Background:Patients' perceptions of medication significantly influence therapeutic outcomes, particularly among individuals with Acute Coronary Syndrome (ACS). The Beliefs about Medicines Questionnaire (BMQ) is a widely utilized instrument for evaluating patients' beliefs regarding their medications. However, a validated, culturally relevant, and linguistically accurate Indonesian version of the BMQ is currently unavailable. The absence of such adaptation restricts the tool's effectiveness in assessing beliefs among post-ACS patients in Indonesia, where these beliefs may substantially impact treatment adherence and clinical outcomes. Therefore, translation, validation, and cultural adaptation of the BMQ are essential to ensure its accuracy in evaluating patient beliefs within the Indonesian context. Purpose:To develop and validate an Indonesian version of the BMQ questionnaire, ensuring its linguistic and cultural appropriateness for use specifically among post-ACS patients in Indonesia. This validated version is crucial for regions with a high burden of cardiovascular disease, where belief patterns can inform tailored adherence interventions. Patients and methods:This cross-sectional study was conducted with post-acute coronary syndrome (ACS) patients who received treatment in June and July 2025 at two hospitals in Makassar, South Sulawesi, Indonesia. We adhered to the established guidelines for forward-backward translation and recruited 96 post-ACS outpatients. The inclusion criteria encompassed individuals aged ≥18 years who had been diagnosed with ACS, had undergone therapy for a minimum of six months, and had provided written consent to participate. The psychometric evaluation by Horne et al., comprised confirmatory factor analysis, item-total validity assessed through Pearson correlation, internal consistency measured using Cronbach's alpha, and inter-rater reliability. Results:The Indonesian-translated BMQ instrument was tested for validity and reliability among 96 post-ACS patients. All 18 items demonstrated strong validity with r-count values exceeding the r-table threshold (0.1996). Cronbach's alpha values were all ≥0.750 across domains, indicating high overall reliability. Pilot feedback prompted minor wording refinements to enhance clarity and cultural resonance. These results confirm that the instrument reliably measures patient beliefs about medicine in this population. Conclusion:The psychometric properties of the Indonesian version of the BMQ align with those documented in the original study. Our findings indicate that the Indonesian adaptation of the BMQ is a valid and reliable instrument for evaluating treatment-related beliefs in patients with post-acute coronary syndrome (ACS) in South Sulawesi, Indonesia. However, further psychometric assessments are necessary to confirm its broader applicability across different regions and patient populations, particularly in population-based studies and routine pharmacy practice settings.
Background High quality shared decision-making (SDM) conversations involve people with or at risk of osteoporosis and clinicians working together to decide, where appropriate, which evidence-based medicines best fit the person’s life, beliefs, and values. The improving uptake of Fracture Prevention drug treatments (iFraP) intervention comprises a computerised Decision Support Tool (DST), clinician training package and information resources, designed for use in UK Fracture Liaison Service (FLS) consultations. The iFraP intervention will be tested in a pragmatic, parallel-group, individual randomised controlled trial in patients referred to four FLSs in England. This mixed methods process evaluation aims to assess which components of iFraP were delivered and how (fidelity), whether iFraP results in a change in osteoporosis drug treatment initiation rates and how, and how context affects implementation of iFraP and outcomes. Methods We will collect quantitative data using (1) Case Report Forms completed by FLS clinicians; (2) self-reported questionnaires completed by patient participants; and (3) DST analytic data. We will collect qualitative data using (1) semi-structured interviews with patients who receive the iFraP intervention in their FLS appointment, FLS clinicians delivering iFraP appointments, and primary care clinicians that have consulted with a patient following their iFraP FLS appointment; and (2) FLS consultation recordings. A triangulation protocol will be used to integrate the quantitative and qualitative findings to generate novel insights about the intervention under evaluation. Discussion The process evaluation, alongside the trial, will help to understand what elements of the iFraP intervention were delivered and how, the mechanisms of impact and how context affected implementation and outcomes, and intervention acceptability. Mixed methods interpretation will lead to further insights about the implementation of SDM and DSTs in-practice. Trial registration ISRCTN: 10606407, 21/11/2022 https://doi.org/10.1186/ISRCTN10606407
Purpose:Patients' necessity beliefs and concerns about antipsychotic medication may influence medication adherence. This study aimed to identify factors predicting necessity beliefs and concerns about antipsychotic medication. Patients and Methods:This longitudinal study included patients with psychotic disorders from 31 Norwegian specialist mental health care units at baseline (0 months; N=310) and 12 months (n=151), reflecting attrition. We investigated associations between patients' sociodemographic and clinical characteristics, their perceptions of medication support (MedSupport questionnaire), and their medication necessity beliefs and concerns (Beliefs about Medicines Questionnaire; BMQ) at baseline. We assessed change in BMQ subscales from baseline to 12 months and factors associated with the change. The data were analyzed using linear mixed-effects models. Results:At baseline, higher MedSupport scores were associated with higher BMQ-Necessity (β=0.18 (95% confidence interval (CI)=0.04 to 0.33)) and lower BMQ-Concerns (β=-0.29 (95% CI=-0.42 to -0.16)) subscales. Higher educational level and higher number of psychotropic medications were associated with higher BMQ-Necessity. Higher symptom load and medication side effects were associated with higher BMQ-Concerns. Patients' beliefs about their medications became more negative over time, ie BMQ-Necessity scores decreased (-0.35 (95% CI=-0.60 to -0.11)) and BMQ-Concerns increased (0.25 (95% CI=0.05 to 0.45)). Higher dose of psychotropic medications at baseline and female sex was associated with an increase in BMQ-Necessity. A higher number of antipsychotic medications was associated with an increase in BMQ-Concerns from baseline to 12 months. Conclusion:Patients who experienced better medication support had significantly more positive medication beliefs at study start. Patients' views about their medications became significantly more negative over the one-year follow-up, highlighting the potential need for clinicians to provide follow-up support to address the doubts and concerns that might emerge over the course of treatment.
Background Good quality shared decision-making (SDM) conversations involve people with, or at risk of osteoporosis and clinicians collaborating to decide, where appropriate, which evidence-based medicines best fit the person’s life, beliefs, and values. We developed the improving uptake of Fracture Prevention drug treatments (iFraP) intervention comprising a computerised Decision Support Tool (DST), clinician training package and information resources, for use in UK Fracture Liaison Service consultations. Two primary objectives to determine (1) the effect of the iFraP intervention on patient-reported ease in decision-making about osteoporosis medicines, and (2) cost-effectiveness of iFraP intervention compared to usual NHS care. Secondary objectives are to determine the iFraP intervention effect on patient reported outcome and experience measures, clinical effectiveness (osteoporosis medicine adherence), and to explore intervention acceptability, mechanisms, and processes underlying observed effects, and intervention implementation. Methods The iFraP trial is a pragmatic, parallel-group, individual randomised controlled trial in patients referred to a Fracture Liaison Service, with nested mixed methods process evaluation and health economic analysis. Participants aged ≥50 years (n=380) are randomised (1:1 ratio) to one of two arms: (1) iFraP intervention (iFraP-i) or (2) comparator usual NHS care (iFraP-u) and are followed up at 2-weeks and 3-months. The primary outcome is ease of decision-making assessed 2 weeks after the consultation using the Decisional Conflict Scale (DCS). The primary objectives will be addressed by comparing the mean DCS score in each trial arm (using analysis of covariance) for patients given an osteoporosis medicine recommendation, alongside a within-trial cost-effectiveness and value of information (VoI) analysis. Process evaluation data collection includes consultation recordings, semi-structured interviews, and DST analytics. Discussion The iFraP trial will answer important questions about the effectiveness of the new ‘iFraP’ osteoporosis DST, coupled with clinician training, on SDM and informed initiation of osteoporosis medicines. Trial registration: ISRCTN 10606407, 21/11/2022 https://doi.org/10.1186/ISRCTN10606407
Background A person’s beliefs about treatment influence their engagement and adherence to that treatment. The Necessity-Concerns Framework suggests that adherence is influenced by a person’s judgement of their own need for treatment (necessity beliefs) and concerns about the potential adverse consequences of taking the treatment. This study was conducted to explore the Necessity-Concerns Framework for elexacaftor-tezacaftor-ivacaftor (ETI) therapy (Kaftrio) in adults with cystic fibrosis (CF).Methods A total of 64 adults with CF were maintained on ETI therapy as part of their routine CF care, and completed the Beliefs about Medicines Questionnaire. Patient demographics, lung function, body mass index and quality of life using the Cystic Fibrosis Questionnaire Revised were collected as part of routine clinical care. Duration of ETI therapy along with medicines possession ratio was recorded.Results Patients reported strong beliefs about the necessity of ETI therapy. The majority of patients (78%) reported low concerns about ETI therapy while 22% of patients reported high concerns. A small number of patients (n=4) had concerns which were stronger than their beliefs about necessity.Discussion Patients reported strong beliefs in the necessity of ETI therapy. Although concerns were lower, a significant proportion of the sample had strong concerns about their ETI therapy. By being aware of people with CF’s necessity and concerns beliefs around ETI therapy clinical teams will be better armed to engage them in treatment decisions and support optimal adherence.
OBJECTIVES:Implementation of more stringent LDL-C targets, as recommended by ESC/EAS guidelines, may be influenced by physician understanding of patient preferences. We aimed to understand patient preferences for lipid lowering therapy (LLT) management, perceptions of LLT and unmet needs, alongside physician predictions. We also investigated physician and patient therapy choices in two clinical scenarios. METHODS:450 physicians (224 primary care and 226 specialists) across Germany, Italy, and the UK were analysed. RESULTS:Patients reported a high prevalence of unmet needs in relation to support with treatment which was not apparent to physicians. Clinicians underestimated the proportion of patients with doubts about their perceived need for LLT (predicted 40%; actual 64%), treatment concerns (predicted 40%; actual 78.7%), and unmet information needs (32% physician agreement; actual 75%). Despite having negative attitudes to existing treatments, 82% of patients were open to treatment intensification if their LLT was suboptimal (vs. 55% physician agreement). Furthermore, only 16.7% of patients believed repeated prescription changes would lead to non-adherence (vs. 52.4% physician agreement). Presented with case studies, physicians chose progressive LLT more often for the high CV risk case with statin intolerance than for the very high CV risk uncontrolled case (82.7% vs. 61.6%). In both cases, approximately 50% of patients chose progressive LLT. CONCLUSION:More comprehensive physician and patient support is needed to optimize LLT treatment. This should address patient and clinician barriers to treatment escalation and facilitate shared decision-making.
OBJECTIVE:To evaluate if, and how, clinicians elicit and address health and medicine beliefs in osteoporosis consultations, and to evaluate the impact of a conversation aid (CA) on clinician behaviour. METHODS:Secondary analysis of 107 video-recorded consultations from two trials evaluating CAs, using a bespoke coding tool to record the presence or absence of clinician shared decision-making (SDM) behaviours. In addition to descriptive statistics, Fisher's exact test examined differences between consultations with and without CAs. RESULTS:Clinicians framed osteoporosis as a bone density (92 %) and/or fracture risk problem (78 % overall (96 % usual care vs 62 % aided, p < 0.001)). Biopsychosocial consequences of fractures were rarely mentioned. Clinicians asked questions to elicit beliefs in 58 % of consultations, most commonly general views on medications (47 % usual care vs 26 % aided, p = 0.03). Clinicians rarely asked about beliefs related to osteoporosis (n = 3), perceived need for (n = 1), concerns about (n = 5), or practical issues (n = 6) with medication. Clinicians used persuasion techniques more commonly in aided consultations (88 % vs 64 %, p = <0.001). Patient understanding was infrequently checked (12 %). CONCLUSIONS:Clinicians miss opportunities to support patients to get the best from osteoporosis medications by tailoring communications to address necessity, beliefs, concerns and practicalities. PRACTICE IMPLICATIONS:We need better methods for supporting clinicians in eliciting patient beliefs about osteoporosis and the medications recommended to treat it, including their need, safety, and practical issues.
Rapid molecular diagnostic tests improve antimicrobial stewardship (AMS) by facilitating earlier refinement of antimicrobial therapy. The INHALE trial tested the application of the BioFire FilmArray Pneumonia Panel (Pneumonia Panel) for antibiotic prescribing for hospital-acquired and ventilator-associated pneumonias (HAP/VAP) in UK intensive care units (ICUs). We report a behavioral study embedded within the INHALE trial examining clinicians' perceptions of using these tests. Semi-structured interviews were conducted with 20 ICU clinicians after using the Pneumonia Panel to manage suspected HAP/VAP. Thematic analysis identified factors reinforcing perceptions of the necessity to modify antibiotic prescribing in accordance with test results and doubts/concerns about doing so. While most acknowledged the importance of AMS, the test's impact on prescribing decisions was limited. Concerns about potential consequences of undertreatment to the patient and prescriber were often more salient than AMS, sometimes leading to "just-in-case" antibiotic prescriptions. Test results indicating a broad-spectrum antibiotic were unnecessary often failed to influence clinicians to avoid an initial prescription or de-escalate antibiotics early as they considered their use to be necessary to protect the patient and themselves, "erring on the side of caution." Some clinicians described cases where antibiotics would be prescribed for a sick patient regardless of test results because, in their opinion, it fits with the clinical picture-"treating the patient, not the result." Our findings illustrate a tension between prescribing guidelines and clinicians' "mindlines," characterized by previous experiences. This highlights the need for a "technology plus" approach, recognizing the challenges clinicians face when applying technological solutions to patient care.IMPORTANCERapid molecular diagnostic tests for pathogens and resistance genes may improve antibiotic-prescribing decisions and stewardship. However, clinicians' desire to protect their patients with antibiotics often overrides more distal concerns about possible resistance selection, limiting the application of these tests in practice. Findings underscore the challenge of changing prescribing decisions based on technical results or guidelines, highlighting factors such as clinicians' previous experience and "knowledge in practice" as more proximal drivers of these decisions. Implementation strategies for technological solutions to antimicrobial resistance must be "behaviorally intelligent," recognizing the challenges facing clinicians when making "life or death" prescribing decisions.CLINICAL TRIALSThis study is registered with ISRCTN as ISRCTN16483855.
Abstract Background Tuberculosis (TB) stigma may be a barrier to engagement in testing and treatment for TB infection (TBI). We systematically reviewed the available evidence on how TB stigma influences engagement with TBI testing and treatment. Methods Electronic databases (e.g., CINAHL, Central, OVID) were searched from 1963 to 1st August 2024. Quantitative, qualitative, and mixed-method studies reporting the effects of TB stigma on engagement with TBI testing and treatment were included in the review. Descriptive synthesis was applied to the quantitative studies, and thematic analysis was applied to qualitative studies. The risk of bias was assessed by using the mixed methods appraisal tool. Results Seventeen studies were included in the review (12 qualitative, four quantitative and one mixed methods). TB stigma was complex and multifactorial with six overlapping domains: public, anticipated, self, experienced, secondary, and structural. Perceptions or experiences of stigma were associated with lower rates of engagement in testing and adherence to treatment in TBI. Conclusions Perceptions of TB stigma among people with TBI were related to the common social representation of TB disease such as its being contagious or disease of the poor. Negative perceptions of active TB appear to carry over to its infection, despite people being informed about the nature of TBI. Our findings could inform more effective communication to support TBI testing and treatment engagement.
Background Antiretroviral therapy has transformed human immunodeficiency virus infection intoa chronic condition associated with normal life expectancy. In the United Kingdom, the uptake of antiretroviral therapy is generally high, but a delay in starting antiretroviral therapy and non-adherence compromise the health and well-being of people living with human immunodeficiency virus, increase the risk of transmission of human immunodeficiency virus and increase National Health Service costs. Objectives The overall aim was to improve antiretroviral therapy uptake and adherence by addressing perceptual and practical barriers. The objectives were to (1) identify culturally specific beliefs and other factors influencing uptake of and adherence to antiretroviral therapy that have not emerged in previous research; (2) refine existing methods for assessing perceptual and practical barriers to antiretroviral therapy uptake and adherence; (3) develop an intervention to increase antiretroviral therapy uptakeand adherence; (4) determine intervention feasibility and acceptability; (5) evaluate intervention efficacy;(6) assess the short- and long-term costs and cost-effectiveness of the interventions and (7) prepare for implementation within the National Health Service. Design Objective 1 – in-depth interviews with Black African and Black Caribbean people living with human immunodeficiency virus (n = 52); objective 2 – adaptation of the Beliefs about Medicines Questionnaire; objective 3 – development of the Supporting UPtake and Adherence to antiretroviral therapy service intervention; objective 4 – feasibility study (n = 213) and acceptability/process interviews (n = 24); objective 5 – observational study (n = 484) and randomised controlled trial (n = 143); objective 6 – systematic review, cost-effectiveness analysis (n = 210) and economic modelling; and objective 7 – preparatory implementation work with people living with human immunodeficiency virus and human immunodeficiency virus clinic staff. Setting National Health Service human immunodeficiency virus clinics in England with a high proportion of ethnic minority populations. Participants People living with human immunodeficiency virus. Interventions Adherence support – cognitive–behavioural therapy plus care as usual. Main outcome measures Workstream 1 – adapted Beliefs about Medicines Questionnaire–antiretroviral therapy. Workstream 2 – feasibility study: participant recruitment and withdrawal rates. Workstream 3 – randomised controlled trial – primary outcome: medication event monitoring system adherence. Workstream 4 – incremental cost-effectiveness ratio. Results Workstream 1 – qualitative studies were used to refine the Beliefs about Medicines Questionnaire – antiretroviral therapy and, together with our preparatory research, to inform the cognitive–behavioural therapy-based intervention. Workstream 2 – recruitment to the randomised controlled trial and observational study was deemed feasible. Thematic analysis of exit interviews with recipients of the SUPA intervention demonstrated that the intervention was acceptable and addressed perceptual and practical barriers to antiretroviral therapy. In Workstream 3, we did not meet the recruitment targets and our trial was underpowered for the primary outcome: 143 participants met the inclusion criteria and were randomised (care as usual, n = 72; care as usual plus cognitive–behavioural therapy, n = 71). There was no significant effect of cognitive–behavioural therapy on the primary end point. Of the 112 participants (care as usual, n = 55; cognitive–behavioural therapy, n = 57) for whom sufficient data for primary end-point analysis were available, 17 (15.2%) met the primary end point (> 80% of months with an average monthly adherence of ≥ 90%) [9 (16.4%) in the care-as-usual group and 8 (14.0%) in the cognitive–behavioural therapy group (p = 0.94)]. Secondary end points: median Medication Event Monitoring System adherence at 12 months was 61.9% in the care-as-usual group and 66.5% in the cognitive–behavioural therapy group (p = 0.40), representing a 7.5% uplift in adherence. Participants who were randomised to receive the intervention, based on perceptions of antiretroviral therapy at baseline (low antiretroviral therapy necessity beliefs, and/or high antiretroviral therapy concerns), experienced a greater decrease in antiretroviral therapy concerns [care as usual −0.9 (95% confidence interval −1.4 to −0.5) vs. cognitive–behavioural therapy −0.6 (95% confidence interval −0.8 to −0.3); p = 0.03], treatment intrusiveness [median change in highly active antiretroviral treatment (antiretroviral therapy) Intrusiveness Scale scores: care as usual −0.5 (95% confidence interval −5.6 to 18.0) vs. cognitive–behavioural therapy −5.6 (95% confidence interval −20.4 to 1.2); p = 0.03] and depression scores [median change in depression score: care as usual 0 (95% confidence interval −1.5 to 2.0) vs. cognitive–behavioural therapy −1 (95% confidence interval −3 to 0); p = 0.02] between baseline and 12 months. Workstream 4 – cognitive–behavioural therapy resulted in 0.056 more quality-adjusted life-years than care as usual (95% confidence interval 0.0029 to 0.083). The incremental cost-effectiveness ratio was £11,189 per quality-adjusted life-year. At a threshold of £20,000 per quality-adjusted life-year, there was > 90% likelihood that the intervention would be more cost-effective than care as usual. There was a 13% likelihood that the intervention would produce more quality-adjusted life-years and result in lower health and social care costs than care as usual. A Markov model showed that, over the longer term, cognitive–behavioural therapy results in fewer quality-adjusted life-years and higher costs and, therefore, care as usual would be the more cost-effective option. Limitations Our primary outcome of full Medication Event Monitoring System adherence was problematic, our randomised controlled trial was underpowered and we were unable to demonstrate a significant difference in our primary outcome. Conclusions Patients who received the Supporting UPtake and Adherence to antiretroviral therapy service intervention benefited from a reduction in antiretroviral therapy concerns, a reduction in antiretroviral therapy intrusiveness and reduced depressive symptoms, and from improved quality of life. The intervention was likely to be cost-effective for the National Health Service within 12 months. Future work Given the difficulty in recruiting people at a high risk of non-engagement with human immunodeficiency virus care, future work assessing the effectiveness of adherence interventions may require alternative, non-standard randomised controlled trial designs. Further studies are necessary to recalibrate our understanding of the levels of antiretroviral therapy adherence necessary to achieve viral load suppression. Study registration The trial is registered as ISRCTN35514212 and the study is registered as CRD42019072431. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research Programme (NIHR award ref: RP-PG-0109-10047) and is published in full in Programme Grants for Applied Research; Vol. 13, No. 8. See the NIHR Funding and Awards website for further award information. Plain language summary Human immunodeficiency virus treatment (known as antiretroviral therapy) is very effective, but some patients do not get the full benefit because they delay treatment or miss doses. This increases the chances of getting ill and the risk of passing human immunodeficiency virus on to others. There are many reasons why people delay treatment or take less than has been prescribed, including beliefs and concerns about treatment and practical difficulties. People from United Kingdom Black African and Caribbean communities often experience difficulties with human immunodeficiency virus treatment, but few studies have focused on this group. We interviewed 52 people from Black African and Caribbean communities about their views and experiences of human immunodeficiency virus and its treatment, and designed questionnaires to measure these. After consulting with people living with human immunodeficiency virus, we developed a new service to help people get the best from human immunodeficiency virus treatment (i.e. Supporting UPtake and Adherence to antiretroviral therapy). The Supporting UPtake and Adherence to antiretroviral therapy service included a video and booklet about human immunodeficiency virus and antiretroviral therapy and up to four meetings or telephone calls with a nurse to address questions and concerns. We compared the Supporting UPtake and Adherence to antiretroviral therapy service with usual National Health Service care to test whether or not patients who received the Supporting UPtake and Adherence to antiretroviral therapy intervention were more likely to take antiretroviral therapy as prescribed by their doctor (known as adherence). We also tested whether or not the Supporting UPtake and Adherence to antiretroviral therapy programme benefited patients by reducing antiretroviral therapy concerns and practical difficulties, and if it improved depression and provided value for money for the National Health Service. It was more difficult than we expected to recruit people to the trial. Because of this, and difficulties in measuring the amount of antiretroviral therapy taken, we did not show that people who received the Supporting UPtake and Adherence to antiretroviral therapy intervention took more antiretroviral therapy over 12 months than those who received normal care. People who received the Supporting UPtake and Adherence to antiretroviral therapy intervention benefited from reduced concerns about antiretroviral therapy and antiretroviral therapy interfered less in their lives. People who received the Supporting UPtake and Adherence to antiretroviral therapy intervention were also less depressed and used fewer extra National Health Service services. The Supporting UPtake and Adherence to antiretroviral therapy service represented value for money in the short term. Scientific summary Background Antiretroviral therapy (ART) is highly effective and the majority of people living with human immunodeficiency virus (PLWH) in the UK now have an undetectable viral load and a near-normal life expectancy and pose a low risk of onward human immunodeficiency virus (HIV) transmission. However, adherence to ART is necessary to suppress and maintain an undetectable HIV viral load. Substantial numbers of PLWH in the UK are not prescribed ART or have a detectable viral load when prescribed ART. This is a problem because both delays to start ART and non-adherence compromise the health and well-being of PLWH, increase the risk of HIV transmission and increase NHS costs. There is a need for a pragmatic, evidence-based approach to increase uptake and adherence to ART. Interventions to increase adherence across long-term conditions have had limited success, and it is not yet clear which strategies are most effective. To optimise engagement with ART, there is a need to understand why people with HIV may not want to, or be unable to, initiate and take ART. Our preparatory research was conducted across multiple chronic illnesses, including HIV infection, and in different cultural contexts and showed that adherence was consistently related to both perceptions of their treatment [i.e. how patients judged their personal necessity for treatment (necessity beliefs) relative to their concerns about potential adverse effects] and practical difficulties with taking treatment, such as limitations in capability and opportunity. This work influenced the National Institute for Health and Care Excellence (NICE) guidelines for adherence that recommend tailoring adherence support to address the specific perceptual and practical barriers that are salient for the individual. Aim The aim of this programme was to improve engagement with ART (uptake and adherence) by addressing perceptual and practical barriers, providing the evidence base for HIV care and informing the implementation of NHS policy. Figure a shows an overview of the programme and highlights the various components of each workstream (WS). FIGURE aProgramme overview. AC, ancillary study; BMQ, Beliefs about Medicines Questionnaire; CAU, care as usual; CBT, cognitive–behavioural therapy; IPA, interpretative phenomenological analysis; RCT, randomised controlled trial; SUPA, Supporting UPtake and Adherence to ART. Objectives Identify culturally specific beliefs and other factors influencing uptake of and adherence to ART that have not emerged in previous research. Refine our existing methods for eliciting and measuring the salient perceptual and practical factors influencing uptake of and adherence to ART. Develop an intervention (including intervention manuals, materials and therapeutic intervention) to increase uptake of and adherence to ART. Determine the feasibility and acceptability of the intervention. Evaluate the efficacy of the intervention for increasing ART uptake and adherence. Assess the costs and cost-effectiveness of providing the intervention in the short and long term. Prepare for implementation within the NHS. Methods and results Workstream 1: intervention development Workstream 1 addressed objectives 1–3 in three studies from discussions with our patient and public involvement group, clinical advisors and our analysis of gaps in the published literature on adherence to antiretrovirals, it became apparent that people from UK Black African and Caribbean communities often experience difficulties with HIV treatment, but few studies have focused on this group. We therefore paid particular attention to this group in our intervention development studies. Study 1 identified culturally specific beliefs and other factors influencing the uptake of and adherence to ART in Black African and Caribbean communities that have not emerged in previous research. We interviewed 52 men and women from Black African and Caribbean communities in London who had been identified as having previous or current problems adhering to their medication. Two separate analyses were conducted. The first used interpretative phenomenological analysis to understand the lived experiences of taking ART among a group of women from West Africa (n = 10), which was a previously under-represented community in HIV adherence research. The analysis identified issues and challenges that the women experienced with adherence to ART. The following three overarching themes were identified: (1) negative experiences of medication, (2) temporal improvement and (3) spurs to adherence. The second analysis used framework analysis to identify perceptual and practical barriers to adherence (n = 52). This analysis of in-depth interviews with people with demonstrated suboptimal adherence showed that perceptual barriers to ART could be grouped into two overarching themes: doubts about the need for ART and concerns about potential harm and stigma. The findings of our preparative research were discussed with patient representatives and practising clinicians from centres with a large proportion of men who have sex with men (MSM). The consistent view was that our preparative research findings remained relevant for MSM and that further research in this group to inform our measures of perceptual and practical barriers to ART was unnecessary. Study 2 refined existing methods to measure patients’ perceptions of ART. The study 1 findings were used to refine our measures of perceptual and practical barriers to ART uptake and adherence with four items added to the Beliefs about Medicines Questionnaire (BMQ)-ART. Study 3 developed an intervention to address barriers and facilitate ART uptake and adherence. Medical Research Council guidance was applied to develop a cognitive–behavioural therapy (CBT)-based intervention to support uptake and adherence to ART. The intervention, intervention manual and animations were developed by an Intervention Development Group, including experts in adherence, behaviour change theory, CBT, HIV medicine, nursing, pharmacy and HIV patient advocacy. It was informed by our preparatory research and the findings of study 1, incorporating: standardised information about HIV and its treatment, designed to address common, adherence-related misconceptions and concerns and signpost patients to further support to help overcome practical difficulties with taking ART and reduce the degree to which ART interfered with daily living (ART intrusiveness), delivered through an animated video and a booklet personalised discussion with a HIV nurse to introduce the Supporting UPtake and Adherence to ART (SUPA) video and booklet and address barriers to adherence, applying CBT techniques in up to four sessions – the first was face to face, with further sessions in clinic or by telephone follow-up, determined by patient preference. The intervention manual and animation were reviewed by the SUPA management group and members of the target population. User testing and further development of materials were conducted with PLWH, who were recruited through the Africa Advocacy Foundation (AAF). Workstream 2: feasibility and acceptability of the Supporting UPtake and Adherence to antiretroviral therapy (cognitive–behavioural therapy) intervention Study 4 determined the feasibility and acceptability of the SUPA (CBT) intervention. Study 4 included the following two components. Quantitative feasibility study nested within the randomised controlled trial to determine the feasibility of the Supporting UPtake and Adherence to antiretroviral therapy intervention Over an initial period of 14 months, 213 PLWH were recruited to an observational study, of whom 86 were eligible for the randomised controlled trial (RCT) and 46 were successfully randomised [23 to the care as usual (CAU) group and 23 to the CBT group]. Rates of attrition were low: of the 213 patients enrolled in the observational study, only 5 were not reached for follow-up appointments. Of the 46 patients randomised, 2 withdrew. Qualitative feasibility study The qualitative feasibility study was a thematic analysis of qualitative interviews conducted with people randomised to receive the SUPA intervention. This analysis determined the acceptability of the SUPA intervention and explored the process of change. Twenty-four people from the PLWH community in the UK were interviewed about their experiences of taking part in the trial and receiving the SUPA intervention. Participants reported various reasons for enrolling in the trial, including the desire to learn about HIV and its treatment, play an active role in their health care, and give something back to other PLWH. Intervention sessions gave participants the opportunity to discuss their concerns about ART and to receive confidential advice and support. Participants indicated that the intervention materials were relevant and accessible. The findings indicated that the intervention addressed misconceptions about HIV, provided a rationale for taking ART, reduced concerns about ART and provided practical strategies for adherence and emotional support. Workstream 3: randomised controlled trial efficacy of the Supporting UPtake and Adherence to antiretroviral therapy cognitive–behavioural therapy-based intervention to support antiretroviral therapy uptake and adherence The efficacy of the SUPA intervention was examined in a RCT. A two-step consent process was followed. ART-naive PLWH who had received a treatment offer were recruited from eight HIV clinics in England to take part in an observational study. Participants completed the BMQ-ART, and those who had perceptual barriers to ART (doubts about personal need for ART and/or concerns about ART), and were therefore deemed at risk of non-adherence, were invited to take part in the RCT. Those who consented to take part in the RCT were randomised to receive CAU or CBT (Figure b). Those who were not eligible for the RCT or who declined to take part remained in the observational study and completed the BMQ-ART at the 3-, 6- and 12-month follow-ups. FIGURE bThe SUPA study trial design. The primary end point was designed to capture both a delay to initiate treatment and non-adherence, and was developed in discussion with NIHR. In the months prior to ART initiation, adherence was set to 0%. After starting ART, the proportion of days within the month with full adherence was assessed using Medication Event Monitoring System (MEMS®) (AARDEX Group, Seraing, Belgium). Adherence within each patient-month was then classified as being good (≥ 90%) or poor (< 90%), and the prespecified primary outcome was met if individuals achieved good adherence in > 80% of the months during which they were under follow-up. The secondary outcomes were percentage MEMS adherence, self-reported adherence, changes in beliefs about ART, ART intrusiveness and practical difficulties with ART, perceptions of HIV, depression and anxiety, viral load suppression, regimen switches, treatment failure, and disengagement from care. Between March 2014 and July 2017, 1575 patients were assessed for eligibility, of whom 143 were randomised (CAU, n = 72; CBT, n = 71). Recruitment was challenging, and our target of 372 was not reached. The observational study included 484 individuals who were not eligible or chose not to take part in the RCT (RCT-eligible decliners at high non-adherence risk, n = 27; not eligible for RCT at low non-adherence risk, n = 457). Owing to the challenges in using MEMS, the number of participants with sufficient data for primary end-point analysis was 112 (CAU, n = 55; CBT, n = 57). Of those, 17 participants (15.2%) met the primary end point (> 80% of months, with an average monthly adherence of ≥ 90%) [9 (16.4%) in the CAU group and 8 (14.0%) in the CBT group (p = 0.94)]. There was no significant difference in the primary outcome (i.e. MEMS adherence) between the CBT and CAU groups at 12 months. There was a 7% improvement in median percentage adherence by MEMS in the CBT group relative to the CAU group (61.9% CAU and 66.5% CBT; p = 0.40). There was a significant increase in the proportion of people with high adherence (by self-reported Medication Adherence Report Scale) at 3 months’ follow-up (75% CAU and 81% CBT; p = 0.02). Participants randomised to receive CAU plus CBT benefited from a significantly greater reduction in ART concerns, ART intrusiveness and depression between baseline and 12 months than those randomised to receive CAU. There were no significant differences between the randomised groups in ART necessity beliefs (which were high in both groups), anxiety, illness perceptions, viral load, cluster of differentiation 4 (CD4) T-cell count, rates of treatment failure or treatment switches. Workstream 4: economic studies Workstream 4, study 6, addressed objective 6: assessing the costs and cost-effectiveness of the SUPA intervention in the short and long term. It comprised three substudies, as follows. Systematic review of economic evaluations of antiretroviral therapy adherence interventions A systematic literature search identified 20 studies reporting costs or cost-effectiveness of interventions to increase adherence to ART in PLWH. The quality of the economic evaluations was assessed. There was evidence of improved adherence and favourable cost-effectiveness ratios in people receiving adherence interventions compared with the control conditions. However, these effects tended to be short term. Trial-based cost-effectiveness analysis of the Supporting UPtake and Adherence to antiretroviral therapy intervention Use of the intervention and other health and social care services and HIV-specific medications were measured in the RCT (i.e. study 5) and costs were calculated. Quality-adjusted life-years (QALYs) were generated from the EuroQol-5 Dimensions, five-level version (EQ-5D-5L). Costs were compared at baseline and each follow-up time point. QALYs were compared, controlling for baseline EQ-5D-5L tariffs. Cost-effectiveness was assessed by combining incremental costs and incremental QALYs using an incremental cost-effectiveness ratio (ICER). The mean costs among the CBT group were £621 more than for the CAU group. This difference was not statistically significant [95% confidence interval (CI) –£569 to £1462]. CBT resulted in 0.056 more QALYs over the follow-up period than CAU, and this was significant (95% CI 0.0029 to 0.083). The ICER was £9143 per QALY. At a threshold of £20,000 per QALY, there was more than a 90% likelihood that CBT would be more cost-effective than CAU. There was a 19% likelihood that CBT would produce more QALYs and result in lower health and social care costs than CAU. A simulation model of the long-term cost-effectiveness of the intervention A Markov model was used to extrapolate for 15 years, in 12-month cycles beyond the trial period. Health states were defined by CD4 T-cell counts and all-cause mortality. The expected costs for those receiving CBT and CAU in the 15 years after the trial follow-up were less for CBT than for CAU, but CBT also resulted in fewer QALYs. Combining the trial period with the 15-year extrapolation period resulted in CBT having costs that were lower by £470 and 0.47 fewer QALYs. Therefore, in the long term, CAU is cost-effective with an ICER of £1187 per QALY. Workstream 5: preparing for implementation within the National Health Service Workstream 5 was intended to address objective 7: prepare for implementation within the NHS. Owing to the extended time needed for recruitment to the RCT, we were unable to carry out a full implementation WS. We have planned implementation strategies informed by NICE guidance on how to change practice. These involve identifying barriers to implementation by conducting study discussion groups in HIV clinics, discussion of our findings with HIV commissioners and conducting focus groups with PLWH at AAF. Workstream 6 (additional workstream): ancillary studies During the programme, we conceived an additional seven ancillary studies (WS6): patients’ perceptions of standard care ART perceptions and treatment outcomes in HIV-positive patients starting ART to protect their partners (treatment as prevention) compared with clinical need the level ART adherence required to achieve virological suppression in treatment-naive patients a systematic review and meta-analysis examining the content of effective adherence interventions beliefs about ART as predictors of side effects (analysis of historical data) associations between self-reported adherence and electronic monitoring of adherence the effect of the SUPA intervention on rates of engagement with HIV services. These ancillary studies were conceived on the assumption of complete and timely recruitment to the SUPA RCT; however, recruitment was lower and slower than expected for this hard-to-reach study population. Consequently, only six ancillary studies were feasible (1–6). Conclusions The SUPA programme fulfilled its objectives to develop and evaluate a pragmatic, theory-based intervention to support ART uptake and adherence among PLWH at risk of non-adherence by addressing perceptual and practical barriers. Recruitment to the SUPA RCT was slower than anticipated and our trial was underpowered with no effect on the primary outcome measure of adherence over 12 months. However, the SUPA intervention benefited recipients by reducing ART concerns, ART intrusiveness and depression and improving quality of life. It was also cost-effective during the follow-up period. Study registration The trial is registered as ISRCTN35514212 and the study is registered as CRD42019072431. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research Programme (NIHR award ref: RP-PG-0109-10047) and is published in full in Programme Grants for Applied Research; Vol. 13, No. 8. See the NIHR Funding and Awards website for further award information.
Vaccine hesitancy is a leading threat to public health, but little is known about the beliefs and mindsets that drive vaccine hesitancy, especially among people of Black ethnicities. This study aimed to understand vaccine related beliefs and their relationship with SARS-CoV-2 vaccine uptake in UK residents of Black ethnicities living with HIV. Adults of self-reported Black ethnicities with HIV were recruited at 12 clinics in England. Participants completed questionnaires in clinic, including an adapted version of the Beliefs about Medicines Questionnaire (BMQ) to assess Necessity and Concerns beliefs about the SARS-CoV-2 vaccine. SARS-CoV-2 vaccination status was ascertained through self-report and shared care records. A total of 863 participants were enrolled between June 2021 and October 2022, most of whom (92%) had received at least one dose of the SARS CoV-2 vaccine. After adjusting for age and region of birth, higher perceived need for the vaccine (OR = 2.39, 95% CI = 1.51–3.81), fewer concerns about the vaccine (OR = 0.16, 95% CI = 0.08–0.30), and weaker endorsement of COVID-19 Conspiracy Beliefs (OR = 0.31, 95% CI = 0.19–0.50) were associated with vaccination uptake. Being born outside sub-Saharan Africa was associated with reduced odds of being vaccinated. This study shows the importance of specific beliefs driving vaccine hesitancy and uptake. Further studies should explore the role of these beliefs and mindsets in influencing uptake of other vaccinations, and to work with key stakeholders to explore how to address vaccine hesitancy and improve vaccine uptake in these and other populations.
Objectives To examine public beliefs about antibiotics, AMR, and knowledge of antibiotic use, and how these relate to self-reported antibiotic use.Methods Two hundred and fifty participants from 23 countries completed a cross-sectional, online survey assessing beliefs about antibiotics and AMR, knowledge of antibiotics, and antibiotic use. Descriptive statistics, Mann-Whitney U tests and Spearman's rho correlations were used to understand relationships between outcomes.Key findings Respondents generally viewed antibiotics positively, with particularly strong beliefs regarding their benefit (M = 16.48 out of 20, SD = 2.62) and few concerns regarding their harm (M = 3.98 out of 10, SD = 1.82). Greater benefit beliefs about antibiotics were associated with fewer concerns about their overuse (P < .0001) and harm (P < .0001). Stronger perceived importance of AMR was associated with greater beliefs about the benefits of antibiotics (P = .006), greater concerns about their overuse (P = .009), and increased knowledge of appropriate use (P = .006). Those who reported inappropriately using their last antibiotics had greater concerns about overuse (P = .12) and less knowledge regarding appropriate use (P = .015), compared to those who did not.Conclusions Generally, the public tends to view antibiotics as having strong benefits and have few concerns about their harm, which may have implications for inappropriate use. These initial findings highlight beliefs that could be targeted in messages to reduce inappropriate demand for antibiotics.
Introduction Poor adherence to recommended vitamin and mineral supplementation after bariatric surgery is common and challenging for healthcare professionals to identify. There are several questionnaires for self-reporting of adherence to chronic medication, but none has so far been evaluated for assessment of adherence to vitamin and mineral supplementation after bariatric surgery. The aim of this study was to assess the accuracy of the 5-item Medication Adherence Report Scale (MARS-5) in measuring adherence to vitamin and mineral supplementation post bariatric surgery (gastric bypass or sleeve gastrectomy). Method The psychometric properties of MARS-5 for vitamin and mineral supplementation were validated in two cohorts: one at 1 year post bariatric surgery ( n = 120) and the other at 2 years post-surgery ( n = 211). MARS-5 was compared to pharmacy refill data for vitamin B 12 and combined calcium/vitamin D as reference. Results Correlation analyses demonstrated that the MARS-5 had acceptable validity compared to objectively measured adherence rates from pharmacy refill data (calculated as continuous, multiple-interval measures of medication availability/gaps-coefficient ranged from 0.49 to 0.54). Internal reliability (Cronbach’s α ) was high: 0.81 and 0.95, respectively. There was a clear ceiling effect where one out of three had a maximum score on MARS-5. Conclusion MARS-5 demonstrated acceptable psychometric properties for assessment of adherence to vitamin and mineral supplementation post bariatric surgery. Graphical Abstract
IntroductionAdherence to medicines in osteoporosis is poor, with estimated 1 year persistence rates between 16% and 60%. Poor adherence is complex, relating to combinations of fear of side effects, beliefs about medication being unnecessary, doubts about effectiveness and the burden of medication management. This is compounded by an absence of monitoring, as many patients are effectively discharged from ongoing care following the initial prescription. Clinical pharmacists in general practice are a relatively new workforce in the UK NHS; this is an unexplored professional group that could provide person-centred, adherence-focused interventions in an osteoporosis context.A model consultation intervention to be delivered by clinical pharmacists in general practice for patients already prescribed fracture prevention medications will be developed using existing evidence and theory and empirical qualitative work outlined in this protocol.Methods and analysisWe will investigate the current practice and barriers and facilitators to a clinical pharmacist-led osteoporosis intervention, including exploring training needs, through focus groups with people living with osteoporosis, pharmacists, general practitioners, osteoporosis specialists and service designers/commissioners. Framework analysis will identify and prioritise salient themes, followed by mapping codes to the theoretical domains framework and normalisation process theory to understand integration and implementation issues.We will further develop the content and model of care for the new consultation intervention through co-design workshops with stakeholder and patient and public involvement and engagement group members. The intervention in practice will be refined in a sequential process with workshops and in-practice testing with people prescribed fracture prevention medication, pharmacists and the multidisciplinary team.Ethics and disseminationEthical approval was obtained from NHS North West—Greater Manchester South Research Ethics Committee (Ref 23/NW/0199). Dissemination and knowledge mobilisation will be facilitated through a range of national bodies/stakeholders. Impact and implementation plans will accelerate this research towards a future clinical trial to determine cost and clinical effectiveness.
BackgroundReducing antimicrobial resistance (AMR) is a priority for public health. Inappropriate patient demand is an important driver of unnecessary antibiotic use. To develop an effective intervention to reduce inappropriate demand for antibiotics in upper respiratory tract infections (URTIs), it is important to identify patient perceptions that influence demand for, and appropriate use of antibiotics.AimTo identify and describe the beliefs about antibiotics necessity and concerns that patients with URTIs have, in Riyadh, Saudi Arabia.MethodAn exploratory qualitative approach was used. One-to-one, face-to-face or telephone semi-structured interviews were conducted with participants recruited using purposive sampling (based on age and gender) from primary healthcare centre in Riyadh, Saudi Arabia were conducted. Only adult patients who currently experience URTIs symptoms and agreed to participate were recruited. Recruitment for interviews continued until data saturation point was reached. The interview guide explored patients’ necessity beliefs and concerns about antibiotics, AMR perceptions, and expectations from URTIs consultation. Interview transcripts were coded using QSR NVivo 12 using framework analysis informed by the Necessity-Concerns Framework to identify key motivations driving antibiotic requests and consultations.Resultsthe study interviewed 32 participants (44% were male, average age was 36.84). Results identified that the patients often relate their personal need for antibiotics when encountering an URTIs symptoms to the type, severity and duration of symptoms. Patients also linked antibiotics with quicker recovery, generally expressing few concerns about antibiotics mainly because of its short duration of use. However, some conveyed their concern about frequent administration of antibiotics and effect on the body’s immune system function, which may make them more prone to infections in the future. Participants varied widely in their awareness of AMR; this was associated with many misconceptions, such as confusing AMR with antibiotics efficacy and tolerance. Interestingly, the interplay between necessity beliefs and concerns was observed to influence the decision to start and stop antibiotic, potentially impacting inappropriate antibiotic demand and unnecessary use.ConclusionThis study highlighted important beliefs and misconceptions about antibiotics and AMR in Saudi population which can be targeted in future interventions to reduce inappropriate demand for antibiotics and optimise appropriate usage.
IntroductionDespite anti-inflammatory reliever (AIR) therapy now being the preferred treatment choice across all severities of asthma, many patients are still “attached” to their short-acting beta2-agonist (SABA) reliever, believing this to be the best way to control their asthma. To encourage individuals to switch to AIR, it is important to first identify the beliefs that patients hold about AIR.ObjectiveThe aim of this paper was to describe the initial development and validation of the BMQ-AIR©, a six-item screening tool which assesses and identifies patients’ treatment beliefs about switching to AIR therapy.MethodsStatements were identified from the primary literature that assessed patients’ perceptions of AIR therapy and adapted from the Beliefs about Medicines Questionnaire (BMQ). Internal reliability was examined using Cronbach’s alpha coefficient. Construct validity was evaluated by comparing scores on BMQ-AIR© with a validated measure of medication adherence and SABA beliefs.ResultsA total of 446 participants completed the online survey. The BMQ-AIR© contained two subscales with three items each. Both the Necessity and Concerns subscales demonstrated good internal reliability, with Cronbach’s α-values of 0.70 and 0.69, respectively. Both subscales were negatively correlated with self-report inhaled corticosteroid adherence (Necessity: r = −0.28, p < 0.0001; Concerns: r = −0.28, p < 0.0001) and positively correlated with SRQ scores (Necessity: r = 0.51, p < 0.0001; Concerns: r = 0.44, p < 0.0001).ConclusionPreliminary findings indicate that BMQ-AIR© demonstrates satisfactory reliability and validity. BMQ-AIR© is a promising tool that may help tailor interventions to an individual’s specific beliefs and barriers to switching to better support individuals in stopping SABA and initiating AIR therapy.
Background In patients with asthma, over-reliance and overuse of short-acting beta 2 agonist (SABA) is common and associated with increased morbidity and mortality. Patient beliefs are a key driver of inappropriate reliever use. A recently developed, brief, online intervention has been shown to identify and shift patient beliefs that drive inappropriate reliever use. Whether this intervention works to shift beliefs in individuals with asthma when delivered by community pharmacists is unknown. Objective To investigate the feasibility and acceptability of a brief community pharmacist-delivered behavior change intervention, and its effect on beliefs about SABA and SABA use in patients with asthma. Methods This is a non-randomised, before- and after- study of 120 individuals aged 18 years and older, prescribed a SABA for their asthma symptoms, presenting to one of two enrolled community pharmacies in Auckland, New Zealand. At enrolment, all participants will complete the SABA Reliance Questionnaire (SRQ), Asthma Control Test and 5-item Medication Adherence Report Scale via an online survey platform. Control participants will receive usual asthma care from their community pharmacy. Intervention participants will receive the intervention to shift any misplaced beliefs about SABA, comprising the SRQ to identify individual beliefs about SABA, then personalized information and discussion between pharmacist and patient based on the specific responses to the questionnaires. Those on SABA monotherapy and/or are at risk of SABA overuse will be referred to the general practitioner. Effect on beliefs about SABA and actual SABA use will be assessed by the SRQ and dispensing records, respectively. Feasibility will be evaluated through participant recruitment and retention rates, intervention fidelity, appropriateness and procedures of outcome measures pre- and post-intervention, and acceptability by obtaining feedback from participants (both patients and pharmacists) on the intervention.