How to summarise and report written qualitative data from patients: a method for use in cancer support care

Goals of work: Determination of key themes to aid the analysis of qualitative data collected at three cancer support centres in England, using the Measure Yourself Concerns and Wellbeing (MYCaW) questionnaire. Patients and methods: People with cancer who use complementary therapies experience and value a wide range of treatment effects, yet tools are urgently required to quantitatively measure these outcomes. MYCAW is an individualised questionnaire used in cancer support centres providing complementary therapies, scoring 'concerns or problems' and 'wellbeing' and collects qualitative data about other major events in a patient's life and what has been most important to the patient. Content analysis on 782 MYCaW questionnaires from people at these cancer support centres was carried out. The "concerns", "other things going on in their life" and "important aspects of centre" were thematically categorised, externally validated by a focus group and the inter-rater reliability calculated. Main results: Clinical information from a cancer patient's perspective was collected that is not measured on standard quality of life questionnaires; furthermore some themes acknowledge the multifaceted aspects of CAM provision, rather than information only relating to the therapeutic intervention. Categories for qualitative MYCaW analysis have been established providing a tool for future research and/or service delivery improvement within cancer support centres such as these. Conclusions: The established themes provide a framework to aid analysis of qualitative aspects of complementary therapy care for people with cancer, improving our understanding of how the patient’s cancer experience can be aided by complementary therapies in specialized cancer centres

Tourniquet use for knee replacement surgery

Background Many surgeons prefer to perform total knee replacement surgery with the aid of a tourniquet. A tourniquet is an occlusive device that restricts distal blood flow to help create a bloodless field during the procedure. A tourniquet may be associated with increased risk of pain and complications. Objectives To determine the benefits and harms of tourniquet use in knee replacement surgery. Search methods We searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) up to 26 March 2020. We searched clinicaltrials.gov, the World Health Organization trials portal, and several international registries and joint registries up to March 2020. Selection criteria We included randomised controlled trials (RCTs) comparing knee replacement with use of a tourniquet versus without use of a tourniquet and non‐randomised studies with more than 1000 participants. Major outcomes included pain, function, global assessment of success, health‐related quality of life, serious adverse events (including venous thromboembolism, infection, re‐operation, and mortality), cognitive function, and survival of the implant. Minor outcomes included blood loss, economic outcomes, implant stability, and adverse events. Data collection and analysis Two review authors screened abstracts and full texts, extracted data, performed risk of bias assessments, and assessed the certainty of the evidence using the GRADE approach. Main results We included 41 RCTs with 2819 participants. Trials included from 20 to 199 participants. Mean age ranged between 58 and 84 years. More than half of the RCTs had unclear risk of selection bias and unclear risk of performance and detection bias due to absence of blinding of participants and surgeons. Major outcomes Pain: at postoperative day 1, pain (on a scale from zero to 10, with higher scores indicating worse pain) was ranked at 4.56 points after surgery without a tourniquet and at 1.25 points (MD) higher (95% CI 0.32 higher to 2.19 higher) with a tourniquet (8 studies; 577 participants), for an absolute difference of 12.5% higher pain scores (95% CI 3.2% higher to 21.9% higher) and a relative difference of 19% higher pain scores (95% CI 3.4% higher to 49% higher) with a tourniquet. Evidence for these findings was of moderate certainty, downgraded due to risk of bias. Knee replacement with a tourniquet probably led to higher postoperative pain scores at day 1, although this difference may or may not be noticeable to patients (based on a minimal clinically important difference (MCID) of 1.0). Function: at 12 months, tourniquet use probably makes little or no difference to function, based on an MCID of 5.3 for Knee Society Score (KSS) and 5.0 for Oxford Knee Score (OKS). Mean function (on a scale from 0 to 100, with higher scores indicating better outcomes) was 90.03 points after surgery without a tourniquet and was 0.29 points worse (95% CI 1.06 worse to 0.48 better) on a 0 to 100 scale, absolute difference was 0.29% worse (1.06% worse to 0.48% better), with a tourniquet (5 studies; 611 participants). This evidence was downgraded to moderate certainty due to risk of bias. Global assessment of success: low‐certainty evidence (downgraded due to bias and imprecision) indicates that tourniquet use may have little or no effect on success. At six months, 47 of 50 (or 940 per 1000) reported overall successful treatment after surgery without a tourniquet and 47 of 50 (or 940 per 1000) with a tourniquet (risk ratio (RR) 1.0, 95% CI 0.91 to 1.10) based on one study with 100 participants. Health‐related quality of life: at six months, tourniquet may have little or no effect on quality of life. The 12‐Item Short Form Survey (SF‐12) score (mental component from zero to 100 (100 is best)) was 54.64 after surgery without a tourniquet and 1.53 (MD) better (95% CI 0.85 worse to 3.91 better) with a tourniquet (1 study; 199 participants); absolute difference was 1.53% better (0.85% worse to 3.91% better). Evidence was of low certainty, downgraded due to risk of bias and small number of participants. Serious adverse events: the risk of serious adverse events was probably higher with tourniquet; 26 of 898 (29 per 1000) reported events following surgery without a tourniquet compared to 53 of 901 (59 per 1000) with a tourniquet (RR 1.73, 95% CI 1.10 to 2.73) in 21 studies (1799 participants). Twenty‐nine more per 1000 patients (95% CI 3 to 50 more per 1000 patients) had a serious adverse event with a tourniquet. Forty‐eight (95% CI 20 to 345) participants would need to have surgery without a tourniquet to avoid one serious adverse event. This evidence was downgraded to moderate certainty due to risk of bias. Cognitive function: one study reported cognitive function as an outcome; however the data were incompletely reported and could not be extracted for analysis. Survival of implant: it is uncertain if tourniquet has an effect on implant survival due to very low certainty evidence (downgraded for bias, and twice due to very low event rates); 2 of 107 (19 per 1000) required revision surgery in the surgery with a tourniquet group compared to 1 of 107 (9 per 1000) without a tourniquet group at up to two years' follow‐up (RR 1.44, 95% CI 0.23 to 8.92). This equates to a 0.4% (0.7% lower to 7% more) increased absolute risk in surgery with a tourniquet. Authors' conclusions Moderate certainty evidence shows that knee replacement surgery with a tourniquet is probably associated with an increased risk of serious adverse events. Surgery with a tourniquet is also probably associated with higher postoperative pain, although this difference may or may not be noticeable to patients. Surgery with a tourniquet does not appear to confer any clinically meaningful benefit on function, treatment success or quality of life. Further research is required to explore the effects of tourniquet use on cognitive function and implant survival, to identify any additional harms or benefits. If a tourniquet continues to be used in knee replacement surgery, patients should be informed about the potential increased risk of serious adverse events and postoperative pain.</p

Development of Measure Yourself Concerns and Wellbeing for informal caregivers of people with cancer – a multicentred study

Purpose: Measure Yourself Concerns and Wellbeing (MYCaW) is a validated person-centred measure of the concerns and wellbeing of people affected by cancer. Research suggests that the concerns of informal caregivers (ICs) are as complex and severely rated as people with cancer, yet MYCaW has only been used to represent cancer patients’ concerns and wellbeing. This paper reports on the development of a new qualitative coding framework for MYCaW to capture the concerns of ICs, to better understand the needs of this group. Methods: This multicentred study involved collection of data from ICs receiving support from two UK cancer support charities (Penny Brohn UK and Cavendish Cancer Care). Qualitative codes were developed through a detailed thematic analysis of ICs’ stated concerns. Results: Thematic analysis of IC questionnaire data identified key themes which were translated into a coding framework with two overarching sections; 1. ‘informal caregiver concerns for self’ and 2. ‘informal caregiver concerns for the person with cancer’. Supercategories with specific accompanying codes were developed for each section. Two further rounds of framework testing across different cohorts allowed for iterative development and refinement of the framework content. Conclusions: This is the first person-centred tool specifically designed for capturing IC’s concerns through their own words. This coding framework will allow for IC data to be analysed using a rigorous and reproducible method, and therefore reported in a standardised way. This may also be of interest to those exploring the needs of ICs of people in other situations

Individualised and complex experiences of integrative cancer support care: combining qualitative and quantitative data

Objectives: The widespread use of complementary therapies alongside biomedical treatment by people with cancer is not supported by evidence from clinical trials. We aimed to use combined qualitative and quantitative data to describe and measure individualised experiences and outcomes. Materials and methods In three integrative cancer support centres (two breast cancer only) in the UK, consecutive patients completed the individualised outcome questionnaire Measure Yourself Concerns and Wellbeing (MYCaW) before and after treatment. MYCaW collects quantitative data (seven-point scales) and written qualitative data and the qualitative data were analysed using published categories. Results: Seven hundred eighty-two participants, 92% female, mean age 51 years, nominated a wide range of concerns. Psychological and emotional concerns predominated. At follow-up, the mean change (improvement) in scores (n = 588) were: concern 1, 2.06 (95% CI 1.92–2.20); concern 2, 1.74 (95% CI 1.60–1.90); and well-being, 0.64 (95% CI 0.52–0.75). The most common responses to ‘what has been the most important aspect for you?’ were ‘receiving complementary therapies on an individual or group basis’ (26.2%); ‘support and understanding received from therapists’ (17.1%) and ‘time spent with other patients at the centres’ (16.1%). Positive (61.5%) and negative (38.5%) descriptions of ‘other things affecting your health’ correlated with larger and smaller improvement in concerns and well-being, respectively. Conclusions: In a multicentre evaluation, the MYCaW questionnaire provides rich data about patient experience, changes over time and perceptions of what was important to each individual with cancer within that experience. It is unlikely that meaningful evaluations of this complex intervention could be carried out by quantitative methods alone

Development of social contact and loneliness measures with validation in social prescribing

Aims This paper describes two patient-reported measures of social contact and loneliness, which are closely related concepts. The first measure (R-Outcomes Social Contact measure) was developed from scratch, based on customer needs and literature review. It covers emotional and social aspects using positive terms. The second measure (R-Outcomes Loneliness measure) is adapted from the GSS Loneliness Harmonised Standard. Both measures are patient-reported outcome measures, based on patients’ own perception of how they feel.Method This development started in 2016 in response to customers’ requests to measure social contact/loneliness for patients in social prescribing projects.Both measures are compared with three other loneliness measures (the GSS Loneliness Harmonised Standard, De Jong Gierveld and Campaign to End Loneliness). Both measures are short (36 and 21 words, respectively). Mean improvement is reported as a positive number on a 0–100 scale (where high is good).We tested the psychometric performance and construct validity of the R-Outcomes Social Contact measure using secondary analysis of anonymised data collected before and after social prescribing interventions in one part of Southern England.Results In the validation study, 728 responses, collected during 2019–2020, were analysed. 90% were over 70 years old and 62% women. Cronbach’s α=0.76, which suggests that it is appropriate to use a single summary score. Mean Social Contact scores before and after social prescribing intervention were 59.9 (before) and 66.7 (after, p&lt;0.001).Exploratory factor analysis shows that measures for social contact, health status, health confidence, patient experience, personal well-being, medication adherence and social determinants of health are correlated but distinct factors. Construct validation shows that the results are consistent with nine hypotheses, based on the loneliness literature.Conclusion The R-Outcomes Social Contact measure has good psychometric and construct validation results in a population referred to social prescribing. It is complementary to other R-Outcomes measures

Impact of psychological counselling service at Penny Brohn UK

Background: For people with cancer, research has shown counselling may be beneficial for wellbeing, anxiety, depression and helping with the sexual side-effects of cancer. Penny Brohn UK (PBUK) is a cancer charity that supports people to live well with cancer. It offers face-to-face or telephone counselling for anyone aged over 18 with a cancer diagnosis and their close supporters.Method: PBUK’s counselling service was evaluated using the validated person-centred outcome measure MYCaW (Measure Yourself Concerns and Wellbeing), measuring the impact of cancer support services on the severity of people’s cancer related concerns and wellbeing. Concerns were rated at the start of counselling and re-rated at the end of the last session. Qualitative data was captured on the MYCaW tool regarding other things going on in people’s life affecting health and what was important about the service they received. Data was analysed using the accompanying qualitative coding framework.Data was analysed for all clients who had attended counselling appointments in January- December 2017 and provided full pre- post-counselling MYCaW data.Results: 40 clients provided pre-post MYCaW data and attended an average of 6 sessions (range 1 to 18). Psychological and emotional concerns were top rated for concern 1 and 2 (81% and 78% respectively). Prior to counselling, concerns were rated fairly severely (5.1/6 for concern 1 and 2; 6 being the worst). After counselling concerns showed a statistically significant improvement (2.2/6 and 2/6 for concern 1 and 2 respectively, p<.000 for both). 90% of clients showed a clinically significant improvement in their concerns. Qualitative data indicated that counselling at PBUK gave clients the opportunity to talk, provided time for themselves and made them feel supported and understood.Conclusion: Counselling at PBUK led to a statistically significant improvement in cancer-related concerns and wellbeing. A larger sample is needed to explore this further.Disclosure: Funded by Penny Brohn UKCorresponding author: Helen Seer

Exploration of the impact of the Penny Brohn UK Living Well Course on Cancer Survivors' employment and active community role status

Background: Over 750,000 people of working age in the UK are estimated to live with or beyond cancer, with 63,000 wishing to, but not working. Penny Brohn UK is a leading cancer support charity, offering the Living Well Course (LWC) which supports those affected by cancer to live healthy and active lives, including returning to work after cancer. No existing research has examined the impact of LWC on cancer survivors' employment or volunteering status to date. This study provides an initial exploration of the issue.Aims: This study aimed to add to existing patient activation and patient-reported quality of life outcome evaluations of LWC by providing a 12-month follow-up to explore the long-term impact of LWC upon employment and volunteering status.Methods: A mixed-method longitudinal design was applied with data collected at baseline, 6 months and 12 month follow up. Data from 43 clients were collected at 12-month follow-up using the PAM-10 and a bespoke Long-Term Follow-Up Questionnaire.Results: Logistic regression showed statistically significant improvements in volunteering and employment status, as well as diet, exercise, relationships, utilisation of self-help techniques and patient resulting from attending LWC. A smaller non-significant result was found between levels of patient activation and employment and volunteering status.Conclusions: Attending a Penny Brohn UK LWC had a significant positive impact upon volunteering and employment status of those who attended. This paper adds support for the use of holistic patient-centred interventions for improving employment outcomes for people living with and beyond cancer

Evaluation of Penny Brohn UK’s national programme of ‘Living Well With and Beyond Cancer’ services

Background: Penny Brohn UK (PBUK) is a leading UK charity specialising in helping people live well with the impact of cancer. National Lottery’s Big Lottery funding between 2015-18 has supported PBUK Living Well with and Beyond Cancer (LWWBC) services in five areas of the UK. Services include Living Well courses (LWC), Follow-Up (FU) support.Method: Pre and 6-weeks post-LWWBC questionnaires used were: Patient Activation Measure (PAM) for health self-management, Measure Yourself Concerns and Wellbeing (MYCaW) for concerns and wellbeing perception, and Patient Reported Experience Measure for personal reflection on support gained.Results: 145 courses (123 LWC and 22 FU), located in North England (8), South Coast (32), Midlands (29), South East (43) and South West (33) are running over 3 years. 901 people with cancer enrolled in the first 2 years with between 12-23% (111-206) evaluation postal response rate for pre-post paired data. Year 3 is still underway. Years 1 and 2 data as follows: 43% (48/111) had a meaningful improvement in their post Patient Activation Measure scores indicating they were more likely to go on to self-manage their health. 87% (163/188) of people stated they had been better able to self-manage their own health after LWWBC services.70% (144/206) had a clinically significant improvement in their MYCaW main cancer related concerns, and 43% (89/205) had a clinically significant improvement in MYCaW wellbeing.There were reported improvements in: diet (87% 174/199), exercise (74% 143/193) relationship issues (63% 120/189) and use of stress management techniques (90% 179/199). Of the 199 respondents, 65% reported subsequently attending a meditation or group and 60% joined an exercise class after the LWWBC. Patterns of improvement in MYCaW cancer-related concerns and wellbeing were reported across all regions, demonstrating a successful expansion of PBUK support services across England.Conclusion: PBUK’s LWWBC evaluation responses indicate a positive and potentially beneficial experience.Disclosure: Funded by Penny Brohn U