The objective of this study was to investigate the association between HPV infection and anxiety in women who were unaware they had been tested specifically for HPV, to determine if any anxiety experienced by HPV-positive women could be due to causes other than learning of test results. METHODS: This study was nested within a randomised controlled trial of management of women with abnormal cervical cytology conducted in the United Kingdom with recruitment between 1999 and 2002. At baseline, prior to having a sample taken for HPV testing, the results of which were not disclosed, women were assessed for anxiety using the Hospital Anxiety and Depression Scale and asked about fears of developing cervical cancer ("cancer worries"); this assessment was repeated at 12, 18, 24, and 30 months of follow-up. Logistic regression and generalized estimating equations were used for the cross-sectional (baseline) and longitudinal analyses, respectively. RESULTS: Among the 2842 participants, there was no association between HPV status and anxiety among white women. Among non-white women, however, anxiety was less common among HPV-positive than HPV-negative women (adjusted odds ratio 0.41, 95% confidence interval 0.22 to 0.77). Among non-smokers, cancer worry was more common in HPV-positive than HPV-negative women; the opposite association was observed among ex-smokers. CONCLUSIONS: Associations between HPV status and anxiety may be explained by factors other than learning of test results and may vary by ethnicity and lifestyle factors.