Objective: Chemotherapy-induced cognitive impairments are reported by many cancer survivors. Research to date has not provided a clear description of their nature, extent, mechanisms, and duration. To investigate the impairments and factors that could influence their identification and severity, the present meta-analysis brings together research on this topic in adult cancer patients. Method: Our random-model meta-analysis includes 44 studies investigating the cognitive performance of adults treated with chemotherapy for non-central nervous system malignancies, primarily breast and testicular cancer. We conducted several subgroup analyses to identify the level of cognitive impairments in longitudinal and cross-sectional studies. We also pursued several multilevel model regressions to investigate the impact of methodological (study quality) and clinical moderators (diagnosis, age, time since treatment) on the observed effect sizes. Results: Cognitive impairments were found in cross-sectional studies in immediate free recall, delayed memory, verbal memory, delayed recognition memory, selective attention, and attention capacity. Surprisingly, prior to chemotherapy, patients performed better than matched controls. In longitudinal studies, patients’ performance increased from baseline to follow-up, an effect that was stronger in patients than controls. None of the chosen moderators influenced the magnitude of estimated summary effect sizes. Conclusions: The likelihood to identify impairments rests on the type of design employed, as memory and attention impairments are only detected in cross-sectional studies. We discuss the lack of significant impact of moderators on the effect sizes despite the heterogeneity of results, while providing recommendations toward decreasing the heterogeneity in future studies.
IntroductionMedically unexplained symptoms (MUS) are common in primary-care and secondary-care settings. Persistent symptoms of MUS are associated with a variety of poor outcomes including increased disability, poor quality of life and high healthcare costs. The aim of this systematic review is to review the relevant literature to determine the prevalence of MUS in patients who are high users of healthcare and/or who accrue high healthcare costs.Methods and analysisThis review will include studies with cases that are either high users of general healthcare or are patients who accrue high healthcare costs, aged ≥18 years and where a recognised measure of MUS, either a standardised clinical interview or questionnaire, was employed. The following citation databases MEDLINE, PsycINFO, EMBASE, CINAHL, PROSPERO and the Cochrane library will be systematically searched from inception to 30 June 2018. The Cochrane library was included because of the significant proportion of non-observational studies currently published in the database. The prevalence of MUS and associated disorders along with the costs or use of healthcare associated with the presence of MUS will be estimated with 95% CI. If possible, study results will be pooled into a meta-analysis. However, if heterogeneity is high, data analysis will be presented descriptively.Ethics and disseminationEthical approval is not required for this systematic review since only data from existing studies will be used. Results of this review will be disseminated in peer-reviewed publications and at national and international conferences.PROSPERO registration numberCRD42018100388
Background/aims New classes of cancer drugs bring a range of unknown and undesirable adverse events. Adverse event monitoring is essential in phase I trials to assess toxicity and safety. In phase II, the focus is also on efficacy but robust data on adverse events continue to inform the safety and the adverse event profile. Standard, clinician-led monitoring has been shown to underestimate patients’ symptoms. Hence, patient-reported adverse event monitoring has been argued to complement and improve the information on adverse events in early phase clinical trials. With advances in information technology, real-time patient self-reported adverse events in trials are feasible. This study explored the experiences and procedures for reporting adverse events in early phase trials among patients, clinical staff, and trial staff, and their views on using an electronic patient-reported outcome adverse event system in this setting. Methods Qualitative interviews were conducted with patients, purposively sampled across ages, gender, and different phases of trials, and with clinical and trial-related staff involved in early phase trials (e.g. consultants, research nurses, hospital-based trial assistants/data managers, trial unit management staff). Interviews explored patient experiences and views on current adverse event reporting processes and electronic patient-reported outcome adverse event reporting. Framework analysis techniques were used to analyse the data. Results Interviewees were from two hospital trusts with early phase portfolios in England and a trial unit, and included sixteen patients, five consultants, four research nurses, five hospital-based trial staff, and two trial unit staff. Interviews identified three key themes (patient experiences, data flow, and views on electronic patient-reported outcome adverse event reporting). Stakeholders emphasised the intensity of trials for patients and the importance of extensive information provision within the uncertainty of early phase trial drugs. Regular face-to-face appointments for patients supplemented by telephone contact aimed to capture any adverse events. Delayed or under-reporting of mild- or low-severity symptoms was evident among patients. Hospital-based staff highlighted the challenges of current data collection including intense timescales, monitoring by trial sponsors, and high workload. Positive views on electronic patient-reported outcome adverse events highlighted that this could provide a more comprehensive and accurate view on the side effects of new drugs. Clinical staff emphasised patient safety and the need for clear responsibilities for monitoring. The need for careful decision-making about data flow and symptom attribution was highlighted; with trial unit staff emphasising the need for clinician review. Conclusion Technology advances mean it is timely to explore the benefits and challenges of electronic patient-reported outcome adverse event reporting. This is a complex area warranting further consideration within the trial community. We have developed an online patient self-reporting tool and a small pilot with early phase trial patients is underway.
Background: Increasing numbers of ovarian cancer patients are living longer and requiring regular follow-up to detect disease recurrence. New models of follow-up care are needed to meet the growing number and needs of this patient group. The potential for patient-reported outcome measures (PROMs) to capture key symptoms and online technology to facilitate long-term follow-up has been suggested. Objectives: Prior to a pilot study exploring the potential for electronic patient-reported symptom monitoring, the content of an online intervention was developed via Delphi methodology. Design and setting: A Delphi process was conducted aiming to obtain consensus amongst the clinicians and patients from 4 hospitals on the key aspects to monitor during follow-up after ovarian cancer treatment, and how to monitor them in an online intervention. A two round Delphi was conducted. Consensus was defined as at least 70% agreement. Results: Out of 43 participants, 30 (18 patients, 12 healthcare professionals) completed round 1 and 19 (11 patients, 8 healthcare professionals) completed round 2. Consensus was reached on the key symptoms to monitor, and the importance of monitoring both duration and frequency of symptoms. Opportunity for review of psychological wellbeing and holistic needs were considered important by both groups. The frequency of online questionnaire completion, timeframe for patients to reflect on (e.g. during the past X weeks), and the choice of PROMs items to monitor symptoms did not reach the consensus threshold. Conclusion: It is crucial that any intervention and the selection of PROMs is fully described to ensure transparency about the development and decisions taken. In this work, a set of key symptoms and areas to monitor were agreed, which has informed the design of an online intervention and a subsequent pilot study is now underway. The proposed model of remote follow-up using electronic PROMs could be adapted and explored in other cancer sites.
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