Improving Medication Safety in Cancer Services for Ethnic Minority Consumers: Protocol for a Pilot Feasibility and Acceptability Study of a Co-Designed Consumer Engagement Intervention.

BACKGROUND: People from ethnic minorities are often exposed to unsafe care contributing to poorer health care outcomes. Medication safety is a high-risk area requiring intervention to improve care outcomes. Using an adapted, experience-based co-design process with cancer service staff and patients from ethnic minorities, a medication communication tool was created: Making it Meaningful (MiM). OBJECTIVE: We aim to test whether the MiM tool is feasible and acceptable for use with ethnic minority consumers in cancer services in Australia. METHODS: A single site, controlled before and after this pilot study, will be used. Patients from Mandarin- and Russian-speaking backgrounds are eligible for inclusion. In total, 40 patients from these cultural backgrounds will be recruited and stratified by language to the intervention and control groups, with 20 participants in the intervention and 20 in the control group. Further, 4 health practitioners will be recruited and trained to use the MiM. Clinicians providing care for patients in the intervention will use the MiM during their usual appointment while providing medication communication using standard care processes for the control group. Telephone surveys will be conducted with participants at 3 time points, T1 before the intervention, T2 1 week post intervention, and T3 1 month post intervention, to assess knowledge and self-efficacy in medication management, perceived usability, and acceptability of the MiM. Qualitative interviews with clinicians who have used the MiM will be conducted 1 month postintervention to explore their perceptions of MiM feasibility and acceptability. RESULTS: Ethical approval for this research has been provided by the South Eastern Sydney Area Health Human Research Ethics Committee (HRECXXX). Bilingual field-workers, 1 Mandarin-speaking and 1 Russian-speaking, are contacting eligible patients to enroll. It is anticipated that recruitment will be completed by October 2023, with data collection completed by December 2023. CONCLUSIONS: Using experience-based co-design, we identified communication about medication, particularly between appointments, as a key issue impacting the safety of care for patients from ethnic minorities accessing cancer services. Increasing consumer engagement in medication management was identified as a strategy to reduce medication safety problems in cancer care; the MiM strategy was developed to address this issue. It is anticipated that by using the MiM, patient knowledge about prescribed medications and confidence in medication management will increase. Evidence from the pilot study will be used to inform a full-scale trial of the MiM tool with a range of ethnic minority communities accessing cancer services. A full-scale trial will seek to determine whether the MiM intervention is effective in knowledge and confidence about medication management, but also whether this improves patient outcomes in cancer care. TRIAL REGISTRATION: Australian New Zealand Clinical Trials ACTRN12622001260718p; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=384658&isReview=true. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/49902.

Development and consensus process for a clinical pathway for the assessment and management of chemotherapy-induced peripheral neuropathy.

BACKGROUND: Cancer patients treated with neurotoxic chemotherapy are at risk of developing neurological symptoms that can impact functional capacity and quality of life. However, there are no standardised pathways to assess and manage chemotherapy-induced peripheral neurotoxicity (CIPN). This study aimed to determine consensus on statements regarding a CIPN assessment and management clinical pathway. METHODS: A CIPN clinical pathway (CIPN-path) was developed and reviewed by an expert multi-disciplinary panel and consumers. Agreement with 18 statements regarding four content themes (pretreatment review, screening and assessment, management and referral, and CIPN-path feasibility) were assessed by 70 Australian respondents (68 health professionals, 2 consumers), using a 2-stage Delphi survey process to reach consensus. Respondents rated statements using a 5-point Likert scale to determine the level of agreement, with consensus defined as ≥ 80% of respondents agreeing with each statement. RESULTS: The consensus was reached for 14 of 18 items after stage 1 and all items after stage 2. Feedback was obtained for all items to refine the CIPN-path. There was an agreement on important characteristics of the CIPN-path, including pretreatment screening, regular patient-reported assessment, and a stepped-care approach to investigating and managing symptom burden. There was a lack of agreement on who should oversee CIPN assessment, which may differ according to the structure and resources of each site. CONCLUSIONS: There was an overall agreement concerning the CIPN-path to assess and manage CIPN, which may be adapted accordingly to the resources of each clinic. The CIPN-path may assist teams across different health services in identifying CIPN symptoms, aiding decision-making, and reducing morbidity from CIPN.

Implementing the use of objective medication adherence data in routine clinical practice via the digital CFHealthHub platform: situation analysis and strategy development using the theoretical domains framework.

BACKGROUND: Preventative inhaled treatments preserve lung function and reduce exacerbations in cystic fibrosis (CF). Self-reported adherence to these treatments is over-estimated. An online platform (CFHealthHub) has been developed with patients and clinicians to display real-time objective adherence data from dose-counting nebulisers, so that clinical teams can offer informed treatment support. METHODS: In this paper, we identify pre-implementation barriers to healthcare practitioners performing two key behaviours: accessing objective adherence data through the website CFHealthHub and discussing medication adherence with patients. We aimed to understand barriers during the pre-implementation phase, so that appropriate strategy could be developed for the scale up of implementing objective adherence data in 19 CF centres. Thirteen semi-structured interviews were conducted with healthcare practitioners working in three UK CF centres. Qualitative data were coded using the theoretical domains framework (TDF), which describes 14 validated domains to implementation behaviour change. RESULTS: Analysis indicated that an implementation strategy should address all 14 domains of the TDF to successfully support implementation. Participants did not report routines or habits for using objective adherence data in clinical care. Examples of salient barriers included skills, beliefs in consequences, and social influence and professional roles. The results also affirmed a requirement to address organisational barriers. Relevant behaviour change techniques were selected to develop implementation strategy modules using the behaviour change wheel approach to intervention development. CONCLUSIONS: This paper demonstrates the value of applying the TDF at pre-implementation, to understand context and to support the development of a situationally relevant implementation strategy.

Feasibility study for supporting medication adherence for adults with cystic fibrosis: mixed-methods process evaluation.

OBJECTIVES: To undertake a process evaluation of an adherence support intervention for people with cystic fibrosis (PWCF), to assess its feasibility and acceptability. SETTING: Two UK cystic fibrosis (CF) units. PARTICIPANTS: Fourteen adult PWCF; three professionals delivering adherence support ('interventionists'); five multi-disciplinary CF team members. INTERVENTIONS: Nebuliser with data recording and transfer capability, linked to a software platform, and strategies to support adherence to nebulised treatments facilitated by interventionists over 5 months (± 1 month). PRIMARY AND SECONDARY MEASURES: Feasibility and acceptability of the intervention, assessed through semistructured interviews, questionnaires, fidelity assessments and click analytics. RESULTS: Interventionists were complimentary about the intervention and training. Key barriers to intervention feasibility and acceptability were identified. Interventionists had difficulty finding clinic space and time in normal working hours to conduct review visits. As a result, fewer than expected intervention visits were conducted and interviews indicated this may explain low adherence in some intervention arm participants. Adherence levels appeared to be >100% for some patients, due to inaccurate prescription data, particularly in patients with complex treatment regimens. Flatlines in adherence data at the start of the study were linked to device connectivity problems. Content and delivery quality fidelity were 100% and 60%-92%, respectively, indicating that interventionists needed to focus more on intervention 'active ingredients' during sessions. CONCLUSIONS: The process evaluation led to 14 key changes to intervention procedures to overcome barriers to intervention success. With the identified changes, it is feasible and acceptable to support medication adherence with this intervention. TRIAL REGISTRATION NUMBER: ISRCTN13076797; Results.

Dose-response patterns in low and high intensity cognitive behavioral therapy for common mental health problems.

BACKGROUND: Cognitive-behavioral therapy (CBT) is effective for the treatment of common mental health problems, but the number of sessions required to maximize improvement in routine care remains unclear. AIM: This study aimed to examine the dose-response effect in low (LiCBT) and high (HiCBT) intensity CBT delivered in stepped care services. METHODS: A multi-service data set included N = 102 206 patients across N = 16 services. The study included patients with case-level depression and/or anxiety symptoms who accessed LiCBT and/or HiCBT. Patients with posttreatment reliable and clinically significant improvement in standardized outcome measures (PHQ-9, GAD-7) were classified as treatment responders. Survival analyses assessed the number of sessions necessary to detect 50%, 75%, and 95% of treatment responders. The 50% and 95% percentiles were used to define the lower and upper boundaries of an adequate dose of therapy that could be used to inform the timing of treatment progress reviews. Analyses were then stratified by diagnosis, and cox regression was used to identify predictors of time-to-remission. RESULTS: Most responders (95%) attained RCSI within 7 sessions of LiCBT and 14 sessions of HiCBT. Patients with social anxiety disorder, posttraumatic stress disorder, and obsessive-compulsive disorder required HiCBT and lengthier treatments (6-16 sessions) to maximize improvement. CONCLUSIONS: Distinctive dose-response patterns are evident for LiCBT and HiCBT, which can be used to support treatment planning and routine outcome monitoring.

The dose-response effect in routinely delivered psychological therapies: A systematic review.

The dose-response effect refers to the relationship between the dose (e.g., length, frequency) of treatment and the subsequent probability of improvement. This systematic review aimed to synthesize the literature on the dose-response effect in routine psychological therapies delivered to adult patients with mental health problems. Twenty-six studies were eligible for inclusion. Different methodological approaches have been used to examine the dose-response effect; including survival analysis, multilevel modelling and descriptive cluster analyses. Replicated and consistent support was found for a curvilinear (log-linear or cubic) relationship between treatment length and outcomes, with few exceptions such as eating disorders and severe psychiatric populations. Optimal doses of psychotherapy in routine settings range between 4 and 26 sessions (4-6 for low intensity guided self-help) and vary according to setting, clinical population and outcome measures. Weekly therapy appears to accelerate the rate of improvement compared to less frequent schedules. Most of the reviewed evidence is from university counselling centres and outpatient psychotherapy clinics for common mental health problems. There is scarce and inconclusive evidence in clinical samples with chronic and severe mental disorders.

Autistic traits and cognitive abilities associated with two molecular causes of Silver-Russell syndrome.

Silver-Russell syndrome is a rare genetic imprinting disorder. Two molecular causes of Silver-Russell syndrome have been identified: loss of methylation on chromosome 11p15 (11p15 LOM) and maternal uniparental disomy for chromosome 7 (matUPD7). Current understanding of the cognitive and behavioral phenotypes associated with these two molecular subtypes is limited. This study aimed to address this gap in the literature. The Social Responsiveness Scale (SRS-2) was used to assess autistic traits in individuals with 11p15 LOM (n = 47) and matUPD7 (n = 32). A subset of participants with 11p15 LOM (n = 18) and matUPD7 (n = 15) completed in-person assessments: the Autism Diagnostic Observation Schedule (ADOS-2) and the British Ability Scales (BAS3). Overall, 37.50% of the matUPD7 group and 10.64% of the 11p15 LOM group scored above the SRS-2 severe clinical cut-off. Based on the ADOS-2, 33.33% of the matUPD7 participants and 11.11% of the 11p15 LOM participants scored above cut-off for autism spectrum/autism. Intellectual ability was significantly lower in the matUPD7 group (M = 79.86) compared with the 11p15 LOM group (M = 98.56). However, there was no evidence of an uneven cognitive profile associated with either group or of an association between autistic traits and intellectual ability. Although both 11p15 LOM and matUPD7 have the same clinical diagnosis of Silver-Russell syndrome, there are some differences in the cognitive and behavioral phenotypes between these two molecular subtypes. This has implications for considering access to services, intervention, and support within these populations, particularly in relation to learning and behavior. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Supporting medication adherence for adults with cystic fibrosis: a randomised feasibility study.

BACKGROUND: Preventative medication reduces hospitalisations in people with cystic fibrosis (PWCF) but adherence is poor. We assessed the feasibility of a randomised controlled trial of a complex intervention, which combines display of real time adherence data and behaviour change techniques. METHODS: Design: Pilot, open-label, parallel-group RCT with concurrent semi-structured interviews. PARTICIPANTS: PWCF at two Cystic Fibrosis (CF) units. Eligible: aged 16 or older; on the CF registry. Ineligible: post-lung transplant or on the active list; unable to consent; using dry powder inhalers. INTERVENTIONS: Central randomisation on a 1:1 allocation to: (1) intervention, linking nebuliser use with data recording and transfer capability to a software platform, and behavioural strategies to support self-management delivered by trained interventionists (n = 32); or, (2) control, typically face-to-face meetings every 3 months with CF team (n = 32). OUTCOMES: RCT feasibility defined as: recruitment of ≥ 48 participants (75% of target) in four months (pilot primary outcome); valid exacerbation data available for ≥ 85% of those randomised (future RCT primary outcome); change in % medication adherence; FEV1 percent predicted (key secondaries in future RCT); and perceptions of trial procedures, in semi-structured interviews with intervention (n = 14) and control (n = 5) participants, interventionists (n = 3) and CF team members (n = 5). RESULTS: The pilot trial recruited to target, randomising 33 to intervention and 31 to control in the four-month period, June-September 2016. At study completion (30th April 2017), 60 (94%; Intervention = 32, Control =28) participants contributed good quality exacerbation data (intervention: 35 exacerbations; control: 25 exacerbation). The mean change in adherence and baseline-adjusted FEV1 percent predicted were higher in the intervention arm by 10% (95% CI: -5.2 to 25.2) and 5% (95% CI -2 to 12%) respectively. Five serious adverse events occurred, none related to the intervention. The mean change in adherence was 10% (95% CI: -5.2 to 25.2), greater in the intervention arm. Interventionists delivered insufficient numbers of review sessions due to concentration on participant recruitment. This left interventionists insufficient time for key intervention procedures. A total of 10 key changes that were made to RCT procedures are summarised. CONCLUSIONS: With improved research processes and lower monthly participant recruitment targets, a full-scale trial is feasible. TRIAL REGISTRATION: ISRCTN13076797 . Prospectively registered on 07/06/2016.

Making the invisible visible: the availability and desirability of adherence data in routine CF care- findings from a national questionnaire survey.

Background: Inhaled medications for cystic fibrosis (CF) are effective but adherence is low. Clinicians find it difficult to estimate how much treatment people with CF (PWCF) take, whilst objective adherence measurement demonstrates that patients are poorly calibrated with a tendency to over-estimate actual adherence. The diagnostic approach to a PWCF with deteriorating clinical status and very low adherence is likely to be different to the approach to a deteriorating patient with optimal adherence. Access to objective adherence data in routine consultations could help to overcome diagnostic challenges for clinicians and people with CF. Attitudes of clinicians to the use and importance of routinely available adherence data is unknown. Methods: We conducted an online questionnaire survey with UK CF centres. We asked five questions relating to the current use and perception of objective measurements of adherence in routine care. Results: A total of eight CF centres completed the questionnaire. Few of the responding centres have adherence data readily available in routine clinics (13% of centres use medicines possession ratio; of centres with access to I-nebs® it was estimated that 17% of patients had I-neb data regularly available in clinics). All centres considered the availability of objectively measured adherence data to be important. Respondents identified that systems developed to provide adherence data in clinical practice must provide data to both clinicians and patients that is readily understood and easy to use. Conclusions: Centres perceived the availability of adherence data in routine care to be important but objective measures of adherence is rarely available at present.

Studies on the diversity of the distinct phylogenetic lineage encompassing Glomus claroideum and Glomus etunicatum.

Morphological and molecular characters were analysed to investigate diversity within isolates of the Glomus claroideum/Glomus etunicatum species group in the genus Glomus. The inter- and intra-isolate sequence diversity of the large subunit (LSU) rRNA gene D2 region of eight isolates of G. claroideum and G. etunicatum was studied using PCR-single strand conformational polymorphism (SSCP)-sequencing. In addition, two isolates recently obtained from Southern China were included in the analysis to allow for a wider geographic screening. Single spore DNA isolation confirmed the magnitude of gene diversity found in multispore DNA extractions. An apparent overlap of spore morphological characters was found between G. claroideum and G. etunicatum in some isolates. Analysis of the sequence frequencies in all G. etunicatum and G. claroideum isolates (ten) showed that four LSU D2 sequences, representing 32.1% of the clones analysed for multispore extraction (564) were found to be common to both species, and those sequences were the most abundant in four of the ten isolates analysed. The frequency of these sequences ranged between 23.2% and 87.5% of the clones analysed in each isolate. The implications for the use of phenotypic characters to define species in arbuscular mycorrhizal fungi are discussed. The current position of G. claroideum/G.etunicatum in the taxonomy of the Glomeromycota is also discussed.