Validation of the Premature Infant Pain Profile-Revised (PIPP-R)

Objectives

To examine the construct validity, inter-rater reliability, and feasibility of the Premature Infant Pain Profile-Revised in infants of varying gestational ages, diagnoses, and procedures.

Methods

A prospective cross-over study with infants in three gestational age groups (26–31, 32–36, and ≥ 37 weeks) at three university-affiliated Neonatal Intensive Care Units in Canada. One hundred and ninety five bedside nurses and expert raters rated 202 hospitalized infants' pain during scheduled procedures using the measure. An expert rater and a nurse independently assessed infants' pain scores, using the Premature Infant Pain Profile-Revised, during 246 scheduled pairs of painful and non-painful procedures in the 202 infants. Nurses also completed a feasibility survey on using the measure in a clinical setting. To establish construct validity, pain scores were computed during painful and non-painful procedures. Inter-rater reliability between pain experts and nurses was calculated. A 5-point Likert scale was used to measure feasibility in terms of clarity, ease of use, and time to complete.

Results

Irrespective of gestational age, Premature Infant Pain Profile-Revised scores were significantly higher during painful procedures (mean 6.7 [SD 3.0]) compared to non-painful procedures (mean 4.8 [SD 2.9]). There was a high degree of correlation between nurses' and experts' ratings for painful (all R² = 0.92, p < 0.001) and non-painful (all R² = 0.87, p < 0.001) procedures. Mean scores on all feasibility indicators were equal to or higher than 3.8.

Discussion

The Premature Infant Pain Profile Revised has beginning construct validation, inter-rater reliability, and is considered feasible by clinicians. Concurrent validation studies should be considered.     

Clinical evaluation of patients with temporomandibular joint implants

PURPOSE: An undetermined number of patients with temporomandibular joint (TMJ) symptoms have been treated with intra-articular disc implants composed of Teflon ethylene/propylene or Teflon polytetrafluoroethylene and aluminum oxide (Proplast-Teflon; Vitek, Houston, TX). These implants have shown the potential to fragment in situ resulting in nonbiodegradable particles that stimulate a giant cell reaction and lead to degeneration of local structures, pain, and limitation of mandibular opening. We examined the possible relationship between TMJ implants and persistent pain, responses to sensory stimuli, quality of life, and systemic immune dysfunction. PATIENTS AND METHODS: This case series (32 patients) were referred from university-based orofacial pain centers and private practices from across the United States. Laboratory and clinical assessments evaluated orofacial pain symptoms, neurologic function, clinical signs and symptoms of rheumatologic disease, physical function, systemic measures of immune function, and behavioral measures. RESULTS: We found that TMJ implant patients appeared to have altered sensitivity to sensory stimuli, a higher number of tender points with a diagnosis of fibromyalgia, increased self-report of chemical sensitivity, higher psychologic distress and significantly lower functional ability. Systemic illness or autoimmune disease was not evident in this series of TMJ implant patients. CONCLUSIONS: Significant problems were noted on clinical assessment of TMJ implant patients. This is a US government work. There are no restrictions on its use.     

Capacity for training in clinical research: status and opportunities

The ability to base patient care on scientific evidence depends in part on the results of translational and applied research. The shortage of trained clinical researchers identified by several sources limits the availability of clinical research studies upon which to base evidence-based therapeutics. This premise suggests that the dental profession needs to train more clinical researchers and faculty to conduct clinical research and to teach its applications to practice. Increasing opportunities for clinical research training in a variety of settings should eventually increase the numbers of clinical researchers, raise faculty involvement in clinical research, and promote science transfer. This paper reports on the current status of clinical research in dental schools, specifies the diverse groups involved in the clinical research enterprise, and identifies underutilized opportunities and partnerships for clinical research training. Data on federal and nonfederal funding of clinical research and training programs are presented. Existing and novel mechanisms for expanding clinical research training throughout and across traditional as well as unconventional environments are explored.     

Preemptive vs preventive analgesia: which approach improves clinical outcomes?

Administering a drug that blocks painful (nociceptive) input from entering the central nervous system before a surgical procedure attenuates the development of changes that manifest as increased pain at later time points. Clinically, this strategy predicts not only less pain during the initial postoperative period, but also lowers the intensity of pain during the days after the procedure. By lessening pain during recovery, fewer analgesics are consumed, which results in fewer adverse drug reactions (i.e. side effects) complicating the postoperative course and delaying the patient's return to normal activities. The patient can be assured that the postoperative pain associated with the procedure will be minimized, thereby decreasing postoperative apprehension, increasing patient motivation for enduring the procedure, and enhancing the probability of a smooth postoperative course. The adaptation of this method as a standard clinical practice has been delayed by controversy over whether the pharmacological intervention should be administered before the surgical event (preemptive analgesia), before pain onset (preventive analgesia), or by repeat administration over the expected postoperative course. Evidence reviewed in this article supports all of these approaches for decreasing the development of central sensitization, attenuating postoperative pain, decreasing analgesic consumption, and enhancing recovery.     

Comorbidity Burden in Trial-Aligned Patients with Established Gout in Germany,UK, US,and France: a Retrospective Analysis

Introduction

Patients with gout have numerous comorbidities. We aimed to estimate the prevalence and incidence rates of renal and cardiovascular morbidities in trial-aligned patients with established gout in Germany (DE), the United Kingdom (UK), the United States (US), and France (FR).

Methods

This longitudinal cohort study used retrospective data from IMS Disease Analyzer? (DE, FR), Clinical Practice Research Datalink–Hospital Episode Statistics (UK), and IMS’ PharMetrics Plus database linked with outpatient laboratory results (US). Included patients were ≥18 years at index date (January 1, 2010; all dates +1 year for FR), with continuous enrollment during the pre-index year, had “prevalent established gout” determined by data in the pre-index year, and ≥1 documented visit after index date; additional inclusion/exclusion criteria were aligned with recent gout clinical trials. Look-back for comorbidity prevalence extended to January 1, 2003 (US: January 1, 2009). Follow-up for incidence extended from index date to at most March 26, 2013 (FR: May 31, 2014). Events of interest were identified by diagnostic codes and/or laboratory data.

Results

The trial-aligned cohorts included 35,118 (DE), 24,607 (UK), 121,591 (US), and 17,338 (FR) patients. Among renal conditions, baseline diagnosis of chronic kidney disease/renal failure was most prevalent in the UK followed by DE; abnormal serum creatinine was most prevalent in the UK. Hypertension was the most prevalent cardiovascular diagnosis in all countries, followed by ischemic heart disease (IHD) and myocardial infarction. Incidence rates (per 100 patient-years) for new/worsening renal impairment ranged from 1.67 (DE) to 4.34 (US) and for nephrolithiasis diagnosis from 0.31 (FR) to 3.79 (US). The incidence rates for hypertension diagnosis were highest among cardiovascular-related events, ranging from 3.23 (UK) to 20.27 (US), followed by IHD.

Conclusions

Patients with established gout such as those included in gout trials have a high burden of established morbidity and new diagnoses of morbid events. Consideration of comorbidities, which greatly exacerbate disease burden, is important in gout management.

Funding

AstraZeneca.