ABSTRACT
Aim: Several studies have found subcutaneous (SC) and intravenous (IV) administration of similar drugs for long-lasting immunological and autoimmune diseases to have similar clinical effectiveness, meaning that what patients report they prefer is, or should be, a major factor in treatment choices. Therefore, it is important to systematically compile evidence regarding patient preferences, treatment satisfaction and health-related quality of life (HRQL) using SC or IV administration of the same drug. Materials & methods: PubMed database searches were run on 15 October 2021. Studies involving patients with experience of both home-based SC and hospital-based IV administration of immunoglobulins or biological therapies for the treatment of any autoimmune disease or primary immunodeficiencies (PIDs) were included. The outcomes assessed were patient preferences, treatment satisfaction and HRQL. Preference data were meta-analyzed using a random-effects model. Results: In total, 3504 citations were screened, and 46 publications describing 37 studies were included in the review. There was a strong overall preference for SC over IV administration, with similar results seen for PIDs and autoimmune diseases: PID, 80% (95% confidence interval [CI], 64-94%) preferred SC; autoimmune diseases, 83% (95% CI: 73-92%); overall, 82% (95% CI: 75-89%). The meta-analysis also found that 84% (95% CI: 75-92%) of patients preferred administration at home to treatment in hospital. Analysis of treatment satisfaction using the life quality index found consistently better treatment interference and treatment setting scores with SC administration than with IV administration. Conclusion: Compared with IV infusions in hospital, patients tend to prefer, to be more satisfied with and to report better HRQL with SC administration of the same drug at home, primarily due to the greater convenience. This study contributes to evidence-based care of patients with autoimmune diseases or PIDs.
Subject(s)
Immune System Diseases , Patient Preference , Quality of Life , Adult , Humans , Administration, Intravenous/psychology , Immune System Diseases/drug therapy , Injections, Subcutaneous/psychology , Patient Preference/statistics & numerical data , Patient Reported Outcome Measures , Patient Satisfaction/statistics & numerical dataABSTRACT
OBJECTIVES: The objective of this study was to compare the attitudes and beliefs of PCU physicians leaders in the United States versus Canada regarding the subcutaneous method in the administration of medications and hydration in order to gain a better understanding as to why variations in practice exist. METHODS: This survey trial took place from November 2022 to May 2023. The MD Anderson Cancer Center institutional review board in Houston, Texas, approved this study. The participants were the physician leaders of the acute palliative care units (PCUs) in the United States and Canada. The survey comprised questions formulated by the study investigators regarding the perceived comfort, efficiency, and preference of using the subcutaneous versus the intravenous method. The consent form and survey links were emailed to the participants. RESULTS: Sixteen PCUs were identified in the United States and 15 PCUs in Canada. Nine US and 8 Canadian physicians completed the survey. Physicians in Canada were more likely to use the subcutaneous route for administering opioids, antiemetics, neuroleptics, and hydration. They preferred subcutaneous over intravenous or intramuscular routes (p = 0.017). Canadian physicians felt their nursing staff was more comfortable with subcutaneous administration (p = 0.022) and that it was easier to administer (p = 0.02). US physicians felt the intravenous route was more efficient (p = 0.013). SIGNIFICANCE OF RESULTS: The study results suggest that exposure to the subcutaneous route influences a physician's perception. Further research is needed to explore ways to incorporate its use to a greater degree in the US healthcare system.
Subject(s)
Attitude of Health Personnel , Palliative Care , Physicians , Humans , Canada , Palliative Care/methods , Palliative Care/standards , Palliative Care/psychology , United States , Surveys and Questionnaires , Physicians/psychology , Physicians/statistics & numerical data , Male , Female , Adult , Middle Aged , Fluid Therapy/methods , Fluid Therapy/standards , Fluid Therapy/psychology , Fluid Therapy/statistics & numerical data , Injections, Subcutaneous/methods , Injections, Subcutaneous/psychologyABSTRACT
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 â cycles 4-6 SC: 77.5% â 72.5%; cycles 1-3 SC â cycles 4-6 IV: 77.5% â 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.
Subject(s)
Antibodies, Monoclonal, Humanized/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Breast Neoplasms/therapy , Neoadjuvant Therapy/methods , Patient Preference/statistics & numerical data , Trastuzumab/administration & dosage , Adult , Aged , Aged, 80 and over , Breast Neoplasms/diagnosis , Breast Neoplasms/immunology , Breast Neoplasms/pathology , Chemotherapy, Adjuvant/methods , Chemotherapy, Adjuvant/psychology , Chemotherapy, Adjuvant/statistics & numerical data , Cross-Over Studies , Drug Combinations , Female , Humans , Infusions, Intravenous/adverse effects , Infusions, Intravenous/psychology , Injections, Subcutaneous/adverse effects , Injections, Subcutaneous/psychology , Middle Aged , Neoadjuvant Therapy/psychology , Neoadjuvant Therapy/statistics & numerical data , Neoplasm Staging , Patient Satisfaction , Receptor, ErbB-2/analysis , Receptor, ErbB-2/metabolism , Young AdultABSTRACT
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.
Subject(s)
Anesthesia, Local/methods , Anesthetics, Local/administration & dosage , Dermatologic Surgical Procedures/adverse effects , Injections, Subcutaneous/methods , Pain/prevention & control , Anesthesia, Local/adverse effects , Feedback, Sensory/physiology , Humans , Injections, Subcutaneous/adverse effects , Injections, Subcutaneous/instrumentation , Injections, Subcutaneous/psychology , Needles/adverse effects , Pain/etiology , Pain/physiopathology , Pain/psychology , Pain Perception/physiology , Syringes/adverse effectsABSTRACT
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.
Subject(s)
Anxiety/psychology , Depression/psychology , Diabetes Mellitus, Type 1/psychology , Stress, Psychological/psychology , Adolescent , Anger , Child , Diabetes Mellitus, Type 1/diagnosis , Diabetes Mellitus, Type 1/drug therapy , Grief , Humans , Hypoglycemic Agents/administration & dosage , Injections, Subcutaneous/psychology , Insulin/administration & dosage , Irritable Mood , Needs Assessment , Psychological Distress , Suicidal IdeationABSTRACT
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.
Subject(s)
Antiviral Agents/administration & dosage , Immunoglobulins/administration & dosage , Immunologic Factors/administration & dosage , Quality of Life , Adult , Female , Hepatitis B/prevention & control , Humans , Immunoglobulins/adverse effects , Immunologic Factors/adverse effects , Injections, Subcutaneous/methods , Injections, Subcutaneous/psychology , Liver Transplantation/adverse effects , Liver Transplantation/psychology , Male , Middle Aged , Patient Satisfaction , Surveys and QuestionnairesABSTRACT
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.
Subject(s)
Antirheumatic Agents/administration & dosage , Fear/psychology , Injections, Subcutaneous/psychology , Needles , Nurse-Patient Relations , Parent-Child Relations , Patient Education as Topic , Rheumatic Diseases/drug therapy , Adalimumab/administration & dosage , Adolescent , Adult , Antibodies, Monoclonal, Humanized/administration & dosage , Child , Child, Preschool , Etanercept/administration & dosage , Female , Humans , Male , Methotrexate/administration & dosage , Nurses , Pain, Procedural/psychology , Parents , Qualitative ResearchABSTRACT
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.
Subject(s)
Buprenorphine/therapeutic use , Delayed-Action Preparations/therapeutic use , Drug Users/psychology , Injections, Subcutaneous/psychology , Opiate Substitution Treatment/psychology , Opioid-Related Disorders/drug therapy , Adult , Australia/epidemiology , Cross-Sectional Studies , Female , Humans , Male , Middle Aged , Patient PreferenceABSTRACT
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.
Subject(s)
Heparin, Low-Molecular-Weight/therapeutic use , Neoplasms/complications , Patient Satisfaction , Perception/physiology , Thrombosis/drug therapy , Thrombosis/etiology , Adult , Anticoagulants/therapeutic use , Female , Hemorrhage/chemically induced , Hemorrhage/epidemiology , Hemorrhage/psychology , Humans , Injections, Subcutaneous/psychology , Long-Term Care/psychology , Long-Term Care/statistics & numerical data , Male , Medication Adherence/psychology , Medication Adherence/statistics & numerical data , Middle Aged , Neoplasms/drug therapy , Neoplasms/epidemiology , Neoplasms/psychology , Patient Acceptance of Health Care/psychology , Patient Acceptance of Health Care/statistics & numerical data , Patient Satisfaction/statistics & numerical data , Prospective Studies , Quality of Life , Surveys and Questionnaires , Thrombosis/epidemiology , Thrombosis/psychology , Time Factors , Venous Thromboembolism/drug therapy , Venous Thromboembolism/epidemiology , Venous Thromboembolism/etiologyABSTRACT
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.
Subject(s)
Diabetes Mellitus, Type 1/drug therapy , Diabetes Mellitus, Type 1/psychology , Hypoglycemic Agents/administration & dosage , Insulin Infusion Systems , Adult , Attitude to Health , Blood Glucose/analysis , Blood Glucose Self-Monitoring/psychology , Diabetes Mellitus, Type 1/blood , Female , Glycated Hemoglobin/analysis , Humans , Injections, Subcutaneous/psychology , Insulin/administration & dosage , Insulin Infusion Systems/psychology , Internet , Male , Middle Aged , Perception , Self-Management/methods , Self-Management/psychology , Surveys and Questionnaires , Young AdultABSTRACT
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.
Subject(s)
Adalimumab/administration & dosage , Anti-Inflammatory Agents/administration & dosage , Inflammatory Bowel Diseases/drug therapy , Pain Perception/physiology , Pain, Procedural/physiopathology , Adalimumab/chemistry , Adult , Anti-Inflammatory Agents/chemistry , Anxiety/etiology , Drug Compounding , Female , Humans , Injections, Subcutaneous/adverse effects , Injections, Subcutaneous/psychology , Male , Medication Adherence/statistics & numerical data , Middle Aged , Pain, Procedural/etiology , Self Administration/adverse effects , Self Administration/psychology , Surveys and QuestionnairesABSTRACT
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.
Subject(s)
Injections, Subcutaneous/psychology , Parent-Child Relations , Parents/psychology , Child , HumansABSTRACT
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.
Subject(s)
Contraceptive Agents, Female/administration & dosage , Medroxyprogesterone Acetate/administration & dosage , Patient Satisfaction/statistics & numerical data , Adult , Female , Humans , Injections, Subcutaneous/psychology , Self Administration/psychologyABSTRACT
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.
Subject(s)
Antibodies, Monoclonal/administration & dosage , Hypercholesterolemia/drug therapy , Injections, Subcutaneous/psychology , Patient Acceptance of Health Care/statistics & numerical data , Surveys and Questionnaires/standards , Adult , Aged , Aged, 80 and over , Antibodies, Monoclonal, Humanized , Clinical Trials, Phase III as Topic , Cross-Sectional Studies , Factor Analysis, Statistical , Female , Humans , Hypercholesterolemia/blood , Hypercholesterolemia/psychology , Lipoproteins, LDL/blood , Male , Middle Aged , Patient Satisfaction , Psychometrics , Reproducibility of Results , United StatesABSTRACT
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.
Subject(s)
Injections, Subcutaneous/psychology , Patient Preference , Self Administration/psychology , Choice Behavior , Drug Administration Routes , Humans , Injections, Subcutaneous/adverse effects , Injections, Subcutaneous/instrumentation , Perception , Self Administration/adverse effects , Self Administration/instrumentationABSTRACT
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.
Subject(s)
Injections, Subcutaneous/statistics & numerical data , Multiple Sclerosis/drug therapy , Patient Preference/statistics & numerical data , Adult , Choice Behavior , Female , Humans , Injections, Subcutaneous/adverse effects , Injections, Subcutaneous/psychology , Internet , Male , Medication Adherence/psychology , Medication Adherence/statistics & numerical data , Middle Aged , Multiple Sclerosis/psychology , Patient Preference/psychology , Self Administration/methods , Self Administration/psychology , Self Administration/statistics & numerical data , Surveys and Questionnaires , Time Factors , United StatesABSTRACT
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.
Subject(s)
Hypercholesterolemia/drug therapy , Hypolipidemic Agents/administration & dosage , Injections, Subcutaneous/psychology , Quality of Life , Surveys and Questionnaires/standards , Aged , Cardiovascular Diseases/epidemiology , Female , Humans , Hypolipidemic Agents/adverse effects , Male , Middle Aged , Patient Preference , Psychometrics , Qualitative Research , Reproducibility of Results , Risk FactorsSubject(s)
Adaptation, Psychological , Diabetes Mellitus, Type 1/nursing , Diabetes Mellitus, Type 1/psychology , Insulin/administration & dosage , Life Style , Self Care/psychology , Drug Administration Schedule , Humans , Injections, Subcutaneous/nursing , Injections, Subcutaneous/psychology , Male , Medication Adherence/psychology , SwitzerlandABSTRACT
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.
Subject(s)
Anxiety/prevention & control , Cartoons as Topic , Injections, Intramuscular/psychology , Injections, Subcutaneous/psychology , Pain Management/methods , Stress, Psychological/prevention & control , Adult , Child , Fear , Female , Humans , MaleABSTRACT
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.