Text Messages With Financial Incentives for Men With Obesity: A Randomized Clinical Trial.

Importance: Effective weight loss interventions are needed for men with obesity. Objective: To determine whether an intervention that combined text messaging with financial incentives attained significant weight loss at the 12-month follow-up compared with the control group and whether an intervention of text messaging alone attained significant weight loss at the 12-month follow-up compared with the control group. Design, Setting, and Participants: An assessor-blinded randomized clinical trial conducted in Belfast, Bristol, and Glasgow areas in the UK. A total of 585 men with body mass index (BMI) of 30 or more were enrolled between July 2021 and May 2022. Final follow-up occurred June 2023. Interventions: Participants were randomly assigned to 12 months of behavioral focused text messages combined with financial incentives (n = 196), 12 months of behavioral focused text messages alone (n= 194), or a waiting list (control group; n= 195). The financial incentive consisted of a monetary reward that was lost if weight loss targets were not met. All participants received weight management information and a pedometer at baseline. Main Outcomes and Measures: The 2 primary comparisons were the 12-month comparison of within-participant weight change between the text messaging with financial incentive group and the control group and the comparison between the text messaging alone group and the control group (minimum clinically important difference, 3%). The P value defined for statistical significance was P < .025 for each comparison. Results: Of the 585 men (mean [SD] age, 50.7 [13.3] years; mean weight, 118.5 [19.9] kg; mean BMI, 37.7 [5.7]; 525 [90%] White), 227 (39%) lived in postal code areas with lower socioeconomic status, and 426 (73%) completed the 12-month follow-up. At the 12-month follow-up, compared with the control group, the mean percent weight change was significantly greater in the text messaging with financial incentive group (mean difference, -3.2%; 97.5% CI, -4.6% to -1.9%; P < .001) but was not significantly greater in the text messaging alone group (mean difference, -1.4%; 97.5% CI, -2.9% to 0.0, P = .05). The mean (SD) weight changes were -5.7 (7.4) kg for the text messaging with financial incentives group, -3.0 (7.5) kg for the text messaging alone group, and -1.5 (6.6) kg for the control group. The 12-month mean (SD) percentage weight changes from baseline were -4.8% (6.1%) for the text messaging with financial incentives group, -2.7% (6.3%) for text messaging alone group, and -1.3% (5.5%) for the control group. Of 366 adverse events reported, the most common were infections (83 [23%]). Of the 23 serious adverse events (6.3%), 12 (52%) occurred in the text messaging with financial incentives group, 5 (22%) in the texts messaging alone group, and 6 (26%) in the control group. None were considered related to participating in a trial group. Conclusion and Relevance: Among men with obesity, an intervention with text messaging with financial incentive significantly improved weight loss compared with a control group, whereas text messaging alone was not significantly better than the control condition. These findings support text messaging combined with financial incentives to attain weight loss in men with obesity. Trial Registration: isrctn.org Identifier: ISRCTN91974895.

Understanding non-recreational prescription medication-sharing behaviours: a systematic review.

BACKGROUND: Prescription medication sharing refers to the lending or borrowing of prescription medications where the recipient is someone other than the person for whom the prescription is intended. Sharing prescription medication can cause significant harm. Adverse consequences include an increased risk of side effects, delayed health seeking, and severity of disease. Prevalence estimates vary across different populations and people's reasons for, and perceptions of risks from, sharing are poorly understood. AIM: To better understand prescription medication-sharing behaviours and practices - specifically, the prevalence, types of medications, reasons, perceived benefits and risks, and factors associated with medication sharing. DESIGN AND SETTING: This systematic review included primary studies in any setting, focusing on people who engage in medication sharing. METHOD: Electronic databases were searched from inception of databases to February 2023. RESULTS: In total, 19 studies were included. Prevalence of lifetime sharing ranged from 13% to 78%. All 19 studies reported that analgesics were the most shared, followed by antibiotics (n = 12) and allergy medication (n = 9). Common reasons for sharing were running out of medication (n = 7), cost (n = 7), and emergency (n = 6). Perceived benefits included resolution of the problem and convenience. Perceived risks included adverse drug reactions and misdiagnosis. Characteristics associated with sharing included age, female sex, having asthma, and unused medicines stored at home. CONCLUSION: Findings suggest that medication-sharing behaviour is common and involves a range of medicines for a variety of reasons. Data on the prevalence and predictors of prescription medication sharing are inconsistent. A better understanding of non-modifiable and potentially modifiable behavioural factors that contribute to sharing is needed to support development of effective interventions aimed at mitigating unsafe sharing practices.

Defining usual care comparators when designing pragmatic trials of complex health interventions: a methodology review.

BACKGROUND: Pragmatic trials evaluating complex health interventions often compare them to usual care. This comparator should resemble care as provided in everyday practice. However, usual care can differ for the same condition, between patients and practitioners, across clinical sites and over time. Heterogeneity within a usual care arm can raise methodological and ethical issues. To address these it may be necessary to standardise what usual care entails, although doing so may compromise a trial's external validity. Currently, there is no guidance detailing how researchers should decide the content of their usual care comparators. We conducted a methodology review to summarise current thinking about what should inform this decision. METHODS: MEDLINE, Embase, CINAHL and PsycINFO were searched from inception to January 2022. Articles and book chapters that discussed how to identify or develop usual care comparators were included. Experts in the field were also contacted. Reference lists and forward citation searches of included articles were screened. Data were analysed using a narrative synthesis approach. RESULTS: One thousand nine hundred thirty records were identified, 1611 titles and abstracts screened, 112 full texts screened, and 16 articles included in the review. Results indicated that the content of a usual care comparator should be informed by the aims of the trial, existing care practices, clinical guidelines, and characteristics of the target population. Its content should also be driven by the trial's requirements to protect participants, inform practice, and be methodologically robust, efficient, feasible and acceptable to stakeholders. When deciding the content of usual care, researchers will need to gather information about these drivers, balance tensions that might occur when responding to different trial objectives, and decide how usual care will be described and monitored in the trial. DISCUSSION: When deciding the content of a usual care arm, researchers need to understand the context in which a trial will be implemented and what the trial needs to achieve to address its aim and remain ethical. This is a complex decision-making process and trade-offs might need to be made. It also requires research and engagement with stakeholders, and therefore time and funding during the trial's design phase. TRIAL REGISTRATION: PROSPERO CRD42022307324.

Prescribing benzodiazepines in young adults with anxiety: A qualitative study of GP perspectives.

BACKGROUND: Incident benzodiazepine prescriptions in primary care for anxiety decreased between 2003-2018. However, from 2008, incident prescribing of benzodiazepines for anxiety increased among those aged 18-34. There are increasing concerns around prescribing of benzodiazepines. Further, although guidelines state benzodiazepines should only be prescribed short-term, in 2017, 44% of incident prescriptions were prescribed for longer than the recommended duration of two to four weeks. AIM: To understand when and why GPs prescribe benzodiazepines for anxiety in young adults. DESIGN AND SETTING: In-depth interviews with 17 GPs from ten practices in South West England. METHOD: Interviews were conducted by telephone or videocall. A topic guide was used to ensure consistency across interviews. Interviews were audio-recorded, transcribed verbatim and data analysed using reflexive thematic analysis. RESULTS: GPs described caution in prescribing benzodiazepines for anxiety in young adults, but thought they had an important role in acute situations. GPs described caution in prescribing duration, but some thought longer-term prescriptions could be appropriate. GPs perceived that some young adults requested benzodiazepines and suggested this might be because they wanted quick symptom relief. GPs noted that refusing to prescribe felt uncomfortable and that the number of young adults presenting to general practice, already dependant on benzodiazepines, had increased. CONCLUSION: Patient-driven factors for prescribing benzodiazepines suggest there are current unmet treatment needs among young adults with anxiety. Given increases in prescribing in this age group, it may be timely to revisit the role of benzodiazepines in the management of people with anxiety in primary care.

Exploring GPs' views on beta-blocker prescribing for people with anxiety disorders: a qualitative study.

BACKGROUND: Between 2003-2018, incident prescriptions of beta-blockers for anxiety increased substantially, particularly in young adults. NICE guidance for anxiety does not recommend beta-blockers, probably due to a lack of evidence to support such use. Recent reports have highlighted the potential risks of beta-blockers. AIM: To understand when and why GPs prescribe beta-blockers for people with anxiety. DESIGN AND SETTING: In-depth interviews with 17 GPs. METHOD: Interviews were held by telephone or videocall. A topic guide was used to ensure consistency across interviews. Interviews were audio-recorded, transcribed verbatim and analysed thematically. RESULTS: Many GPs viewed beta-blockers as 'low-risk', particularly in young adults. Some GPs viewed beta-blockers as an alternative to benzodiazepines, acting quickly and not leading to dependence. GPs reflected that some patients appeared to want an 'immediate fix' to their symptoms which GPs thought beta-blockers could potentially offer. This was salient in light of substantial waiting lists for talking therapies and delays in antidepressants taking effect. GPs described how some patients seemed more willing to try beta-blockers than antidepressants, as patients did not perceive them as 'mental health drugs' and therefore potentially more acceptable and less stigmatising. Further, GPs viewed beta-blockers as 'patient-led', with patients managing their own dose and frequency, without GP input. CONCLUSION: Many GPs think beta-blockers have a role to play in the management of anxiety. Given recent increases in the prescribing of these drugs in primary care, there is a need to assess their safety and effectiveness as a treatment for people with anxiety disorders.

How can we improve support for women with perinatal anxiety in primary care? A qualitative study.

BACKGROUND: Perinatal anxiety (PNA) occurs during pregnancy and up to 12 months post-partum. PNA affects more than 21% of women and can impact adversely on mothers, children and their families. National Institute for Health and Care Excellence (NICE) guidance identified evidence gaps around non-pharmacological interventions for PNA. AIM: This qualitative study aimed to understand the perspectives of a variety of Perinatal Mental Health (PMH) stakeholders about non-pharmacological interventions for PNA. METHOD: Ethics approval. Semi-structured interviews with women with lived experience of PNA, healthcare professionals (HCPs), voluntary community and social enterprise (VCSE) stakeholders and commissioners. Topic guide modified in response to emerging themes. Interviews digitally recorded with consent, transcribed, and analysed thematically. A patient advisory group was involved throughout the study. RESULTS: There were 25 interviews conducted. Women with PNA expressed a wish to choose from a range of non-pharmacological interventions, which are often delivered by VSCE organisations or not commissioned within the NHS. HCPs described a hierarchy of interventions that can be offered to women, often related to severity of a woman's PNA. PMH VCSE stakeholders emphasised that their services are flexible and accessible for women with PNA. CONCLUSION: Tension exists between what is currently recommended by NICE and thus commissioned, and the types of intervention that women want to access, including support from VCSE services. Clinicians should be aware of local VCSE organisations which provide care for women with PNA. There is an evidence gap around the effectiveness of various interventions delivered by VCSE organisations, which requires further exploration.

Eye-movement desensitisation and reprocessing therapy (EMDR) to prevent transition to psychosis in people with an at-risk mental state (ARMS): mixed method feasibility study.

BACKGROUND: Trauma plays an important role in the development of psychosis, but no studies have investigated whether a trauma-focused therapy could prevent psychosis. AIMS: This study aimed to establish whether it would be feasible to conduct a multicentre randomised controlled trial (RCT) to prevent psychosis in people with an at-risk mental state (ARMS), using eye-movement desensitisation and reprocessing therapy (EMDR). METHOD: This started as a mixed-method randomised study comparing EMDR to treatment as usual but, as a result of low participant recruitment, was changed to a single-arm feasibility study. The proposed primary outcome for an RCT was transition to psychosis at 12-month follow-up. Data on secondary outcomes were also collected. Qualitative interviews were conducted with patients and therapists. RESULTS: Fourteen participants were recruited from the Early Intervention teams. Most people who expressed an interest in taking part attended an assessment to determine eligibility. All those eligible consented to take part. A total of 64% (7 of 11) of participants who were offered EMDR were followed up at 12 months. Of the 11 participants offered EMDR, one (11%, 95% CI: 0.2%, 48%) transitioned to psychosis. Nine patients and three therapists were interviewed. Participants who completed therapy (n = 4; mean 10.5 sessions) found EMDR helpful, but those who discontinued (n = 6; mean 5.2 sessions) said it had not benefitted them overall. Therapists said EMDR could be effective, although not for all patients. CONCLUSIONS: Future studies recruiting people with an ARMS to an RCT may need to extend recruitment beyond Early Intervention teams. Although some individuals found EMDR helpful, reasons for discontinuing need to be addressed in future studies.

Collaborative discussions between pharmacists and general practitioners to optimise patient medication: a qualitative study within a clinical trial.

BACKGROUND: There has been significant investment in pharmacists working in UK general practice to improve the effective and safe use of medicines. However, evidence of how to optimise collaboration between GPs and pharmacists in the context of polypharmacy (multiple medication) is lacking. AIM: To explore GP and pharmacist views and experiences of in-person, inter-professional collaborative discussions (IPCDs) as part of a complex intervention to optimise medication use for patients with polypharmacy in general practice. DESIGN AND SETTING: A mixed-method process evaluation embedded within the Improving Medicines use in People with Polypharmacy in Primary Care (IMPPP) trial conducted in Bristol and the West Midlands. METHOD: Audio-recordings of IPCDs between GPs and pharmacists, and individual semi-structured interviews exploring their reflections on these discussions. All recordings were transcribed verbatim and analysed thematically. RESULTS: Fourteen practices took part in the process evaluation (Feb 2021- Sept 2023). Seventeen IPCD meetings were audio recorded discussing 30 patients (range of 1-6 patients per meeting). Six GPs and 13 pharmacists were interviewed. The IPCD was highly valued by GPs and pharmacists who described benefits including: strengthening their working relationship; learning from each other; and gaining in confidence to manage more complex patients. It was often challenging, however, to find time for the IPCDs. CONCLUSION: The model of IPCD studied provided protected time for GPs and pharmacists to work together to deliver whole-patient care, with both professions finding this beneficial. Protected time for inter-professional liaison and collaboration, and structured interventions may facilitate improved patient care.

Could primary care records be used to identify women at risk of perinatal anxiety? A mixed-methods study.

BACKGROUND: Perinatal anxiety (PNA) occurs throughout the antenatal period or up to 1 year after childbirth, with a prevalence of 21%. AIM: To investigate if primary care records could be used to identify women at 'higher risk' of PNA. METHOD: Mixed-methods approach using quantitative and qualitative methods. Quantitative data analysis used Clinical Practice Research Datalink and IQVIA Medical Research Data to identify risk factors for PNA. Interviews explored the lived experiences of women with PNA about predisposing factors for PNA and acceptability of being informed of risk; and perspectives of primary healthcare professionals and Voluntary, Community, and Social Enterprise practitioners about risk communication. Interviews were conducted online, digitally recorded with consent, transcribed, and anonymised prior to analysis. Data were thematically analysed. Patient and clinical advisory groups informed each stage of the research. RESULTS: Women reflected on both positive and negative impacts of being identified at higher risk of PNA, a lack of understanding of how primary care records are used, and who has access to them. All interview participants suggested predisposing factors that would not be coded in primary care records. Quantitative analysis demonstrated that some predisposing factors for PNA can be identified in a woman's primary care records. Initial analysis suggests associations between PNA and infant health and healthcare use. CONCLUSION: While identification of higher risk of PNA may be acceptable, some factors that may contribute to PNA are not coded in primary care records. Identifying and managing PNA is needed to improve infant health.

Co-designing a nature-based intervention to promote postnatal mental health for mothers and their infants: a complex intervention development study in England.

OBJECTIVES: There is burgeoning evidence for the potential of nature-based interventions to improve wellbeing. However, the role of nature in enhancing maternal mental health, child development and early relationships remains relatively unexplored. This study aimed to develop a co-designed nature-based intervention to improve postnatal mothers' and infants' wellbeing. DESIGN, SETTING AND PARTICIPANTS: Person-based and co-design approaches informed the planning and design of the postnatal nature-based intervention. In stage 1, a multidisciplinary team was formed to agree research questions and appropriate methodology, and a scoping review was conducted. Six qualitative focus groups were then held with 30 mothers and 15 professional stakeholders. In stage 2, intervention guiding principles and a logic model were developed, and a stakeholder consensus meeting was convened to finalise the prototype intervention. The research was conducted in Bristol, UK, across voluntary, educational and community-based healthcare settings. RESULTS: Stakeholder consultation indicated significant enthusiasm for a postnatal nature-based intervention. A scoping review identified little existing research in this area. Focus group data are reported according to four broad themes: (1) perceived benefits of a group postnatal nature-based intervention, (2) potential drawbacks and barriers to access, (3) supporting attendance and implementation, and (4) ideas for intervention content. The developed intervention was tailored for mothers experiencing, or at risk of, postnatal mental health difficulties. It was identified that the intervention should facilitate engagement with the natural world through the senses, while taking into account a broad range of postnatal-specific practical and psychological needs. CONCLUSIONS: To our knowledge, this is the first reported use of person-based and co-design approaches to develop a postnatal nature-based intervention. The resulting intervention was perceived by target users to address their needs and preferences. Further research is needed to determine the feasibility, clinical and cost-effectiveness of this approach.