The Patient, Investigator, Nurse, Carer Questionnaire (PINC-Q): a cross-sectional, retrospective, non-interventional study exploring the impact of less frequent medication administration with paliperidone palmitate 3-monthly as maintenance treatment for schizophrenia.

BACKGROUND: To understand the implications of switching from paliperidone palmitate 1-monthly (PP1M) to paliperidone palmitate 3-monthly (PP3M) treatment of schizophrenia from the perspective of four key stakeholders: patients, physicians, nurses and carers. METHODS: This was a cross-sectional, retrospective, non-interventional study comprising a one-time questionnaire (PINC-Q) for adult patients (aged ≥18 years) with schizophrenia (International Classification of Diseases; ICD-10) and their physician, nurse and carer. Questionnaires were developed in association with patient and carer advocacy groups (GAMIAN and EUFAMI) and following an advisory board formed of psychiatrists and nurses. The degree of alignment between stakeholders was also examined. RESULTS: Responses were received from a total of 224 evaluable patients. For most patients (88.4%), responses were received from at least two other stakeholders. Patients were moderately ill with mild-to-moderate lack of insight and had received PP1M for a mean (standard deviation [SD]) of 23.9 (21.28) months before switching to PP3M (duration mean [SD] 12.8 [3.72] months). The most frequently reported reasons to switch from PP1M to PP3M were 'to live life as normally as possible' and 'patient convenience'. Over 79% of responses within each stakeholder group stated that PP3M helped the patients, with increased patient activity and social involvement, improved frequency and quality of physician-patient and nurse-patient communication and decreased perceived stigma. CONCLUSIONS: The results of this study add to the increasing body of evidence supporting the benefits of PP3M in a population of patients with schizophrenia representative of real-world clinical practice.

Impact on carer burden when stable patients with schizophrenia transitioned from 1-monthly to 3-monthly paliperidone palmitate.

RATIONALE: Reducing the frequency of long-acting injectable antipsychotic medication may reduce carer burden. OBJECTIVES: To evaluate the impact of reduced frequency of long-acting injectable antipsychotic medication on carer burden in stable patients with schizophrenia. METHODS: Carer burden was assessed using the Involvement Evaluation Questionnaire (IEQ) within a 52-week, prospective, single-arm, non-randomised, open-label, international, multicentre study evaluating the impact of transitioning stable patients with schizophrenia to paliperidone palmitate 3-monthly (PP3M) from paliperidone palmitate 1-monthly (PP1M). RESULTS: 159 carers completed the IEQ (mean [standard deviation, SD] age: 54.8 [12.8] years); 52.2% were the patients' parent and > 50% had >32 h/week of patient contact. At baseline, mean [SD] IEQ total score was in the lower range (23.8 [12.6]), reflecting patient stabilisation. At last observation carried forward (LOCF) endpoint, the IEQ total score decreased by a mean (95% CI) of -4.0 (-5.9, -2.1), indicating a significant overall reduction in carer burden (P < 0.0001). The six IEQ items with the highest carer burden at baseline were within the urging and worrying domains, in which burden was significantly improved at LOCF endpoint (P < 0.0001). Exploratory analyses found that higher carer burden was associated with lower functional remission (Personal and Social Performance score >70) at baseline and LOCF endpoint, and with the patient being part of the carer's household. Shorter disease duration correlated with better general health of carers at LOCF endpoint. CONCLUSION: Reducing the frequency of antipsychotic medication administration in stable patients with schizophrenia by switching from PP1M to PP3M may reduce carer burden.

[Become the expert and embrace a positive attitude: communication strategies for discussing long-acting injectable antipsychotic treatment with patients living with schizophrenia].

Patients with schizophrenia often experience relapses that negatively impact long-term outcomes. Continuous antipsychotic treatment can reduce relapse risk; however, this can be hindered by nonadherence resulting from the poor insight, which is often associated with schizophrenia. A strong patient-physician-carer alliance can improve patient insight, and adherence. Long-acting injectable antipsychotic treatment (LAT) provides continuous treatment; however, its acceptance by the patient is often compromised by a lack of physician-patient communication. The COMP approach (Connectedness, Openness, Motivation, Partnership) was developed to build effective communication and aid discussions around treatment. Insights on COMP fed into the development of COMPLETE - a tool for discussing LAT with eligible patients including the following components: 'Life goals', 'Establish connection between goals and therapy', 'Therapy introduction' and 'Encourage long-term motivation'. The overarching objective of COMPLETE is to improve long-term outcomes in patients with schizophrenia. This article discusses the development of COMPLETE and its potential use in the management of schizophrenia.

Factors and their weight in reducing life expectancy in schizophrenia.

BACKGROUND: Schizophrenia is associated with a wide range of socioeconomic and health-related problems, as well as 10-25 potential life-years lost. While lifestyle choices, comorbidities, and choice of medication are associated with schizophrenia disease burden and mortality, real-world evidence on the impact of these factors on expected life-years among patients with schizophrenia is limited. METHODS: In this study, register-based, nationwide data from patients with schizophrenia in Finland during 1972-2015 were analysed to determine influential factors associated with mortality and to demonstrate their impact on expected life-years in patients with schizophrenia. RESULTS: Factors reducing all-cause mortality were use of antipsychotics: HR 0.46 (95 % CI: 0.45, 0.47), ever use of lipid-modifying agents: HR 0.71 (95 % CI 0.68, 0.73), antidepressants HR 0.87 (95 % CI 0.85, 0.90), and lithium HR 0.90 (95 % CI 0.86, 0.95). Factors increasing all-cause mortality were cardiovascular disease: HR 2.41 (95 % CI: 2.34, 2.49), liver disease: HR 1.98 (95 % CI: 1.78, 2.21), renal disease: HR 1.63 (95 % CI:1.56, 1.70), diabetes: HR 1.40 (95 % C:1.35, 1.45), history of switching antipsychotics: HR 1.39 (95 % CI: 1.35, 1.44), longer duration of previous hospitalisations HR 1.96 (95 % CI: 1.90, 2.02), history of substance abuse HR 1.38 (95 % CI: 1.30, 1.46), and ever use of benzodiazepines HR 1.12 (95 % CI: 1.09, 1.16). CONCLUSIONS: The results from this study could serve to motivate clinicians to support and encourage patients to adhere to antipsychotic treatment and achieve a healthier lifestyle, which could, in turn, increase the expected life-years of patients with schizophrenia.

Treating Schizophrenia: Open Conversations and Stronger Relationships Through Psychoeducation and Shared Decision-Making.

Integrated pharmacological and psychosocial treatments, such as psychoeducation (PE) and shared decision-making (SDM), have been shown to significantly improve outcomes for people living with schizophrenia (PLWS). Underpinning the success of these interventions is a strong therapeutic relationship between PLWS, their carers, and their healthcare team. While many recognize the value of this relationship, implementation of the interventions necessary to facilitate its construction remain low. In this article, we identify the barriers to developing productive therapeutic relationships and explain how PE and SDM, taking into account cultural difference, can improve adherence to treatment, strengthen therapeutic relationships, and ultimately equip patients to achieve better functional outcomes.

Effect of Paliperidone Palmitate 3-Month Formulation on Goal Attainment and Disability After 52 Weeks' Treatment in Patients with Clinically Stable Schizophrenia.

PURPOSE: This pragmatic clinical study aimed to assess goal attainment among patients with schizophrenia treated with paliperidone palmitate 3-monthly (PP3M) and its relation to their level of disability, and whether patients achieved symptomatic remission at the study endpoint. PATIENTS AND METHODS: Goal attainment was assessed as a secondary endpoint using Goal Attainment Scaling (GAS) within a 52-week, prospective, single-arm, non-randomized, open-label, international, multicenter study evaluating the impact of transitioning stable patients with schizophrenia from paliperidone palmitate 1-monthly (PP1M) to PP3M. Additional exploratory analyses were performed to investigate the relationship between disability and functioning as measured by the World Health Organization Disability Assessment Schedule (WHODAS), Version 2.0, symptomatic remission, and goal attainment. RESULTS: Overall, 305 patients were enrolled, of whom 281 (92.1%) provided GAS data at baseline. Of these, 160 achieved symptomatic remission at the last observation carried forward (LOCF) endpoint. The most common category of goals was "self" related, of which work-related was most frequent. Two-thirds of patients (67.7%) achieved at least one goal at the LOCF endpoint. Goal achievement was positively associated with lower baseline symptoms and symptomatic remission at LOCF endpoint, and with lower WHODAS scores at baseline and LOCF endpoint and greater WHODAS score improvements from baseline. Age, duration of disease, and duration of PP1M treatment before the switch did not impact goal setting and goal attainment. The proportion of patients with remunerated work status increased by 11.3% at LOCF endpoint. CONCLUSION: The results of this secondary endpoint analysis indicate that continued treatment of patients with schizophrenia with PP3M following stabilization with PP1M may facilitate attainment of patients' personal goals and reduce disability, especially, but not exclusively, in patients with symptomatic remission achieved at LOCF.

Stable patients with schizophrenia switched to paliperidone palmitate 3-monthly formulation in a naturalistic setting: impact of patient age and disease duration on outcomes.

BACKGROUND: Paliperidone palmitate 3-monthly (PP3M) is a second-generation, long-acting injectable antipsychotic formulation indicated for the maintenance treatment of adults with schizophrenia first stabilized with paliperidone palmitate 1-monthly (PP1M). This exploratory post hoc subgroup analysis of the 52-week, phase 3b REMISSIO study analysed outcomes according to patient age and disease duration in a naturalistic clinical setting. METHODS: Outcomes of patients with schizophrenia were analysed according to age [<35 years (n = 123) versus ⩾35 years (n = 182)] and disease duration [⩽3 years (n = 72) versus >3 years (n = 233)]. The primary efficacy outcome was the proportion of patients achieving symptomatic remission according to the Andreasen criteria. Adverse events were monitored throughout the study. RESULTS: At endpoint (last observation carried forward), 60.7% (95% CI: 51.4%, 69.4%) of younger patients and 54.1% of older patients (95% CI: 46.6%, 61.6%) achieved symptomatic remission. The proportions for patients with disease duration ⩽3 years and >3 years were similar: 57.8% (45.4%, 69.4%) versus 56.5% (49.8%, 62.9%). Functional remission was reached by 45.4% (36.2%, 54.8%) of patients aged <35 years and 36% (28.9%, 43.6%) of patients aged ⩾35 years with a similar pattern when analysed by disease duration. PP3M had a favourable safety profile and was generally well tolerated in both age groups. CONCLUSION: Patients with schizophrenia, previously stabilized on PP1M, may benefit from PP3M treatment with some additional potential improvements if started early in the disease course. CLINICAL TRIALSGOV: NCT02713282.

Methodological challenges in indirect treatment comparisons: spotlight on a recent comparison of long-acting injectable aripiprazole versus paliperidone palmitate in the treatment of schizophrenia.

In a recent study, an indirect treatment comparison was performed to examine the relative efficacy and tolerability of aripiprazole once monthly and paliperidone palmitate once monthly. The authors concluded that the results may suggest relative advantages for aripiprazole once monthly over paliperidone palmitate once monthly in the short-term treatment of schizophrenia. However, the validity of the study is compromised as an indirect treatment comparison using extant data may violate important assumptions. Other methodological issues identified further highlight the challenges of performing indirect treatment comparisons.