Using Buzzy, Shotblocker, and Bubble Blowing in a Pediatric Emergency Department to Reduce the Pain and Fear Caused by Intramuscular Injection: A Randomized Controlled Trial.

INTRODUCTION: Procedural pain in general, and intramuscular (IM) injection pain in particular, is one of the most distressing and painful health care experiences for children. Pharmacologic and nonpharmacologic methods are used as forms of pain control for children undergoing acute painful interventions in emergency departments. METHODS: This study was a prospective, randomized controlled trial. The sample consisted of children aged 5 to 10 years old who required IM injections. Children were placed in 4 subgroups through randomization, using a computer program: the Buzzy (MMJ Labs. Atlanta, GA) group (n = 40), the ShotBlocker (Bionix Development Corporation, Toledo, OH) group (n = 40), the bubble-blowing group (n = 40), and the control group (n = 40). Immediately before and after the injection, the children, their parents, and an observer were asked to evaluate the child's level of fear. The Oucher scale was also employed by the observers, children, and parents immediately after the procedure to assess the level of pain in the children in each group. RESULTS: No statistically significant difference was determined between the control and intervention groups in terms gender, age, previous pain experienced with injection, the parent who was with the child, the parent's age. A significant difference was found between the intervention and control groups in terms of levels of pain and fear during IM injection. Pain and fear were notably less in the group of children receiving the Buzzy intervention. DISCUSSION: The Buzzy intervention should be used when children are undergoing IM injections to reduce their levels of pain and fear.

Barriers to initiation of extended release naltrexone among HIV-infected adults with alcohol use disorders.

Alcohol consumption is a major risk factor for the acquisition of HIV/AIDS and is associated with greater disease burden and mortality among those who become HIV-infected. Of the extant pharmacological treatments for alcohol use disorders, naltrexone is recognized as one of the most efficacious, producing robust reductions in alcohol craving and use. Given that treatment with oral naltrexone has been limited by problems with adherence, which are particularly prevalent among individuals with multiple chronic, co-occurring conditions, long-acting formulations may be a promising approach for HIV-infected substance users. However, little is known about the barriers to initiation of extended-release naltrexone (XR-NTX) treatment among alcohol users living with HIV. In this report we present and discuss the content analysis of open-ended survey questions, as well as lessons learned, with regards to barriers to initiation and maintenance of XR-NTX treatment collected as part of an RCT evaluating a cognitive behavioral text messaging intervention for HIV-infected adults with alcohol use disorders. Barriers to initiation and maintenance of XR-NTX pharmacotherapy among HIV+ individuals with alcohol use disorders seem to fall in one of two categories: [1] barriers that are amenable to change, which include distance and transportation issues, fear of injections, and belief that alcohol use does not warrant pharmacotherapy, and [2] barriers that are not amenable to change, such as the potential interaction of XR-NTX with another medication regimen.

Differences in efficiency, satisfaction and adverse events between self-administered intradermal and nurse-administered intramuscular influenza vaccines in hospital workers.

UNLABELLED: Vaccinating healthcare workers against influenza takes tens of thousands of hours of work annually. This study was undertaken to determine the acceptability, success rate, and time to vaccinate healthcare workers in nurse-led groups that self-vaccinated with intradermal influenza vaccine compared with nurse-administered intramuscular vaccine. METHODS: Volunteer hospital workers were randomly assigned to groups that either self-administered intradermal influenza vaccine (Intanza(®)) in a nurse-led group or received nurse-administered intramuscular vaccine (Vaxigrip(®)). Research assistants timed vaccination procedures; pre- and post-injection questionnaires assessed acceptability and reactogenicity. RESULTS: 810 adults, 21-69 years of age, from two study sites were vaccinated: 401 self-administered the intradermal vaccine while 409 received their intramuscular vaccine from a nurse. Of those who self-administered for the first time, 98.5% were successful on their first attempt with an additional 1.5% on their second attempt. Acceptability was high: 96% were very or somewhat certain that they administered the vaccine correctly, 83% would choose intradermal influenza vaccine again and of those, 75% would choose self-administration again, if given the choice. It took 51.3-72.6s per person for the nurses to guide the groups through the self-administration process, which was significantly less time than it took to individually administer the intramuscular vaccines (93.6s). CONCLUSION: Self-administration of intradermal influenza vaccine by people working in healthcare settings is a possible alternative to nurse administered vaccinations, with nurse-led group sessions a good way of teaching the technique while being available to respond to unanticipated problems (NCT01665807).

A randomised controlled trial examining the effectiveness of cartoons as a distraction technique.

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.

Explaining adherence to self-care behaviours amongst adolescents with food allergy: a comparison of the health belief model and the common sense self-regulation model.

OBJECTIVES: To identify explanations for adherence to self-care behaviours amongst adolescents with food allergy-induced anaphylaxis using two social cognition models: the health belief model (HBM) and the common sense self-regulation model (CS-SRM). DESIGN: Cross-sectional self-completion questionnaire study to gain initial evidence of the two models' feasibility/effectiveness in explaining adherence in an adolescent food-allergic population. METHODS: Participants aged 13-19 years with a diagnosis of severe food allergy and a prescription of an adrenaline auto-injector were recruited from hospital outpatients. Adherence to self-care behaviours was measured in addition to constructs from the HBM and CS-SRM. RESULTS: One hundred and eighty-eight food-allergic adolescents completed the questionnaire. The HBM, specifically the constructs perceived severity and barriers, accounted for 21% of the explained variance in adherence behaviours. CS-SRM constructs, illness identity, timeline cyclical beliefs and emotional representations explained 25% of the variance. CONCLUSIONS: Both models performed similarly in explaining adherence to self-care behaviours in adolescents with food allergy. Interventions designed to elicit personal barriers to adherence and to address perceptions of severity and the unpredictable nature of symptoms may be more effective in improving adherence to self-care behaviours than current interventions.

A qualitative study of experiences with and perceptions regarding long-acting injectable antipsychotics: Part I-patient perspectives.

OBJECTIVE: Despite the well-acknowledged problem of poor adherence to antipsychotic (AP) medication, long-acting injectables (LAIs) that could improve adherence are underused in Canada. Attitudes concerning LAIs among patients and psychiatrists may contribute to this underuse. Our objective was to investigate perceptions of and attitudes toward LAIs among patients in Canada. METHOD: Focus groups were conducted with 34 patients with a diagnosis of schizophrenia spectrum psychoses in 4 Canadian provinces. The focus groups inquired about experiences with and attitudes toward LAI APs. The sessions were audiotaped and transcribed verbatim, and transcripts were coded using a combination of deductive and inductive methods. RESULTS: Four themes emerged: awareness of and knowledge about LAIs; perceptions about LAIs; cost and convenience considerations; and issues arising from the coercive context under which LAIs were often prescribed. Nine patients had never heard about LAIs, and some others reported not having understood what was discussed with them regarding LAIs. Patients had typically heard about LAIs in either a context of coercion or of medication nonadherence. Patients had positive and negative perceptions concerning LAIs. The positive perceptions centred on relapse prevention and reduced effort in ensuring adherence, and the negative perceptions centred on financial costs and the inconvenience of appointments to receive injections. CONCLUSION: To enhance LAI usage, some of the issues that need to be addressed are the inadequacy of information given to patients, the element of coercion involved in LAI introduction, the pragmatic barriers to LAI uptake by patients, and negative subjective perceptions about LAIs.

Objectif : Malgré le problème largement reconnu de la mauvaise observance des antipsychotiques (AP), les injectables à action prolongée (IAP) qui pourraient améliorer l'observance sont sous-utilisés au Canada. Les attitudes à l'égard des IAP chez les patients et les psychiatres peuvent contribuer à cette sous-utilisation. Notre objectif était d'enquêter sur les perceptions et les attitudes des patients à l'égard des IAP au Canada. Méthode : Des groupes de discussion ont été formés de 34 patients ayant reçu un diagnostic de psychose du spectre de la schizophrénie dans 4 provinces canadiennes. Les groupes de discussion portaient sur les expériences avec les AP IAP et les attitudes à leur égard. Les séances ont fait l'objet d'un enregistrement sonore et ont été transcrites textuellement, et ces transcriptions ont été codées à l'aide d'une combinaison de méthodes déductives et inductives. Résultats : Quatre thèmes se sont dégagés : conscience et connaissance des IAP; perceptions des IAP; considérations concernant le coût et la commodité; et les questions liées au contexte coercitif dans lequel les IAP sont souvent prescrits. Neuf patients n'avaient jamais entendu parler des IAP, et d'autres ont déclaré ne pas avoir compris lorsqu'on a discuté avec eux des IAP. Les patients avaient habituellement entendu parler des IAP dans un contexte soit de coercition, soit de non-observance des médicaments. Les patients avaient des perceptions positives et négatives à l'égard des IAP. Les perceptions positives étaient axées sur la prévention de la rechute et l'effort réduit pour maintenir l'observance, et les perceptions négatives portaient sur les coûts financiers et la complication des rendez-vous pour recevoir les injections. Conclusion : Afin d'accroître l'utilisation des IAP, il faut aborder certaines questions, notamment l'insuffisance de l'information donnée aux patients, l'élément de coercition présent dans l'instruction aux IAP, les obstacles pratiques à la prise d'IAP par les patients, et les perceptions subjectives négatives à l'égard des IAP.

A qualitative study of experiences with and perceptions regarding long-acting injectable antipsychotics: part II-physician perspectives.

OBJECTIVE: In many countries, including Canada, a small proportion of people with psychotic disorders receive long-acting injectable (LAI) antipsychotics (APs), despite their demonstrated effectiveness and possible advantages for improving adherence rates. Attitudes regarding LAIs among physicians may influence their prescribing practices and thereby contribute to the underuse of LAIs. Here, we report on a qualitative study of perceptions and attitudes toward LAIs among psychiatrists in Canada. METHOD: Focus groups were conducted with 24 psychiatrists in 4 Canadian provinces. The focus groups inquired about experiences with and attitudes toward LAI APs. The sessions were audiotaped and transcribed verbatim, and transcripts were coded using a hybrid process of deductive and inductive methods. A brief pre-focus group questionnaire was administered. RESULTS: The pre-focus group questionnaires indicated that psychiatrists in our study prescribed the oral formulation of APs most of the time and had limited experience with LAIs. The focus groups yielded 4 main themes: limited knowledge about and experience with LAIs; attitudes toward LAIs (beliefs about negative perceptions of patients regarding LAIs, personal bias against needles, and consensus about some advantages of LAIs); prescribing practices around LAIs (generally seen as a last-resort option for patients with a history of nonadherence); and pragmatic barriers to using LAIs (for example, cost, storage, and staffing). CONCLUSION: Several factors may be contributing to the underuse of LAIs and the continuing stigmatized and coercive image of LAIs. Psychiatrists may benefit from better education about LAIs, and from self-examination of their attitudes to LAIs and their prescribing practices.

Objectif : Dans de nombreux pays, dont le Canada, seule une petite proportion de personnes souffrant de troubles psychotiques reçoit des antipsychotiques (AP) injectables à action prolongée (IAP), malgré leur efficacité démontrée et leurs avantages possibles d'améliorer les taux d'observance. Les attitudes des médecins à l'égard des IAP peuvent influencer leurs pratiques de prescription et subséquemment contribuer à la sous-utilisation des IAP. Ici, nous faisons le compte rendu d'une étude qualitative des perceptions et des attitudes à l'égard des IAP chez les médecins du Canada. Méthode : Des groupes de discussion ont été formés de 24 psychiatres dans 4 provinces canadiennes. Les groupes de discussion portaient sur les expériences avec les AP IAP et les attitudes à leur égard. Les séances ont fait l'objet d'un enregistrement sonore et ont été transcrites textuellement, et ces transcriptions ont été codées à l'aide d'une procédure hybride de méthodes déductives et inductives. Un questionnaire abrégé a été administré avant le groupe de discussion. Résultats : Les questionnaires précédant le groupe de discussion ont indiqué que les psychiatres de notre étude prescrivaient la formule orale des AP la plupart du temps, et qu'ils avaient une expérience limitée des IAP. Les groupes de discussion ont dégagé 4 principaux thèmes : une expérience et des connaissances limitées des IAP; les attitudes à l'égard des IAP (croyances que les patients ont des perceptions négatives à l'égard des IAP, préjugés personnels contre les aiguilles, et consensus à propos de certains avantages des IAP); les pratiques de prescription des IAP (généralement vus comme une option de derniers recours pour les patients ayant des antécédents de non-observance); et les obstacles pratiques (par exemple, coût, entreposage, et dotation en personnel) à l'utilisation des IAP. Conclusion : Plusieurs facteurs peuvent contribuer à la sous-utilisation des IAP et à l'image coercitive et stigmatisée des IAP qui se poursuit. Les psychiatres pourraient bénéficier d'une meilleure formation sur les IAP, et d'un auto-examen de leurs attitudes à l'égard des IAP et de leurs pratiques de prescription.

Long-acting injectable antipsychotics: recommendations for clinicians.

A major source of limitation to the real effectiveness of antipsychotics is the high rate of patient nonadherence or, more frequently, partial adherence. Using long-acting injectable (LAI) formulations is likely to reduce the impact of such adherence problems. Conversely, the use of LAIs in Canada remains low relative to many other jurisdictions. Based on effectiveness data from randomized control trials and other, less rigorous, studies, as well as our 2 qualitative studies exploring numerous issues around the use of LAIs, including their low use, we put forward 10 different recommendations for consideration by clinicians. These are also based on the experience of many clinicians and clinician scientists. These recommendations address mostly clinical challenges associated with the use of LAIs. Their application in clinical settings is illustrated in our report through several case examples highlighting the large variation across patients and different phases of illness. It is recommended that LAIs should be considered as a treatment option for psychotic disorders across all phases, including the first 2 to 5 critical years.

Une source importante de limitation de l'efficacité réelle des antipsychotiques est le taux élevé de non-observance ou plus souvent, d'observance partielle des patients. Recourir à des formules injectables à action prolongée (IAP) est susceptible de réduire l'effet de ces problèmes d'observance. À l'inverse, l'utilisation des IAP au Canada demeure faible relativement à de nombreux autres pays. Selon les données d'efficacité tirées d'essais randomisés contrôlés et d'autres études moins rigoureuses, ainsi que de nos 2 études qualitatives explorant de nombreuses questions liées à l'utilisation des IAP, y compris leur faible utilisation, nous présentons 10 différentes recommandations aux fins d'examen par les cliniciens. Celles-ci sont également basées sur l'expérience de nombreux cliniciens et scientifiques cliniciens, et abordent surtout les problèmes cliniques associés à l'utilisation des IAP. Leur application en milieu clinique est illustrée dans notre rapport par plusieurs exemples de cas mettant en évidence la vaste variation entre les patients et les différentes phases de la maladie. Il est recommandé de considérer les IAP comme option de traitement pour toutes les phases des troubles psychotiques, y compris les 2 à 5 premières années cruciales.

Attitudes towards the administration of long-acting antipsychotics: a survey of physicians and nurses.

BACKGROUND: Discontinuation of antipsychotic treatment for schizophrenia can interrupt improvement and exacerbate the illness. Reasons for discontinuing treatment are multifactorial and include adherence, efficacy and tolerability issues. Poor adherence may be addressed through non-pharmacological approaches as well as through pharmacological ones, ie ensured delivery of medication, such as that achieved with long-acting injectable (LAI) antipsychotics. However, attitudes of healthcare professionals (HCPs) towards LAI antipsychotics may influence their prescribing decisions and may influence medication choices offered to patients. We therefore conducted a survey to investigate factors driving LAI use as well as physician and nurse attitudes to LAI antipsychotics and to different injection sites. METHODS: An independent market research agency conducted the survey of HCPs across Europe. Participants were recruited by telephone and completed the survey online. Using conjoint analyses (a multivariate statistical technique analysing preferences on the basis of ranking a limited number of attributes which are presented repetitively), attitudes to oral versus LAI medication and gluteal versus deltoid injection routes were assessed. RESULTS: A total of 891 HCPs across Europe were surveyed. Of these, 40% would choose LAI antipsychotics for first episode patients whereas 90% would select LAI antipsychotics for chronic patients with two to five psychotic episodes. Dominant elements in antipsychotic choice were low sedation but no tardive dyskinesia, no or mild pain at injection and low risk of embarrassment or impact upon therapeutic alliance. Eighty-six per cent of respondents considered that having the choice of a deltoid as well as gluteal administration site was beneficial over not having that choice. Two thirds of respondents said they agreed that medication administration via the deltoid muscle may reduce social embarrassment associated with LAI antipsychotics and most respondents (61%) believed that administration of LAI antipsychotics into the deltoid muscle as opposed to the gluteal muscle may be more respectful to the patient. CONCLUSIONS: In this survey of physicians and nurses, attitudes towards LAI antipsychotics compared with oral medication were generally positive. Respondents considered that the availability of a deltoid administration route would offer increased choice in LAI antipsychotic administration and may be perceived as more respectful and less socially embarrassing.

A model for pain behavior in individuals with intellectual and developmental disabilities.

The dearth of information on the pain experience of individuals with intellectual and developmental disabilities (IDD) calls for a more comprehensive understanding of pain in this population. The Non-Communicating Adults Pain Checklist (NCAPC) is an 18-item behavioral scale that was recently found to be reliable, valid, sensitive and clinically feasible to assess pain levels in adults with IDD. The aim of the present article is to propose and examine a pain model for adults with IDD. The procedure involved videotaping 228 participants (mean age: 38.7 years) before and during an influenza vaccination. The pain model was constructed using previously collected data, by means of confirmatory factor analysis of the sum scores, using the half split procedure. The model was tested on a randomized group of participants (N=89) for generalization. The constructed model seems to reflect two categories of pain responses: a basic response consisting of physiological measures and body reaction, and an advanced response consisting of vocal and emotional reactions, as well as facial and protective expressions. The model presented excellent Goodness of Fit Index (0.99) and an acceptable RMSEA value (0.061). We conclude that the current article presents a first-of-its-kind model of pain behavior in adults with IDD.

Health-related quality of life advantage of long-acting injectable antipsychotic treatment for schizophrenia: a time trade-off study.

BACKGROUND: This study was undertaken to estimate utility values for alternative treatment intervals for long acting antipsychotic intramuscular injections for the treatment of schizophrenia. METHODS: Vignettes were developed using the published literature and an iterative consultation process with expert clinicians and patient representative groups. Four vignettes were developed. The first was a vignette of relapsed/untreated schizophrenia. The other three vignettes presented a standardised picture of well-managed schizophrenia with variations in the intervals between injections: once every 2-weeks, 4-weeks and 3-months. A standardised time trade off (TTO) approach was used to obtain utility values for the vignettes. As a societal perspective was sought, a representative sample of individuals from across the community (Sydney, Australia) was recruited. Ninety-eight people completed the TTO interview. The vignettes were presented in random order to prevent possible ordering effects. RESULTS: A clear pattern of increasing utility was observed with increasing time between injections. Untreated schizophrenia was rated as very poor health-related quality of life with a mean (median) utility of 0.27 (0.20). The treated health states were rated at much higher utilities and were statistically significantly different (p < 0.001) from each other: (1) 2-weekly: mean (median) utility = 0.61 (0.65); (2) 4-weekly: mean (median) utility = 0.65 (0.70); (3) 3-monthly: mean (median) utility = 0.70 (0.75). CONCLUSIONS: This study has provided robust data indicating that approximately a 0.05 utility difference exists between treatment options, with the highest utility assigned to 3-monthly injections.

[Study on how schizophrenic patients perceive treatment with injections in the deltoid muscle]. / Étude sur la perception du traitement injectable dans le muscle deltoïde par les patients souffrant de troubles schizophréniques.

UNLABELLED: Despite the advantages of antipsychotic treatments via the injectable route of administration, there are still reservations regarding this type of therapy, notably among health professionals. A survey conducted with patients suffering from schizophrenic disorders revealed the positive opinion that they had of their treatment. Another survey showed that nearly half of the patients preferred an injectable form, and two thirds felt they were cared for better, because of the injectable treatment. The slow release form of risperidone allows a choice between two injection sites: the deltoid muscle or the gluteal muscle. A recent study showed the satisfaction of the health professionals towards this novel form. The survey presented here was aimed at collecting the opinion of patients regarding the possibility of choosing the injection site, and the changes it would make. OBJECTIVES AND METHODS: The survey was carried out by the BVA Institute during the first half of 2011. The interviews with the schizophrenic patients, followed-up as out patients and treated with long lasting antipsychotics (n=281), were conducted face to face at the hospital by BVA interviewers specialised in the field of health, without the presence of any health professionals. A total of 32 centres participated in the survey; 38% of the interviews took place in the Paris area and 62% in various regions. RESULTS: Different dimensions were analysed. (1) The perception of injectable treatment was largely positive: among all the patients, 75% claimed they currently felt better once they had started the injectable treatment. (2) The choice of the injection site appeared important to a majority of patients (70% of the total sample; 79% of patients had experienced both sites of injection), 56% claimed that it was legitimate that they be given the choice and they felt that they were thus able to participate in their treatment (58%), their treatment was more acceptable (54%), and they found that their relationship with the doctor or nurse was enhanced (53%). (3) The preference regarding the injection site went to the deltoid muscle, among those who had experienced both sites. (4) The perception of the injection sites confirms this preference, the positive qualifications often being associated with the deltoid site, and the negative qualifications with the gluteal site. CONCLUSION: The survey presented here could contribute in convincing the health professionals to propose the choice to patients between the two injection sites in order to improve their compliance to treatment. Patients would therefore play a role in the choice of their treatment and hence become more involved in the follow-up.

The relationship between attitudes towards different containment measures and their usage in a national sample of psychiatric inpatients.

The aims of this report were to explore the relationships between patients' approval of containment measures, their levels of usage and patients' individual experience of each measure. Additionally the psychometric properties of the Attitudes to Containment Measures Questionnaire (ACMQ) were tested. A cross-sectional design was used. The ACMQ was completed by 1361 patients across 136 acute psychiatric wards from three regions in England that participated in the 'City 128' study. Staff on each ward completed the Patient-Staff Conflict Checklist - Shift Report at the end of each shift to log how often each containment measure was used. Frequency of patient reported containment correlated with rates reported by staff. Patients had separate attitudes to each containment measure rather than an attitude towards containment in general. High frequency of coerced intramuscular (IM) medication use was associated with negative attitudes to nearly all types of containment. The ACMQ has good construct validity. In wards where high levels of IM medication are used, all patients have lower approval ratings for a number of other containment measures. This suggests that IM medication has a negative impact not only on those subjected to it but also patients who witness it. Measures to reduce the negative impact of IM medication are discussed.

An open-label, multicenter study to evaluate the safe and effective use of the single-use autoinjector with an Avonex® prefilled syringe in multiple sclerosis subjects.

BACKGROUND: The ability to self-inject in patients with multiple sclerosis (MS) has been associated with a reduced risk of missed injections and drug discontinuation, and a beneficial effect on patients' independence. However, injection anxiety, needle phobia and disease-related disability are major barriers to a patient's ability to self-administer treatment. Use of an autoinjector may improve patients' ability to self-inject. This study evaluated the safe and effective use of Avonex Pen™ (prefilled pen), a single use autoinjector, for intramuscular delivery of interferon beta-1a (IM IFNß-1a, Avonex) in MS patients. METHODS: This was a Phase IIIb, open-label, single-country, multicenter trial in MS patients currently using IM IFNß-1a prefilled syringes. Patients received weekly 30 mcg IM IFNß-1a treatment over 4 weeks. On Day 1, patients self-administered IM IFNß-1a using a prefilled syringe at the clinic. On Day 8, patients received training on the prefilled pen and self-administered IM IFNß-1a using the device. On Day 15, patients self-administered IM IFNß-1a at home using the prefilled pen. A final injection occurred at the clinic on Day 22 when patients self-administered IM IFNß-1a using the prefilled pen while clinic staff observed and completed a detailed questionnaire documenting patients' ability to self-inject with the device. Serum neopterin levels were evaluated pre and post-injection on Days 1 and 8. Adverse events were monitored throughout. RESULTS: Seventy-one (96%) patients completed the study. The overall success rate in safely and effectively using the prefilled pen was 89%. No device malfunctions occurred. One unsuccessful administration occurred at Day 22 due to patient error; no patient injury resulted. Patients gave the prefilled pen high ratings (8.7-9.3) on a 10-point scale for ease of use (0 = extremely difficult, 10 = extremely easy). Ninety-four percent of patients preferred the prefilled pen over the prefilled syringe. Induction of serum neopterin levels, serving as a biomarker for type 1 interferon action, was similar to that of the prefilled syringe. The prefilled pen demonstrated a safety profile comparable to the prefilled syringe. CONCLUSIONS: The prefilled pen is a safe and effective device for administration of IM IFNß-1a and represents an alternative method for self-injection for MS patients using this therapy. TRIAL REGISTRATION: This study is registered at clinicaltrials.gov, identifier: NCT00828204.

Reducing immunization discomfort in 4- to 6-year-old children: a randomized clinical trial.

OBJECTIVE: The goal was to test a multifaceted distraction method designed to reduce injection-associated pain in school-aged children. METHODS: A clinical trial evaluated 41 children, 4 to 6 years of age, who were given 3 standard prekindergarten immunizations; 21 were assigned randomly to an office routine control group, whereas 20 received a multifaceted, discomfort-reducing intervention. The intervention added verbal suggestions of diminished sensation and a visual focusing activity to the use of ethyl chloride, an established pain-reducing measure. The distraction materials used for the intervention consisted of topical ethyl chloride spray, an improvised, plastic, multipronged arm gripper, and a vibrating instrument descending on the contralateral arm, which provided the focusing task and visual distraction. RESULTS: According to patient and parent Faces Pain Scale-Revised scores and nonblinded, video-taped observations scored according to the face-legs-activity-crying-consolability method, the intervention group showed highly significant reductions in pain and discomfort, compared with the control group (patient self-report, P < .0013; parent report, P < .0002; observation score, P < .0001). CONCLUSION: This multifaceted distraction intervention reduced significantly the pain and discomfort of childhood immunizations in children 4 to 6 years of age.

Injection anxiety remains a long-term barrier to medication adherence in multiple sclerosis.

OBJECTIVE: To evaluate the contribution injection anxiety to disease modifying therapy (DMT) adherence among individuals with multiple sclerosis (MS). Injection anxiety has been associated with medication discontinuation early in the course of treatment, but little is known about the relationship between injection anxiety and sustained DMT adherence over time. METHOD: Eighty-nine outpatients receiving care at a Veterans Administration MS clinic completed a telephone survey at baseline and monthly telephone follow-up for 6 months. RESULTS: Participants were established DMT users (M = 3.43 years, SD = 3.29), with relatively high adherence overall (over 80% achieved 80% adherence or greater). Using logistic regression and controlling for demographics, MS disability, type of DMT, and time on DMT, the authors found that baseline injection anxiety predicted lower levels of adherence at 4 months and 6 months, with a similar trend at 2 months. CONCLUSION: Sustained adherence to DMT remains a challenge for a subset of individuals with MS well beyond the initial period of acclimation. Injection anxiety is an important and promising target of psychological intervention during all periods of medication use.

Cortisol response to inoculation in 4-year-old children.

This study examined whether there was a cortisol response to inoculation or if pre-inoculation levels were already elevated due to an anticipatory response to going to the doctors' office. For 4-year-old children, a base saliva sample was obtained in the home on a non-stress day, and a pre-inoculation saliva sample was obtained in the doctors' office prior to the stress. Doctors' office pre-inoculation cortisol was higher than home-based cortisol, suggesting the occurrence of an anticipatory cortisol response to the impending stress. Post-inoculation cortisol levels (+20 min) were comparable to home-based cortisol, indicating that there was no cortisol response to the inoculation itself. While there was no mean increase in cortisol, individual differences in cortisol response existed. Cortisol increases were related to important aspects of child behavioral functioning, including internalizing and externalizing behavior ratings.

A prospective baseline versus on-treatment study assessing patient perceptions of using a smaller needle when injecting intramuscular interferon beta-1 a (Avonex).

This study assessed patient perceptions of using a smaller needle (1-inch, 25-gauge) to administer weekly intramuscular (IM) interferon beta-1 a (IFNbeta-1 a [Avonex]) injections. Patients received 1 IM IFNbeta-1 a injection at baseline using the standard needle (1.25-inch, 23-gauge), followed by 4 weekly injections using the smaller needle. The primary end points were change in self-reported visual analog scale scores for preinjection anxiety and postinjection pain, assessed at baseline and once weekly during the 4 weeks of therapy with the smaller needle. Secondary evaluations included assessment of patient perception of ease of use and fear of self-injection with 2 questionnaires, and changes in the number of injection-site reactions. Patients had a mean decrease of 25 +/- 31 mm (baseline mean, 46 mm; 4-week mean, 21 mm; p = .0002) in anxiety score and a mean decrease of 22 +/- 29 mm (baseline mean, 41 mm; 4-week mean, 19 mm; p = .0003) in pain score. Overall, patients thought the smaller needle was easier to use than the standard needle. Qualitative measurements suggested patients who self-injected IM IFNbeta-1 a experienced less fear when using the smaller needle. Preinjection preparation parameters decreased throughout the course of the treatment period. No patients experienced injection-site reactions with the smaller needle. Patients preferred using a smaller needle to administer their weekly IM IFNbeta-1 a injection.

Adherence to therapy: using an evidence-based protocol.

The number of patients receiving injectable medications has increased significantly during the past few years. Today, patients with hepatitis, rheumatoid arthritis, and multiple sclerosis are added to the list of those, namely diabetics, who have been instructed in self-administration of injectable medications. Currently, some of these medications create significant skin site reactions, and patients tend to discontinue the medications without informing the healthcare provider. Determining the problem and developing a research study that provides evidence to demonstrate methods to help patients adhere to agreed-upon treatment modalities can be accomplished within the clinical practice setting. This study provided a method to decrease skin reactions with interferon 1-b injections for multiple sclerosis patients and has been continued as a method with other like medications.