Collaborative evaluation of a pilot involvement opportunity: Cochrane Common Mental Disorders Voice of Experience College.

BACKGROUND: Involving consumers in systematic reviews can make them more valuable and help achieve goals around transparency. Systematic reviews are technically complex and training can be needed to enable consumers to engage with them fully. The Cochrane Common Mental Disorders group sought to engage people with lived experience of mental health problems in the Voice of Experience College, three workshops introducing them to systematic review methods and to opportunities to contribute as Cochrane consumers. We aimed to collectively evaluate the College from the perspective of both facilitators and consumers, to critically reflect on the experience, and to identify how the College could be sustained and spread to other review groups. METHODS: This study was a longitudinal qualitative and collaborative evaluation, structured around normalisation process theory. Both facilitators and consumers were involved in not only providing their perspectives but also reflecting on these together to identify key learning points. RESULTS: The workshops were positively evaluated as being engaging and supportive, largely due to the relational skills of the facilitators, and their willingness to engage in joint or two-way learning. The College suffered from a lack of clarity over the role of consumers after the College itself, with a need for greater communication to check assumptions and clarify expectations. This was not achieved due to pandemic disruptions, which nevertheless demonstrated that resources for involvement were not prioritised as core business during this period. CONCLUSIONS: Soft skills around communication and support are crucial to effective consumer engagement. Sustaining involvement requires sustained communication and opportunities to reflect together on opportunities and challenges. This requires committed resources to ensure involvement activity is prioritised. This is critical as negative experiences later in the involvement journey can undermine originally positive experiences if contributors are unclear as to what their involvement can lead to. Open discussions about this are necessary to avoid conflicting assumptions. The spread of the approach to other review groups could be achieved by flexibly adapting to group-specific resources and settings, but maintaining a core focus on collaborative relationships as the key mechanism of engagement. PATIENT AND PUBLIC CONTRIBUTION: Public contributors were collaborators throughout the evaluation process and have co-authored the paper.

Chair-based yoga programme for older adults with multimorbidity: RCT with embedded economic and process evaluations.

Background: Older adults with multimorbidity experience impaired health-related quality of life and treatment burden. Yoga has the potential to improve several aspects of health and well-being. The British Wheel of Yoga's Gentle Years Yoga© programme was developed specifically for older adults, including those with chronic conditions. A pilot trial demonstrated feasibility of using Gentle Years Yoga in this population, but there was limited evidence of its effectiveness and cost-effectiveness. Objective: To determine the effectiveness and cost-effectiveness of the Gentle Years Yoga programme in addition to usual care versus usual care alone in older adults with multimorbidity. Design: Pragmatic, multisite, individually randomised controlled trial with embedded economic and process evaluations. Setting: Participants were recruited from 15 general practices in England and Wales from July 2019 with final follow-up in October 2022. Participants: Community-dwelling adults aged 65 years and over with multimorbidity, defined as two or more chronic health conditions from a predefined list. Interventions: All participants continued with any usual care provided by primary, secondary, community and social services. The intervention group was offered a 12-week programme of Gentle Years Yoga. Main outcome measures: The primary outcome and end point were health-related quality of life measured using the EuroQol-5 Dimensions, five-level version utility index score over 12 months. Secondary outcomes were health-related quality of life, depression, anxiety, loneliness, incidence of falls, adverse events and healthcare resource use. Results: The mean age of the 454 randomised participants was 73.5 years; 60.6% were female, and participants had a median of three chronic conditions. The primary analysis included 422 participants (intervention, n = 227 of 240, 94.6%; usual care, n = 195 of 214, 91.1%). There was no statistically or clinically significant difference in the EuroQol-5 Dimensions, five-level version utility index score over 12 months: the predicted mean score for the intervention group was 0.729 (95% confidence interval 0.712 to 0.747) and for usual care it was 0.710 [95% confidence interval (CI) 0.691 to 0.729], with an adjusted mean difference of 0.020 favouring intervention (95% CI -0.006 to 0.045, p = 0.14). No statistically significant differences were observed in secondary outcomes, except for the pain items of the Patient-Reported Outcomes Measurement Information System-29. No serious, related adverse events were reported. The intervention cost £80.85 more per participant (95% CI £76.73 to £84.97) than usual care, generated an additional 0.0178 quality-adjusted life-years per participant (95% CI 0.0175 to 0.0180) and had a 79% probability of being cost-effective at the National Institute for Health and Care Excellence threshold of £20,000 per quality-adjusted life-year gained. The intervention was acceptable to participants, with seven courses delivered face to face and 12 online. Limitations: Self-reported outcome data raise the potential for bias in an unblinded trial. The COVID-19 pandemic affected recruitment, follow-up and the mode of intervention delivery. Conclusions: Although the Gentle Years Yoga programme was not associated with any statistically significant benefits in terms of health-related quality of life, mental health, loneliness or falls, the intervention was safe, acceptable to most participants and highly valued by some. The economic evaluation suggests that the intervention could be cost-effective. Future work: Longer-term cost-effectiveness modelling and identifying subgroups of people who are most likely to benefit from this type of intervention. Trial registration: This trial is registered as ISRCTN13567538. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 17/94/36) and is published in full in Health Technology Assessment; Vol. 28, No. 53. See the NIHR Funding and Awards website for further award information.

It is common for older adults to have two or more long-term health conditions. These conditions affect quality of life differently, with some people feeling well and others needing healthcare support. The Gentle Years Yoga programme was developed to improve quality of life for older adults, including those with long-term health conditions. We wanted to see how well the programme worked and if it offered good value for money for the NHS. We tested whether offering a 12-week course of Gentle Years Yoga improved the quality of life and reduced anxiety, depression, loneliness and falls for people aged 65 years and over who had two or more long-term health conditions. We recruited 454 people through general practices across England and Wales, with 240 people selected at random to be invited to take part in the Gentle Years Yoga programme and the other 214 to continue with their usual care and not be offered Gentle Years Yoga. The average age of participants was 74 years, nearly two-thirds were female and the number of long-term health conditions participants had ranged from two to nine (average was three). They completed four questionnaires over a 12-month period. We also interviewed some of the participants and the yoga teachers to find out how the approach worked in practice. The yoga was delivered either face to face or online. We did not find any significant benefits in terms of quality of life, anxiety, depression, loneliness or falls. At interview, some yoga participants noted no or a modest impact on their health or lifestyle, while others described Gentle Years Yoga as transformative, having substantial impacts and improvements on their physical health and emotional well-being. Because running the yoga classes was relatively inexpensive and some insignificant benefits were seen, the Gentle Years Yoga programme may be good value for money.

Patient and primary care practitioners' perspectives on consultations for fibromyalgia: a qualitative evidence synthesis.

BACKGROUND: Fibromyalgia presents a challenge to both the patients experiencing symptoms and the staff aiming to treat them. This qualitative review aimed to synthesise how patients and practitioners experience primary care consultations, develop a rounded picture of how they perceive each other, the challenges to primary care consultation and how they might be tackled. METHODS: CINAHL, Embase, CENTRAL and Medline were searched from inception to November 2021. Qualitative studies were included if they explored the perspectives and experiences of either fibromyalgia patients or primary care practitioners. Quantitative data, studies not published in English, not set in primary care or that did not distinguish the type of patient or clinician were excluded. Included studies were analysed using thematic synthesis and their quality assessed. RESULTS: In total, 30 studies met the inclusion criteria. Thematic synthesis identified three overarching themes: (1) life turned upside down - exploring the chaos experienced by patients as they seek help; (2) negative cycle - highlighting how patient and practitioner factors can create a detrimental cycle; and (3) breaking the cycle - validating patient-doctor relationships underpinned by clear communication can help break the negative cycle. CONCLUSIONS: Fibromyalgia patients experience uncertainty and chaos that can clash with the attitudes of GPs and the help they can feasibly provide. Difficult consultations in which neither the GP nor patient are satisfied can easily occur. Promoting supportive, reciprocal and open patient-doctor relationships is essential. Future research is required to further explore GP attitudes and to develop an intervention that could improve consultations, patient outcomes and GP satisfaction.

Effectiveness and cost-effectiveness of offering a chair-based yoga programme in addition to usual care in older adults with multiple long-term conditions: a pragmatic, parallel group, open label, randomised controlled trial.

Background: People with multiple long-term conditions are more likely to have poorer health-related quality of life (HRQOL). Yoga has the potential to improve HRQOL. Gentle Years Yoga© (GYY) is a chair-based yoga programme for older adults. We investigated the effectiveness and cost-effectiveness of the GYY programme in older adults with multiple long-term conditions. Methods: In this pragmatic, multi-site, open, randomised controlled trial, we recruited adults aged ≥65 years with ≥2 long-term conditions from 15 primary care practices in England and Wales. Participants were randomly assigned to usual care control or a 12-week, group-based, GYY programme delivered face-to-face or online by qualified yoga teachers. The primary outcome was HRQOL (EQ-5D-5L) over 12 months. Secondary outcomes included anxiety, depression, falls, loneliness, healthcare resource use, and adverse events. Results: Between October 2019 and October 2021, 454 participants were randomised between the intervention (n=240) and control (n=214) groups. Seven GYY courses were delivered face-to-face and 12 courses were delivered online. The mean number of classes attended among all intervention participants was nine (SD 4, median 10). In our intention-to-treat analysis (n=422), there was no statistically significant difference between trial groups in the primary outcome of HRQOL (adjusted difference in mean EQ-5D-5L = 0.020 [favouring intervention]; 95% CI -0.006 to 0.045, p=0.14). There were also no statistically significant differences in key secondary outcomes. No serious, related adverse events were reported. The incremental cost-effectiveness ratio was £4,546 per quality-adjusted life-year (QALY) and the intervention had a 79% probability of being cost-effective at a willingness-to-pay threshold of £20,000 per QALY. The intervention was acceptable to most participants and perceived as useful by some. Conclusions: The offer of a 12-week chair-based yoga programme in addition to usual care did not improve HRQOL in older adults with multiple long-term conditions. However, the intervention was safe, acceptable, and probably cost-effective.

Enclosing a pen in a postal questionnaire follow-up to increase response rate: a study within a trial.

Background: Poor response rates to follow-up questionnaires can adversely affect the progress of a randomised controlled trial and the validity of its results. This embedded 'study within a trial' aimed to investigate the impact of including a pen with the postal 3-month questionnaire completed by the trial participants on the response rates to this questionnaire. Methods: This study was a two-armed randomised controlled trial nested in the Gentle Years Yoga (GYY) trial. Participants in the intervention group of the GYY trial were allocated 1:1 using simple randomisation to either receive a pen (intervention) or no pen with their 3-month questionnaire (control). The primary outcome was the proportion of participants sent a 3-month questionnaire who returned it. Secondary outcomes were time taken to return the questionnaire, proportion of participants sent a reminder to return the questionnaire, and completeness of the questionnaire. Binary outcomes were analysed using logistic regression, time to return by Cox Proportional Hazards regression and number of items completed by linear regression. Results: There were 111 participants randomised to the pen group and 118 to the no pen group who were sent a 3-month questionnaire. There was no evidence of a difference in return rates between the two groups (pen 107 (96.4%), no pen 117 (99.2%); OR 0.23, 95% CI 0.02 to 2.19, p=0.20). Furthermore, there was no evidence of a difference between the two groups in terms of time to return the questionnaire (HR 0.90, 95% CI 0.69 to 1.18, p=0.47), the proportion of participants sent a reminder (OR 0.85, 95% CI 0.48 to 1.53, p=0.60) nor the number of items completed (mean difference 0.51, 95% CI -0.04 to 1.06, p=0.07). Conclusion: The inclusion of a pen with the postal 3-month follow-up questionnaire did not have a statistically significant effect on response rate.

Are stentless valves superior to modern stented valves? A prospective randomized trial.

BACKGROUND: It is presumed that stentless aortic bioprostheses are hemodynamically superior to stented bioprostheses. A prospective randomized controlled trial was undertaken to compare stentless versus modern stented valves. METHODS AND RESULTS: Patients with severe aortic valve stenosis (n=161) undergoing aortic valve replacement (AVR) were randomized intraoperatively to receive either the C-E Perimount stented bioprosthesis (n=81) or the Prima Plus stentless bioprosthesis (n =80). We assessed left ventricular mass (LVM) regression with transthoracic echocardiography (TTE) and magnetic resonance imaging (MRI). Transvalvular gradients were measured postoperatively by Doppler echocardiography to compare hemodynamic performance. There was no difference between groups with regard to age, symptom status, need for concomitant coronary artery bypass surgery, or baseline LVM. LVM regressed in both groups but with no significant difference between groups at 1 year. In a subset of 50 patients, MRI was also used to assess LVM regression, and again there was no significant difference between groups at 1 year. Hemodynamic performance of the 2 valves was similar with no difference in mean and peak systolic transvalvular gradients 1 year after surgery. In patients with reduced ventricular function (left ventricular ejection fraction [LVEF] <60%), there was a significantly greater improvement in LVEF from baseline to 1 year in stentless valve recipients. CONCLUSIONS: Both stented and stentless bioprostheses are associated with excellent clinical and hemodynamic outcomes 1 year after AVR. Comparable hemodynamics and LVM regression can be achieved using a second-generation stented pericardial bioprosthesis. In patients with ventricular impairment, stentless bioprostheses may allow for greater improvement in left ventricular function postoperatively.

Early clinical and hemodynamic outcomes after stented and stentless aortic valve replacement: results from a randomized controlled trial.

BACKGROUND: Stentless aortic bioprostheses were shown to be hemodynamically superior to earlier generations of stented bioprostheses. Modern stented valve designs have improved hemodynamics. A prospective randomized controlled trial was undertaken to compare stentless versus modern stented valves. Our aim was to determine any differences in early postoperative clinical and hemodynamic outcomes. METHODS: Patients with severe aortic valve stenosis (n = 161) undergoing aortic valve replacement were randomized intraoperatively to receive either the C-E Perimount (Edwards Lifesciences, Irvine, CA) pericardial stented bioprosthesis (n = 81) or the Prima Plus (Edwards Lifesciences) (porcine stentless bioprosthesis (n = 80). Transthoracic echocardiograms were performed at one week and eight weeks postoperatively to assess left ventricular mass (LVM) and transvalvular gradients (TVG). RESULTS: There were no differences between the two groups in baseline characteristics. Cardiopulmonary bypass and ischemic times were longer in the stentless group. Despite similar native aortic annular diameters, the mean size of the prosthesis used in the stentless group was 2.1 mm (SD = 2.8) larger (p < 0.001). Early (30-day) mortality (stentless 3.7% vs stented 2.5%; p = 0.68) and morbidity was similar between groups. Eight weeks postoperatively, LVM (stentless 199 +/- 70 vs stented 204 +/- 66 grams; p = 0.32) and TVG decreased in both groups (mean systolic gradient; stentless 10 +/- 3 vs stented 10 +/- 4 mm Hg; p = 0.54) but there was no significant difference between groups. CONCLUSIONS: Despite longer ischemic times in the stentless group, early postoperative outcomes were similar. Both stented and stentless aortic valve replacement offers excellent hemodynamics and can be achieved with low perioperative mortality.