Tailored psychological intervention for anxiety or depression in COPD (TANDEM): a randomised controlled trial.

BACKGROUND: The TANDEM multicentre, pragmatic, randomised controlled trial evaluated whether a tailored psychological intervention based on a cognitive behavioural approach for people with COPD and symptoms of anxiety and/or depression improved anxiety or depression compared with usual care (control). METHODS: People with COPD and moderate to very severe airways obstruction and Hospital Anxiety and Depression Scale subscale scores indicating mild to moderate anxiety (HADS-A) and/or depression (HADS-D) were randomised 1.25:1 (242 intervention and 181 control). Respiratory health professionals delivered the intervention face-to-face over 6-8 weeks. Co-primary outcomes were HADS-A and HADS-D measured 6 months post-randomisation. Secondary outcomes at 6 and 12 months included: HADS-A and HADS-D (12 months), Beck Depression Inventory II, Beck Anxiety Inventory, St George's Respiratory Questionnaire, social engagement, the EuroQol instrument five-level version (EQ-5D-5L), smoking status, completion of pulmonary rehabilitation, and health and social care resource use. RESULTS: The intervention did not improve anxiety (HADS-A mean difference -0.60, 95% CI -1.40-0.21) or depression (HADS-D mean difference -0.66, 95% CI -1.39-0.07) at 6 months. The intervention did not improve any secondary outcomes at either time-point, nor did it influence completion of pulmonary rehabilitation or healthcare resource use. Deaths in the intervention arm (13/242; 5%) exceeded those in the control arm (3/181; 2%), but none were associated with the intervention. Health economic analysis found the intervention highly unlikely to be cost-effective. CONCLUSION: This trial has shown, beyond reasonable doubt, that this cognitive behavioural intervention delivered by trained and supervised respiratory health professionals does not improve psychological comorbidity in people with advanced COPD and depression or anxiety.

Digital interventions to improve adherence to maintenance medication in asthma.

BACKGROUND: Asthma is the most common chronic lung condition worldwide, affecting 334 million adults and children globally. Despite the availability of effective treatment, such as inhaled corticosteroids (ICS), adherence to maintenance medication remains suboptimal. Poor ICS adherence leads to increased asthma symptoms, exacerbations, hospitalisations, and healthcare utilisation. Importantly, suboptimal use of asthma medication is a key contributor to asthma deaths. The impact of digital interventions on adherence and asthma outcomes is unknown. OBJECTIVES: To determine the effectiveness of digital interventions for improving adherence to maintenance treatments in asthma. SEARCH METHODS: We identified trials from the Cochrane Airways Trials Register, which contains studies identified through multiple electronic searches and handsearches of other sources. We also searched trial registries and reference lists of primary studies. We conducted the most recent searches on 1 June 2020, with no restrictions on language of publication. A further search was run in October 2021, but studies were not fully incorporated. SELECTION CRITERIA: We included randomised controlled trials (RCTs) including cluster- and quasi-randomised trials of any duration in any setting, comparing a digital adherence intervention with a non-digital adherence intervention or usual care. We included adults and children with a clinical diagnosis of asthma, receiving maintenance treatment. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures for data collection. We used GRADE to assess quantitative outcomes where data were available. MAIN RESULTS: We included 40 parallel randomised controlled trials (RCTs) involving adults and children with asthma (n = 15,207), of which eight are ongoing studies. Of the included studies, 30 contributed data to at least one meta-analysis. The total number of participants ranged from 18 to 8517 (median 339). Intervention length ranged from two to 104 weeks. Most studies (n = 29) reported adherence to maintenance medication as their primary outcome; other outcomes such as asthma control and quality of life were also commonly reported. Studies had low or unclear risk of selection bias but high risk of performance and detection biases due to inability to blind the participants, personnel, or outcome assessors. A quarter of the studies had high risk of attrition bias and selective outcome reporting. We examined the effect of digital interventions using meta-analysis for the following outcomes: adherence (16 studies); asthma control (16 studies); asthma exacerbations (six studies); unscheduled healthcare utilisation (four studies); lung function (seven studies); and quality of life (10 studies). Pooled results showed that patients receiving digital interventions may have increased adherence (mean difference of 14.66 percentage points, 95% confidence interval (CI) 7.74 to 21.57; low-certainty evidence); this is likely to be clinically significant in those with poor baseline medication adherence. Subgroup analysis by type of intervention was significant (P = 0.001), with better adherence shown with electronic monitoring devices (EMDs) (23 percentage points over control, 95% CI 10.84 to 34.16; seven studies), and with short message services (SMS) (12 percentage points over control, 95% CI 6.22 to 18.03; four studies). No significant subgroup differences were seen for interventions having an in-person component versus fully digital interventions, adherence feedback, one or multiple digital components to the intervention, or participant age. Digital interventions were likely to improve asthma control (standardised mean difference (SMD) 0.31 higher, 95% CI 0.17 to 0.44; moderate-certainty evidence) - a small but likely clinically significant effect. They may reduce asthma exacerbations (risk ratio 0.53, 95% CI 0.32 to 0.91; low-certainty evidence). Digital interventions may result in a slight change in unscheduled healthcare utilisation, although some studies reported no or a worsened effect. School or work absence data could not be included for meta-analysis due to the heterogeneity in reporting and the low number of studies. They may result in little or no difference in lung function (forced expiratory volume in one second (FEV1)): there was an improvement of 3.58% predicted FEV1, 95% CI 1.00% to 6.17%; moderate-certainty evidence); however, this is unlikely to be clinically significant as the FEV1 change is below 12%. Digital interventions likely increase quality of life (SMD 0.26 higher, 95% CI 0.07 to 0.45; moderate-certainty evidence); however, this is a small effect that may not be clinically significant. Acceptability data showed positive attitudes towards digital interventions. There were no data on cost-effectiveness or adverse events. Our confidence in the evidence was reduced by risk of bias and inconsistency. AUTHORS' CONCLUSIONS: Overall, digital interventions may result in a large increase in adherence (low-certainty evidence). There is moderate-certainty evidence that digital adherence interventions likely improve asthma control to a degree that is clinically significant, and likely increase quality of life, but there is little or no improvement in lung function. The review found low-certainty evidence that digital interventions may reduce asthma exacerbations. Subgroup analyses show that EMDs may improve adherence by 23% and SMS interventions by 12%, and interventions with an in-person element and adherence feedback may have greater benefits for asthma control and adherence, respectively. Future studies should include percentage adherence as a routine outcome measure to enable comparison between studies and meta-analysis, and use validated questionnaires to assess adherence and outcomes.

Impact of the first national COVID-19 lockdown on referral of women experiencing domestic violence and abuse in England and Wales.

BACKGROUND: The lockdown periods to curb COVID-19 transmission have made it harder for survivors of domestic violence and abuse (DVA) to disclose abuse and access support services. Our study describes the impact of the first COVID-19 wave and the associated national lockdown in England and Wales on the referrals from general practice to the Identification and Referral to Improve Safety (IRIS) DVA programme. We compare this to the change in referrals in the same months in the previous year, during the school holidays in the 3 years preceding the pandemic and the period just after the first COVID-19 wave. School holiday periods were chosen as a comparator, since families, including the perpetrator, are together, affecting access to services. METHODS: We used anonymised data on daily referrals received by the IRIS DVA service in 33 areas from general practices over the period April 2017-September 2020. Interrupted-time series and non-linear regression were used to quantify the impact of the first national lockdown in March-June 2020 comparing analogous months the year before, and the impact of school holidays (01/04/2017-30/09/2020) on number of referrals, reporting Incidence Rate Ratio (IRR), 95% confidence intervals and p-values. RESULTS: The first national lockdown in 2020 led to reduced number of referrals to DVA services (27%, 95%CI = (21,34%)) compared to the period before and after, and 19% fewer referrals compared to the same period in the year before. A reduction in the number of referrals was also evident during the school holidays with the highest reduction in referrals during the winter 2019 pre-pandemic school holiday (44%, 95%CI = (32,54%)) followed by the effect from the summer of 2020 school holidays (20%, 95%CI = (10,30%)). There was also a smaller reduction (13-15%) in referrals during the longer summer holidays 2017-2019; and some reduction (5-16%) during the shorter spring holidays 2017-2019. CONCLUSIONS: We show that the COVID-19 lockdown in 2020 led to decline in referrals to DVA services. Our findings suggest an association between decline in referrals to DVA services for women experiencing DVA and prolonged periods of systemic closure proxied here by both the first COVID-19 national lockdown or school holidays. This highlights the need for future planning to provide adequate access and support for people experiencing DVA during future national lockdowns and during the school holidays.

PRimary care rEsponse to domestic violence and abuse in the COvid-19 panDEmic (PRECODE): protocol of a rapid mixed-methods study in the UK.

BACKGROUND: The implementation of lockdowns in the UK during the COVID-19 pandemic resulted in a system switch to remote primary care consulting at the same time as the incidence of domestic violence and abuse (DVA) increased. Lockdown-specific barriers to disclosure of DVA reduced the opportunity for DVA detection and referral. The PRECODE (PRimary care rEsponse to domestic violence and abuse in the COvid-19 panDEmic) study will comprise quantitative analysis of the impact of the pandemic on referrals from IRIS (Identification and Referral to Improve Safety) trained general practices to DVA agencies in the UK and qualitative analysis of the experiences of clinicians responding to patients affected by DVA and adaptations they have made transitioning to remote DVA training and patient support. METHODS/DESIGN: Using a rapid mixed method design, PRECODE will explore and explain the dynamics of DVA referrals and support before and during the pandemic on a national scale using qualitative data and over four years of referrals time series data. We will undertake interrupted-time series and non-linear regression analysis, including sensitivity analyses, on time series of referrals to DVA services from routinely collected data to evaluate the impact of the pandemic and associated lockdowns on referrals to the IRIS Programme, and analyse key determinants associated with changes in referrals. We will also conduct an interview- and observation-based qualitative study to understand the variation, relevance and feasibility of primary care responses to DVA before and during the pandemic and its aftermath. The triangulation of quantitative and qualitative findings using rapid analysis and synthesis will enable the articulation of multiscale trends in primary care responses to DVA and complex mechanisms by which these responses have changed during the pandemic. DISCUSSION: Our findings will inform the implementation of remote primary care and DVA service responses as services re-configure. Understanding the adaptation of clinical and service responses to DVA during the pandemic is crucial for the development of evidence-based, effective remote support and referral beyond the pandemic. TRIAL REGISTRATION: PRECODE is an observational epidemiologic study, not an intervention evaluation or trial. We will not be reporting results of an intervention on human participants.

Acceptability of a theory-based adherence intervention for adults with asthma - a person-based approach.

Objective: Nonadherence to inhaled corticosteroids contributes to poor asthma control. This study evaluated two different theory-based intervention approaches to address nonadherence in adults with asthma using a person-based, qualitative approach to investigate comprehensibility, coherence and acceptability.Methods: The two intervention approaches addressed treatment beliefs and misconceptions in asthma, aiming to provide a common-sense rationale for medication adherence. Approach one reframed asthma using a concept of balance, the second approach was more traditional presenting medical consequences of nonadherence. We ran three focus group interviews involving 19 adults with asthma to investigate patient acceptability of the intervention approaches and their influence on perceptions of asthma and medication.Results: Approach one was perceived as novel compared to current practice, logical and easily understandable. Its use of non-medical jargon was perceived as representing information more positively, moving away from stigmatizing people with asthma. Approach two was perceived as not sufficiently novel, not applicable to everyone's illness experience and triggering fear.Conclusions: Patient feedback allowed us to refine our intervention strategy prior to running costly feasibility trials. Patient-based approaches for intervention planning may facilitate implementation and acceptability of interventions in practice.

Pharmacists and medication adherence in asthma: a systematic review and meta-analysis.

The Lancet Asthma Commission highlighted that non-adherence remains a persistent barrier within asthma care. Medical consultations remain pivotal in addressing non-adherence, but interest in additional adherence support from pharmacists is increasing. This systematic review and meta-analysis aims to evaluate how effective pharmacist-led interventions are in improving medication adherence in adults with asthma.Studies were included if they had adult participants with asthma, pharmacist-led or collaborative care interventions, randomised controlled trial designs comparing interventions with usual pharmacist care, and a medication adherence outcome. We analysed adherence data using the standardised mean difference (d) and the remaining data were synthesised narratively.From 1159 records, 11 were included in the narrative synthesis and nine in the meta-analysis. The meta-analysis for adherence produced a medium effect size of d=0.49 (se=0.08, 95% CI 0.35-0.64, p<0.0001) with low statistical heterogeneity.In line with the Perceptions and Practicalities Approach, interventions targeted to address both the perceptions and practicalities that influence individual motivation and ability to adhere were more effective. Contextual factors (country and healthcare setting) were also influential. Our findings suggest that with adequate remuneration and integration into asthma care, pharmacists can help improve adherence in asthma.

Evidence that self-affirmation improves phosphate control in hemodialysis patients: a pilot cluster randomized controlled trial.

BACKGROUND: Hemodialysis patients are at risk of serious health complications, yet treatment non-adherence remains high. PURPOSE: Warnings about health risks associated with non-adherence may trigger defensive reactions. We studied whether an intervention based on self-affirmation theory (Steele 1988) reduced patients' resistance to health-risk information and improved adherence. METHODS: One hundred twelve patients either self-affirmed or completed a matched control task before reading about the risks associated with a lack of phosphate control. Serum phosphate was collected from baseline up to 12 months. RESULTS: Self-affirmed patients had significantly reduced serum phosphate levels at 1 and 12 months. However, contrary to the predictions derived from self-affirmation theory, self-affirmed participants and controls did not differ in their evaluation of the health-risk information, behavioural intention or self-efficacy. CONCLUSIONS: A low-cost, high-reach health intervention based on self-affirmation theory was shown to reduce serum phosphate over a 12 month period. Further work is required to identify mediators of the observed effects.

A tailored psychological intervention for anxiety and depression management in people with chronic obstructive pulmonary disease: TANDEM RCT and process evaluation.

Background: People with chronic obstructive pulmonary disease have high levels of anxiety and depression, which is associated with increased morbidity and poor uptake of effective treatments, such as pulmonary rehabilitation. Cognitive-behavioural therapy improves mental health of people with long-term conditions and could potentially increase uptake of pulmonary rehabilitation, enabling synergies that could enhance the mental health of people with chronic obstructive pulmonary disease. Aim: Our aim was to develop and evaluate the clinical effectiveness and cost effectiveness of a tailored cognitive-behavioural approach intervention, which links into, and optimises the benefits of, routine pulmonary rehabilitation. Design: We carried out a pragmatic multicentre randomised controlled trial using a 1.25 : 1 ratio (intervention : control) with a parallel process evaluation, including assessment of fidelity. Setting: Twelve NHS trusts and five Clinical Commissioning Groups in England were recruited into the study. The intervention was delivered in participant's own home or at a local NHS facility, and by telephone. Participants: Between July 2017 and March 2020 we recruited adults with moderate/very severe chronic obstructive pulmonary disease and mild/moderate anxiety and/or depression, meeting eligibility criteria for assessment for pulmonary rehabilitation. Carers of participants were invited to participate. Intervention: The cognitive-behavioural approach intervention (i.e. six to eight 40- to 60-minute sessions plus telephone support throughout pulmonary rehabilitation) was delivered by 31 trained respiratory healthcare professionals to participants prior to commencing pulmonary rehabilitation. Usual care included routine pulmonary rehabilitation referral. Main outcome measures: Co-primary outcomes were Hospital Anxiety and Depression Scale - anxiety and Hospital Anxiety and Depression Scale - depression at 6 months post randomisation. Secondary outcomes at 6 and 12 months included health-related quality of life, smoking status, uptake of pulmonary rehabilitation and healthcare use. Results: We analysed results from 423 randomised participants (intervention, n = 242; control, n = 181). Forty-three carers participated. Follow-up at 6 and 12 months was 93% and 82%, respectively. Despite good fidelity for intervention delivery, mean between-group differences in Hospital Anxiety and Depression Scale at 6 months ruled out clinically important effects (Hospital Anxiety and Depression Scale - anxiety mean difference -0.60, 95% confidence interval -1.40 to 0.21; Hospital Anxiety and Depression Scale - depression mean difference -0.66, 95% confidence interval -1.39 to 0.07), with similar results at 12 months. There were no between-group differences in any of the secondary outcomes. Sensitivity analyses did not alter these conclusions. More adverse events were reported for intervention participants than for control participants, but none related to the trial. The intervention did not generate quality-of-life improvements to justify the additional cost (adjusted mean difference £770.24, 95% confidence interval -£27.91 to £1568.39) to the NHS. The intervention was well received and many participants described positive affects on their quality of life. Facilitators highlighted the complexity of participants' lives and considered the intervention to be of potential valuable; however, the intervention would be difficult to integrate within routine clinical services. Our well-powered trial delivered a theoretically designed intervention with good fidelity. The respiratory-experienced facilitators were trained to deliver a low-intensity cognitive-behavioural approach intervention, but high-intensity cognitive-behavioural therapy might have been more effective. Our broad inclusion criteria specified objectively assessed anxiety and/or depression, but participants were likely to favour talking therapies. Randomisation was concealed and blinding of outcome assessment was breached in only 15 participants. Conclusions: The tailored cognitive-behavioural approach intervention delivered with fidelity by trained respiratory healthcare professionals to people with chronic obstructive pulmonary disease was neither clinically effective nor cost-effective. Alternative approaches that are integrated with routine long-term condition care are needed to address the unmet, complex clinical and psychosocial needs of this group of patients. Trial registration: This trial is registered as ISRCTN59537391. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 13/146/02) and is published in full in Health Technology Assessment; Vol. 28, No. 1. See the NIHR Funding and Awards website for further award information.

People with long-standing lung problems, such as chronic obstructive pulmonary disease, often also have anxiety and depression, which further reduces their quality of life. Two existing treatments could help. Pulmonary rehabilitation (a programme of exercise and education) improves both the physical and mental health of people with chronic obstructive pulmonary disease. Cognitive­behavioural therapy (a talking therapy) may reduce anxiety and depression. The TANDEM [Tailored intervention for Anxiety and Depression Management in chronic obstructive pulmonary disease (COPD)] intervention linked these two treatments by providing talking therapy based on cognitive­behavioural therapy during the waiting time following referral for pulmonary rehabilitation. The TANDEM treatment was delivered by respiratory healthcare professionals (e.g. nurses or physiotherapists) trained to deliver the talking therapy in six to eight weekly sessions. The sessions were conducted in the participant's home (or another convenient location), with brief telephone support during the pulmonary rehabilitation. Of 423 participants recruited to the study, 242 participants received TANDEM talking therapy and 181 participants received usual care (including a referral to pulmonary rehabilitation). We measured mental health, quality of life, social life, attendance at pulmonary rehabilitation and healthcare use in both groups at 6 and 12 months. Forty-three carers joined the study and we assessed their mental well-being. We interviewed patients, carers and health professionals to find out their views and experience of the TANDEM treatment. We also examined whether or not the TANDEM treatment was good value for money. The TANDEM treatment did not improve the mental or the physical health of people with chronic obstructive pulmonary disease. In addition, the TANDEM treatment cost the NHS an extra £770 per patient, which was not good value for money. The TANDEM treatment was well received, and many participants told us how it had helped them. Heath-care professionals noted how participants did not just have chronic obstructive pulmonary disease, but were coping with many physical, mental and social problems. The TANDEM intervention was not effective and, therefore, other strategies will be needed to help people with chronic obstructive pulmonary disease and mental health problems live with their condition.

Adapting domestic abuse training to remote delivery during the COVID-19 pandemic: a qualitative study of views from general practice and support services.

BACKGROUND: Identifying and responding to patients affected by domestic violence and abuse (DVA) is vital in primary care. There may have been a rise in the reporting of DVA cases during the COVID-19 pandemic and associated lockdown measures. Concurrently general practice adopted remote working that extended to training and education. IRIS (Identification and Referral to Improve Safety) is an example of an evidence-based UK healthcare training support and referral programme, focusing on DVA. IRIS transitioned to remote delivery during the pandemic. AIM: To understand the adaptations and impact of remote DVA training in IRIS-trained general practices by exploring perspectives of those delivering and receiving training. DESIGN AND SETTING: Qualitative interviews and observation of remote training of general practice teams in England were undertaken. METHOD: Semi-structured interviews were conducted with 21 participants (three practice managers, three reception and administrative staff, eight general practice clinicians, and seven specialist DVA staff), alongside observation of eight remote training sessions. Analysis was conducted using a framework approach. RESULTS: Remote DVA training in UK general practice widened access to learners. However, it may have reduced learner engagement compared with face-to-face training and may challenge safeguarding of remote learners who are domestic abuse survivors. DVA training is integral to the partnership between general practice and specialist DVA services, and reduced engagement risks weakening this partnership. CONCLUSION: The authors recommend a hybrid DVA training model for general practice, including remote information delivery alongside a structured face-to-face element. This has broader relevance for other specialist services providing training and education in primary care.

General practice wide adaptations to support patients affected by DVA during the COVID-19 pandemic: a rapid qualitative study.

BACKGROUND: Reporting of domestic violence and abuse (DVA) increased globally during the pandemic. General Practice has a central role in identifying and supporting those affected by DVA. Pandemic associated changes in UK primary care included remote initial contacts with primary care and predominantly remote consulting. This paper explores general practice's adaptation to DVA care during the COVID-19 pandemic. METHODS: Remote semi-structured interviews were conducted by telephone with staff from six localities in England and Wales where the Identification and Referral to Improve Safety (IRIS) primary care DVA programme is commissioned.  We conducted interviews between April 2021 and February 2022 with three practice managers, three reception and administrative staff, eight general practice clinicians and seven specialist DVA staff. Patient and public involvement and engagement (PPI&E) advisers with lived experience of DVA guided the project. Together we developed recommendations for primary care teams based on our findings. RESULTS: We present our findings within four themes, representing primary care adaptations in delivering DVA care: 1. Making general practice accessible for DVA care: staff adapted telephone triaging processes for appointments and promoted availability of DVA support online. 2. General practice team-working to identify DVA: practices developed new approaches of collaboration, including whole team adaptations to information processing and communication 3. Adapting to remote consultations about DVA: teams were required to adapt to challenges including concerns about safety, privacy, and developing trust remotely. 4. Experiences of onward referrals for specialist DVA support: support from specialist services was effective and largely unchanged during the pandemic. CONCLUSIONS: Disruption caused by pandemic restrictions revealed how team dynamics and interactions before, during and after clinical consultations contribute to identifying and supporting patients experiencing DVA. Remote assessment complicates access to and delivery of DVA care. This has implications for all primary and secondary care settings, within the NHS and internationally, which are vital to consider in both practice and policy.

Physiotherapy informed by Acceptance and Commitment Therapy for chronic low back pain: A mixed-methods treatment fidelity evaluation.

OBJECTIVES: A randomized controlled trial of a new type of Physiotherapy informed by Acceptance and Commitment Therapy (PACT), found that it improved functioning in people with chronic low back pain compared to usual physiotherapy care. Fidelity evaluation is necessary to understand trial processes and outcomes. This study evaluated PACT treatment fidelity including delivery, receipt, and enactment. DESIGN: A mixed-methods study nested within a randomized controlled trial was conducted. METHODS: A total of 72 (20% of total) PACT treatment audio files were independently assessed by two raters, according to a novel framework developed to measure PACT treatment content adherence, therapeutic alliance, ACT competence, and treatment enactment. Interview transcripts from 19 trial participants randomized to PACT were analysed thematically for evidence of treatment receipt and enactment. RESULTS: PACT physiotherapists delivered treatment as intended with high content adherence and satisfactory therapeutic alliance, but ACT competence was low. Qualitative findings indicated participant receipt of 11/17 and enactment of 3/17 components; 89% (n = 17) and 47% (n = 9) of participants reported treatment receipt and enactment of at least one component, respectively. CONCLUSIONS: This mixed-methods study of PACT treatment demonstrated high fidelity reflecting treatment content delivery and receipt, and therapeutic alliance. There was some evidence of treatment enactment in participants with chronic low back pain. Low ACT competence could be addressed through additional support and adaptations to therapeutic processes for delivery by physiotherapists.

Choosing not to take phosphate binders: the role of dialysis patients' medication beliefs.

OBJECTIVE: Patients with end-stage renal disease (ESRD) receiving haemodialysis are at risk of cardiovascular disease and bone disorders related to high levels of serum phosphate (PO(4)). Phosphate binders are an important treatment; however, non-adherence remains a significant issue. This study investigates whether patients' beliefs about medicines predict intentional non-adherence to phosphate binders. METHOD: This was a cross-sectional study of ESRD patients (n = 76). Non-adherence was measured in two ways: (1) the self-report Medication Adherence Questionnaire (MAQ) and (2) 3-month average level of serum phosphate. The Beliefs about Medicines questionnaire was used to assess general and specific beliefs towards phosphate medicines. RESULTS: Eleven (14.5% of 76) patients reported being intentionally non-adherent to phosphate binders. Patients' beliefs that phosphate binders were less necessary were significantly associated with intentional self-reported non- adherence. Furthermore, patients with greater concerns about phosphate binders had higher serum phosphate levels. CONCLUSION: Assessing patient beliefs about medicines is a reliable indicator of intentional non-adherence to treatment with phosphate binders. These findings may help in identifying ways in which adherence rates to phosphate binders can be improved.

The TANDEM trial: protocol for the process evaluation of a randomised trial of a complex intervention for anxiety and/or depression in people living with chronic obstructive pulmonary disease (COPD).

BACKGROUND: TANDEM is a randomised controlled trial of a complex healthcare intervention to improve the psychological and physical health of people living with chronic obstructive pulmonary disease (COPD) and anxiety and/or depression. Based on health psychology theory set out in a logic model, respiratory health professionals were recruited and trained to deliver a cognitive behavioural approach intervention (The TANDEM intervention) under the supervision of senior cognitive behavioural practitioners. Here, we describe the protocol for the process evaluation commissioned alongside the trial. A realist approach that includes attention to describing contexts and mechanisms has been adopted. METHODS: We set up a multi-disciplinary team to develop and deliver the process evaluation. The mixed-methods design incorporates quantitative process data; monitoring of intervention fidelity; qualitative interviews with patients, carers, health professionals (facilitators) and clinical supervisors about their perspectives on acceptability of the intervention; and exploration with all stakeholders (including management/policy-makers) on future implementation. Normalisation process theory (NPT) will inform data collection and interpretation with a focus on implementation. Quantitative process data will be analysed descriptively. Qualitative interview data will be analysed before the trial outcomes are known using analytic induction and constant comparison to develop themes. Findings from the different elements will be reported separately and then integrated. CONCLUSION: Detailed description and analysis of study processes in a research trial such as TANDEM enables research teams to describe study contexts and mechanisms and to examine the relationship with outcomes. In this way, learning from the trial goes beyond the randomised control trial (RCT) model where effectiveness is prioritised and makes it possible to explore issues arising for post-trial study implementation. TRIAL REGISTRATION: ISRCTN ISRCTN59537391 . Registered on 20 March 2017. Trial protocol version 6.0, 22 April 2018. Process evaluation protocol version 4.0, 1 November 2020.

Experiences of training and delivery of Physical therapy informed by Acceptance and Commitment Therapy (PACT): a longitudinal qualitative study.

OBJECTIVES: Physiotherapy informed by Acceptance and Commitment Therapy (PACT) is a novel intervention that is related to improved disability and functioning in people with chronic lowback pain. This study explored physiotherapists experiences over time of the PACT training programme and intervention delivery. DESIGN: A longitudinal qualitative study using semi-structured, in-depth, individual interviews at three time points was conducted. METHODS: A phenomenological approach underpinned the methods. Interviews followed topic-guides developed a priori. Transcribed interviews were coded inductively to generate themes. Data were member checked by participants and validated by two researchers. PARTICIPANTS: Eight clinical physiotherapists from three secondary care centres in the United Kingdom (n = 5 female; age, 24 to 44 years; duration of practice, 3 to 14 years) were included. RESULTS: Five themes emerged from the data. Experiential learning techniques were challenging but valued because they bridged theoretical principles and concepts with practice. Ongoing individual and group supervision was beneficial, but required tailoring and tapering. PACT delivery extended physiotherapy skills and practice, including techniques that acknowledged and addressed patient treatment expectations. With experience, participants desired greater flexibility and autonomy to tailor PACT delivery. CONCLUSIONS: PACT training and delivery were acceptable to physiotherapists. Existing skills were developed and additional, applicable approaches were provided that addressed psychosocial and behavioural aspects of chronic low back pain.

Physical Therapy Informed by Acceptance and Commitment Therapy (PACT) Versus Usual Care Physical Therapy for Adults With Chronic Low Back Pain: A Randomized Controlled Trial.

Chronic low back pain (CLBP) is a major cause of global disability and improving management is essential. Acceptance and commitment therapy (ACT) is a promising treatment for chronic pain but has not been modified for physical therapy. This randomized controlled trial (RCT) compared physical therapy informed by ACT (PACT) against standard care physical therapy for patients with CLBP. Patients with CLBP (duration ≥12 weeks, mean 3 years) were recruited from physical therapy clinics in 4 UK public hospitals. The Roland-Morris Disability Questionnaire (RMDQ) at 3 months' post-randomization was the primary outcome. Two hundred forty-eight participants (59% female, mean age = 48) were recruited and 219 (88.3%) completed measures at 3 and/or 12 months' follow-up. At 3 months, PACT participants reported better outcomes for disability (RMDQ mean difference = 1.07, p = .037, 95% CI = -2.08 to -.07, d = .2), Patient Specific Functioning (p = .008), SF12 physical health (p = .032), and treatment credibility (p < .001). At 12 months' follow-up, there were no significant differences between groups. PACT was acceptable to patients and clinicians and feasible to deliver. Physical therapists incorporated psychological principles successfully and treatment was delivered with high (≥80%) fidelity. Our results may inform the management of CLBP, with potential benefits for patients, health care providers, and society. PERSPECTIVE: Psychologically informed physical therapy has great potential but there are challenges in implementation. The training and support included in the PACT trial enabled the intervention to be delivered as planned. This successfully reduced disability in the short but not long term. Findings could inform physical therapists' treatment of CLBP.

Pharmacist-led adherence support in general practice: a qualitative interview study of adults with asthma.

OBJECTIVES: The National Health Service (NHS) in England recently introduced general practice pharmacists (GPPs) to provide medication-focused support to both patients and the general practice team. This healthcare model may benefit people with asthma, who currently receive suboptimal care and demonstrate low medication adherence. This study aimed to explore the perspectives of adults with asthma on the potential for pharmacist-led adherence support delivered in general practice, with a focus on how these perspectives are formed. DESIGN AND SETTING: The study was conducted in the United Kingdom (UK) utilising a qualitative interview methodology. Participants were invited to partake in a telephone-based semistructured interview, followed by an online questionnaire for demographic details and asthma history. Qualitative data were analysed using thematic analysis. PARTICIPANTS: Participants (n=17) were adults with asthma in the UK with a prescription for an inhaled corticosteroid. Participants did not have previous experience with GPPs and were asked to provide their views on a proposed GPP-led service. RESULTS: Participant perspectives of GPPs were determined by trust in pharmacists, perceived gaps in asthma care and the perceived strain on the NHS. Trust was based on pharmacists' perceived clinical competency, established over time, and gauged through a 'benchmarking' process. GPP's fit in current asthma care was assessed based on potential role overlap with other healthcare professionals, continuity of care and medication-related support needs. Participants navigated the NHS based on a perceived hierarchy of healthcare professionals (general practitioners on top, nurses, then pharmacists), and this influenced their perspectives of GPPs. CONCLUSION: While the GPP scheme shows promise based on the perspectives of people with asthma, the identified barriers to optimal patient engagement and service implementation will need to be addressed for the service to be effective.

Patient involvement in questionnaire design: tackling response error and burden.

Questionnaires capture patient perspectives succinctly and at relatively low cost, making them a popular data collection tool for health researchers. However, questionnaire data can be affected by response error and response burden. Patient involvement during questionnaire design can help reduce the effect of response error and burden. This paper describes a novel approach for patient involvement during questionnaire design, combining methods from cognitive interviewing (Think Aloud Tasks) with an open-ended follow-up discussion to collate and act on patient feedback, while also taking account of the common challenges in questionnaire design (i.e. response error and burden). The strengths and limitations of this approach are discussed, and recommendations are made for future use.

Physiotherapy informed by Acceptance and Commitment Therapy (PACT): protocol for a randomised controlled trial of PACT versus usual physiotherapy care for adults with chronic low back pain.

INTRODUCTION: Chronic low back pain (CLBP) is a common condition and source of significant suffering, disability and healthcare costs. Current physiotherapy treatment is moderately effective. Combining theory-based psychological methods with physiotherapy could improve outcomes for people with CLBP. The primary aim of this randomised controlled trial (RCT) is to evaluate the efficacy of Physiotherapy informed by Acceptance and Commitment Therapy (PACT) on functioning in patients with CLBP. METHODS AND ANALYSIS: The PACT trial is a two-armed, parallel-group, multicentre RCT to assess the efficacy of PACT in comparison with usual physiotherapy care (UC). 240 patients referred to physiotherapy with CLBP will be recruited from three National Health Service (NHS) hospitals trusts. Inclusion criteria are: age ≥18 years, CLBP ≥12-week duration, scoring ≥3 points on the Roland-Morris Disability Questionnaire (RMDQ) and adequate understanding of spoken and written English to participate. Patients will be randomised to PACT or UC (120 per arm stratified by centre) by an independent randomisation service and followed up at 3 and 12 months post randomisation. The sample size of 240 will provide adequate power to detect a standardised mean difference of 0.40 in the primary outcome (RMDQ; 5% significance, 80% power) assuming attrition of 20%. Analysis will be by intention to treat conducted by the trial statistician, blind to treatment group, following a prespecified analysis plan. Estimates of treatment effect at the follow-up assessments will use an intention-to-treat framework, implemented using a linear mixed-effects model. ETHICS AND DISSEMINATION: This trial has full ethical approval (14/SC/0277). It will be disseminated via peer-reviewed publications and conference presentations. The results will enable clinicians, patients and health service managers to make informed decisions regarding the efficacy of PACT for patients with CLBP. TRIAL REGISTRATION NUMBER: ISRCTN95392287; Pre-results.

Evidence of improved fluid management in patients receiving haemodialysis following a self-affirmation theory-based intervention: A randomised controlled trial.

OBJECTIVE: Haemodialysis patients are at risk of serious health complications; yet, treatment non-adherence remains high. Warnings about health risks associated with non-adherence may trigger defensive reactions. We studied whether an intervention based on self-affirmation theory reduced resistance to health-risk information and improved fluid treatment adherence. DESIGN: In a cluster randomised controlled trial, 91 patients either self-affirmed or completed a matched control task before reading about the health-risks associated with inadequate fluid control. OUTCOME MEASURES: Patients' perceptions of the health-risk information, intention and self-efficacy to control fluid were assessed immediately after presentation of health-risk information. Interdialytic weight gain (IDWG), excess fluid removed during haemodialysis, is a clinical measure of fluid treatment adherence. IDWG data were collected up to 12 months post-intervention. RESULTS: Self-affirmed patients had significantly reduced IDWG levels over 12 months. However, contrary to predictions derived from self-affirmation theory, self-affirmed participants and controls did not differ in their evaluation of the health-risk information, intention to control fluid or self-efficacy. CONCLUSION: A low-cost, high-reach health intervention based on self-affirmation theory was shown to reduce IDWG over a 12-month period, but the mechanism by which this apparent behaviour change occurred is uncertain. Further work is still required to identify mediators of the observed effects.

Medication beliefs are associated with phosphate binder non-adherence in hyperphosphatemic haemodialysis patients.

OBJECTIVES: Patients with end-stage kidney disease receiving haemodialysis (HD) are at risk of cardiovascular disease and bone disorders related to high levels of serum phosphate. We studied the association between medication beliefs and depressive symptoms, with non-adherence to phosphate binding medication in a group of HD patients at risk of complications due to hyperphosphatemia. DESIGN: Cross-sectional design. METHODS: Baseline data from 112 patients participating in a randomized controlled trial, evaluating an adherence intervention, are presented. All patients had serum phosphate levels >1.6 mmol/l at baseline. Adherence was measured by (1) serum phosphate and (2) Medication Adherence Report Scales (MARS). Beliefs about Medicines (BMQ) and depressive symptoms (PHQ-9) were also evaluated. RESULTS: Beliefs about Medicines Questionnaire necessity, but not concerns, beliefs were found to correlate with serum phosphate (r = -.23, p < .05) and self-reported adherence (r = .35, p < .01). In regression models, controlling for demographic, clinical and psychological variables, necessity beliefs explained the variance of serum phosphate (ß = -.22, p = .01) and self-reported adherence (ß = .30, p ≤ .01). Both BMQ concerns and depressive symptoms were not related to non-adherence. CONCLUSION: Patients' beliefs about the necessity of their prescribed phosphate binding medications explain variation in non-adherence levels, measured both subjective and objectively. Dialysis patient's medication beliefs are potentially modifiable targets for future interventions.