Mary Wells

Intervention description is not enough: evidence from an in-depth multiple case study on the untold role and impact of context in randomised controlled trials of seven complex interventions

BackgroundA number of single case reports have suggested that the context within which intervention studies take place may challenge the assumptions that underpin randomised controlled trials (RCTs). However, the diverse ways in which context may challenge the central tenets of the RCT, and the degree to which this information is known to researchers or subsequently reported, has received much less attention. In this paper, we explore these issues by focusing on seven RCTs of interventions varying in type and degree of complexity, and across diverse contexts.MethodsThis in-depth multiple case study using interviews, focus groups and documentary analysis was conducted in two phases. In phase one, a RCT of a nurse-led intervention provided a single exploratory case and informed the design, sampling and data collection within the main study. Phase two consisted of a multiple explanatory case study covering a spectrum of trials of different types of complex intervention. A total of eighty-four data sources across the seven trials were accessed.ResultsWe present consistent empirical evidence across all trials to indicate that four key elements of context (personal, organisational, trial and problem context) are crucial to understanding how a complex intervention works and to enable both assessments of internal validity and likely generalisability to other settings. The ways in which context challenged trial operation was often complex, idiosyncratic, and subtle; often falling outside of current trial reporting formats. However, information on such issues appeared to be available via first hand ‘insider accounts’ of each trial suggesting that improved reporting on the role of context is possible.ConclusionsSufficient detail about context needs to be understood and reported in RCTs of complex interventions, in order for the transferability of complex interventions to be assessed. Improved reporting formats that require and encourage the clarification of both general and project-specific threats to the likely internal and external validity need to be developed. In addition, a cultural change is required in which the open and honest reporting of such issues is seen as an indicator of study strength and researcher integrity, rather than a symbol of a poor quality study or investigator ability.

Psychological, surgical, and sociodemographic predictors of pain outcomes after breast cancer surgery: A population-based cohort study

Summary Risk factors for chronic pain up to 9 months after breast cancer surgery include younger age, psychological vulnerability, axillary clearance surgery, and severe acute postoperative pain. ABSTRACT Chronic postsurgical pain (CPSP) is a common postoperative adverse event affecting up to half of women undergoing breast cancer surgery, yet few epidemiological studies have prospectively investigated the role of preoperative, intraoperative, and postoperative risk factors for pain onset and chronicity. We prospectively investigated preoperative sociodemographic and psychological factors, intraoperative clinical factors, and acute postoperative pain in a prospective cohort of 362 women undergoing surgery for primary breast cancer. Intraoperative nerve handling (division or preservation) of the intercostobrachial nerve was recorded. At 4 and 9 months after surgery, incidence of chronic painful symptoms not present preoperatively was 68% and 63%, respectively. Univariate analysis revealed that multiple psychological factors and nerve division was associated with chronic pain at 4 and 9 months. In a multivariate model, independent predictors of CPSP at 4 months included younger age and acute postoperative pain (odds ratio [OR] 1.34, 95% confidence interval [CI] 1.12 to 1.60), whereas preoperative psychological robustness (OR 0.70, 95% CI 0.49 to 0.99), a composite variable comprising high dispositional optimism, high positive affect, and low emotional distress, was protective. At 9 months, younger age, axillary node clearance (OR 2.97, 95% CI 1.09 to 8.06), and severity of acute postoperative pain (OR 1.17, 95% CI 1.00 to 1.37) were predictive of pain persistence. Of those with CPSP, 25% experienced moderate to severe pain and 40% were positive on Douleur Neuropathique 4 and Self‐Complete Leeds Assessment of Neuropathic Symptoms and Signs pain scales. Overall, a high proportion of women report painful symptoms, altered sensations, and numbness in the upper body within the first 9 months after resectional breast surgery and cancer treatment.

Supporting 'work-related goals' rather than 'return to work' after cancer? A systematic review and meta-synthesis of 25 qualitative studies

This study aimed to systematically review and synthesise qualitative studies of employment and cancer.

Promoting research participation : Why not advertise altruism?

Participation rates have a major impact on the quality, cost and timeliness of health research. There is growing evidence that participation rates may be falling and that new research governance structures and procedures may be increasing the likelihood of recruitment bias. It may be possible to encourage public reflection about research participation and enhance recruitment by providing information about the potential benefits of research to others as well as to research participants and by stimulating debate and influencing social expectations about involvement. Publicly funded and charitable bodies use various forms of advertising to encourage altruistic behaviour and generate social expectations about donating money, blood and organs for the benefit of others. Consideration should be given to the use of similar persuasive communications to promote wider participation in health research generally.

The effect of mammography pain on repeat participation in breast cancer screening: A systematic review

Uptake is crucial to reducing breast cancer mortality through screening. This review synthesised all available evidence on mammography pain as a deterrent to subsequent breast screening. Ten databases were searched. Studies containing empirical data relating mammography pain to breast screening re-attendance were included (n = 20). In the most robust studies asking women why they had not re-attended, 25%-46% cited pain, equivalent to approximately 47,000-87,000 women per year in England. The most robust evidence for an association between pain experienced at a previous mammogram and subsequent rates of re-attendance suggests that women who previously experienced pain are more likely than those who did not to fail to re-attend: RR 1.34 (95% CI: 0.94-1.91). The complexity of the pain phenomenon and of screening behaviours must be recognised. However, there is sufficient evidence to conclude that painful mammography contributes to non-re-attendance. Given the importance of cumulative participation, effective pain-reducing interventions in mammography are needed.

A systematic review of interventions for eating and drinking problems following treatment for head and neck cancer suggests a need to look beyond swallowing and trismus

PURPOSE The incidence of head and neck cancer (HNC) is increasing, and treatment advances have contributed to improvements in survival. However, a growing number of HNC survivors now live with the long-term consequences of cancer treatment, in particular, problems with eating. The combined effects of HNC cancer, intensive chemotherapy, radiotherapy and surgery have a profound impact on functional, psychological, social and physical aspects of eating. Evidence is needed to underpin new rehabilitation approaches to address these complex problems. This review aimed to identify and summarise the evidence for rehabilitation interventions aimed at alleviating eating problems after HNC treatment. METHODS A systematic review of studies indexed in Medline, CinAHL and PsycINFO using search terms relevant to a wide range of aspects of eating. Publications reporting empirical findings regarding physical, functional and/or psychosocial factors were included. RESULTS Twenty-seven studies were identified. Fifteen focussed on swallowing exercises, eight on interventions to improve jaw mobility and four on swallowing and jaw exercises. None included interventions to address the complex combination of functional, physical and psychological problems associated with eating in this patient group. CONCLUSIONS This review highlights that, whilst there is some evidence to support interventions aimed at improving swallowing and jaw mobility following treatment for HNC, studies are limited by their size and scope. Larger, high quality studies, which include patient-reported outcome measures, are required to underpin the development of patient-centred rehabilitation programmes. There is also a particular need to develop and evaluate interventions, which address the psychological and/or social aspects of eating.

“It makes you feel so full of life” LiveWell, a feasibility study of a personalised lifestyle programme for colorectal cancer survivors

GoalsThe acceptability and feasibility of a 3-month personalised lifestyle (diet, exercise and weight management) intervention in overweight adults who had completed curative treatment for colorectal cancer were assessed by qualitative interviews, quality-of-life questionnaires and subjective and objective measures of diet and activity.Main resultsOver a 4-month period, 28 of 37 (75%) patients met the inclusion criteria and 20 (71%) of the eligible patients agreed to participate in the study and 18 (90%) completed the 3-month study. Reported adherence related to tailored advice, personalised feedback and family support. Reported barriers included time following surgery, fatigue, having a stoma or chronic diarrhoea and conflicting advice from clinicians. A weight change of −1.2 (±4.4) kg was achieved overall and −4.1 (±3.7) kg in the ten who had lost weight.ConclusionsColorectal cancer survivors will participate in a lifestyle change initiative. Interventions should be personalised to suit abilities, provide feedback on personal goals and encourage social support. Intervention timing and attaining greater support from clinicians should be explored prior to the development of an efficacy trial.

Patients and carer experiences of care provision after a diagnosis of lung cancer in Scotland

IntroductionThis qualitative study was set out to explore experiences of care provision of 60 patients diagnosed with lung cancer and a carer of their choiceMaterials and methodsParticipants were invited to take part in three in-depth interviews over a 6-month period. After considerable sample attrition due to worsening disease or death over the study period, 23 complete patient data sets were available for analysis. Fifteen complete carer data sets were analysed.ResultsFour key domains of need were identified: (1) the pathway to confirmation of diagnosis, (2) communication of diagnosis, treatment options and prognosis, (3) provision of co-ordinated, family-oriented care and (4) support away from acute services. Discernable shifts in patients’ needs were apparent over time within and across the four domains, illustrating a complex relationship between the categories of need experienced by patients and carers.DiscussionAround the time of diagnosis, the priorities of patients and carers centred around their needs for information about the process of treatment and the options open to them. As time went on, they appeared to experience feelings of greater isolation and physical dependency and were particularly aware of deficiencies in the coordination of supportive care. Many patients appeared to rely on the relationship they had developed with their hospital consultant and, therefore, found it difficult to make the transition into palliative care or at least a more primary-care-led service once treatment was over.ConclusionData from the study point to the importance of heightening general practitioner awareness of potential signs and symptoms of lung cancer. Findings indicate the need to evaluate the benefits to patients and carers of rapid access to diagnostic tests and results and support the establishment of effective and streamlined supportive care pathways for patients with lung cancer.

Chronic preoperative pain and psychological robustness predict acute postoperative pain outcomes after surgery for breast cancer

Background:Few epidemiological studies have prospectively investigated preoperative and surgical risk factors for acute postoperative pain after surgery for breast cancer. We investigated demographic, psychological, pain-related and surgical risk factors in women undergoing resectional surgery for breast cancer.Methods:Primary outcomes were pain severity, at rest (PAR) and movement-evoked pain (MEP), in the first postoperative week.Results:In 338 women undergoing surgery, those with chronic preoperative pain were three times more likely to report moderate to severe MEP after breast cancer surgery (OR 3.18, 95% CI 1.45–6.99). Increased psychological ‘robustness’, a composite variable representing positive affect and dispositional optimism, was associated with lower intensity acute postoperative PAR (OR 0.63, 95% CI 0.48–0.82) and MEP (OR 0.71, 95% CI 0.54–0.93). Sentinel lymph node biopsy (SLNB) and intraoperative nerve division were associated with reduced postoperative pain. No relationship was found between preoperative neuropathic pain and acute pain outcomes; altered sensations and numbness postoperatively were more common after axillary sample or clearance compared with SLNB.Conclusion:Chronic preoperative pain, axillary surgery and psychological robustness significantly predicted acute pain outcomes after surgery for breast cancer. Preoperative identification and targeted intervention of subgroups at risk could enhance the recovery trajectory in cancer survivors.

Patient, carer and health service outcomes of nurse-led early discharge after breast cancer surgery: a randomised controlled trial

Patients with breast cancer who require axillary clearance traditionally remain in hospital until their wound drains are removed. Early discharge has been shown to improve clinical outcomes, but there has been little assessment of the psychosocial and financial impact of early discharge on patients, carers and the health service. This study aimed to evaluate the effectiveness of a nurse-led model of early discharge from hospital. Main outcome measures were quality of life and carer burden. Secondary outcomes included patient satisfaction, arm morbidity, impact on community nurses, health service costs, surgical cancellations and in-patient nursing dependency. A total of 108 patients undergoing axillary clearance with mastectomy or wide local excision for breast cancer were randomised to nurse-led early discharge or conventional stay. Nurse-led early discharge had no adverse effects on quality of life or patient satisfaction, had little effect on carer burden, improved communication between primary and secondary care, reduced cancellations and was safely implemented in a mixed rural/urban setting. In total, 40% of eligible patients agreed to take part. Nonparticipants were significantly older, more likely to live alone and had lower emotional well being before surgery. This study provides further evidence of the benefits of early discharge from hospital following axillary clearance for breast cancer. However, if given the choice, most patients prefer to stay in hospital until their wound drains are removed.