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1.
Eur J Cancer ; 152: 223-232, 2021 07.
Artículo en Inglés | MEDLINE | ID: mdl-34147014

RESUMEN

AIM: The aim of the study was to assess patient preference for the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) in patients with HER2-positive early breast cancer in PHranceSCa (NCT03674112). MATERIALS AND METHODS: Patients who completed neoadjuvant P + H + chemotherapy + surgery were randomised 1:1 to three intravenous (IV) P + H cycles followed by three cycles of PH FDC SC or vice versa (crossover) and then chose subcutaneous (SC) injection or IV infusion to continue up to 18 cycles (continuation). Assessments were via patient and healthcare professional (HCP) questionnaires. RESULTS: One hundred and sixty patients were randomised (cut-off: 24 February 2020); 136 (85.0%, 95% confidence interval: 78.5-90.2%) preferred SC; 22 (13.8%) preferred IV; 2 (1.3%) had no preference. The main reasons for SC preference were reduced clinic time (n = 119) and comfort during administration (n = 73). One hundred and forty-one patients (88.1%) were very satisfied/satisfied with SC injection versus 108 (67.5%) with IV infusion; 86.9% chose PH FDC SC continuation. HCP perceptions of median patient treatment room time ranged from 33.0-50.0 min with SC and 130.0-300.0 min with IV. Most adverse events (AEs) were grade 1/2 (no 4/5s); serious AE rates were low. AE rates before and after switching were similar (cycles 1-3 IV → cycles 4-6 SC: 77.5% → 72.5%; cycles 1-3 SC → cycles 4-6 IV: 77.5% → 63.8%). CONCLUSION: Most patients strongly preferred PH FDC SC over P + H IV. PH FDC SC was generally well tolerated, with no new safety signals (even when switching), and offers a quicker alternative to IV infusion.


Asunto(s)
Anticuerpos Monoclonales Humanizados/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Neoplasias de la Mama/terapia , Terapia Neoadyuvante/métodos , Prioridad del Paciente/estadística & datos numéricos , Trastuzumab/administración & dosificación , Adulto , Anciano , Anciano de 80 o más Años , Neoplasias de la Mama/diagnóstico , Neoplasias de la Mama/inmunología , Neoplasias de la Mama/patología , Quimioterapia Adyuvante/métodos , Quimioterapia Adyuvante/psicología , Quimioterapia Adyuvante/estadística & datos numéricos , Estudios Cruzados , Combinación de Medicamentos , Femenino , Humanos , Infusiones Intravenosas/efectos adversos , Infusiones Intravenosas/psicología , Inyecciones Subcutáneas/efectos adversos , Inyecciones Subcutáneas/psicología , Persona de Mediana Edad , Terapia Neoadyuvante/psicología , Terapia Neoadyuvante/estadística & datos numéricos , Estadificación de Neoplasias , Satisfacción del Paciente , Receptor ErbB-2/análisis , Receptor ErbB-2/metabolismo , Adulto Joven
2.
Arch Dermatol Res ; 313(4): 291-293, 2021 May.
Artículo en Inglés | MEDLINE | ID: mdl-32266531

RESUMEN

There has been an exponential growth in the number of dermatologic procedures performed over the past two decades. This surge in procedural volumes is accompanied by increasing utilization of local anesthetics. A proper technique in administering local anesthesia is necessary to minimize pain and promote comfort, as it is often regarded as the most painful part of cutaneous procedures. Pain is a psychophysiological phenomenon that involves attention, cognitive appraisal, and emotion. Sensory feedback and anxiety are two important aspects of pain perception. This article aims to introduce a novel way that minimizes pain and discomfort associated with local anesthetics. It is the authors' experience that painless injection is achievable by keeping syringes/needles out of sight, proceeding with injection without pre-procedure warning, and engaging patients in a conversation or simple tasks.


Asunto(s)
Anestesia Local/métodos , Anestésicos Locales/administración & dosificación , Procedimientos Quirúrgicos Dermatologicos/efectos adversos , Inyecciones Subcutáneas/métodos , Dolor/prevención & control , Anestesia Local/efectos adversos , Retroalimentación Sensorial/fisiología , Humanos , Inyecciones Subcutáneas/efectos adversos , Inyecciones Subcutáneas/instrumentación , Inyecciones Subcutáneas/psicología , Agujas/efectos adversos , Dolor/etiología , Dolor/fisiopatología , Dolor/psicología , Percepción del Dolor/fisiología , Jeringas/efectos adversos
3.
Diabet Med ; 37(10): 1640-1652, 2020 10.
Artículo en Inglés | MEDLINE | ID: mdl-32619028

RESUMEN

AIM: To understand the psychosocial experience of children and identify their primary support needs following a type 1 diabetes diagnosis. METHODS: A systematic review and narrative synthesis of the literature in this area was conducted. RESULTS: A total of 32 studies were included in the review. At diagnosis, the majority of children experienced high distress, including grief, anxiety, anger, irritation and injection anxiety. The intensity of this reaction decreased rapidly over the following weeks. At diagnosis, rates of depressive symptoms, anxiety, stress disorders and suicidal ideation were elevated. The initial reaction tended to peak shortly after diagnosis and declined over the following year. Thereafter, symptoms of depression and anxiety appeared to increase once again, corresponding with the children's experience of diabetes management and implications as being more difficult and upsetting. Injection anxiety, distress and depressive symptoms persisted for a smaller group of children. CONCLUSION: The initial high prevalence of depressive symptoms following diagnosis is transitional and should be regarded as a normal adaptive response. To facilitate this adaptive process, specific child-centred support should be prioritized as an integrated part of early diabetes care. Our findings point to five inter-related support needs following a type 1 diabetes diagnosis: (1) children need time to adjust to the diagnosis; (2) children need supportive relationships; (3) children need an opportunity for meaningful participation and appropriate protection; (4) children need to engage and explore; and (5) children need to feel supported, but not different.


Asunto(s)
Ansiedad/psicología , Depresión/psicología , Diabetes Mellitus Tipo 1/psicología , Estrés Psicológico/psicología , Adolescente , Ira , Niño , Diabetes Mellitus Tipo 1/diagnóstico , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Pesar , Humanos , Hipoglucemiantes/administración & dosificación , Inyecciones Subcutáneas/psicología , Insulina/administración & dosificación , Genio Irritable , Evaluación de Necesidades , Distrés Psicológico , Ideación Suicida
4.
Health Qual Life Outcomes ; 18(1): 99, 2020 Apr 10.
Artículo en Inglés | MEDLINE | ID: mdl-32276633

RESUMEN

BACKGROUND: Hepatitis B immunoglobulin (HBIG) therapy is available in intravenous (IV) or intra-muscular (IM) formulations. Recently, a subcutaneous (SC) formulation was introduced. This study evaluated changes in quality of life when liver transplant (LT) recipients were switched from IV or IM HBIG to the SC formulation. METHODS: This multicentre, observational study involved adults who had undergone LT at least 1 year prior to study entry. Quality of life was evaluated using the ITaLi-Q questionnaire, assessing the impact of HBIG therapy on daily activities and patient satisfaction, and the SF-36 Health Survey. Patients completed the questionnaires prior to switching from IV or IM HBIG to SC HBIG and 6 months later. RESULTS: Eighty-six patients were enrolled; before the switch, 68.6% were receiving IM HBIG and 31.4% IV HBIG. After 6 months, significant improvements in 7 of the 8 ITaLi-Q domains were found, particularly side effects, need for support to adhere to the therapy and satisfaction with the HBIG therapy. Significant improvements in several SF-36 domains were documented, including physical functioning, physical and emotional role limitations, pain, social functioning, physical and mental summary scores. CONCLUSIONS: The SC route of administration reduces side effects and their interference with daily life, ameliorates negative feelings, and increases patient autonomy.


Asunto(s)
Antivirales/administración & dosificación , Inmunoglobulinas/administración & dosificación , Factores Inmunológicos/administración & dosificación , Calidad de Vida , Adulto , Femenino , Hepatitis B/prevención & control , Humanos , Inmunoglobulinas/efectos adversos , Factores Inmunológicos/efectos adversos , Inyecciones Subcutáneas/métodos , Inyecciones Subcutáneas/psicología , Trasplante de Hígado/efectos adversos , Trasplante de Hígado/psicología , Masculino , Persona de Mediana Edad , Satisfacción del Paciente , Encuestas y Cuestionarios
5.
Pediatr Rheumatol Online J ; 18(1): 13, 2020 Feb 07.
Artículo en Inglés | MEDLINE | ID: mdl-32033566

RESUMEN

BACKGROUND: Treatment of rheumatic diseases in children often includes long-term needle injections, which represent a risk for refusing medication based on potential needle-fear. How nurses manage children's fear and pain during the initial educational training session of subcutaneous injections, may affect the management of the subsequent injections in the home settings. The aim of this study was to explore how children expressed fear and pain during these training sessions, and how adults' communication affected children's expressed emotions. METHODS: This qualitative explorative study used video observations and short interviews during training sessions in a rheumatic hospital ward. Participants were children between five and fifteen years (n = 8), their parents (n = 11) and nurses (n = 7) in nine training sessions in total. The analysis followed descriptions of thematic analysis and interaction analysis. RESULTS: The children expressed fears indirectly as cues and nonverbal signs more often than direct statements. Three children stated explicit being afraid or wanting to stop. The children worried about needle-pain, but experienced the stinging pain after the injection more bothersome. The technical instructions were detailed and comprehensive and each nurse shaped the structure of the sessions. Both nurses and parents frequently offered coping strategies unclearly without sufficient time for children to understand. We identified three main adult communication approaches (acknowledging, ambiguous and disregarding) that influenced children's expressed emotions during the training session. CONCLUSIONS: Children's expression of fear was likely to be indirectly, and pain was mostly related to the injection rather than the needle stick. When adults used an acknowledging communication and offered sufficient coping strategies, children seemed to become involved in the procedure and acted with confidence. The initial educational training session may have a great impact on long-term repeated injections in a home setting by providing children with confidence at the onset.


Asunto(s)
Antirreumáticos/administración & dosificación , Miedo/psicología , Inyecciones Subcutáneas/psicología , Agujas , Relaciones Enfermero-Paciente , Relaciones Padres-Hijo , Educación del Paciente como Asunto , Enfermedades Reumáticas/tratamiento farmacológico , Adalimumab/administración & dosificación , Adolescente , Adulto , Anticuerpos Monoclonales Humanizados/administración & dosificación , Niño , Preescolar , Etanercept/administración & dosificación , Femenino , Humanos , Masculino , Metotrexato/administración & dosificación , Enfermeras y Enfermeros , Dolor Asociado a Procedimientos Médicos/psicología , Padres , Investigación Cualitativa
6.
Gastroenterol Hepatol ; 43(1): 9-13, 2020 Jan.
Artículo en Inglés, Español | MEDLINE | ID: mdl-31492425

RESUMEN

BACKGROUND: There is limited information regarding the impact of patients' perception of injection pain on adherence to treatments, specifically in inflammatory bowel disease (IBD) patients. Therefore, we aimed to determine the impact of the pain associated with the subcutaneous administration of adalimumab in patients with IBD treated with the old formulation and the new low-volume/citrate-free formulation. METHODS: A specifically-designed questionnaire was completed by 76 patients with IBD, who started treatment with adalimumab before the availability of the low-volume/citrate-free formulation and were switched to this new formulation. Intensity of pain was measured by using visual analog scales (VAS). RESULTS: A total of 62 patients (82%) experienced injection-related pain with the initial formulation. The perception of pain was associated with a decreased adherence to the treatment (37%), an increase in pre-administration anxiety (25%) or, as a consequence, the patient required someone else to carry out the injection (21%). Younger age was the only factor associated with pain perception. After switching to the new formulation, perception of pain persisted only in 2 patients (3%). Among those who felt pain with the initial formulation, pre-administration anxiety disappeared in 44%; 32% and 42% stated that the new formulation eased adherence and self-administration. CONCLUSIONS: The perception of pain related to the subcutaneous administration of therapy negatively impacts on treatment adherence in IBD patients. Improved formulations for subcutaneous administration of drugs can positively impact patients' convenience and adherence.


Asunto(s)
Adalimumab/administración & dosificación , Antiinflamatorios/administración & dosificación , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Percepción del Dolor/fisiología , Dolor Asociado a Procedimientos Médicos/fisiopatología , Adalimumab/química , Adulto , Antiinflamatorios/química , Ansiedad/etiología , Composición de Medicamentos , Femenino , Humanos , Inyecciones Subcutáneas/efectos adversos , Inyecciones Subcutáneas/psicología , Masculino , Cumplimiento de la Medicación/estadística & datos numéricos , Persona de Mediana Edad , Dolor Asociado a Procedimientos Médicos/etiología , Autoadministración/efectos adversos , Autoadministración/psicología , Encuestas y Cuestionarios
7.
Curr Diabetes Rev ; 16(8): 874-880, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-31057119

RESUMEN

BACKGROUND: Technological developments concerning the treatment of Type 1 Diabetes Mellitus have been rapid in the latest years. Insulin infusion systems along with continuous glucose monitoring, as well as long-acting insulin analogues, are part of this progress. OBJECTIVE: The aim of this study is to present the illness perceptions in type 1 diabetes mellitus, with or without the use of an insulin pump. Sexual life and body image among therapy groups subjected to subcutaneous insulin infusion (CSII) therapy and multiple daily injections (MDI) therapy were also examined. METHODS: A modified version of the Brief Illness Perception Questionnaire was used. One hundred and nine adults with type 1 diabetes mellitus, (males / females ratio 1:2.3) completed the online survey. Thirty six of them (33%) used CSII therapy and 73 of them (67%) used MDI therapy. RESULTS: Statistically important differences among the CSII and MDI therapy groups were found in treatment control, illness comprehensibility, representations of control, representation of body image and in the perception of sex life. There was no statistically significant difference among the different types of therapy for participants' negative perception of diabetes. DISCUSSION AND CONCLUSION: Negative perceptions of MDI users in treatment control, illness comprehensibility, representations of control, body image and sex life with the insulin pump, differentiate CSII and MDI therapy groups to a significant degree. According to the research, these parameters seem to interfere with accepting CSII therapy for MDI users and discourage them.


Asunto(s)
Diabetes Mellitus Tipo 1/tratamiento farmacológico , Diabetes Mellitus Tipo 1/psicología , Hipoglucemiantes/administración & dosificación , Sistemas de Infusión de Insulina , Adulto , Actitud Frente a la Salud , Glucemia/análisis , Automonitorización de la Glucosa Sanguínea/psicología , Diabetes Mellitus Tipo 1/sangre , Femenino , Hemoglobina Glucada/análisis , Humanos , Inyecciones Subcutáneas/psicología , Insulina/administración & dosificación , Sistemas de Infusión de Insulina/psicología , Internet , Masculino , Persona de Mediana Edad , Percepción , Automanejo/métodos , Automanejo/psicología , Encuestas y Cuestionarios , Adulto Joven
8.
Support Care Cancer ; 28(1): 287-293, 2020 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-31044304

RESUMEN

PURPOSE: Our objective was to compare patient's expectations to their experience and to identify factors predictive of patient's perception of long-term LMWH for the treatment of cancer-associated thrombosis (CAT). METHODS: Results from the validated Perception Anticoagulant Treatment Questionnaires (PACTQ) completed before inclusion (PACTQ1 for expectations) and at the end (PACTQ2 for convenience and satisfaction) of the 6-month TROPIQUE study were studied with principal component analysis. Possible predictive factors of improved perception of LMWH treatment were analyzed with the Kruskall-Wallis test. RESULTS: Among 409 included patients treated with LMWH, 269 PACT-Q1 and 139 PACT-Q2 were evaluable for treatment perception. Patients had high expectations (A1-A7 score of 26.7 ± 3.5, max = 35). Treatment cost (A7 = 1.90 ± 1.31) and concern about a mistake in anticoagulation (A5 = 1.93 ± 1.12) had little importance while LMWH treatment was considered easy to use (A4 = 4.20 ± 0.93). Six-month treatment with LMWH was associated with a high rate of convenience (B1-B11, C1-C2 = 55.1 ± 8.38, max = 65) and a high satisfaction score (D1-D7 = 25.1 ± 4.32, max = 35). Patients' confidence in treatment and perception of possible LMWH side effects were moderate while perception of autonomy and independence significantly improved at the end of the study compared to inclusion. PACT-Q2 satisfaction score was low in patients who experienced bleeding (PACT-Q2 24.1 ± 3.3 vs. 25.1 ± 4.3). LMWH twice daily tended to be found less convenient compared than once daily (53.3 ± 7.2 vs. 55.0 ± 8.3). CONCLUSION: CAT patients had a good perception of the 6-month LMWH treatment when comparing expectations and experience. Using a quantitative scale validated in the general population for VTE and subcutaneous injection and including a large number of patients, bleeding complications and LMWH twice daily were associated with a nonsignificant trend towards a worsen perception.


Asunto(s)
Heparina de Bajo-Peso-Molecular/uso terapéutico , Neoplasias/complicaciones , Satisfacción del Paciente , Percepción/fisiología , Trombosis/tratamiento farmacológico , Trombosis/etiología , Adulto , Anticoagulantes/uso terapéutico , Femenino , Hemorragia/inducido químicamente , Hemorragia/epidemiología , Hemorragia/psicología , Humanos , Inyecciones Subcutáneas/psicología , Cuidados a Largo Plazo/psicología , Cuidados a Largo Plazo/estadística & datos numéricos , Masculino , Cumplimiento de la Medicación/psicología , Cumplimiento de la Medicación/estadística & datos numéricos , Persona de Mediana Edad , Neoplasias/tratamiento farmacológico , Neoplasias/epidemiología , Neoplasias/psicología , Aceptación de la Atención de Salud/psicología , Aceptación de la Atención de Salud/estadística & datos numéricos , Satisfacción del Paciente/estadística & datos numéricos , Estudios Prospectivos , Calidad de Vida , Encuestas y Cuestionarios , Trombosis/epidemiología , Trombosis/psicología , Factores de Tiempo , Tromboembolia Venosa/tratamiento farmacológico , Tromboembolia Venosa/epidemiología , Tromboembolia Venosa/etiología
9.
Addiction ; 115(7): 1295-1305, 2020 07.
Artículo en Inglés | MEDLINE | ID: mdl-31860767

RESUMEN

AIMS: To examine perceptions of extended-release (XR) buprenorphine injections among people who regularly use opioids in Australia. DESIGN: Cross-sectional survey prior to implementation. XR-buprenorphine was registered in Australia in November 2018. SETTING: Sydney, Melbourne and Hobart. Participants A total of 402 people who regularly use opioids interviewed December 2017 to March 2018. MEASUREMENTS: Primary outcome concerned the proportion of participants who believed XR-buprenorphine would be a good treatment option for them, preferred weekly versus monthly injections and perceived advantages/disadvantages of XR-buprenorphine. Independent variables concerned the demographic characteristics and features of current opioid agonist treatment (OAT; medication-type, dose, prescriber/dosing setting, unsupervised doses, out-of-pocket expenses and travel distance). FINDINGS: Sixty-eight per cent [95% confidence interval (CI) = 63-73%] believed XR-buprenorphine was a good treatment option for them. They were more likely to report being younger [26-35 versus > 55 years; odds ratio (OR) = 3.16, 95% CI = 1.12-8.89; P = 0.029], being female (OR = 1.67, 95% CI = 1.04-2.69; P = 0.034), < 10 years school education (OR = 1.87, 95% CI = 1.12-3.12; P = 0.016) and past-month heroin (OR = 1.81, 95% CI = 1.15-2.85; P = 0.006) and methamphetamine use (OR = 1.90, 95% CI = 1.20-3.01; P = 0.006). Fifty-four per cent reported no preference for weekly versus monthly injections, 7% preferred weekly and 39% preferred monthly. Among OAT recipients (n = 255), believing XR-buprenorphine was a good treatment option was associated with shorter treatment episodes (1-2 versus ≥ 2 years; OR = 3.93, 95% CI = 1.26-12.22; P = 0.018), fewer unsupervised doses (≤ 8 doses past-month versus no take-aways; OR = 0.50; 95% CI = 0.27-0.93; P = 0.028) and longer travel distance (≥ 5 versus < 5 km; OR = 2.10, 95% CI = 1.20-3.65; P = 0.009). Sixty-nine per cent reported 'no problems or concerns' with potential differences in availability, flexibility and location of XR-buprenorphine. CONCLUSIONS: Among regular opioid users in Australia, perceptions of extended-release buprenorphine as a good treatment option are associated with being female, recent illicit drug use and factors relating to the (in)convenience of current opioid agonist treatment.


Asunto(s)
Buprenorfina/uso terapéutico , Preparaciones de Acción Retardada/uso terapéutico , Consumidores de Drogas/psicología , Inyecciones Subcutáneas/psicología , Tratamiento de Sustitución de Opiáceos/psicología , Trastornos Relacionados con Opioides/tratamiento farmacológico , Adulto , Australia/epidemiología , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Prioridad del Paciente
10.
Soins Pediatr Pueric ; 40(310): 27-30, 2019.
Artículo en Francés | MEDLINE | ID: mdl-31543231

RESUMEN

Studies and the experience of caregivers in paediatric hospital departments reveal the difficulties encountered by families and children when the treatment of a chronic disease requires injections to be administered by the family at home. Many treatments in paediatrics are administered by subcutaneous injection which means parents need to perform this procedure on their child, often for organisational reasons. However, injecting medication into one's child is not easy for the parent, even when the technique is mastered.


Asunto(s)
Inyecciones Subcutáneas/psicología , Relaciones Padres-Hijo , Padres/psicología , Niño , Humanos
11.
Contraception ; 98(5): 418-422, 2018 11.
Artículo en Inglés | MEDLINE | ID: mdl-29758176

RESUMEN

OBJECTIVE: To describe women's experiences with subcutaneous depot medroxyprogesterone acetate (DMPA-SC) to inform scale-up of self-administered DMPA-SC. STUDY DESIGN: We conducted a 12-month randomized controlled trial in Malawi to measure DMPA-SC continuation rates. A total of 731 women presenting at six Ministry of Health clinics or to community health workers (CHWs) in rural communities were randomized to receive DMPA-SC administered by a provider or be trained to self-inject DMPA-SC. Data collectors contacted women after the reinjection window at 3, 6 and 9 months to collect data on satisfaction and use; self-injectors were also queried about storage and disposal of DMPA-SC. We compared frequencies of injection experiences and satisfaction by study group and over time. RESULTS: Ninety-two percent of women who self-injected felt it was easy to do the first time. Women in the self-administered group primarily gave themselves the injection versus having someone else inject them; stored DMPA-SC mostly in bags, often in ways to keep the product away from others; and properly disposed of DMPA-SC in pit latrines. Women in both groups used printed calendars to remember when to get/be given their next injection. Both groups reported high satisfaction with DMPA-SC. CONCLUSIONS: Women in low-resource settings can be successfully trained by public sector CHWs and clinic-based providers to self-inject and to appropriately store and dispose of DMPA-SC. DMPA-SC and self-injection are acceptable and feasible in a low-resource setting. IMPLICATIONS: Self-administered and provider-administrated DMPA-SC should be scaled up, and the lessons learned during our trial should be applied to future scale-up efforts.


Asunto(s)
Anticonceptivos Femeninos/administración & dosificación , Acetato de Medroxiprogesterona/administración & dosificación , Satisfacción del Paciente/estadística & datos numéricos , Adulto , Femenino , Humanos , Inyecciones Subcutáneas/psicología , Autoadministración/psicología
12.
Value Health ; 20(3): 430-440, 2017 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-28292488

RESUMEN

BACKGROUND: Alirocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor, significantly reduces low-density lipoprotein cholesterol, but requires subcutaneous injections rather than oral pills. To measure patients' acceptance of this treatment modality, a new patient-reported outcome, the Injection-Treatment Acceptance Questionnaire (I-TAQ), was developed. OBJECTIVES: To psychometrically evaluate the I-TAQ with patients at high risk of cardiovascular events receiving alirocumab. METHODS: The 22-item, 5-domain I-TAQ was administered cross-sectionally to 151 patients enrolled in alirocumab clinical trials. Item response distributions, factor and multitrait analyses, interitem correlations, correlations with an existing measure of acceptance (convergent validity), and comparison of known-groups were performed to assess the I-TAQ's psychometric properties. RESULTS: Completion rates were high, with no patients missing more than two items and 91.4% missing no data. All items displayed high ceiling effects (>30%) because of high treatment acceptance. Factor analysis supported the a priori hypothesized item-domain structure with good fit indices (root mean square error approximation = 0.070; comparative fit index = 0.988) and high factor loadings. All items demonstrated item convergent validity (item-scale correlation ≥0.40), except for the side effects domain, which was limited by small numbers (n = 46). Almost all items correlated most highly with the domain to which they were assigned (item discriminant validity). Internal reliability was acceptable for all domains (Cronbach α range 0.72-0.88) and convergent validity was supported by a logical pattern of correlations with the Chronic Treatment Acceptance Questionnaire. CONCLUSIONS: These findings provide initial evidence of validity and reliability for the I-TAQ in patients treated with subcutaneous alirocumab. The I-TAQ could prove to be a valuable patient-reported outcome for therapies requiring subcutaneous injection.


Asunto(s)
Anticuerpos Monoclonales/administración & dosificación , Hipercolesterolemia/tratamiento farmacológico , Inyecciones Subcutáneas/psicología , Aceptación de la Atención de Salud/estadística & datos numéricos , Encuestas y Cuestionarios/normas , Adulto , Anciano , Anciano de 80 o más Años , Anticuerpos Monoclonales Humanizados , Ensayos Clínicos Fase III como Asunto , Estudios Transversales , Análisis Factorial , Femenino , Humanos , Hipercolesterolemia/sangre , Hipercolesterolemia/psicología , Lipoproteínas LDL/sangre , Masculino , Persona de Mediana Edad , Satisfacción del Paciente , Psicometría , Reproducibilidad de los Resultados , Estados Unidos
13.
Patient ; 9(4): 281-92, 2016 08.
Artículo en Inglés | MEDLINE | ID: mdl-26792584

RESUMEN

BACKGROUND: Subcutaneous injections allow for self-administration, but consideration of patients' perspectives on treatment choice is important to ensure adherence. Previous systematic reviews have been limited in their scope for assessing preferences in relation to other routes of administration. OBJECTIVE: Our objective was to examine patients' perspectives on subcutaneously administered self-injectable medications when compared with other routes or methods of administration for the same medicines. METHODS: Nine electronic databases were searched for publications since 2000 using terms pertaining to methods of administration, choice behavior, and adverse effects. Eligibility for inclusion was determined through reference to specific criteria by two independent reviewers. Results were described narratively. RESULTS: Of the 1726 papers screened, 85 met the inclusion criteria. Studies were focused mainly on methods of insulin administration for diabetes but also included treatments for pediatric growth disorders, multiple sclerosis, HIV, and migraine. Pen devices and autoinjectors were favored over administration with needle and syringe, particularly with respect to ergonomics, convenience, and portability. Inhalation appeared to be more acceptable than subcutaneous injection (in the case of insulin), but how subcutaneous infusion, intramuscular injection, and needle-free injection devices compare with subcutaneous injections in terms of patient preference is less certain. CONCLUSIONS: The review identified a number of studies showing the importance of the methods and routes of drug delivery on patient choice. However, studies were prone to bias, and further robust evidence based on methodologically sound approaches is required to demonstrate how patient choice might translate to improved adherence.


Asunto(s)
Inyecciones Subcutáneas/psicología , Prioridad del Paciente , Autoadministración/psicología , Conducta de Elección , Vías de Administración de Medicamentos , Humanos , Inyecciones Subcutáneas/efectos adversos , Inyecciones Subcutáneas/instrumentación , Percepción , Autoadministración/efectos adversos , Autoadministración/instrumentación
14.
Patient ; 9(2): 171-80, 2016 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-26259849

RESUMEN

BACKGROUND AND OBJECTIVE: Patients' perceptions and experiences of medication efficacy, medication adverse events, dosing frequency, and dosing complexity have been found to influence adherence to injectable disease-modifying treatments (DMTs) in patients with multiple sclerosis (MS). The aim of this study was to quantify patient preferences for features of injectable DMTs for MS. METHODS: Adult patients in the United States (US) with a self-reported diagnosis of MS completed an online discrete-choice experiment survey to assess preference for a number of features of a hypothetical injectable DMT. Patients chose hypothetical treatments in paired comparisons, where each treatment was described by features or attributes, including the number of years until disability progression, the number of relapses in the next 4 years, injection time, the frequency of injections, the occurrence of flu-like symptoms (FLS), and severity of injection-site reactions. Random-parameters logit regression parameters were used to calculate preference weights of attribute levels and the relative importance of changes in treatment features. RESULTS: Of the 205 patients who completed the survey, 192 provided sufficient data for analysis. The results indicated a broad range of tradeoffs that patients would be willing to make. With regard to this, the relative importance of an improvement in the number of years until disability progression from 1 to 2 (i.e., vertical distance between preference weights for these attribute levels) was 0.9 [95% confidence interval (CI) 0.5-1.2], the relative importance of this change was approximately equivalent to that of an improvement from 12 injections per month to two (mean 0.8, 95% CI 0.4-1.2), or approximately equivalent to a decrease from four to one relapses in the next 4 years (mean 0.8, 95% CI 0.5-1.2), or FLS 3 days after every injection to 3 days after some injections (mean 1.0, 95% CI 0.6-1.4). CONCLUSIONS: These results suggest that an improvement in treatment efficacy may be as important as a reduction in injection frequency or a reduction in some adverse events for patients who self-administer injectable DMTs for MS. Understanding the preferences of patients who use injectable treatments will inform the development of such treatments, which may in turn improve patient medication adherence and well-being.


Asunto(s)
Inyecciones Subcutáneas/estadística & datos numéricos , Esclerosis Múltiple/tratamiento farmacológico , Prioridad del Paciente/estadística & datos numéricos , Adulto , Conducta de Elección , Femenino , Humanos , Inyecciones Subcutáneas/efectos adversos , Inyecciones Subcutáneas/psicología , Internet , Masculino , Cumplimiento de la Medicación/psicología , Cumplimiento de la Medicación/estadística & datos numéricos , Persona de Mediana Edad , Esclerosis Múltiple/psicología , Prioridad del Paciente/psicología , Autoadministración/métodos , Autoadministración/psicología , Autoadministración/estadística & datos numéricos , Encuestas y Cuestionarios , Factores de Tiempo , Estados Unidos
15.
Value Health ; 18(8): 1000-7, 2015 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-26686784

RESUMEN

BACKGROUND: New therapies in development for lowering low-density lipoprotein cholesterol, such as alirocumab, require administration by subcutaneous injections. There is a need to assess the acceptance of such treatments and their mode of administration. OBJECTIVES: To develop a novel patient-reported outcome measure, the Injection-Treatment Acceptance Questionnaire (I-TAQ), and assess its content validity using qualitative methods. METHODS: Concepts generated from a literature and instrument review informed the initial drafting of 17 items in the I-TAQ, with item wording adapted from three existing instruments. Three rounds of qualitative interviews were conducted with 29 US-English speaking patients at high cardiovascular risk. Concept elicitation questioning was used to explore patients' treatment experiences followed by cognitive debriefing of the I-TAQ using "think-aloud" methods. Verbatim transcripts were analyzed using thematic analysis. RESULTS: Qualitative analysis of concept elicitation data identified the following relevant concepts: perceived efficacy, side effects, self-efficacy, convenience, and overall acceptance. Seven (24%) patients discussed an initial fear of needles, but described this as subsiding with no impact on adherence. Five items were added after round one interviews, three of which were retained after round two testing in which two further items were added, forming the conceptually comprehensive 22-item I-TAQ. Patients demonstrated good understanding of item wording, instructions, response scales, and recall period. CONCLUSIONS: Successive rounds of in-depth interviews resulted in a treatment acceptance measure with strong content validity. Pending demonstration of its psychometric properties, the I-TAQ may prove to be a valuable measure of patients' perspectives toward being treated with low-density lipoprotein cholesterol-lowering therapies requiring subcutaneous injections.


Asunto(s)
Hipercolesterolemia/tratamiento farmacológico , Hipolipemiantes/administración & dosificación , Inyecciones Subcutáneas/psicología , Calidad de Vida , Encuestas y Cuestionarios/normas , Anciano , Enfermedades Cardiovasculares/epidemiología , Femenino , Humanos , Hipolipemiantes/efectos adversos , Masculino , Persona de Mediana Edad , Prioridad del Paciente , Psicometría , Investigación Cualitativa , Reproducibilidad de los Resultados , Factores de Riesgo
17.
Nurs Child Young People ; 27(3): 28-33, 2015 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-25858408

RESUMEN

AIM: Distress and pain associated with immunisation are significant problems for children, carers and healthcare professionals. This study was designed to determine whether distraction by watching cartoons during immunisation could reduce the distress and pain perceived by the children. METHODS: A sample of 35 six year olds was randomly assigned to one of two groups: the first was distracted by standard techniques during immunisation, the second by watching cartoons. Levels of distress were measured with the amended observation scale of behavioural distress, and of pain by the Wong-Baker FACES pain rating scale. RESULTS: The levels of distress were significantly lower in the group distracted by cartoons compared with children who received traditional distraction techniques during immunisation. CONCLUSION: By using an easy, cheap intervention, children's first introduction to health services can be made a positive experience which will decrease the number developing pre-procedural anxiety or a fear of needles.


Asunto(s)
Ansiedad/prevención & control , Dibujos Animados como Asunto , Inyecciones Intramusculares/psicología , Inyecciones Subcutáneas/psicología , Manejo del Dolor/métodos , Estrés Psicológico/prevención & control , Adulto , Niño , Miedo , Femenino , Humanos , Masculino
18.
Breast ; 24(2): 166-70, 2015 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-25623753

RESUMEN

BACKGROUND: The 2 Cohort randomised PrefHer trial examined the preferences of HER2+ve primary breast cancer patients for intravenous (IV) or subcutaneous (SC) delivery of trastuzumab via a Single Injectable Device (SID) or hand-held syringe (HHS). The novel approach and design of the study permitted an in-depth exploration of patients' experiences, the impact that different modes of delivery had on patients' well-being and implications for future management. METHODS: The preferences, experiences and general comments of patients in the PrefHer study were collected via specific semi-structured interview schedules. Exploratory analyses of data were conducted using standard methodology. The final question invited patients to make further comments, which were divided into 9 thematic categories - future delivery, compliments, time/convenience, practical considerations, pain/discomfort, study design, side-effects, psychological impact, and perceived efficacy. RESULTS: 267/467 (57%) patients made 396 additional comments, 7 were neutral, 305 positive and 86 negative. The three top categories generating the largest number of comments were compliments and gratitude about staff and being part of PrefHer (75/396; 19%), the potential future delivery of SC trastuzumab (73/396; 18%), and practical considerations about SC administration (60/396; 15%). CONCLUSIONS: Eliciting patient preferences about routes of administration of drugs via comprehensive interviews within a randomised cross-over trial yielded rich and important information. The few negative comments made demonstrated a need for proper staff training in SC administration Patients were grateful to have been part of the trial, and would have liked to continue with SC delivery. The possibility of home administration in the future also seemed acceptable. EUDRACT NUMBER: 2010-024099-25.


Asunto(s)
Antineoplásicos/administración & dosificación , Neoplasias de la Mama/tratamiento farmacológico , Prioridad del Paciente/psicología , Satisfacción del Paciente , Trastuzumab/administración & dosificación , Administración Intravenosa/psicología , Estudios Cruzados , Femenino , Humanos , Inyecciones Subcutáneas/psicología
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