Development and initial validation of MedHipPro-Q: a questionnaire assessing medication management of hip fracture patients in different care settings.

BACKGROUND: A validated questionnaire to assess medication management of hip fracture patients within and outside the hospital setting was lacking. The study aims were to describe the hip fracture patient pathway, and develop a valid and feasible questionnaire to assess clinicians' experience with medication management of hip fracture patients in different care settings throughout the patient pathway. METHODS: This qualitative, descriptive methodological study used strategic and snowball sampling. The questionnaire was developed, and face and content validity explored through interviews with stakeholders. Phase I described the hip fracture patient pathway, and identified questionnaire dimensions in semi-structured interviews with management and clinicians (n = 37). The patient pathway was also discussed in six meetings (n = 70). Phase II refined a first draft of the questionnaire through cognitive interviews with future respondents (n = 23). The draft was modified after each interview. Post hoc, cognitive interview data were analysed using matrix analysis to condense problems and solutions into themes and subthemes. Phase III, converted the final version to a digital format, and tested its feasibility with a subset of the cognitive interview participants (n = 21) who completed the questionnaire and provided feedback. RESULTS: Phase I: Hip fracture patients were cared for in at least three different care settings, and went through at least four handovers between and within primary and secondary care. Three questionnaire dimensions were identified: 1) Medication reconciliation and review, 2) Communication of key information, and 3) Profession and setting. Phase II: The MedHipPro-Q was representative of how the different professions experienced medication management in all settings, and hence showed face and content validity. Post hoc analysis: Problem themes (with sub-themes) were Representativeness (-of patient pathway and -of respondent reality) and Presentation (Language and Appearance). Solution themes (with sub-themes) were: Content (added or deleted) and Presentation (modified appearance or corrected language). Phase III: Participants did not identify technical, linguistic or content flaws in the questionnaire, and the digital version was considered feasible for use. CONCLUSION: The novel MedHipPro-Q showed good face and content validity, and was feasible for use throughout the hip fracture patient pathway. The rigorous development process supports its construct validity and reliability.

The Complexities of Nurses' Pain Assessment in Hospitalized Preverbal Children.

BACKGROUND: Preverbal children are at increased risk for underassessment of pain. Pain is a social transaction involving the child in pain and the nurse assessor. However, our understanding of the nurse's part in this transaction is limited. AIMS: The aim of this study was to explore nurses' assessment of pain in hospitalized preverbal children based on self-selected clinical examples. DESIGN: Qualitative, descriptive design. SETTINGS: Five different hospital units in Canada and Norway. All units had an observational pain scale for preverbal children available for use. PARTICIPANTS/SUBJECTS: Nurses (N = 22) with ≥1 year experience caring for preverbal children. METHODS: Individual, semistructured interviews. Data were analyzed using inductive thematic analysis. RESULTS: Nurses' assessment of pain in hospitalized preverbal children emerged as a nonlinear complex process incorporating different actions and reflections in response to the child's situation and expression of distress. Information from parents was routinely included in the assessment, although further parental involvement varied considerably. Although each assessment was personalized to the individual child, the nurse used previous experiences to interpret observations of and information from the child and the parents. Few nurses described using structured pain scales, but when used, these scales were included as only one aspect of their overall assessment. CONCLUSIONS: Nurses preferred pain assessment based on clinical judgment and tailored to the individual child. Implementation strategies that aim to integrate structured pain scales with clinical judgment to assess pain may be more likely to succed. Further examination of this approach is warranted.

Cultural adaptation and harmonization of four Nordic translations of the revised Premature Infant Pain Profile (PIPP-R).

BACKGROUND: Preterm infants are especially vulnerable to pain. The intensive treatment often necessary for their survival unfortunately includes many painful interventions and procedures. Untreated pain can lead to both short- and long-term negative effects. The challenge of accurately detecting pain has been cited as a major reason for lack of pain management in these non-verbal patients. The Premature Infant Pain Profile (PIPP) is one of the most extensively validated measures for assessing procedural pain in premature infants. A revised version, PIPP-R, was recently published and is reported to be more user-friendly and precise than the original version. The aims of the study were to develop translated versions of the PIPP-R in Finnish, Icelandic, Norwegian, and Swedish languages, and to establish their content validity through a cultural adaptation process using cognitive interviews. METHODS: PIPP-R was translated using the recommendations from the International Society for Pharmacoeconomics and Outcomes Research and enhanced with cognitive interviews. The respondent nurse was given a copy of the translated, national version of the measure and used this together with a text describing the infant in the film to assess the pain of an infant in a short film. During the assessment the nurse was asked to verbalize her thought process (thinking aloud) and upon completion the interviewer administered probing questions (verbal probing) from a structured interview guide. The interviews were recorded, transcribed, and analyzed using a structured matrix approach. RESULTS: The systematic approach resulted in translated and culturally adapted versions of PIPP-R in the Finnish, Icelandic, Norwegian and Swedish languages. During the cultural adaptation process several problems were discovered regarding how the respondent understood and utilized the measure. The problems were either measure problems or other problems. Measure problems were solved by a change in the translated versions of the measure, while for other problems different solutions such as education or training were suggested. CONCLUSIONS: This study have resulted in translations of the PIPP-R that have content validity, high degree of clinical utility and displayed beginning equivalence with each other and the original version of the measure.

Pain assessment practices in Swedish and Norwegian neonatal care units.

BACKGROUND: The use of measurement scales to assess pain in neonates is considered a prerequisite for effective management of pain, but these scales are still underutilised in clinical practice. AIM: The aim of this study was to describe and compare pain assessment practices including the use of pain measurement scales in Norwegian and Swedish neonatal care units. METHODS: A unit survey investigating practices regarding pain assessment and the use of pain measurement scales was sent to all neonatal units in Sweden and Norway (n = 55). All Norwegian and 92% of Swedish units responded. RESULTS: A majority of the participating units (86.5%) assessed pain. Swedish units assessed and documented pain and used pain measurement scales more frequently than Norwegian units. The most frequently used scales were different versions of Astrid Lindgren's Pain Scale (ALPS) in Sweden and Echelle Douleur Inconfort Noveau-Ne (EDIN), ALPS and Premature Infant Pain Profile (PIPP) in Norway. Norwegian head nurses had more confidence in their pain assessment method and found the use of pain measurement scales more important than their Swedish colleagues. CONCLUSION: The persisting difference between Swedish and Norwegian units in pain assessment and the use of pain measurement scales are not easily explained. However, the reported increased availability and reported use of pain measurement scales in neonatal care units in both countries may be seen as a contribution towards better awareness and recognition of pain, better pain management and potentially less suffering for vulnerable neonates.

Assessment of continuous pain in newborns admitted to NICUs in 18 European countries.

AIM: Continuous pain occurs routinely, even after invasive procedures, or inflammation and surgery, but clinical practices associated with assessments of continuous pain remain unknown. METHODS: A prospective cohort study in 243 neonatal intensive care units (NICUs) from 18 European countries recorded the frequency of pain assessments, use of mechanical ventilation, sedation, analgesia or neuromuscular blockade for each neonate for up to 28 days after NICU admission. RESULTS: Only 2113 of 6648 (31.8%) of neonates received assessments of continuous pain, occurring variably among tracheal ventilation (TrV, 46.0%), noninvasive ventilation (NiV, 35.0%) and no ventilation (NoV, 20.1%) groups (p < 0.001). Daily assessments for continuous pain occurred in only 10.4% of all neonates (TrV: 14.0%, NiV: 10.7%, NoV: 7.6%; p < 0.001). More frequent assessments of continuous pain occurred in NICUs with pain guidelines, nursing champions and surgical admissions (all p < 0.01), and for newborns <32 weeks gestational age, those requiring ventilation, or opioids, sedatives-hypnotics, general anaesthetics (O-SH-GA) (all p < 0.001), or surgery (p = 0.028). Use of O-SH-GA drugs increased the odds for pain assessment in the TrV (OR:1.60, p < 0.001) and NiV groups (OR:1.40, p < 0.001). CONCLUSION: Assessments of continuous pain occurred in less than one-third of NICU admissions and daily in only 10% of neonates. NICU clinical practices should consider including routine assessments of continuous pain in newborns.

The COMFORT behavioural scale provides a useful assessment of sedation, pain and distress in toddlers undergoing minor elective surgery.

AIM: The COMFORT behavioural scale was developed to assess sedation, pain and distress in children unable to report pain. Our aims were to test construct validity of the scale in toddlers undergoing minor surgery and determine the inter-rater reliability of the scale. METHODS: We consecutively enrolled 45 children aged 12-36 months from a Norwegian surgical outpatient care unit. The level of sedation, pain and distress was assessed before and after surgery with the COMFORT behavioural scale. Inter-rater reliability was estimated and construct validity was tested based on a priori defined hypotheses. A 2.5-point (15%) change in the scale was considered clinically important. RESULTS: We obtained 307 scores covering most of the scale's range, but a floor effect was clearly present. Inter-rater reliability was high between assessors (intraclass correlation coefficient = 0.96; 95% CI 0.92-0.98). Clinically important differences were seen between baseline and light sedation (3.1 points, p < 0.001) and between light and deep sedation (4.6 points, p = 0.002). The difference between baseline and our definition of a pain/distress state was not clinically important (1.5 points, p = 0.039). CONCLUSION: The COMFORT behavioural scale can provide one aspect of an overall clinical assessment of sedation, and probably pain and distress, in toddlers before and after surgery.

"I have to obey my pain" - children's experiences of pain burden in cerebral palsy.

PURPOSE: To explore pain experiences of children with cerebral palsy, and how it influences their everyday life. METHOD: Fourteen children with CP between eight and seventeen years old were included, using a purposeful sampling strategy. They had different experiences of pain, and different degrees of physical and cognitive impairments. Sixteen individual semi-structured interviews were carried out, and analyzed using inductive thematic analysis. RESULTS: Data analysis resulted in the main theme "I have to obey my pain" and four themes were identified. Experiences regarding pain varied ("My pain is mine alone"). Both pain itself and the use of cognitive strategies to cope with pain involved a mental struggle ("Pain brings me down"). The children had to make adjustments to manage their pain ("I want to participate, but I have to rest"). The most important help was to be understood, but adults also provided valuable help with interventions like stretching, medication and adjustment of activity levels ("Others can help me"). CONCLUSION: Pain was a determining feature in the lives of these children with CP. The wide variety of experiences and challenges emphasized the need for tailored management strategies developed together with each child and their parents.IMPLICATIONS FOR REHABILITATIONChildren with cerebral palsy had varied experiences of pain, and health professionals need to tailor their pain management approaches to the individual child.Health services should offer pain education to expand children's repertoire of pain management strategies.When a child's pain influences their daily activities, health services must ensure that the school is informed of the child's situation, and able to make necessary adjustments.Health professionals should strive to include children's own descriptions whenever possible to make sure children feel heard and believed.Even children with communicative and cognitive impairments were able to self-report when necessary adjustments in the communication situation were made.

"Pain is one piece of a complex jigsaw puzzle" - experiences of raising a child with cerebral palsy who has pain.

Purpose: To explore experiences of parenting a child with CP and pain.Method: Fourteen mothers and one father of children (9-16) with CP were included. All children had pain regularly, but the frequency and intensity of their pain experiences varied. Their motor function varied from GMFCS level I to V. Cognitive abilities varied from normal to moderate cognitive deficits. All children could express themselves verbally. Semi structured individual interviews were carried out, and results were developed using inductive thematic analysis.Results: The analysis resulted in the main theme "My child's pain is just one piece of a complex jigsaw puzzle". The main theme was developed by four mutually exclusive, but related themes: "My child's struggle burdens me", "Pain and CP direct our everyday life", "I want to be in control, but cannot always be" and "We are the only ones who understand the complexity".Conclusion: Parents of children with CP experience pain as one aspect of a bigger picture. They need help and support to cope with their child's pain, and professional helpers need to address the complexity pain is a part of.IMPLICATIONS FOR REHABILITATIONParents of children with cerebral palsy (CP) experience their child's pain as one piece in a jigsaw puzzle, and counseling needs to address the complexity rather than the separate parts of the picture.Health professionals should support parents in evaluation and management of their child's pain, as a feeling of competence in pain management is important to reduce parental stress.Health professionals should inform themselves about the life situation of parents whose child with CP has pain, and encourage them to seek practical support and apply for relevant support schemes that can make their everyday life easier.Parents of children with CP should be encouraged to take part in a diagnosis-specific support group, where they can meet with others in a similar situation, in order to reduce their feeling of being alone with their challenges.

Clinical pharmacist intervention to improve medication safety for hip fracture patients through secondary and primary care settings: a nonrandomised controlled trial.

BACKGROUND: Hip fracture patients face a patient safety threat due to medication discrepancies and adverse drug reactions when they have a combination of high age, polypharmacy and several care transitions. Consequently, optimised pharmacotherapy through medication reviews and seamless communication of medication information between care settings is necessary. The primary aim of this study was to investigate the impact on medication management and pharmacotherapy. The secondary aim was to evaluate implementation of the novel Patient Pathway Pharmacist intervention for hip fracture patients. METHODS: Hip fracture patients were included in this nonrandomised controlled trial, comparing a prospective intervention group (n = 58) with pre-intervention controls who received standard care (n = 50). The Patient Pathway Pharmacist intervention consisted of the steps: (A) medication reconciliation at admission to hospital, (B) medication review during hospitalisation, (C) recommendation for the medication information in the hospital discharge summary, (D) medication reconciliation at admission to rehabilitation, and (E) medication reconciliation and (F) review after hospital discharge. The primary outcome measure was quality score of the medication information in the discharge summary (range 0-14). Secondary outcomes were potentially inappropriate medications (PIMs) at discharge, proportion receiving pharmacotherapy according to guidelines (e.g. prophylactic laxatives and osteoporosis pharmacotherapy), and all-cause readmission and mortality. RESULTS: The quality score of the discharge summaries was significantly higher for the intervention patients (12.3 vs. 7.2, p < 0.001). The intervention group had significantly less PIMs at discharge (- 0.44 (95% confidence interval - 0.72, - 0.15), p = 0.003), and a higher proportion received prophylactic laxative (72 vs. 35%, p < 0.001) and osteoporosis pharmacotherapy (96 vs. 16%, p < 0.001). There were no differences in readmission or mortality 30 and 90 days post-discharge. The intervention steps were delivered to all patients (step A, B, E, F = 100% of patients), except step (C) medication information at discharge (86% of patients) and step (D) medication reconciliation at admission to rehabilitation (98% of patients). CONCLUSION: The intervention steps were successfully implemented for hip fracture patients and contributed to patient safety through a higher quality medication information in the discharge summary, fewer PIMs and optimised pharmacotherapy. TRIAL REGISTRATION: NCT03695081.

Medication management for patients with hip fracture at a regional hospital and associated primary care units in Norway: a descriptive study based on a survey of clinicians' experience and a review of patient records.

OBJECTIVE: Patients with hip fracture are at high risk of medication errors due to a combination of high age, comorbidities, polypharmacy and several care transitions after fracture. The aim was to study medication management tasks concerning patient safety: medication reconciliation, medication review and communication of key medication information in care transitions. DESIGN: Descriptive study comprising a self-administered clinician survey (MedHipPro-Q) and a retrospective review of hospital medical records of patients with hip fracture. SETTING: Regional hospital and the associated primary care units (South-Eastern Norway). PARTICIPANTS: The survey received responses from 253 clinicians, 61 medical doctors and 192 nurses, involved in the medication management of patients with hip fracture, from acute admittance to the regional hospital, through an in-hospital fast track, primary care rehabilitation and back to permanent residence. Respondents' representativeness was unknown, introducing a risk of selection and non-response bias, and extrapolating findings should be done with caution. The patient records review included a random sample of records of patients with hip fracture (n=50). OUTCOME MEASURES: Medication reconciliation, medication review and communication of medication information from two perspectives: the clinicians' (ie, experiences with medication management) and the practice (ie, documentation of completed medication management). RESULTS: In the survey, most clinicians stated they performed medication reconciliation (79%) and experienced that patients often arrived without a medication list after care transition (37%). Doctors agreed that more patients would benefit from medication reviews (86%). In the hospital patient records, completed medication reconciliation was documented in most patients (76%). Medication review was documented in 2 of 50 patients (4%). Discharge summary guidelines were followed fully for 3 of 50 patients (6%). CONCLUSION: Our study revealed a need for improved medication management for patients with hip fracture. Patients were at risk of medication information not being transferred correctly between care settings, and medication reviews seemed to be underused in clinical practice.

Pain burden in children with cerebral palsy (CPPain) survey: Study protocol.

Pain is a significant health concern for children living with cerebral palsy (CP). There are no population-level or large-scale multi-national datasets using common measures characterizing pain experience and interference (ie, pain burden) and management practices for children with CP. The aim of the CPPain survey is to generate a comprehensive understanding of pain burden and current management of pain to change clinical practice in CP. The CPPain survey is a comprehensive cross-sectional study. Researchers plan to recruit approximately 1400 children with CP (primary participants) across several countries over 6-12 months using multimodal recruitment strategies. Data will be collected from parents or guardians of children with CP (0-17 years) and from children with CP (8-17 years) who are able to self-report. Siblings (12-17 years) will be invited to participate as controls. The CPPain survey consists of previously validated and study-specific questionnaires addressing demographic and diagnostic information, pain experience, pain management, pain interference, pain coping, activity and participation in everyday life, nutritional status, mental health, health-related quality of life, and the effect of the COVID-19 pandemic on pain and access to pain care. The survey will be distributed primarily online. Data will be analyzed using appropriate statistical methods for comparing groups. Stratification will be used to investigate subgroups, and analyses will be adjusted for appropriate sociodemographic variables. The Norwegian Regional Committee for Medical and Health Research Ethics and the Research Ethics Board at the University of Minnesota in USA have approved the study. Ethics approval in Canada, Sweden, and Finland is pending. In addition to dissemination through peer-reviewed journals and conferences, findings will be communicated through the CPPain Web site (www.sthf.no/cppain), Web sites directed toward users or clinicians, social media, special interest groups, stakeholder engagement activities, articles in user organization journals, and presentations in public media.

The evidence supporting the association between the use of pain scales and outcomes in hospitalized children: A systematic review.

BACKGROUND: Systematic use of pain intensity scales is considered a prerequisite for treatment of pain in hospitalized children, but already a decade ago, attention was called to the lack of robust evidence supporting the presumed positive association between their use and desired outcomes. OBJECTIVES: To re-evaluate the evidence supporting the association between the use of pain scales and patient and process outcomes in hospitalized children. DESIGN: Systematic literature review. DATA SOURCES: The online databases PubMed and Cumulative Index of Nursing and Allied Health Literature (CINAHL) were searched from inception to April 15, 2020. REVIEW METHODS: We performed single screening of all records followed by duplicate screening of full texts of interest with a disagreement procedure in place. Studies where the authors evaluated outcomes from the use of self-report or behavioral-based pain scales in children 0-18 years in a hospital setting were included. Emergency care settings were excluded. RESULTS: In a majority of the 32 included studies, complex interventions that included one or more pain scales were evaluated. Process outcomes (e.g., documentation) were most frequently studied. Interventions were commonly associated with improved documentation of pain assessment, while the effect on pain management documentation was inconsistent. However, improvements in process outcomes did not necessarily result in better patient outcomes. In regard to patient outcomes (e.g., pain intensity, side effects, or satisfaction with treatment), some authors reported reduced pain intensity on group level, but the effect on other functional outcomes, child and parent satisfaction, and aspects of safety were inconsistent. Methodological issues, e.g., weak study designs and small samples, biased the results, and it was not possible to determine how pain scales contributed to the overall effects since they were studied as part of complex interventions. CONCLUSIONS: Although both a theoretically founded understanding of pain and clinical experience suggest that the use of pain scales will make a difference for hospitalized children with pain, there is still limited evidence to support this notion. As pain scales have been almost exclusively studied as an aspect of complex interventions, research that determines the active ingredient(s) in a complex intervention and their joint and individual effects on outcomes that are meaningful for the child (for example reduced pain intensity or improved function) are urgently needed. Tweetable abstract: Limited #research supports association between use of pediatric #pain scales and patient outcomes @_randida @PainPearl.

Nurses' perception, knowledge, and use of neonatal pain assessment.

Preterm and sick newborn infants undergo several painful procedures during their hospital stay, potentially leading to short- and long-term negative consequences. Pain assessment should be performed regularly to provide optimal pain management. Nurses' knowledge of and attitude toward neonatal pain assessment affect how pain is assessed and managed in the clinical situation. The aim of this study was to explore Swedish nurses' perception, knowledge, and use of neonatal pain assessment. This descriptive, cross-sectional questionnaire study was conducted across all Swedish neonatal units (n = 38). Respondents were chosen through convenience sampling by the head nurses at each unit. Ten nurses from each unit were asked to complete the survey, which contained both closed and open questions. A majority of the units (30/38; 79%) participated and 232 surveys were returned, a response rate of 61%. Of the nurses, 91% thought that neonatal pain assessment was important. Many nurses mentioned various difficulties with pain assessment and concerns that the scales used might not assess pain correctly. About half of the nurses considered themselves to have enough knowledge of neonatal pain assessment. Those who reported having enough knowledge of pain assessment viewed the pain scales used at their units more positively. Of the nurses, 74% reported using a pain assessment scale several times per work shift. Pain management guidelines were available according to 75% of nurses, but only 53% reported that the guidelines were followed. Although nurses in general expressed a positive attitude toward pain assessment scales, this was not necessarily evident in their clinical practice. Lack of knowledge, available or accessible guidelines, or concerns regarding the validity of available pain scales seemed to limit their use.

The measurement properties of pediatric observational pain scales: A systematic review of reviews.

BACKGROUND: Valid observational pain scales are needed to assess pain and ensure sufficient treatment of pain in children that lack the verbal ability to self-report pain. Published reviews attempt to synthesize results from primary studies validating these scales and based on the findings recommendations may be given, for example which pain scales are the most appropriate for use in different pediatric populations. OBJECTIVES: The aims of this review were to describe how systematic reviews have evaluated and recommended observational pain scales for use in children aged 0-18 years and appraise the evidence underlying these recommendations. DESIGN: Systematic review of reviews. DATA SOURCES: The Cochrane Library, PubMed/MEDLINE, CINAHL, Web of Science, and PsychINFO were searched from inception to September 2016. Reference lists and gray literature were searched for additional studies. REVIEW METHODS: Study selection and data extraction were performed by two reviewers independently with a disagreement procedure in place. Methodological quality or study validity was measured using the Assessment of Multiple Systematic Reviews checklist and risk of bias or internal validity was measured using the Risk of Bias in Systematic Reviews tool. The review protocol was registered with PROSPERO: registration number CRD42016035264. RESULTS: Twelve reviews met the inclusion criteria. Together; they included 65 different observational pain scales for use in children, of which 28 were recommended at least once. Face, Legs, Activity, Cry, Consolability/revised version of Face, Legs, Activity, Cry, Consolability, COMFORT/COMFORT behavioral scale and Children's Hospital of Eastern Ontario Pain Scale were evaluated and recommended most frequently. Few of the included reviews assessed the methodological quality of the studies included in the review. The narrative analysis consisted mostly of a reiteration of the results from the primary studies. In general, more recent reviews showed a lower risk of bias than older ones. CONCLUSIONS: Included reviews exhibited low quality of evidence; thus, their recommendations regarding pain scales for use in clinical practice or research with children that lack the verbal ability to self-report pain should be interpreted with caution.

Sedation and analgesia practices in neonatal intensive care units (EUROPAIN): results from a prospective cohort study.

BACKGROUND: Neonates who are in pain or are stressed during care in the intensive care unit (ICU) are often given sedation or analgesia. We investigated the current use of sedation or analgesia in neonatal ICUs (NICUs) in European countries. METHODS: EUROPAIN (EUROpean Pain Audit In Neonates) was a prospective cohort study of the management of sedation and analgesia in patients in NICUs. All neonates admitted to NICUs during 1 month were included in this study. Data on demographics, methods of respiration, use of continuous or intermittent sedation, analgesia, or neuromuscular blockers, pain assessments, and drug withdrawal syndromes were gathered during the first 28 days of admission to NICUs. Multivariable linear regression models and propensity scores were used to assess the association between duration of tracheal ventilation (TV) and exposure to opioids, sedatives-hypnotics, or general anaesthetics in neonates (O-SH-GA). This study is registered with ClinicalTrials.gov, number NCT01694745. FINDINGS: From Oct 1, 2012, to June 30, 2013, 6680 neonates were enrolled in 243 NICUs in 18 European countries. Mean gestational age of these neonates was 35.0 weeks (SD 4.6) and birthweight was 2384 g (1007). 2142 (32%) neonates were given TV, 1496 (22%) non-invasive ventilation (NIV), and 3042 (46%) were kept on spontaneous ventilation (SV). 1746 (82%), 266 (18%), and 282 (9%) neonates in the TV, NIV, and SV groups, respectively, were given sedation or analgesia as a continuous infusion, intermittent doses, or both (p<0.0001). In the participating NICUs, the median use of sedation or analgesia was 89.3% (70.0-100) for neonates in the TV group. Opioids were given to 1764 (26%) of 6680 neonates and to 1589 (74%) of 2142 neonates in the TV group. Midazolam was given to 576 (9%) of 6680 neonates and 536 (25%) neonates of 2142 neonates in the TV group. 542 (25%) neonates in the TV group were given neuromuscular blockers, which were administered as continuous infusions to 146 (7%) of these neonates. Pain assessments were recorded in 1250 (58%) of 2138, 672 (45%) of 1493, and 916 (30%) of 3017 neonates in the TV, NIV, and SV groups, respectively (p<0.0001). In the univariate analysis, neonates given O-SH-GA in the TV group needed a longer duration of TV than did those who were not given O-SH-GA (mean 136.2 h [SD 173.1] vs 39.8 h [94.7] h; p<0.0001). Multivariable and propensity score analyses confirmed this association (p<0.0001). INTERPRETATION: Wide variations in sedation and analgesia practices occur between NICUs and countries. Widespread use of O-SH-GA in intubated neonates might prolong their need for mechanical ventilation, but further research is needed to investigate the therapeutic and adverse effects of O-SH-GA in neonates, and to develop new and safe approaches for sedation and analgesia. FUNDING: European Community's Seventh Framework Programme.

Cultural adaptation of patient and observational outcome measures: a methodological example using the COMFORT behavioral rating scale.

BACKGROUND: There is little empirical evidence regarding the translation and cultural adaptation of self-report and observational outcome measures. Studies that evaluate and further develop existing practices are needed. OBJECTIVES: This study explores the use of cognitive interviews in the translation and cultural adaptation of observational measures, using the COMFORT behavioral scale as an example, and demonstrates a structured approach to the analysis of data from cognitive interviews. The COMFORT behavioral scale is developed for assessment of distress and pain in a pediatric intensive care setting. DESIGN: Qualitative, descriptive methodological study. SETTING: One general public hospital trust in southern Norway. PARTICIPANTS: N=12. Eight nurses, three physicians and one nurse assistant, from different wards and with experience caring for children. METHODS: We translated the COMFORT behavior scale into Norwegian before conducting individual cognitive interviews. Participants first read and then used the translated version of the COMFORT behavioral scale to assess pain based on a 3-min film vignette depicting an infant in pain/distress. Two cognitive interview techniques were applied: Thinking Aloud (TA) during the assessment and Verbal Probing (VP) afterwards. In TA the participant verbalized his/her thought process while completing the COMFORT behavioral scale. During VP the participant responded to specific questions related to understanding of the measure, information recall and the decision process. We audio recorded, transcribed and analyzed interviews using a structured qualitative method (cross-case analysis based on predefined categories and development of a results matrix). RESULTS: Our analysis revealed two categories of problems: (1) Scale problems, warranting a change in the wording of the scale, including (a) translation errors, (b) content not understood as intended, and (c) differences between the original COMFORT scale and the revised COMFORT behavioral scale; and (2) Rater-context problems caused by (a) unfamiliarity with the scale, (b) lack of knowledge and experience, and (c) assessments based on a film vignette. CONCLUSIONS: Cognitive interviews revealed problems with both the translated and the original versions of the scale and suggested solutions that enhanced the validity of both versions. Cognitive interviews might be seen as a complement to current published best practices for translation and cultural adaptation.

The opinions of clinical staff regarding neonatal procedural pain in two Norwegian neonatal intensive care units.

AIM: Neonates are subjected to numerous painful procedures without sufficient pain management. The aim of this study was to describe the opinions of Norwegian physicians, nurses and nurse assistants who care for neonates, regarding procedural pain in neonates. METHODS: A replication of a previous questionnaire study was conducted in two Norwegian neonatal intensive care units (NICU's). The questionnaire aimed at evaluating procedure painfulness, the current use of pharmacological agents and comfort measures and the optimal use of both. RESULTS: Ninety members of the clinical staff participated, which is a response rate of 87%. Opinions on how procedural pain is currently and optimally managed differed significantly. Although most respondents rated a majority of the listed procedures as being more than moderately painful, pharmacological agents were rarely used, except for the insertion of a chest tube and endotracheal intubation. Comfort measures were also believed to be underutilized, but not to the same degree as pharmacological agents. CONCLUSION: Procedural pain in neonates is not sufficiently managed and both pharmacological agents and comfort measures are underutilized, according to clinicians at two Norwegian NICU's.