A decade of heightened awareness concerning safety issues in healthcare since the Institute of Medicine’s awakening call has resulted in a string of counteroffensive measures. The pace of improvement has been slow and not altogether clear. Rates of patient harm are in general now measured by voluntary reporting and indicator measurements. The use of triggers or clues in random nurse-based reviews to enable identification of patient harm is a more effective method for measuring the overall rate of harm in a health care organisation. Measured actual overall rates of patient harm, their variations and patterns during delivery in the south-east health-care region of Sweden are not previously known. Measurement is important to patient safety improvement, as a foundation for accountability, effort selection and keeping track of results. The patient’s voice must also be much clearer in quality and safety improvement efforts in healthcare. The Institute of Healthcare Improvements Global Trigger Tool for measuring adverse events was used to review 1137 deliveries during 2011 in the seven departments (10% of all cases). Mother and new-born were both evaluated. Thirty eight patient harm events per 1000 patient days were identified, correlating to 13% of admissions. Presupposed rates among staff were double this value. Current patient safety indicators are half this value. One third of patient harm events at birth affected the new-born. Twenty different categories of harm were found. This study shows significantly higher rates of patient harm than previously reported. The nurse reviewers defined the method as valuable and a useful method for measuring harm at delivery. Limitations at this stage are no observed changes in health care delivery or clinical outcomes and that value assessment is based entirely on the judgement of the data-abstractors.

Le recours aux prescriptions sans ou hors AMM, dû principalement au manque d’essais cliniques, est très largement répandu en pédiatrie en particulier chez le nouveau-né. Les prescriptions hors AMM constituent un facteur de risque dans la survenue des effets indésirables médicamenteux (EIM). La pharmacovigilance est indispensable mais insuffisante afin d’évaluer le rapport bénéfice/risque des traitements en particulier lorsque les prescriptions hors AMM sont fréquentes. En combinant plusieurs approches pharmacoépidémiologiques, méta-analytiques et pharmacométriques, ce travail de thèse a pour objectifs de décrire les prescriptions hors AMM en néonatologie et explorer des approches qui permettront d’aboutir à mieux estimer le rapport bénéfice/risque des médicaments pour les enfants. Nous avons confirmé que le taux de prescription hors AMM en néonatologie est important (46%). Même en absence de soins de réanimation, plus de deux tiers des nouveaux-nés reçoivent au moins un médicament hors AMM pendant leur hospitalisation. En utilisant une approche méta-analytique explorant le rapport bénéfice risque du fluconazole en néonatologie en fonction du risque de base dans chaque étude (taux d’infection <10%), nous avons montré que la prophylaxie ciblée sur le risque de base serait plus bénéfique que la prophylaxie systématique des infections fongiques invasives. Nos travaux en pharmacovigilance pédiatrique, ont montré que les deux méthodes de détection actives (collaboration entre pharmaciens et cliniciens et le « trigger tool »), utilisant les dossiers patients informatisés, sont faisables et plus efficaces que la notification spontanée / Many drugs used to treat children in hospitals are either not licensed for use in children or are prescribed outside the terms of their product license (off-label prescribing) because of the lack of clinical trials in this population, and practical difficulties to involve children in clinical research. Drugs used within the specifications of the product license should therefore be less likely to cause ADRs compared to drugs that are either unlicensed or off-label for use in children. With different approaches such as pharmacoepidemiologic, meta-analytic and pharmacometrics, we sought to improve the estimate of the benefit risk ratio of medicines used for treating children. Our observational prospective study in a neonatal unit demonstrated that the prescriptions of unlicensed or off-label drugs in neonatal unit is common (46%). We also used meta-analytic approach in order to estimate the benefit risk ratio of the prophylactic use of fluconazole as a function of the baseline risk. Our results suggest that “systematic fluconazole prophylaxis for all VLBW in NICUs is not warranted by the available evidence and should be adapted to the baseline risk. We also showed that active drug monitoring by using electronic patient files by targeting review chart with a trigger tool in neonates and with close collaboration between the pharmacovigilance center, pharmacologists, and clinicians was necessary and feasible for improving the detection of ADRs in children

Bakgrund: Svenska intensivvårdsregistret (SIR) sammanställer varje år fastställda kvalitetsmått där en av dem är ”Överflyttning till annan intensivvårdsavdelning på grund av egen resursbrist.” Flera studier har visat att de patienter som flyttas mellan intensivvårdsavdelningar har en högre mortalitet och längre vårdtid än de som inte flyttas. Enligt patientsäkerhetslagen ska vårdgivaren förebygga och utreda vårdskador. Ett sätt att mäta vårdrelaterade skador är Global Trigger Tool (GTT). Syfte: Att undersöka frekvensen av skador hos de patienter som överflyttats till annan intensivvårdsavdelning på grund av resursbrist jämfört med en matchad kontrollgrupp. Metod: En retrospektiv, deskriptiv och jämförande pilotstudie. Journaler från patienter som flyttats till annan intensivvårdsavdelning på grund av resursbristscannades efter skador med hjälp av GTT och jämfördes sedan med en kontrollgrupp som inte flyttats mellan intensivvårdsavdelningar. Resultat: I undersökningsgruppen (n=20) återfanns 67 skador med ett genomsnitt på 3,4 skador per patient. I kontrollgruppen (n=40) hittades 80 skador med ett genomsnitt på 2,0 skador per patient. Det fanns en stark tendens (p=0,05) till att undersökningsgruppen hade fler antal skador jämfört med kontrollgruppen. Av de patienter som hade sammanlagt sju skador återfanns 15 % i undersökningsgruppen jämfört med 2,5 % i kontrollgruppen. Slutsats: Tendenser ses till att patienter som flyttas på grund av resursbrist har en högre frekvens av skador jämfört med de som inte flyttas. Klinisk betydelse: Om inte överflyttningar på grund av resursbrist kan undvikas, bör i alla fall fler hänsyn tas när beslut om överflyttning sker, såsom exempelvis mått på sjuklighetoch etiska överväganden. / Background: The Swedish Intensive Care Register (SIR) on a yearly basis puts together appointed quality measurements; one of them is entitled ”Transfer to Another Intensive Care Unit Due to Own Lack of Resources.” Several studies have shown that patients that are being transferred between intensive care units have higher mortality rates and longer stay at hospital, compared to those who do not transfer. According to the Swedish Law for Patient Safety the provider of care shall prevent and investigate adverse events. One way of measuring healthcare related adverse events is the Global Trigger Tool method (GTT). Objectives: To investigate the frequency of adverse events in patients who transfer to another intensive care unit due to lack of resources compared to a matched control group. Methods: A retrospective, descriptive and comparative pilot study was conducted. Medical records from patients who were moved to another intensive care unit due to lack of recourses were scanned for adverse events with GTT and then compared with a control group who had not been transferred between intensive care units. Results: In the experimental group (n=20), 67 adverse events were detected with an average of 3, 4 adverse events per patient. In the control group (n=40), 80 adverse events were detected with an average of 2, 0 adverse events per patient. There was a strong possibility (p=0, 05) that the experi-mental group had a higher incidence of adverse events compared to the control group. As much as 15 percent of the patients in the experimental group had been subjected to, in all, seven adverse events, compared to 2, 5 percent in the control group Conclusion: There is a possibility that patients who transfer due to lack of resources have a higher frequency of adverse events than those who do not transfer. Clinical relevance: If transfers due to lack of resources cannot be eliminated when decision about transfers are being made, more consideration should be given to such things as morbidity and ethics.

DIABETESFOTEN HOS INNELIGGANDE STROKEPATIENTER: RISK, OMFATTNING, OCH OMVÅRDNADSÅTGÄRDERBAKGRUND: Fotkomplikationer är de allvarligaste komplikationerna till diabetes som ofta leder till kostnadskrävande behandlingar och amputation. Stroke resulterar i förlust eller begränsning av tidigare fysiska, psykiska och sociala aktiviteter, inklusive nedsatt förmåga att skydda sina fötter och utföra egenvård. Strokepatienter med diabetes har stor risk att skada sig i den förlamade sidan av kroppen. Nedsatt mobilitet är en riskfaktor som kan orsaka patienten skada. På vårdavdelning för strokedrabbade patienter kan sjuksköterskan genom god omvårdnad och preventiva åtgärder bidra till att risken för utveckling av skada på fötterna hos strokepatienter minskar.SYFTE: Syftet med studien är att kartlägga omfattningen av diabetesfot på en neurologisk klinik samt granska omvårdnadsdokumentationen om preventionsåtgärder hos strokepatienter med diabetes avseende risken att utveckla fotsår.METOD: En retrospektiv journalgranskningsstudie med kvantitativ och kvalitativ ansats. Studien genomfördes på en neurologisk klinik på ett universitetssjukhus i södra Sverige. Samtliga journaler N=101 från strokepatienter med diabetes som vårdades på kliniken från 1 januari 2015 till den 20 december 2015 granskades med hjälp av Global Trigger Tool (GTT). Dataanalysen delades i två delar: deskriptiv statistisk analys och manifest kvalitativ innehållsanalys.RESULTAT: Medianåldern är 78 år (41-93 år). Kvinnor n=40, män n=61. Journalgranskningen visade generellt på bristande dokumentation. Riskbedömning för fotsår var inte dokumenterad i någon av journalerna. För patienter som hade dokumenterade fotsår (n= 3) var lokalisationen av fotsår på samma sida som patienten var förlamad. Dokumenterade preventions- och omvårdnadsåtgärder i sängen: (n=12) och i stolen: (n=0). Enligt IWGDF riskklassifikation identifierades (n =12) som har riskfaktorer för fotproblem och fotsår. Dokumentation av omvårdnadsprocessen följdes inte i journalerna.SLUTSATS: Patienterna har hög ålder, är multisjuka och förlamade helt eller på ena sidan av kroppen. Lokalisationen av fotsår på samma sida som patienten var förlamad. Brister i omvårdnadsdokumentation och preventionsarbete medför risk för patientens säkerhet. Studien ger mer kunskap när det gäller risk för utvecklandet av fotsår hos patienter med stroke och diabetes som vårdas på neurologisk klinik. Studien ger ett underlag för att utveckla klinikens kvalitetsarbete och försäkra patientsäkerhet genom att öka kunskap om diabeteskomplikationer och riktlinjer, omvårdnadsdokumentation enligt omvårdnadsprocessen, samt kritiskt tänkande av omvårdnad. Fler studier om fotsår hos strokepatienter rekommenderas. / THE DIABETIC FOOT IN HOSPITALIZED STROKE PATIENTS: RISK, PREVELANCE AND NURSING ACTIONS.BACKGROUND: Complications in the foot is the most serious one of the diabetes. Often, this leads to expensive treatments and amputation. Stroke results in loss or limitation of previous physiological, psychological and social activities and including a reduced ability to protect their feet and perform self-care. Stroke patients with diabetes have a high risk of injury in the paralyzed side of the body. Impaired mobility is a risk factor that can cause patient harm. On the nursing ward for stroke patients the nurse can through good nursing intervention and preventive actions contribute to the risk of developing damage to their feet in stroke patients decreases.AIM: The aim of the study is to explore the prevalence of diabetic foot at a neurological clinic and review the nursing documentation of preventions actions in stroke patients with diabetes with regard to the risk of developing foot ulcers.METHOD: A retrospective medical record review study with quantitative and qualitative approach. The study was conducted at a neurological clinic at a university hospital in southern Sweden. All the records (n = 101) of stroke patients with diabetes who were treated at the clinic from 1 January 2015 to 20 December 2015. The examination was conducted using Global Trigger Tool (GTT). Data analysis was divided into two parts: the descriptive statistical analysis and manifest content analysis.RESULTS: Median age is 78 years (41-93). Women (n = 40), men (n = 61). Journal review showed insufficient documentation. Risk assessment for foot ulcers was not documented in any of the journals. Patients with documented foot ulcer (n= 3), the localization of ulcers is on the same side as the patient is paralyzed. Prevention and nursing actions, (n = 12) documented action in bed, (n = 0) documented actions in the chair. According IWGDF risk classification (n =12) identified as having risk factors for foot problem and foot ulcer. Documentation of nursing process was not followed in the journals.SUMMARY: The patients had high age with multiple comorbidities and paralyzed in the whole or on one side of the body. The localization of foot ulcers is on the same side as the patient is paralyzed. Insufficiency in nursing documentation and prevention work result in risk to patient safety and impaired quality of care. The study provides more knowledge about the risk of the developing foot ulcer for patients with stroke and diabetes who treated in the neurological clinic. The study provide foundation to develop the clinic quality work and ensure patient safety through increasing knowledge to the clinic about diabetic complications and guidelines, nursing documentation in accordance with the nursing process and critical thinking of nursing. More studies of foot ulcers in stroke patients are recommended. Keywords: diabetes mellitus, diabetes foot ulcers, documentation, Global Trigger Tool, journal examination, nursing, prevention,

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