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1.  Practices and perceptions regarding pain and pain management during routine childhood immunizations: Findings from a focus-group study with nurses working at Toronto Public Health, Ontario 
INTRODUCTION:
Despite the availability of a variety of evidence-based interventions, it has previously been reported that the majority of infants and children undergo vaccine injections without the benefit of analgesia. Nurses in public health administer a substantial number of injections; however, their attitudes and practices surrounding acute pain during vaccine injections have not been previously explored.
METHODS:
A focus-group interview was conducted in Toronto, Ontario, with 10 nurses who immunize children. Participants reported their perceptions and practices with regard to vaccine injection pain and pain management.
RESULTS:
Three key themes emerged: environmental and process factors, perceptions regarding the effectiveness of different analgesic interventions, and perceptions regarding pain and fear. Participants reported a lack of control over their environment, resulting in fear and discomfort for children. They recommended increased support from external partners such as school teachers and administrators. Participants reported that pharmacological interventions, such as topical local anesthetics, were not used; however, psychological and physical interventions were commonly used. Nurses questioned the effectiveness of topical anesthetics, and indicated that more education was required regarding effective analgesic interventions. Needle pain was reported to be the most prominent concern for children undergoing vaccine injections, and children were described as being fearful.
DISCUSSION:
Nurses reported vaccination setting, analgesic effectiveness and relative importance given to pain as important factors for pain and pain management during vaccine injections. Future studies should explore whether additional perspectives are present in vaccinators in other geographical regions. The effectiveness of educational resources and pain management programs aimed at improving current practices should be investigated.
PMCID: PMC3142592  PMID: 22654924
Immunization; Infants/children nurses; Pain management
2.  From the mouth of babes: Getting vaccinated doesn’t have to hurt 
BACKGROUND:
Analgesic interventions are not commonly administered during childhood vaccination, despite the fact that two-thirds of children are afraid of needles and one-tenth are noncompliant with immunization.
OBJECTIVE:
To explore children’s experiences of vaccination and preferences for analgesia.
METHODS:
A total of 17 children (four to 14 years of age) at an independent school in Toronto (Ontario) participated in three focus-group interviews. The majority had previous experience with pain management interventions during vaccination. Thematic content analysis was used to analyze interview transcripts.
RESULTS:
The findings were categorized into three main themes: experience of vaccination; roles and responsibilities regarding pain management; and impact of pain management. Children easily recalled previous vaccinations and discussed fear and distress experienced by themselves and others. Children believed that parents and immunizers should prepare them ahead of time and use interventions to manage and monitor pain. They also wanted adults to support their efforts to lead pain management. Children discussed benefits of managing pain, including reduced unnecessary suffering, improved vaccination experience, reduced risk of developing needle fears and reduced noncompliant behaviours. They were knowledgeable about strategies for reducing pain including distraction, topical anesthetics and injection techniques. They contrasted vaccination with and without pain management, and indicated a preference for pain management.
CONCLUSION:
Children reported that managing vaccination pain is important and that analgesic interventions should routinely be used. Incorporating pain management in the process of vaccination has the potential to improve children’s experiences with vaccination and promote more positive attitudes and behaviours.
PMCID: PMC4173939  PMID: 25285123
Children; Pain management; School-based immunization clinics; Vaccination
3.  Pain prevalence in a pediatric hospital: Raising awareness during Pain Awareness Week 
BACKGROUND:
Despite the evidence and availability of numerous validated pain assessment tools and pain management strategies for infants and children, their use remains inconsistent in clinical practice.
OBJECTIVES:
To describe the prevalence of pain, pain assessment and pain management practices at a tertiary pediatric hospital in Canada.
METHODS:
The cross-sectional study design involved a combination of interviews with children and/or caregivers, and chart audits in five inpatient units. Information regarding pain intensity, painful procedures and pain management strategies was obtained from children and/or caregivers by interview. Patient charts were reviewed for information regarding pain assessment, pain scores, and pharmacological and nonpharmacological interventions.
RESULTS:
Sixty-two children (four days to 17 years of age) participated. Most children or their caregivers (n=51 [84%]) reported that pain was experienced during their hospitalization, with 40 (66%) reporting their worst pain as moderate or severe. Almost one-half reported analgesics were administered before or during their most recent painful procedure. Nineteen (32%) reported sucrose, topical anesthetics or nonpharmacological interventions were used; however, they were documented in only 17% of charts. Pain scores were documented in 34 (55%) charts in the previous 24 h. The majority of the children or their caregiver (n=44 [71%]) were satisfied with pain management at the study hospital.
CONCLUSIONS:
Most infants and children had experienced moderate or severe pain during their hospitalization. Analgesics were frequently used, and although nonpharmacological strategies were reported to be used, they were rarely documented. Most parents and children were satisfied with their pain management.
PMCID: PMC3938348  PMID: 24422206
Children; Infants; Pain; Pain assessment; Pain management
4.  Assessment and Treatment of Pain during Treatment of Buruli Ulcer 
PLoS Neglected Tropical Diseases  2015;9(9):e0004076.
Background
Buruli ulcer (BU) is described as a relatively painless condition; however clinical observations reveal that patients do experience pain during their treatment. Knowledge on current pain assessment and treatment in BU is necessary to develop and implement a future guideline on pain management in BU.
Methodology
A mixed methods approach was used, consisting of information retrieved from medical records on prescribed pain medication from Ghana and Benin, and semi-structured interviews with health care personnel (HCP) from Ghana on pain perceptions, assessment and treatment. Medical records (n = 149) of patients treated between 2008 and 2012 were collected between November 2012 and August 2013. Interviews (n = 11) were audio-taped, transcribed verbatim and qualitatively analyzed.
Principal Findings
In 113 (84%) of the 135 included records, pain medication, mostly simple analgesics, was prescribed. In 48% of the prescriptions, an indication was not documented. HCP reported that advanced BU could be painful, especially after wound care and after a skin graft. They reported not be trained in the assessment of mild pain. Pain recognition was perceived as difficult, as patients were said to suppress or to exaggerate pain, and to have different expectations regarding acceptable pain levels. HCP reported a fear of side effects of pain medication, shortage and irregularities in the supply of pain medication, and time constraints among medical doctors for pain management.
Conclusions
Professionals perceived BU disease as potentially painful, and predominantly focused on severe pain. Our study suggests that pain in BU deserves attention and should be integrated in current treatment.
Author Summary
Buruli ulcer (BU) is considered relatively painless. Nevertheless, observations suggested that patients experience pain during wound care dressings. This study explored views on pain, along with pain assessment and treatment practices. Medical records were reviewed on prescribed pain medication and health care professionals involved in BU treatment were invited for an interview to elicit their views on pain including current pain practices. Interviews were held in private locations, audio-taped, and analyzed qualitatively. In the majority of medical records, pain medication was prescribed. Mostly simple analgesics were prescribed, while health care professionals reported not being trained in the assessment of mild pain, and indications were often missing. Health care professionals indicated advanced BU might be painful, and that pain can increase after wound treatment, and after a skin graft at the donor site. They perceive the recognition of pain as difficult as patients suppress or exaggerate pain, and have different expectations regarding acceptable pain levels. Finally, they indicated a fear of side effects of pain medication, a shortage of, and irregularities in supply of pain medication, and limited time among medical doctors for pain management. These findings indicate pain during BU disease deserves attention and pain practices should be integrated in standard treatment.
doi:10.1371/journal.pntd.0004076
PMCID: PMC4581868  PMID: 26402069
5.  Too many crying babies: a systematic review of pain management practices during immunizations on YouTube 
BMC Pediatrics  2014;14:134.
Background
Early childhood immunizations, although vital for preventative health, are painful and too often lead to fear of needles. Effective pain management strategies during infant immunizations include breastfeeding, sweet solutions, and upright front-to-front holding. However, it is unknown how often these strategies are used in clinical practice. We aimed to review the content of YouTube videos showing infants being immunized to ascertain parents’ and health care professionals’ use of pain management strategies, as well as to assess infants’ pain and distress.
Methods
A systematic review of YouTube videos showing intramuscular injections in infants less than 12 months was completed using the search terms "baby injection" and "baby vaccine" to assess (1) the use of pain management strategies and (2) infant pain and distress. Pain was assessed by crying duration and pain scores using the FLACC (Face, Legs, Activity, Cry, Consolability) tool.
Results
A total of 142 videos were included and coded by two trained individual viewers. Most infants received one injection (range of one to six). Almost all (94%) infants cried before or during the injections for a median of 33 seconds (IQR = 39), up to 146 seconds. FLACC scores during the immunizations were high, with a median of 10 (IQR = 3). No videos showed breastfeeding or the use of sucrose/sweet solutions during the injection(s), and only four (3%) videos showed the infants being held in a front-to-front position during the injections. Distraction using talking or singing was the most commonly used (66%) pain management strategy.
Conclusions
YouTube videos of infants being immunized showed that infants were highly distressed during the procedures. There was no use of breastfeeding or sweet solutions and limited use of upright or front-to-front holding during the injections. This systematic review will be used as a baseline to evaluate the impact of future knowledge translation interventions using YouTube to improve pain management practices for infant immunizations.
doi:10.1186/1471-2431-14-134
PMCID: PMC4049389  PMID: 24885559
YouTube; Infant; Immunization; Pain
6.  A Novel Tool for the Assessment of Pain: Validation in Low Back Pain 
PLoS Medicine  2009;6(4):e1000047.
Joachim Scholz and colleagues develop and validate an assessment tool that distinguishes between radicular and axial low back pain.
Background
Adequate pain assessment is critical for evaluating the efficacy of analgesic treatment in clinical practice and during the development of new therapies. Yet the currently used scores of global pain intensity fail to reflect the diversity of pain manifestations and the complexity of underlying biological mechanisms. We have developed a tool for a standardized assessment of pain-related symptoms and signs that differentiates pain phenotypes independent of etiology.
Methods and Findings
Using a structured interview (16 questions) and a standardized bedside examination (23 tests), we prospectively assessed symptoms and signs in 130 patients with peripheral neuropathic pain caused by diabetic polyneuropathy, postherpetic neuralgia, or radicular low back pain (LBP), and in 57 patients with non-neuropathic (axial) LBP. A hierarchical cluster analysis revealed distinct association patterns of symptoms and signs (pain subtypes) that characterized six subgroups of patients with neuropathic pain and two subgroups of patients with non-neuropathic pain. Using a classification tree analysis, we identified the most discriminatory assessment items for the identification of pain subtypes. We combined these six interview questions and ten physical tests in a pain assessment tool that we named Standardized Evaluation of Pain (StEP). We validated StEP for the distinction between radicular and axial LBP in an independent group of 137 patients. StEP identified patients with radicular pain with high sensitivity (92%; 95% confidence interval [CI] 83%–97%) and specificity (97%; 95% CI 89%–100%). The diagnostic accuracy of StEP exceeded that of a dedicated screening tool for neuropathic pain and spinal magnetic resonance imaging. In addition, we were able to reproduce subtypes of radicular and axial LBP, underscoring the utility of StEP for discerning distinct constellations of symptoms and signs.
Conclusions
We present a novel method of identifying pain subtypes that we believe reflect underlying pain mechanisms. We demonstrate that this new approach to pain assessment helps separate radicular from axial back pain. Beyond diagnostic utility, a standardized differentiation of pain subtypes that is independent of disease etiology may offer a unique opportunity to improve targeted analgesic treatment.
Editors' Summary
Background
Pain, although unpleasant, is essential for survival. Whenever the body is damaged, nerve cells detecting the injury send an electrical message via the spinal cord to the brain and, as a result, action is taken to prevent further damage. Usually pain is short-lived, but sometimes it continues for weeks, months, or years. Long-lasting (chronic) pain can be caused by an ongoing, often inflammatory condition (for example, arthritis) or by damage to the nervous system itself—experts call this “neuropathic” pain. Damage to the brain or spinal cord causes central neuropathic pain; damage to the nerves that convey information from distant parts of the body to the spinal cord causes peripheral neuropathic pain. One example of peripheral neuropathic pain is “radicular” low back pain (also called sciatica). This is pain that radiates from the back into the legs. By contrast, axial back pain (the most common type of low back pain) is confined to the lower back and is non-neuropathic.
Why Was This Study Done?
Chronic pain is very common—nearly 10% of American adults have frequent back pain, for example—and there are many treatments for it, including rest, regulated exercise (physical therapy), pain-killing drugs (analgesics), and surgery. However, the best treatment for any individual depends on the exact nature of their pain, so it is important to assess their pain carefully before starting treatment. This is usually done by scoring overall pain intensity, but this assessment does not reflect the characteristics of the pain (for example, whether it occurs spontaneously or in response to external stimuli) or the complex biological processes involved in pain generation. An assessment designed to take such factors into account might improve treatment outcomes and could be useful in the development of new therapies. In this study, the researchers develop and test a new, standardized tool for the assessment of chronic pain that, by examining many symptoms and signs, aims to distinguish between pain subtypes.
What Did the Researchers Do and Find?
One hundred thirty patients with several types of peripheral neuropathic pain and 57 patients with non-neuropathic (axial) low back pain completed a structured interview of 16 questions and a standardized bedside examination of 23 tests. Patients were asked, for example, to choose words that described their pain from a list provided by the researchers and to grade the intensity of particular aspects of their pain from zero (no pain) to ten (the maximum imaginable pain). Bedside tests included measurements of responses to light touch, pinprick, and vibration—chronic pain often alters responses to harmless stimuli. Using “hierarchical cluster analysis,” the researchers identified six subgroups of patients with neuropathic pain and two subgroups of patients with non-neuropathic pain based on the patterns of symptoms and signs revealed by the interviews and physical tests. They then used “classification tree analysis” to identify the six questions and ten physical tests that discriminated best between pain subtypes and combined these items into a tool for a Standardized Evaluation of Pain (StEP). Finally, the researchers asked whether StEP, which took 10–15 minutes, could identify patients with radicular back pain and discriminate them from those with axial back pain in an independent group of 137 patients with chronic low back pain. StEP, they report, accurately diagnosed these two conditions and was well accepted by the patients.
What Do These Findings Mean?
These findings indicate that a standardized assessment of pain-related signs and symptoms can provide a simple, quick diagnostic procedure that distinguishes between radicular (neuropathic) and axial (non-neuropathic) low back pain. This distinction is crucial because these types of back pain are best treated in different ways. In addition, the findings suggest that it might be possible to identify additional pain subtypes using StEP. Because these subtypes may represent conditions in which different pain mechanisms are acting, classifying patients in this way might eventually enable physicians to tailor treatments for chronic pain to the specific needs of individual patients rather than, as at present, largely guessing which of the available treatments is likely to work best.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000047.
This study is further discussed in a PLoS Medicine Perspective by Giorgio Cruccu and and Andrea Truini
The US National Institute of Neurological Disorders and Stroke provides a primer on pain in English and Spanish
In its 2006 report on the health status of the US, the National Center for Health Statistics provides a special feature on the epidemiology of pain, including back pain
The Pain Treatment Topics Web site is a resource, sponsored partly by associations and manufacturers, that provides information on all aspects of pain and its treatment for health care professionals and their patients
Medline Plus provides a brief description of pain and of back pain and links to further information on both topics (in English and Spanish)
The MedlinePlus Medical Encyclopedia also has a page on low back pain (in English and Spanish)
doi:10.1371/journal.pmed.1000047
PMCID: PMC2661253  PMID: 19360087
7.  Implementation of a new clinical practice guideline regarding pain management during childhood vaccine injections 
Paediatrics & Child Health  2013;18(7):367-372.
OBJECTIVE:
To determine the impact of a multifaceted knowledge translation strategy for a new vaccination pain management guideline on public health immunizers’ attitudes, beliefs and use of pain-relieving strategies during childhood vaccination.
METHOD:
Using a randomized controlled pre-post study design, public health nurses (PHNs) at intervention sites received a multifaceted knowledge translation intervention about new pain management guidelines incorporated in the British Columbia Immunization Program Manual, including education, supplies and online support. Attitudes and beliefs of PHNs toward immunization pain and pain management, and use of pain-relieving strategies were compared for the intervention sites between the pre- and postimplementation phases.
RESULTS:
A total of 516 children were immunized by 31 PHNs pre- and postimplementation in the intervention sites. Postimplementation, satisfaction and confidence with ability to manage pain and willingness to use newly recommended strategies were significantly more positive (P<0.05) in the intervention sites, and overall use of at least one newly recommended strategy increased from 49.8% preintervention to 77.6% postimplementation (P<0.001).
CONCLUSION:
The knowledge translation intervention improved PHN immunizers’ attitudes, beliefs and practices regarding paediatric vaccination pain management. Reducing pain may result in a better immunization experience for children, caregivers and immunizers.
PMCID: PMC3804637  PMID: 24421712
Clinical practice guideline; Immunization; Knowledge translation; Pain management; Public health nursing
8.  The effect of physician’s recommendation on seasonal influenza immunization in children with chronic diseases 
BMC Public Health  2012;12:984.
Background
Despite recommendations by Health Authorities, influenza immunization coverage remains low in children with chronic diseases. Different medical providers involved in the management of children with chronic conditions may affect the pattern of influenza vaccine recommendations and coverage. The likelihood of vaccination by type of provider in children with chronic conditions is poorly understood. Therefore, the objectives of this study were to analyze the pattern and the effect of recommendations for seasonal influenza immunization provided by different physician profiles to families of children with chronic diseases and to measure the frequency of immunization in the study population.
Methods
We recruited children with chronic diseases aged 6 months–18 years who subsequently presented to specialty clinics for routine follow-up visits, during spring 2009, in three Italian Regions Families of children with chronic diseases were interviewed during routine visits at reference centers through a face-to-face interview. We analyzed the following immunization predictors: having received a recommendation toward influenza immunization by a health provider; child’s sex and age; mothers and fathers’ age; parental education and employment; underlying child’s disease; number of contacts with health providers in the previous year. Influenza immunization coverage was calculated as the proportion of children who received at least one dose of seasonal influenza vaccine in the previous season. We calculated prevalence ratios and we used a generalized linear model with Poisson family, log link and robust error variance to assess the effect of socio-demographic variables, underlying diseases, and recommendations provided by physicians on influenza immunization.
Results
We enrolled 275 families of children with chronic diseases. Overall influenza coverage was 57.5%, with a low of 25% in children with neurological diseases and a high of 91.2% in those with cystic fibrosis. While 10.6% of children who did not receive any recommendation toward influenza immunization were immunized, among those who received a recommendation 87.5-94.7% did, depending on the health professional providing the recommendation. Receiving a recommendation by any provider is a strong predictor of immunization (PR = 8.5 95% CI 4.6;15.6) Most children received an immunization recommendation by a specialty (25.8%) or a family pediatrician (23.3%) and were immunized by a family pediatrician (58.7%) or a community vaccinator (55.2%).
Conclusions
Receiving a specific recommendation by a physician is a strong determinant of being immunized against seasonal influenza in children with chronic diseases independently of other factors. Heterogeneity exists among children with different chronic diseases regarding influenza recommendation despite international guidelines. Increasing the frequency of appropriate recommendations toward influenza immunization by physicians is a single powerful intervention that may increase coverage in children with chronic conditions.
doi:10.1186/1471-2458-12-984
PMCID: PMC3585468  PMID: 23153092
Influenza; Immunization; Chronic disease; Children; Physicians; Recommendations
9.  Knowledge translation of the HELPinKIDS clinical practice guideline for managing childhood vaccination pain: usability and knowledge uptake of educational materials directed to new parents 
BMC Pediatrics  2013;13:23.
Background
Although numerous evidence-based and feasible interventions are available to treat pain from childhood vaccine injections, evidence indicates that children are not benefitting from this knowledge. Unrelieved vaccination pain puts children at risk for significant long-term harms including the development of needle fears and subsequent health care avoidance behaviours. Parents report that while they want to mitigate vaccination pain in their children, they lack knowledge about how to do so. An evidence-based clinical practice guideline for managing vaccination pain was recently developed in order to address this knowledge-to-care gap. Educational tools (pamphlet and video) for parents were included to facilitate knowledge transfer at the point of care. The objectives of this study were to evaluate usability and effectiveness in terms of knowledge acquisition from the pamphlet and video in parents of newly born infants.
Methods
Mixed methods design. Following heuristic usability evaluation of the pamphlet and video, parents of newborn infants reviewed revised versions of both tools and participated in individual and group interviews and individual knowledge testing. The knowledge test comprised of 10 true/false questions about the effectiveness of various pain management interventions, and was administered at three time points: at baseline, after review of the pamphlet, and after review of the video.
Results
Three overarching themes were identified from the interviews regarding usability of these educational tools: receptivity to learning, accessibility to information, and validity of information. Parents’ performance on the knowledge test improved (p≤0.001) from the baseline phase to after review of the pamphlet, and again from the pamphlet review phase to after review of the video.
Conclusions
Using a robust testing process, we demonstrated usability and conceptual knowledge acquisition from a parent-directed educational pamphlet and video about management of vaccination pain. Future studies are planned to determine the impact of these educational tools when introduced in clinical settings on parent behaviors during infant vaccinations.
doi:10.1186/1471-2431-13-23
PMCID: PMC3585914  PMID: 23394070
Vaccination; Pain management; Infant/child; Health information; Knowledge translation; Implementation; Parent education
10.  Prevalence of Using Complementary and Alternative Medicine in Children and Its Related Factors in East Iran 
Iranian Journal of Pediatrics  2013;24(1):111-114.
Objective: Recently application of complementary and alternative medicine (CAM) is increasing in children worldwide. The present study was conducted to determine the prevalence, related factors, types, the sources of information and knowledge of mothers for the possible side effects.
Methods: This descriptive and analytical study carried out within three months from April-June 2012 through oral interviews and questionnaires with 300 mothers of children referred to pediatric clinic in Vali-Asr Hospital, Birjand (center of South Khorasan province: East of Iran).
Findings : 35.6% of mothers had used CAM as medication at least once for their children during the last year. There was a significant and direct correlation between using CAM for children with increased maternal age, decreased level of mother’s education, mother being as a housewife and having more than two children. Most (93.3%) common treatments included medicinal herbs, oil rub (26.6 %) and prayer therapy (25.7%). Relative (72%) and neighbors (50%) were the most sources for mother’s information while physicians consist only 2% of the information source. Only 1.3% of mothers knew that CAM may also exert some side effects.
Conclusion: Considering the fact that about one third of mothers used CAM modalities, physicians were the least maternal source of CAM information, nearly all mothers were unaware of the side effects of CAM It is recommended that physicians should learn about the CAM to enable them for providing information to parents regarding its benefits and disadvantages. It is also highly recommended to enhance community knowledge about the proper use of different kinds of CAM.
PMCID: PMC4359593  PMID: 25793055
Complementary Medicine; Alternative Medicine; Unconventional Therapy; Children
11.  Attitudes and concerns of Canadian animal health technologists toward postoperative pain management in dogs and cats. 
The Canadian Veterinary Journal  1998;39(8):491-496.
Three hundred and twenty-two Canadian animal health technologists (AHTs) were surveyed to determine their attitudes toward postoperative pain management in dogs and cats following 6 surgical procedures, their concerns regarding the use of opioid analgesics, and their role within veterinary practices with respect to postoperative pain control. Two hundred and sixty-four (82%) returned the questionnaire. Pain perception was defined as the average of pain rankings for dogs and cats (on a scale of 1 to 10) following abdominal surgery, or the value for dogs or cats if the AHT worked with only 1 of the 2 species. Maximum concern about the risks associated with the postoperative use of morphine or oxymorphone was defined as the highest rating assigned to any of the 6 risks evaluated in either dogs or cats. Animal health technologists reported significantly higher pain perception scores than did veterinarians who completed a similar survey 2 years previously. Higher pain perception scores were associated with decreased satisfaction with the adequacy of analgesic therapy in their practice, higher pain control goals, and attendance at continuing education within the previous 12 months. The majority of AHTs (55%) agreed that one or more risks associated with the use of morphine or oxymorphone outweighed the benefits. The 3 issues that were perceived to pose the greatest risk were respiratory depression, bradycardia, and sedation and excitement, for dogs and cats, respectively. Most AHTs (68%) considered their knowledge related to the recognition and control of pain to be adequate, compared with 24% of veterinarians who responded to a similar previous survey. As for veterinarians, experience gained while in practice was ranked as the most important source of knowledge, while the technical program attended was ranked as least important. Over 88% of the AHTs provided nursing care during the postoperative period, monitored animals for side effects of postoperative analgesic therapy, informed veterinarians when animals were in pain, recommended analgesic therapy when they believed it was warranted, reported that animals received analgesics when they believed it was warranted, administered analgesics under the instruction of a veterinarian, and believed they were part of a team working to provide adequate postoperative pain control.
PMCID: PMC1539404  PMID: 9711387
12.  Pain in hospitalized children: A prospective cross-sectional survey of pain prevalence, intensity, assessment and management in a Canadian pediatric teaching hospital 
BACKGROUND:
Pain is under-recognised and undertreated. Although standards now exist for pain management, it is not known if this has improved care of hospitalized children.
OBJECTIVES:
To benchmark pain prevalence, pain intensity, pain assessment documentation and pharmacological treatment of pain. The aim was to highlight areas of good practice, identify areas for improvement and inform development of hospital standards, education, future audits and the research agenda.
METHODS:
The present prospective cross-sectional survey of all medical and surgical inpatient units took place on a single day at the Hospital for Sick Children (Toronto, Ontario), a Canadian tertiary and quaternary pediatric hospital. A structured, verbally administered questionnaire was used to obtain information on patient demographics, pain before admission, pain intensity during admission and pain treatment. Charts were reviewed to establish frequency of documented pain assessment, the pain assessment tool used and analgesics given. Subgroup analysis was included for age, sex, visible minority or fluency in English, medical versus surgical services and acute pain service input.
RESULTS AND CONCLUSIONS:
Two hundred forty-one (83%) of the 290 inpatients or their carergivers were interviewed. It was found that 27% of patients usually had pain before admission, and 77% experienced pain during admission. Of these, 23% had moderate or severe pain at interview and 64% had moderate or severe pain sometime in the previous 24 h. Analgesics were largely intermittent and single-agent, although 90% of patients found these helpful. Fifty-eight per cent of those with pain received analgesics in the preceding 24 h but only 25% received regular analgesia. Only 27% of children had any pain score documented in the preceding 24 h. It was concluded that pain was infrequently assessed, yet occurred commonly across all age groups and services and was often moderate or severe. Although effective, analgesic therapy was largely single-agent and intermittent. Widespread dissemination of results to all professional groups has resulted in the development of a continuous quality assurance program for pain at the Hospital for Sick Children. A re-audit is planned to evaluate changes resulting from the new comprehensive pain strategies.
PMCID: PMC2670807  PMID: 18301813
Inpatient pain; Pain assessment; Pain intensity; Pain management; Pain prevalence; Pediatric pain
13.  Autologous Growth Factor Injections in Chronic Tendinopathy 
Journal of Athletic Training  2014;49(3):428-430.
Reference:
de Vos RJ, van Veldhoven PLJ, Moen MH, Weir A, Tol JL. Autologous growth factor injections in chronic tendinopathy: a systematic review. Br Med Bull. 2010;95:63–77.
Clinical Question:
The authors of this systematic review evaluated the literature to critically consider the effects of growth factors delivered through autologous whole-blood and platelet-rich–plasma (PRP) injections in managing wrist-flexor and -extensor tendinopathies, plantar fasciopathy, and patellar tendinopathy. The primary question was, according to the published literature, is there sufficient evidence to support the use of growth factors delivered through autologous whole-blood and PRP injections for chronic tendinopathy?
Data Sources:
The authors performed a comprehensive, systematic literature search in October 2009 using PubMed, MEDLINE, EMBASE, CINAHL, and the Cochrane library without time limits. The following key words were used in different combinations: tendinopathy, tendinosis, tendinitis, tendons, tennis elbow, plantar fasciitis, platelet rich plasma, platelet transfusion, and autologous blood or injection. The search was limited to human studies in English. All bibliographies from the initial literature search were also viewed to identify additional relevant studies.
Study Selection:
Studies were eligible based on the following criteria: (1) Articles were suitable (inclusion criteria) if the participants had been clinically diagnosed as having chronic tendinopathy; (2) the design had to be a prospective clinical study, randomized controlled trial, nonrandomized clinical trial, or prospective case series; (3) a well-described intervention in the form of a growth factor injection with either PRP or autologous whole blood was used; and (4) the outcome was reported in terms of pain or function (or both).
Data Extraction:
All titles and abstracts were assessed by 2 researchers, and all relevant articles were obtained. Two researchers independently read the full text of each article to determine if it met the inclusion criteria. If opinions differed on suitability, a third reviewer was consulted to reach consensus. The data extracted included number of participants, study design, inclusion criteria, intervention, control group, primary outcome measures (pain using a visual analog or ordinal scale or function), time of follow-up, and outcomes for intervention and control group (percentage improvement) using a standardized data-extraction form. Function was evaluated in 9 of the 11 studies using (1) the Nirschl scale (elbow function) or the modified Mayo score for wrist flexors and extensors, (2) the Victorian Institute of Sports Assessment-Patella score, a validated outcome measure for patellar tendinopathy, or the Tegner score for patellar tendinopathy, and (3) the rearfoot score from the American Orthopaedic Foot and Ankle Scale for plantar fasciopathy.
The Physiotherapy Evidence Database (PEDro) scale contains 11 items; items 2–11 receive 1 point each for a yes response. Reliability is sufficient (0.68) for the PEDro scale to be used to assess physiotherapy trials. A score of 6 or higher on the PEDro scale is considered a high-quality study; below 6 is considered a low-quality study. The PEDro score results determined the quality of the randomized controlled trial (RCT), nonrandomized clinical trial, or prospective case series (≥6 or <6). A qualitative analysis was used with 5 levels of evidence (strong, moderate, limited, conflicting, or no evidence) to determine recommendations for the use of the intervention. The number of high-quality or low-quality RCT or nonrandomized clinical trial studies with consistent or inconsistent results determined the level of evidence (1–5).
Main Results:
Using the specific search criteria, the authors identified 418 potential sources. After screening of the title or abstract (or both), they excluded 405 sources, which left 13 studies. After viewing the full text, they excluded 2 additional sources (a case report and a study in which the outcome measure was remission of symptoms and not pain or function), leaving 11 studies for analysis. Six of the 11 studies were characterized by an observational, noncontrolled design; the remaining 5 studies were controlled clinical trials, 2 of which had proper randomization.
The mean number of participants included in the studies was 40.5 (range = 20 to 100). Three of the studies were on “tennis elbow,” 1 on “golfer's elbow,” 1 on wrist extensor or flexor tendinopathy, 3 on plantar fasciopathy, and 3 on chronic patellar tendinopathy. Based on the information reported, there was no standardization of frequency or method of growth factor injection treatment or of preparation of the volume, and an optimal mixture was not described. Autologous whole-blood injections were used in 8 studies; in 5 studies, the autologous whole-blood injection was combined with a local anesthetic. In contrast, a local anesthetic was used in only 1 of the 3 PRP injection studies. The authors of the other 2 studies did not report whether a local anesthetic was used. The number of autologous whole-blood and PRP injections varied, ranging from 1 to 3. The centrifuging process was single or double for the PRP injections. In 2 studies, calcium was added to activate the platelets. A visual analogue or ordinal pain scale was used in 10 of the 11 studies. Function was evaluated in 9 of the 11 studies using (1) the Nirschl scale in 4 elbow studies or the modified Mayo score at baseline in 1 elbow study, (2) the Victorian Institute of Sports Assessment-Patella score for 1 study and the Tegner score for 2 of the patellar tendinopathy studies, and (3) the rearfoot score of the American Orthopaedic Foot and Ankle Scale for 1 plantar fasciopathy study. Only 1 study used an appropriate, disease-specific, validated tendinopathy measure (Victorian Institute of Sports Assessment-Patella).
All intervention groups reported a significant improvement in pain or function score (or both), with a mean improvement of 66% over a mean follow-up of 9.4 months. The control groups in these studies also showed a mean improvement of 57%. None of the pain benefits among the intervention groups were greater than those for the control group at final follow-up. In 4 of the studies, the control group and the autologous growth factor injection group had similar results in pain or function or both, whereas in 2 studies, the control group had greater relief in pain than the injection group.
Eleven studies were assessed using the PEDro scale. The PEDro scores for these studies ranged from 1 to 7, with an average score of 3.4. Only 3 studies had PEDro scores of ≥6 and were considered high quality. The 3 high-quality plantar fasciopathy studies used autologous growth factor injections but did not show a significant improvement over the control group. One of the studies that showed no beneficial effect for the autologous growth factor injections was compared with corticosteroids. Compared with other treatments, level 1 (strong) evidence demonstrated that autologous growth factor injections did not improve pain or function in plantar fasciopathy. The PRP injection results were based on 3 low-quality studies, 2 for the patellar tendon and 1 for the wrist flexors-extensors; level 3 (limited) evidence suggests that PRP injections improve pain or function.
Conclusions:
Strong evidence indicates that autologous growth factor injections do not improve plantar fasciopathy pain or function when combined with anesthetic agents or when compared with corticosteroid injections, dry needling, or exercise therapy treatments. Furthermore, limited evidence suggests that PRP injections are beneficial. Except for 2 high-quality RCT studies, the rest were methodologically flawed. Additional studies should be conducted using proper control groups, randomization, blinding, and validated disability outcome measures for pain and function. Until then, the results remain speculative because autologous whole-blood and PRP injection treatments are not standardized.
doi:10.4085/1062-6050-49.3.06
PMCID: PMC4080590  PMID: 24840581
tendon injuries; platelet-rich plasma; injection therapy
14.  The Treatment of Cutaneous Abscesses: Comparison of Emergency Medicine Providers’ Practice Patterns 
Introduction
Cutaneous abscesses are commonly treated in the emergency department (ED). Although incision and drainage (I&D) remains the standard treatment, there is little high-quality evidence to support additional interventions such as pain control, type of incision, and use of irrigation, wound cultures, and packing. Although guidelines exist to support clinician management of abscesses, they do not clearly specify these additional interventions. This study sought to describe the ED treatments administered to adults with uncomplicated superficial cutaneous abscesses, defined as purulent lesions requiring incision and drainage that could be managed in an ED or outpatient setting.
Methods:
Four hundred and seventy-four surveys were distributed to 15 EDs across the United States. Participants were queried about their level of training and practice environment as well as specific questions regarding their management of cutaneous abscesses in the ED.
Results:
In total, 350 providers responded to the survey (74%). One hundred eighty-nine respondents (54%) were attending physicians, 135 (39%) were residents, and 26 (7%) were midlevel providers. Most providers (76%) used narcotics for pain management, 71% used local anesthetic over the roof of the abscess, and 60% used local anesthetic in a field block for pain control. More than 48% of responders routinely used irrigation after (I&D). Eighty-five percent of responders used a linear incision to drain the abscess and 91% used packing in the wound cavity. Thirty-two percent routinely sent wound cultures and 17% of providers routinely prescribed antibiotics. Most providers (73%) only prescribed antibiotics if certain historical factors or physical findings were present on examination. Antibiotic treatment, if used, favored a combination of 2 or more drugs to cover both Streptococcus and methicillin-resistant Staphylococcus aureus (47%). Follow-up visits were most frequently recommended at 48 hours unless wound was concerning and required closer evaluation.
Conclusion:
Variability exists in the treatment strategies for abscess care. Most providers used narcotic analgesics in addition to local anesthetic, linear incisions, and packing. Most providers did not irrigate, order wound cultures, or routinely prescribe oral antibiotics unless specific risk factors or physical signs were present. Limited evidence is available at this time to guide these treatment strategies.
doi:10.5811/westjem.2011.9.6856
PMCID: PMC3582519  PMID: 23447753
15.  Emergency Department Sickle Cell Assessment of Needs and Strengths (ED-SCANS), a Focus Group and Decision Support Tool Development Project 
Objectives
A decision support tool may guide emergency clinicians in recognizing assessment, analgesic and overall management, and health service delivery needs for patients with sickle cell disease (SCD) in the emergency department (ED). We aimed to identify data and process elements important in making decisions regarding evaluation and management of adult patients in the ED with painful episodes of sickle cell disease.
Methods
Qualitative methods using a series of focus groups and grounded theory were used. Eligible participants included adult clients with SCD, and emergency physicians and nurses with a minimum of one year of experience providing care to patients with SCD in the ED. Patients were recruited in conjunction with annual SCD meetings, and providers included clinicians who were and were not affiliated with sickle cell centers. Groups were conducted until saturation was reached, and included a total of two patient groups, three physician groups, and two nurse groups. Focus groups were held in New York, Durham, Chicago, New Orleans, and Denver. Clinician participants were asked the following three questions to guide the discussion: 1) what information would be important to know about patients with SCD in the ED setting to effectively care for them and help you identify patient analgesic, treatment, and referral needs? 2) what treatment decisions would you make with this information? and 3) what characteristics would a decision support tool need to have to make it meaningful and useful? Client participants were asked the same questions with re-wording to reflect what they believed providers should know to provide the best care, and what they should do with the information. All focus groups were audio taped and transcribed. The constant comparative method was used to analyze the data. Two coders independently coded participant responses and identified focal themes based on the key questions. An investigator and assistant independently reviewed the transcripts and met until the final coding structure was determined.
Results
Forty-seven individuals participated (14 persons with SCD, 16 physicians, and 17 nurses) in a total of seven different groups. Two major themes emerged: acute management and health care utilization. Major sub-themes included the following: physiologic findings, diagnostics, assessment and treatment of acute painful episodes, and disposition. The most common minor sub-themes that emerged included past medical history, presence of a medical home (physician or clinic), individualized analgesic treatment plan for treatment of painful episodes, history of present illness, medical home follow-up available, patient reported analgesic treatment that works, and availability of analgesic prescription at discharge. Additional important elements in treatment of acute pain episodes included the use of a standard analgesic protocol, need for fluids and non-pharmacologic interventions, and the assessment of typicality of pain presentation. The patients' interpretation of the need for hospital admission also ranked high.
Conclusions
Participants identified several areas that are important in the assessment, management, and disposition decisions that may help guide best practices for SCD patients in the ED setting.
doi:10.1111/j.1553-2712.2010.00779.x
PMCID: PMC2914333  PMID: 20670322
pain; sickle cell disease; decision support; emergency department
16.  Knowledge, Practices, and Perceived Barriers Regarding Cancer Pain Management Among Physicians and Nurses In Korea: A Nationwide Multicenter Survey 
PLoS ONE  2014;9(8):e105900.
Purpose
Medical professionals’ practices and knowledge regarding cancer pain management have often been cited as inadequate. This study aimed to evaluate knowledge, practices and perceived barriers regarding cancer pain management among physicians and nurses in Korea.
Methods
A nationwide questionnaire survey was administered to physicians and nurses involved in the care of cancer patients. Questionnaire items covered pain assessment and documentation practices, knowledge regarding cancer pain management, the perceived barriers to cancer pain control, and processes perceived as the major causes of delay in opioid administration.
Results
A total of 333 questionnaires (149 physicians and 284 nurses) were analyzed. Nurses performed pain assessment and documentation more regularly than physicians did. Although physicians had better knowledge of pain management than did nurses, both groups lacked knowledge regarding the side effects and pharmacology of opioids. Physicians working in the palliative care ward and nurses who had received pain management education obtained higher scores on knowledge. Physicians perceived patients’ reluctance to take opioids as a barrier to pain control, more so than did nurses, while nurses perceived patients’ tendency to under-report of pain as a barrier, more so than did physicians. Physicians and nurses held different perceptions regarding major cause of delay during opioid administration.
Conclusions
There were differences between physicians and nurses in knowledge and practices for cancer pain management. An effective educational strategy for cancer pain management is needed in order to improve medical professionals’ knowledge and clinical practices.
doi:10.1371/journal.pone.0105900
PMCID: PMC4140841  PMID: 25144641
17.  Improvements in pain outcomes in a Canadian pediatric teaching hospital following implementation of a multifaceted, knowledge translation initiative 
BACKGROUND:
A previous audit performed at a tertiary/quaternary pediatric hospital in Toronto, Ontario, demonstrated suboptimal assessment and treatment of children’s pain. Knowledge translation (KT) initiatives (education, reminders, audit and feedback) were implemented to address identified care gaps; however, the impact is unknown.
OBJECTIVES:
To determine the impact of KT initiatives on pain outcomes including process outcomes (eg, pain assessment and management practices) and clinical outcomes (eg, pain prevalence and intensity); and to benchmark additional pain practices, particularly opioid administration and painful procedures.
METHODS:
Medical records at The Hospital for Sick Children (Toronto, Ontario) were reviewed on a single day in September 2007. Pain assessment and management practices, and pain prevalence and intensity in the preceding 24 h were recorded on a standardized data collection form. Where possible, pain outcomes were compared with previous audit results.
RESULTS:
Records of 265 inpatients were audited. Sixty-three per cent of children underwent a documented pain assessment compared with 27% in an audit conducted previously (P<0.01). Eighty-three per cent of children with documented pain received at least one pain management intervention. Overall, 51% of children received pharmacological therapy, and 15% received either a psychological or physical pain-relieving intervention. Of those assessed, 44% experienced pain in the previous 24 h versus 66% in the previous audit (P<0.01). Fewer children experienced severe pain compared with the first audit (8.7% versus 26.1%; P<0.01). One-third of children received opioids; 19% of these had no recorded pain assessment. Among 131 children who underwent a painful procedure, 21% had a concurrent pain assessment. Painful procedures were accompanied by a pain-relieving intervention in 12.5% of cases.
CONCLUSIONS:
Following KT initiatives, significant improvements in pain processes (pain assessment documentation and pain management interventions) and clinical outcomes (pain prevalence, pain intensity) were observed. Further improvements are recommended, specifically with respect to procedural pain practices and opioid utilization patterns.
PMCID: PMC3401088  PMID: 22606682
Knowledge translation; Pain assessment; Pain intensity; Pain management; Pain prevalence; Painful procedures
18.  Evaluating the Impact of Pain Management (PM) Education on Physician Practice Patterns—A Continuing Medical Education (CME) Outcomes Study 
California Assembly Bill AB487 mandates that all practicing physicians are required to obtain 12 h of Continuing Medical Education in Pain Management and End of Life Care before the year 2006 in order to renew their state license to practice medicine. In order to determine the effectiveness of this bill in influencing the practice of medicine, we conducted the first of five planned annual Pain Management seminars and utilized physician questionnaires to determine possible practice changes as a result of this seminar. Eighty-one physicians representing 17 multiple specialties of medicine enrolled in this seminar. The topics included: management of malignant and non-malignant pain, pharmacology and management of side effects of opiate and non-opiate analgesics, and adjunctive therapies including depression management and spirituality issues. Physicians were asked to respond to an immediate post-seminar questionnaire and were subsequently queried 4 months following the conference. Fifty-one out of 81 physician registrants responded to an immediate post-attendance questionnaire, and 31 responded to the 4-month follow-up questionnaire. Responses included:
EarlyLateI will change/have changed my practice3428I see no need to change my practice62I will await further information71No response regarding practice change4Responses of those who changed their practices included: Increased use of known modalities for pain control21 Earlier referrals to specialists14 More attention to psychosocial aspects14 Use of new drugs/modalities of care11
This audience represents the most motivated group of practitioners electing to receive Pain Management Education long before the mandated deadline. Sixty-seven percent expressed an interest in changing their practice following this intensive educational experience. Ninety percent responding to the follow-up evaluation indicated that their practices had changed, suggesting that this seminar series is effective in altering physician practice patterns (supported by Cancer Center Support Grant CA 33572 and Sarnat Foundation).
doi:10.1007/s13187-010-0040-y
PMCID: PMC3751402  PMID: 20204577
California Assembly Bill AB487; Pain management; Practicing physicians
19.  Older Black Adult Osteoarthritis Pain Communication 
A quantitative descriptive secondary data analysis design was used to describe older Black adult communication of osteoarthritis pain and the communication strategies used to convey the pain information. Pain content from 74 older Black adults with persistent osteoarthritis pain was analyzed with criteria from the American Pain Society arthritis pain management guidelines that included type of pain (nociceptive/neuropathic), quality of pain, source, location, intensity, duration/time course, pain affect, effect on personal lifestyle, functional status, current pain treatments, use of recommended glucosamine sulfate, effectiveness of prescribed treatments, prescription analgesic side effects, weight management to ideal body weight, exercise regimen or physical therapy and/or occupational therapy, and indications for surgery. Communication strategies were analyzed with criteria derived from Communication Accommodation Theory that included being clear, using medical syntax, using ethnic specific syntax, being explicit, and staying on topic when discussing pain. The majority of communicated pain content included pain location, intensity, and timing. Regarding communication strategies, most of the older Black adults used specific descriptions of pain and remained on topic. Fewer used explicit descriptions of pain that produced a vivid mental image, and few used medical terminology. Use of medical syntax and more explicit descriptions might improve communication about pain between healthcare practitioners and patients. Practitioners might assist older Black adults with persistent osteoarthritis pain to communicate important clinical pain information by helping them to use relevant medical terminology and more explicit pain descriptions when discussing pain management.
doi:10.1016/j.pmn.2012.09.001
PMCID: PMC3572295  PMID: 23141080
Black American; pain; communication; arthritis; osteoarthritis; older adult
20.  Ultraviolet Phototherapy Management of Moderate-to-Severe Plaque Psoriasis 
Executive Summary
Objective
The purpose of this evidence based analysis was to determine the effectiveness and safety of ultraviolet phototherapy for moderate-to-severe plaque psoriasis.
Research Questions
The specific research questions for the evidence review were as follows:
What is the safety of ultraviolet phototherapy for moderate-to-severe plaque psoriasis?
What is the effectiveness of ultraviolet phototherapy for moderate-to-severe plaque psoriasis?
Clinical Need: Target Population and Condition
Psoriasis is a common chronic, systemic inflammatory disease affecting the skin, nails and occasionally the joints and has a lifelong waning and waxing course. It has a worldwide occurrence with a prevalence of at least 2% of the general population, making it one of the most common systemic inflammatory diseases. The immune-mediated disease has several clinical presentations with the most common (85% - 90%) being plaque psoriasis.
Characteristic features of psoriasis include scaling, redness, and elevation of the skin. Patients with psoriasis may also present with a range of disabling symptoms such as pruritus (itching), pain, bleeding, or burning associated with plaque lesions and up to 30% are classified as having moderate-to-severe disease. Further, some psoriasis patients can be complex medical cases in which diabetes, inflammatory bowel disease, and hypertension are more likely to be present than in control populations and 10% also suffer from arthritis (psoriatic arthritis). The etiology of psoriasis is unknown but is thought to result from complex interactions between the environment and predisposing genes.
Management of psoriasis is related to the extent of the skin involvement, although its presence on the hands, feet, face or genitalia can present challenges. Moderate-to-severe psoriasis is managed by phototherapy and a range of systemic agents including traditional immunosuppressants such as methotrexate and cyclospsorin. Treatment with modern immunosuppressant agents known as biologicals, which more specifically target the immune defects of the disease, is usually reserved for patients with contraindications and those failing or unresponsive to treatments with traditional immunosuppressants or phototherapy.
Treatment plans are based on a long-term approach to managing the disease, patient’s expectations, individual responses and risk of complications. The treatment goals are several fold but primarily to:
1) improve physical signs and secondary psychological effects,
2) reduce inflammation and control skin shedding,
3) control physical signs as long as possible, and to
4) avoid factors that can aggravate the condition.
Approaches are generally individualized because of the variable presentation, quality of life implications, co-existent medical conditions, and triggering factors (e.g. stress, infections and medications). Individual responses and commitments to therapy also present possible limitations.
Phototherapy
Ultraviolet phototherapy units have been licensed since February 1993 as a class 2 device in Canada. Units are available as hand held devices, hand and foot devices, full-body panel, and booth styles for institutional and home use. Units are also available with a range of ultraviolet A, broad and narrow band ultraviolet B (BB-UVB and NB-UVB) lamps. After establishing appropriate ultraviolet doses, three-times weekly treatment schedules for 20 to 25 treatments are generally needed to control symptoms.
Evidence-Based Analysis Methods
The literature search strategy employed keywords and subject headings to capture the concepts of 1) phototherapy and 2) psoriasis. The search involved runs in the following databases: Ovid MEDLINE (1996 to March Week 3 2009), OVID MEDLINE In-Process and Other Non-Indexed Citations, EMBASE (1980 to 2009 Week 13), the Wiley Cochrane Library, and the Centre for Reviews and Dissemination/International Agency for Health Technology Assessment. Parallel search strategies were developed for the remaining databases. Search results were limited to human and English-language published between January 1999 and March 31, 2009. Search alerts were generated and reviewed for relevant literature up until May 31, 2009.
English language reports and human studies
Ultraviolet phototherapy interventions for plaque-type psoriasis
Reports involving efficacy and/or safety outcome studies
Original reports with defined study methodology
Standardized measurements on outcome events such as technical success, safety, effectiveness, durability, quality of life or patient satisfaction
Non-systematic reviews, letters, comments and editorials
Randomized trials involving side-to-side or half body comparisons
Randomized trials not involving ultraviolet phototherapy intervention for plaque-type psoriasis
Trials involving dosing studies, pilot feasibility studies or lacking control groups
Summary of Findings
A 2000 health technology evidence report on the overall management of psoriasis by The National Institute Health Research (NIHR) Health Technology Assessment Program of the UK was identified in the MAS evidence-based review. The report included 109 RCT studies published between 1966 and June 1999 involving four major treatment approaches – 51 on phototherapy, 32 on oral retinoids, 18 on cyclosporin and five on fumarates.. The absence of RCTs on methotrexate was noted as original studies with this agent had been performed prior to 1966.
Of the 51 RCT studies involving phototherapy, 22 involved UVA, 21 involved UVB, five involved both UVA and UVB and three involved natural light as a source of UV. The RCT studies included comparisons of treatment schedules, ultraviolet source, addition of adjuvant therapies, and comparisons between phototherapy and topical treatment schedules. Because of heterogeneity, no synthesis or meta-analysis could be performed. Overall, the reviewers concluded that the efficacy of only five therapies could be supported from the RCT-based evidence review: photochemotherapy or phototherapy, cyclosporin, systemic retinoids, combination topical vitamin D3 analogues (calcipotriol) and corticosteroids in combination with phototherapy and fumarates. Although there was no RCT evidence supporting methotrexate, it’s efficacy for psoriasis is well known and it continues to be a treatment mainstay.
The conclusion of the NIHR evidence review was that both photochemotherapy and phototherapy were effective treatments for clearing psoriasis, although their comparative effectiveness was unknown. Despite the conclusions on efficacy, a number of issues were identified in the evidence review and several areas for future research were discussed to address these limitations. Trials focusing on comparative effectiveness, either between ultraviolet sources or between classes of treatment such as methotrexate versus phototherapy, were recommended to refine treatment algorithms. The need for better assessment of cost-effectiveness of therapies to consider systemic drug costs and costs of surveillance, as well as drug efficacy, were also noted. Overall, the authors concluded that phototherapy and photochemotherapy had important roles in psoriasis management and were standard therapeutic options for psoriasis offered in dermatology practices.
The MAS evidence-based review focusing on the RCT trial evidence for ultraviolet phototherapy management of moderate-to-severe plaque psoriasis was performed as an update to the NIHR 2000 systemic review on treatments for severe psoriasis. In this review, an additional 26 RCT reports examining phototherapy or photochemotherapy for psoriasis were identified. Among the studies were two RCTs comparing ultraviolet wavelength sources, five RCTs comparing different forms of phototherapy, four RCTs combining phototherapy with prior spa saline bathing, nine RCTs combining phototherapy with topical agents, two RCTs combining phototherapy with the systemic immunosuppressive agents methotrexate or alefacept, one RCT comparing phototherapy with an additional light source (the excimer laser), and one comparing a combination therapy with phototherapy and psychological intervention involving simultaneous audiotape sessions on mindfulness and stress reduction. Two trials also examined the effect of treatment setting on effectiveness of phototherapy, one on inpatient versus outpatient therapy and one on outpatient clinic versus home-based phototherapy.
Conclusions
The conclusions of the MAS evidence-based review are outlined in Table ES1. In summary, phototherapy provides good control of clinical symptoms in the short term for patients with moderate-to-severe plaque-type psoriasis that have failed or are unresponsive to management with topical agents. However, many of the evidence gaps identified in the NIHR 2000 evidence review on psoriasis management persisted. In particular, the lack of evidence on the comparative effectiveness and/or cost-effectiveness between the major treatment options for moderate-to-severe psoriasis remained. The evidence on effectiveness and safety of longer term strategies for disease management has also not been addressed. Evidence for the safety, effectiveness, or cost-effectiveness of phototherapy delivered in various settings is emerging but is limited. In addition, because all available treatments for psoriasis – a disease with a high prevalence, chronicity, and cost – are palliative rather than curative, strategies for disease control and improvements in self-efficacy employed in other chronic disease management strategies should be investigated.
RCT Evidence for Ultraviolet Phototherapy Treatment of Moderate-To-Severe Plaque Psoriasis
Phototherapy is an effective treatment for moderate-to-severe plaque psoriasis
Narrow band PT is more effective than broad band PT for moderate-to-severe plaque psoriasis
Oral-PUVA has a greater clinical response, requires less treatments and has a greater cumulative UV irradiation dose than UVB to achieve treatment effects for moderate-to-severe plaque psoriasis
Spa salt water baths prior to phototherapy did increase short term clinical response of moderate-to-severe plaque psoriasis but did not decrease cumulative UV irradiation dose
Addition of topical agents (vitamin D3 calcipotriol) to NB-UVB did not increase mean clinical response or decrease treatments or cumulative UV irradiation dose
Methotrexate prior to NB-UVB in high need psoriasis patients did significantly increase clinical response, decrease number of treatment sessions and decrease cumulative UV irradiation dose
Phototherapy following alefacept did increase early clinical response in moderate-to-severe plaque psoriasis
Effectiveness and safety of home NB-UVB phototherapy was not inferior to NB-UVB phototherapy provided in a clinic to patients with psoriasis referred for phototherapy. Treatment burden was lower and patient satisfaction was higher with home therapy and patients in both groups preferred future phototherapy treatments at home
Ontario Health System Considerations
A 2006 survey of ultraviolet phototherapy services in Canada identified 26 phototherapy clinics in Ontario for a population of over 12 million. At that time, there were 177 dermatologists and 50 geographic regions in which 28% (14/50) provided phototherapy services. The majority of the phototherapy services were reported to be located in densely populated areas; relatively few patients living in rural communities had access to these services. The inconvenience of multiple weekly visits for optimal phototherapy treatment effects poses additional burdens to those with travel difficulties related to health, job, or family-related responsibilities.
Physician OHIP billing for phototherapy services totaled 117,216 billings in 2007, representing approximately 1,800 patients in the province treated in private clinics. The number of patients treated in hospitals is difficult to estimate as physician costs are not billed directly to OHIP in this setting. Instead, phototherapy units and services provided in hospitals are funded by hospitals’ global budgets. Some hospitals in the province, however, have divested their phototherapy services, so the number of phototherapy clinics and their total capacity is currently unknown.
Technological advances have enabled changes in phototherapy treatment regimens from lengthy hospital inpatient stays to outpatient clinic visits and, more recently, to an at-home basis. When combined with a telemedicine follow-up, home phototherapy may provide an alternative strategy for improved access to service and follow-up care, particularly for those with geographic or mobility barriers. Safety and effectiveness have, however, so far been evaluated for only one phototherapy home-based delivery model. Alternate care models and settings could potentially increase service options and access, but the broader consequences of the varying cost structures and incentives that either increase or decrease phototherapy services are unknown.
Economic Analyses
The focus of the current economic analysis was to characterize the costs associated with the provision of NB-UVB phototherapy for plaque-type, moderate-to-severe psoriasis in different clinical settings, including home therapy. A literature review was conducted and no cost-effectiveness (cost-utility) economic analyses were published in this area.
Hospital, Clinic, and Home Costs of Phototherapy
Costs for NB-UVB phototherapy were based on consultations with equipment manufacturers and dermatologists. Device costs applicable to the provision of NB-UVB phototherapy in hospitals, private clinics and at a patient’s home were estimated. These costs included capital costs of purchasing NB-UVB devices (amortized over 15-20 years), maintenance costs of replacing equipment bulbs, physician costs of phototherapy treatment in private clinics ($7.85 per phototherapy treatment), and medication and laboratory costs associated with treatment of moderate-to-severe psoriasis.
NB-UVB phototherapy services provided in a hospital setting were paid for by hospitals directly. Phototherapy services in private clinic and home settings were paid for by the clinic and patient, respectively, except for physician services covered by OHIP. Indirect funding was provided to hospitals as part of global budgeting and resource allocation. Home therapy services for NB-UVB phototherapy were not covered by the MOHLTC. Coverage for home-based phototherapy however, was in some cases provided by third party insurers.
Device costs for NB-UVB phototherapy were estimated for two types of phototherapy units: a “booth unit” consisting of 48 bulbs used in hospitals and clinics, and a “panel unit” consisting of 10 bulbs for home use. The device costs of the booth and panel units were estimated at approximately $18,600 and $2,900, respectively; simple amortization over 15 and 20 years implied yearly costs of approximately $2,500 and $150, respectively. Replacement cost for individual bulbs was about $120 resulting in total annual cost of maintenance of about $8,640 and $120 for booth and panel units, respectively.
Estimated Total Costs for Ontario
Average annual cost per patient for NB-UVB phototherapy provided in the hospital, private clinic or at home was estimated to be $292, $810 and $365 respectively. For comparison purposes, treatment of moderate-to-severe psoriasis with methotrexate and cyclosporin amounted to $712 and $3,407 annually per patient respectively; yearly costs for biological drugs were estimated to be $18,700 for alefacept and $20,300 for etanercept-based treatments.
Total annual costs of NB-UVB phototherapy were estimated by applying average costs to an estimated proportion of the population (age 18 or older) eligible for phototherapy treatment. The prevalence of psoriasis was estimated to be approximately 2% of the population, of which about 85% was of plaque-type psoriasis and approximately 20% to 30% was considered moderate-to-severe in disease severity. An estimate of 25% for moderate-to-severe psoriasis cases was used in the current economic analysis resulting in a range of 29,400 to 44,200 cases. Approximately 21% of these patients were estimated to be using NB-UVB phototherapy for treatment resulting in a number of cases in the range between 6,200 and 9,300 cases. The average (7,700) number of cases was used to calculate associated costs for Ontario by treatment setting.
Total annual costs were as follows: $2.3 million in a hospital setting, $6.3 million in a private clinic setting, and $2.8 million for home phototherapy. Costs for phototherapy services provided in private clinics were greater ($810 per patient annually; total of $6.3 million annually) and differed from the same services provided in the hospital setting only in terms of additional physician costs associated with phototherapy OHIP fees.
Keywords
Psoriasis, ultraviolet radiation, phototherapy, photochemotherapy, NB-UVB, BB-UVB PUVA
PMCID: PMC3377497  PMID: 23074532
21.  Predicting Patterns of Long-Term CD4 Reconstitution in HIV-Infected Children Starting Antiretroviral Therapy in Sub-Saharan Africa: A Cohort-Based Modelling Study 
PLoS Medicine  2013;10(10):e1001542.
Using data from the ARROW trial, Joanna Lewis and colleagues investigate the CD4 cell count recovery profiles of children infected with HIV starting antiretroviral therapy in Sub-Saharan Africa.
Please see later in the article for the Editors' Summary
Background
Long-term immune reconstitution on antiretroviral therapy (ART) has important implications for HIV-infected children, who increasingly survive into adulthood. Children's response to ART differs from adults', and better descriptive and predictive models of reconstitution are needed to guide policy and direct research. We present statistical models characterising, qualitatively and quantitatively, patterns of long-term CD4 recovery.
Methods and Findings
CD4 counts every 12 wk over a median (interquartile range) of 4.0 (3.7, 4.4) y in 1,206 HIV-infected children, aged 0.4–17.6 y, starting ART in the Antiretroviral Research for Watoto trial (ISRCTN 24791884) were analysed in an exploratory analysis supplementary to the trial's pre-specified outcomes. Most (n = 914; 76%) children's CD4 counts rose quickly on ART to a constant age-corrected level. Using nonlinear mixed-effects models, higher long-term CD4 counts were predicted for children starting ART younger, and with higher CD4 counts (p<0.001). These results suggest that current World Health Organization–recommended CD4 thresholds for starting ART in children ≥5 y will result in lower CD4 counts in older children when they become adults, such that vertically infected children who remain ART-naïve beyond 10 y of age are unlikely ever to normalise CD4 count, regardless of CD4 count at ART initiation. CD4 profiles with four qualitatively distinct reconstitution patterns were seen in the remaining 292 (24%) children. Study limitations included incomplete viral load data, and that the uncertainty in allocating children to distinct reconstitution groups was not modelled.
Conclusions
Although younger ART-naïve children are at high risk of disease progression, they have good potential for achieving high CD4 counts on ART in later life provided ART is initiated following current World Health Organization (WHO), Paediatric European Network for Treatment of AIDS, or US Centers for Disease Control and Prevention guidelines. In contrast, to maximise CD4 reconstitution in treatment-naïve children >10 y, ART should ideally be considered even if there is a low risk of immediate disease progression. Further exploration of the immunological mechanisms for these CD4 recovery profiles should help guide management of paediatric HIV infection and optimise children's immunological development.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Worldwide, about 3.3 million children under 15 years old are infected with HIV, the virus that causes AIDS. More than 90% of these children live in sub-Saharan Africa, where nearly 600 children become infected with HIV every day, usually acquiring the virus from their mother during pregnancy, birth, or breastfeeding. HIV gradually reduces the numbers of CD4 lymphocytes in the immune system, leaving infected individuals susceptible to other infections. HIV infection can be kept in check but not cured with antiretroviral therapy (ART)—cocktails of drugs that have to be taken every day throughout life. ART reduces the amount of virus in the blood (viral load), which allows the immune system to recover (long-term immune reconstitution). Unfortunately, ART is very expensive, but concerted international efforts over the past decade mean that about a third of children who need ART are now receiving it, including half a million children in sub-Saharan Africa.
Why Was This Study Done?
World Health Organization (WHO) guidelines recommend initiation of ART at age-related CD4 cell count thresholds based on the risk of short-term disease progression. The guidelines recommend that all HIV-positive children under two years old begin ART as soon they receive a diagnosis of HIV infection. For children aged 2–5 years, ART initiation is recommended once the CD4 count drops below 750 cells/µl blood, whereas for older children the threshold for ART initiation is 350 CD4 cells/µl. Because of improved ART coverage, many more HIV-infected children now survive into adulthood than in the past. It is therefore important to know how the timing of ART initiation in childhood affects long-term immune reconstitution. Unfortunately, although several studies have examined the effect of ART on immune reconstitution in adults, the results of these studies cannot be extrapolated to children because of age-related differences in immune reconstitution. In this cohort-based modelling study, the researchers investigate long-term CD4 recovery in a cohort (group) of HIV-infected children initiating ART in Uganda and Zimbabwe, and present statistical models that predict patterns of long-term CD4 status based on age and CD4 count at ART initiation.
What Did the Researchers Do and Find?
To investigate long-term CD4 reconstitution in children, the researchers used CD4 counts collected during the ARROW trial, a study designed to investigate monitoring strategies during first-line ART in 1,206 HIV-positive children. In three-quarters of the children, CD4 reconstitution following ART initiation was asymptotic—CD4 counts increased rapidly immediately after ART initiation, then slowed before eventually reaching a constant level of about 80% of the CD4 count expected in an uninfected child of the same age. Using a nonlinear mixed-effects statistical model that fitted this pattern of immune reconstitution, the researchers predicted CD4 trajectories for children starting ART at different ages and with different CD4 counts. Higher long-term counts were predicted for children starting ART earlier and with higher CD4 counts. Thus, to achieve a CD4 count greater than 700 cells/µl at age 20 years, CD4 counts of at least 96 cells/µl, 130 cells/µl, and 557 cells/µl are needed for children aged two, five, and 12 years, respectively, when they initiate ART. Qualitatively distinct reconstitution patterns were seen in the remaining children in the study.
What Do These Findings Mean?
These findings suggest that young HIV-positive, ART-naïve children can achieve high CD4 counts in later life, provided ART is initiated as recommended in the current WHO guidelines. However, the recommended CD4 count thresholds for ART initiation are unlikely to maximize immune reconstitution in treatment-naïve children over ten years old. Rather, these findings suggest that ART initiation should be considered in these older children when their CD4 count is still high—even though they have a low risk of immediate disease progression—in order to achieve higher long-term CD4 levels. The omission of viral load measurements in the researchers' model may limit the accuracy of these findings. Moreover, although the predictions made by the model apply to children who will go on to experience asymptotic recovery, they are less relevant to those with different recovery profiles, who cannot currently be accurately identified. Further exploration of the immunological mechanisms underlying the CD4 recovery profiles described here should improve our understanding of the factors that determine the response of HIV-positive children to ART and provide information to guide the management of HIV infections in children.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001542.
Information is available from the US National Institute of Allergy and Infectious Diseases on HIV infection and AIDS
NAM/aidsmap provides basic information about HIV/AIDS and summaries of recent research findings on HIV care and treatment
Information is available from Avert, an international AIDS charity, on many aspects of HIV/AIDS, including information on HIV and AIDS in Africa and on HIV infection in children (in English and Spanish)
The UNAIDS World AIDS Day Report 2012 provides up-to-date information about the AIDS epidemic and efforts to halt it; the UNAIDS's 2013 Progress Report on the Global Plan provides information on progress towards eliminating new HIV infections among children by 2015
The World Health Organization provides information about universal access to AIDS treatment (in several languages); its 2010 guidelines for ART in infants and children can be downloaded
Information about the ARROW trial is available
Personal stories about living with HIV/AIDS, including stories from young people infected with HIV, are available through Avert, through Nam/aidsmap, and through the charity website Healthtalkonline
doi:10.1371/journal.pmed.1001542
PMCID: PMC3812080  PMID: 24204216
22.  Guideline on allergen-specific immunotherapy in IgE-mediated allergic diseases 
Allergo Journal International  2014;23(8):282-319.
Summary
The present guideline (S2k) on allergen-specific immunotherapy (AIT) was established by the German, Austrian and Swiss professional associations for allergy in consensus with the scientific specialist societies and professional associations in the fields of otolaryngology, dermatology and venereology, pediatric and adolescent medicine, pneumology as well as a German patient organization (German Allergy and Asthma Association; Deutscher Allergie- und Asthmabund, DAAB) according to the criteria of the Association of the Scientific Medical Societies in Germany (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, AWMF).
AIT is a therapy with disease-modifying effects. By administering allergen extracts, specific blocking antibodies, toler-ance-inducing cells and mediators are activated. These prevent further exacerbation of the allergen-triggered immune response, block the specific immune response and attenuate the inflammatory response in tissue.
Products for SCIT or SLIT cannot be compared at present due to their heterogeneous composition, nor can allergen concentrations given by different manufacturers be compared meaningfully due to the varying methods used to measure their active ingredients. Non-modified allergens are used for SCIT in the form of aqueous or physically adsorbed (depot) extracts, as well as chemically modified allergens (allergoids) as depot extracts. Allergen extracts for SLIT are used in the form of aqueous solutions or tablets.
The clinical efficacy of AIT is measured using various scores as primary and secondary study endpoints. The EMA stipulates combined symptom and medication scores as primary endpoint. A harmonization of clinical endpoints, e. g., by using the combined symptom and medication scores (CSMS) recommended by the EAACI, is desirable in the future in order to permit the comparison of results from different studies. The current CONSORT recommendations from the ARIA/GA2LEN group specify standards for the evaluation, presentation and publication of study results.
According to the Therapy allergen ordinance (TAV), preparations containing common allergen sources (pollen from grasses, birch, alder, hazel, house dust mites, as well as bee and wasp venom) need a marketing authorization in Germany. During the marketing authorization process, these preparations are examined regarding quality, safety and efficacy. In the opinion of the authors, authorized allergen preparations with documented efficacy and safety, or preparations tradeable under the TAV for which efficacy and safety have already been documented in clinical trials meeting WAO or EMA standards, should be preferentially used. Individual formulations (NPP) enable the prescription of rare allergen sources (e.g., pollen from ash, mugwort or ambrosia, mold Alternaria, animal allergens) for specific immunotherapy. Mixing these allergens with TAV allergens is not permitted.
Allergic rhinitis and its associated co-morbidities (e. g., bronchial asthma) generate substantial direct and indirect costs. Treatment options, in particular AIT, are therefore evaluated using cost-benefit and cost-effectiveness analyses. From a long-term perspective, AIT is considered to be significantly more cost effective in allergic rhinitis and allergic asthma than pharmacotherapy, but is heavily dependent on patient compliance.
Meta-analyses provide unequivocal evidence of the efficacy of SCIT and SLIT for certain allergen sources and age groups. Data from controlled studies differ in terms of scope, quality and dosing regimens and require product-specific evaluation. Therefore, evaluating individual preparations according to clearly defined criteria is recommended. A broad transfer of the efficacy of certain preparations to all preparations administered in the same way is not endorsed. The website of the German Society for Allergology and Clinical Immunology (www.dgaki.de/leitlinien/s2k-leitlinie-sit; DGAKI: Deutsche Gesellschaft für Allergologie und klinische Immunologie) provides tables with specific information on available products for AIT in Germany, Switzerland and Austria. The tables contain the number of clinical studies per product in adults and children, the year of market authorization, underlying scoring systems, number of randomized and analyzed subjects and the method of evaluation (ITT, FAS, PP), separately given for grass pollen, birch pollen and house dust mite allergens, and the status of approval for the conduct of clinical studies with these products.
Strong evidence of the efficacy of SCIT in pollen allergy-induced allergic rhinoconjunctivitis in adulthood is well-documented in numerous trials and, in childhood and adolescence, in a few trials. Efficacy in house dust mite allergy is documented by a number of controlled trials in adults and few controlled trials in children. Only a few controlled trials, independent of age, are available for mold allergy (in particular Alternaria). With regard to animal dander allergies (primarily to cat allergens), only small studies, some with methodological deficiencies are available. Only a moderate and inconsistent therapeutic effect in atopic dermatitis has been observed in the quite heterogeneous studies conducted to date. SCIT has been well investigated for individual preparations in controlled bronchial asthma as defined by the Global Initiative for Asthma (GINA) 2007 and intermittent and mild persistent asthma (GINA 2005) and it is recommended as a treatment option, in addition to allergen avoidance and pharmacotherapy, provided there is a clear causal link between respiratory symptoms and the relevant allergen.
The efficacy of SLIT in grass pollen-induced allergic rhinoconjunctivitis is extensively documented in adults and children, whilst its efficacy in tree pollen allergy has only been shown in adults. New controlled trials (some with high patient numbers) on house dust mite allergy provide evidence of efficacy of SLIT in adults.
Compared with allergic rhinoconjunctivitis, there are only few studies on the efficacy of SLIT in allergic asthma. In this context, newer studies show an efficacy for SLIT on asthma symptoms in the subgroup of grass pollen allergic children, adolescents and adults with asthma and efficacy in primary house dust mite allergy-induced asthma in adolescents aged from 14 years and in adults.
Aspects of secondary prevention, in particular the reduction of new sensitizations and reduced asthma risk, are important rationales for choosing to initiate treatment early in childhood and adolescence. In this context, those products for which the appropriate effects have been demonstrated should be considered.
SCIT or SLIT with pollen or mite allergens can be performed in patients with allergic rhinoconjunctivitis using allergen extracts that have been proven to be effective in at least one double-blind placebo-controlled (DBPC) study. At present, clinical trials are underway for the indication in asthma due to house dust mite allergy, some of the results of which have already been published, whilst others are still awaited (see the DGAKI table “Approved/potentially completed studies” via www.dgaki.de/Leitlinien/s2k-Leitlinie-sit (according to www.clinicaltrialsregister.eu)). When establishing the indication for AIT, factors that favour clinical efficacy should be taken into consideration. Differences between SCIT and SLIT are to be considered primarily in terms of contraindications. In individual cases, AIT may be justifiably indicated despite the presence of contraindications.
SCIT injections and the initiation of SLIT are performed by a physician experienced in this type of treatment and who is able to administer emergency treatment in the case of an allergic reaction. Patients must be fully informed about the procedure and risks of possible adverse events, and the details of this process must be documented (see “Treatment information sheet”; available as a handout via www.dgaki.de/Leitlinien/s2k-Leitlinie-sit). Treatment should be performed according to the manufacturer‘s product information leaflet. In cases where AIT is to be performed or continued by a different physician to the one who established the indication, close cooperation is required in order to ensure that treatment is implemented consistently and at low risk. In general, it is recommended that SCIT and SLIT should only be performed using preparations for which adequate proof of efficacy is available from clinical trials.
Treatment adherence among AIT patients is lower than assumed by physicians, irrespective of the form of administration. Clearly, adherence is of vital importance for treatment success. Improving AIT adherence is one of the most important future goals, in order to ensure efficacy of the therapy.
Severe, potentially life-threatening systemic reactions during SCIT are possible, but – providing all safety measures are adhered to – these events are very rare. Most adverse events are mild to moderate and can be treated well.
Dose-dependent adverse local reactions occur frequently in the mouth and throat in SLIT. Systemic reactions have been described in SLIT, but are seen far less often than with SCIT. In terms of anaphylaxis and other severe systemic reactions, SLIT has a better safety profile than SCIT.
The risk and effects of adverse systemic reactions in the setting of AIT can be effectively reduced by training of personnel, adhering to safety standards and prompt use of emergency measures, including early administration of i. m. epinephrine. Details on the acute management of anaphylactic reactions can be found in the current S2 guideline on anaphylaxis issued by the AWMF (S2-AWMF-LL Registry Number 061-025).
AIT is undergoing some innovative developments in many areas (e. g., allergen characterization, new administration routes, adjuvants, faster and safer dose escalation protocols), some of which are already being investigated in clinical trials.
Cite this as Pfaar O, Bachert C, Bufe A, Buhl R, Ebner C, Eng P, Friedrichs F, Fuchs T, Hamelmann E, Hartwig-Bade D, Hering T, Huttegger I, Jung K, Klimek L, Kopp MV, Merk H, Rabe U, Saloga J, Schmid-Grendelmeier P, Schuster A, Schwerk N, Sitter H, Umpfenbach U, Wedi B, Wöhrl S, Worm M, Kleine-Tebbe J. Guideline on allergen-specific immunotherapy in IgE-mediated allergic diseases – S2k Guideline of the German Society for Allergology and Clinical Immunology (DGAKI), the Society for Pediatric Allergy and Environmental Medicine (GPA), the Medical Association of German Allergologists (AeDA), the Austrian Society for Allergy and Immunology (ÖGAI), the Swiss Society for Allergy and Immunology (SGAI), the German Society of Dermatology (DDG), the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery (DGHNO-KHC), the German Society of Pediatrics and Adolescent Medicine (DGKJ), the Society for Pediatric Pneumology (GPP), the German Respiratory Society (DGP), the German Association of ENT Surgeons (BV-HNO), the Professional Federation of Paediatricians and Youth Doctors (BVKJ), the Federal Association of Pulmonologists (BDP) and the German Dermatologists Association (BVDD). Allergo J Int 2014;23:282–319
doi:10.1007/s40629-014-0032-2
PMCID: PMC4479478  PMID: 26120539
allergen-specific immunotherapy; AIT; Hyposensitization; guideline; allergen; allergen extract; allergic disease; allergic rhinitis; allergic asthma
23.  Fluoroscopic lumbar interlaminar epidural injections in managing chronic lumbar axial or discogenic pain 
Journal of Pain Research  2012;5:301-311.
Among the multiple causes of chronic low back pain, axial and discogenic pain are common. Various modalities of treatments are utilized in managing discogenic and axial low back pain including epidural injections. However, there is a paucity of evidence regarding the effectiveness, indications, and medical necessity of any treatment modality utilized for managing axial or discogenic pain, including epidural injections. In an interventional pain management practice in the US, a randomized, double-blind, active control trial was conducted. The objective was to assess the effectiveness of lumbar interlaminar epidural injections of local anesthetic with or without steroids for managing chronic low back pain of discogenic origin. However, disc herniation, radiculitis, facet joint pain, or sacroiliac joint pain were excluded. Two groups of patients were studied, with 60 patients in each group receiving either local anesthetic only or local anesthetic mixed with non-particulate betamethasone. Primary outcome measures included the pain relief-assessed by numeric rating scale of pain and functional status assessed by the, Oswestry Disability Index, Secondary outcome measurements included employment status, and opioid intake. Significant improvement or success was defined as at least a 50% decrease in pain and disability. Significant improvement was seen in 77% of the patients in Group I and 67% of the patients in Group II. In the successful groups (those with at least 3 weeks of relief with the first two procedures), the improvement was 84% in Group I and 71% in Group II. For those with chronic function-limiting low back pain refractory to conservative management, it is concluded that lumbar interlaminar epidural injections of local anesthetic with or without steroids may be an effective modality for managing chronic axial or discogenic pain. This treatment appears to be effective for those who have had facet joints as well as sacroiliac joints eliminated as the pain source.
doi:10.2147/JPR.S32699
PMCID: PMC3442746  PMID: 23055773
lumbar disc herniation; axial or discogenic pain; lumbar interlaminar epidural injections; local anesthetic; steroids; controlled comparative local anesthetic blocks; NCT00681447
24.  Determinants of vaccination coverage in rural Nigeria 
BMC Public Health  2008;8:381.
Background
Childhood immunization is a cost effective public health strategy. Expanded Programme on Immunisation (EPI) services have been provided in a rural Nigerian community (Sabongidda-Ora, Edo State) at no cost to the community since 1998 through a privately financed vaccination project (private public partnership). The objective of this survey was to assess vaccination coverage and its determinants in this rural community in Nigeria
Methods
A cross-sectional survey was conducted in September 2006, which included the use of interviewer-administered questionnaire to assess knowledge of mothers of children aged 12–23 months and vaccination coverage. Survey participants were selected following the World Health Organization's (WHO) immunization coverage cluster survey design. Vaccination coverage was assessed by vaccination card and maternal history. A child was said to be fully immunized if he or she had received all of the following vaccines: a dose of Bacille Calmette Guerin (BCG), three doses of oral polio (OPV), three doses of diphtheria, pertussis and tetanus (DPT), three doses of hepatitis B (HB) and one dose of measles by the time he or she was enrolled in the survey, i.e. between the ages of 12–23 months. Knowledge of the mothers was graded as satisfactory if mothers had at least a score of 3 out of a maximum of 5 points. Logistic regression was performed to identify determinants of full immunization status.
Results
Three hundred and thirty-nine mothers and 339 children (each mother had one eligible child) were included in the survey. Most of the mothers (99.1%) had very positive attitudes to immunization and > 55% were generally knowledgeable about symptoms of vaccine preventable diseases except for difficulty in breathing (as symptom of diphtheria). Two hundred and ninety-five mothers (87.0%) had a satisfactory level of knowledge. Vaccination coverage against all the seven childhood vaccine preventable diseases was 61.9% although it was significantly higher (p = 0.002) amongst those who had a vaccination card (131/188, 69.7%) than in those assessed by maternal history (79/151, 52.3%). Multiple logistic regression showed that mothers' knowledge of immunization (p = 0.006) and vaccination at a privately funded health facility (p < 0.001) were significantly correlated with the rate of full immunization.
Conclusion
Eight years after initiation of this privately financed vaccination project (private-public partnership), vaccination coverage in this rural community is at a level that provides high protection (81%) against DPT/OPV. Completeness of vaccination was significantly correlated with knowledge of mothers on immunization and adequate attention should be given to this if high coverage levels are to be sustained.
doi:10.1186/1471-2458-8-381
PMCID: PMC2587468  PMID: 18986544
25.  Effect on Postpartum Hemorrhage of Prophylactic Oxytocin (10 IU) by Injection by Community Health Officers in Ghana: A Community-Based, Cluster-Randomized Trial 
PLoS Medicine  2013;10(10):e1001524.
Cynthia Stanton and colleagues conducted a cluster-randomized controlled trial in rural Ghana to assess whether oxytocin given by injection by community health officers at home births was a feasible and safe option in preventing postpartum hemorrhage.
Please see later in the article for the Editors' Summary
Background
Oxytocin (10 IU) is the drug of choice for prevention of postpartum hemorrhage (PPH). Its use has generally been restricted to medically trained staff in health facilities. We assessed the effectiveness, safety, and feasibility of PPH prevention using oxytocin injected by peripheral health care providers without midwifery skills at home births.
Methods and Findings
This community-based, cluster-randomized trial was conducted in four rural districts in Ghana. We randomly allocated 54 community health officers (stratified on district and catchment area distance to a health facility: ≥10 km versus <10 km) to intervention (one injection of oxytocin [10 IU] one minute after birth) and control (no provision of prophylactic oxytocin) arms. Births attended by a community health officer constituted a cluster. Our primary outcome was PPH, using multiple definitions; (PPH-1) blood loss ≥500 mL; (PPH-2) PPH-1 plus women who received early treatment for PPH; and (PPH-3) PPH-2 plus any other women referred to hospital for postpartum bleeding. Unsafe practice is defined as oxytocin use before delivery of the baby. We enrolled 689 and 897 women, respectively, into oxytocin and control arms of the trial from April 2011 to November 2012. In oxytocin and control arms, respectively, PPH-1 rates were 2.6% versus 5.5% (RR: 0.49; 95% CI: 0.27–0.88); PPH-2 rates were 3.8% versus 10.8% (RR: 0.35; 95% CI: 0.18–0.63), and PPH-3 rates were similar to those of PPH-2. Compared to women in control clusters, those in the intervention clusters lost 45.1 mL (17.7–72.6) less blood. There were no cases of oxytocin use before delivery of the baby and no major adverse events requiring notification of the institutional review boards. Limitations include an unblinded trial and imbalanced numbers of participants, favoring controls.
Conclusion
Maternal health care planners can consider adapting this model to extend the use of oxytocin into peripheral settings including, in some contexts, home births.
Trial registration
ClinicalTrials.gov NCT01108289
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Many women in low-and middle-income countries die unnecessarily during childbirth, even though the solutions to prevent or manage complications are well known. Maternal death rates are highest amongst poor women living in remote areas, as they are least likely to have access to adequate health care. One of the United Nation's Millennium Development Goals is to reduce maternal death rates by three-quarters by 2015. Between 1990 and 2010, these rates were nearly halved. So there is still some way to go to meet the target.
One of the major causes of maternal death is excessive bleeding after birth, known as postpartum hemorrhage (PPH). The highest rates of PPH are found in Africa (28% of births), with an overall global rate of 11%. PPH can be caused by the uterus not contracting after the baby is born, damage to tissues and blood vessels, retention of the placenta, and problems with blood-clotting.
PPH can be prevented by an injection of oxytocin (a hormone) or with tablets of the drug misoprostol immediately after birth. Other drugs exist but are used much less frequently in low-income countries. If the mother does bleed excessively, then these interventions can also be used to treat PPH in the hours following birth. These drugs cause the uterus to contract. Continued severe bleeding requires emergency treatment in hospital. The World Health Organization (WHO) recommends that in situations where women give birth without the assistance of a trained midwife, priority should be given to preventing PPH because access to emergency services may be limited.
Why Was This Study Done?
Of the two most common options for preventing PPH, oxytocin is generally the preferred choice. It has the advantage of having no side effects, whereas misoprostol can cause fever and shivering. A repeat injection of oxytocin can also be given if the mother continues to bleed excessively, whereas a dose of misoprostol after birth should only be given once. A major concern about both drugs is that the timing of administration must be precise. Giving a drug that causes the uterus to contract before birth can be harmful to both mother and baby. A disadvantage of oxytocin is that it requires someone trained and authorized to give an injection. For this reason, oxytocin has so far been generally limited to hospitals and clinics, where it can be administered by medically trained professionals. Another disadvantage is that oxytocin is weakened by heat, which means its storage and use may be impractical in hot countries.
The main aim of this study was therefore to find out whether health workers without midwifery skills are able to administer oxytocin safely when attending home births in poor, rural communities.
What Did the Researchers Do and Find?
The researchers carried out a cluster-randomized controlled trial in four rural districts in Ghana, working with community health officers (CHOs). CHOs are trained for two years in giving childhood immunizations and antenatal and postnatal care, but are not trained midwives. 54 CHOs were randomized to one of two groups. The CHOs in the first group gave a preventative oxytocin injection to the mother at every birth they attended. The oxytocin was administered using a pre-filled, disposable device called Uniject that is easier and quicker to use than a syringe and needle. The packaging also included a heat-sensitive label that indicated whether the oxytocin still met the manufacturer's criteria for an acceptably potent drug. CHOs in the second group acted as controls, and did not give any oxytocin injections to prevent PPH. The women seen by each CHO formed a cluster. Comparisons were made across the clusters of women that either received or did not receive the preventative intervention.
The researchers found that the women who were given a preventative oxytocin injection lost less blood after birth than the women who did not receive a preventative injection. There were also fewer cases of PPH amongst the women who received oxytocin for PPH prevention. 2.6% of the women who received a preventative oxytocin injection experienced PPH, compared to 5.5% of the controls. Therefore the risk of PPH was approximately halved. There were no cases of oxytocin use before delivery of the baby and no difference in the frequency of other birth complications between women in the intervention and control groups.
What Do These Findings Mean?
These findings show that under the trial conditions, CHOs can safely administer oxytocin injections when attending home births in poor, rural settings. This intervention also proved practical to use in the Uniject format.
The study therefore suggests that oxytocin should be considered for use in regions where maternal deaths from PPH are still unacceptably high. There are also several noteworthy limitations, such as unblinding and the imbalance between participant groups. The researchers emphasized that their findings do not mean that oxytocin is always a better choice than misoprostol for home births. Many factors will influence which intervention is the most feasible, such as the local availability of sufficiently skilled health professionals, the relative cost and availability of the two drugs, as well as ease of access to emergency health services.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001524.
This study is further discussed in a PLOS Medicine Perspective by João Paulo Souza
WHO Factsheet on Maternal Mortality
United Nations Population Fund's Goals to improve sexual and reproductive health
doi:10.1371/journal.pmed.1001524
PMCID: PMC3794862  PMID: 24130463

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