Forskning med juridiska förvecklingar : Om tolkningsflexibilitet i kontroversen om mässlingsvaccination och autism

Medical research with jurisdictional consequences: interpretative flexibility in the controversy over MMR vaccination and autism Based on the empirical case of the controversy of MMR vaccination and autism around the turn of the millennium, this paper argues for the analytical importance of the concept of “interpretative flexibility”. As shown, this concept is useful not only for the small subfield of sociology of scientific knowledge (SSK) but also for the broader social sciences. First we analyse, by reference to interpretative flexibility, the initial dispute within medical research concerning evidence for and against a possible link between the measles component of the MMR vaccine and autism. In a second step we move beyond this traditional application of the concept, showing how the interpretative flexibility of the research results remains in society although consensus has been reached in the medical community. This further step is exemplified by two legal events, in Sweden and the US respectively. In both these cases the difficulties in providing uncontested evidence affected institutions and practices at great distance and with different outcomes. Our findings suggest the importance of not only applying the concept of interpretative flexibility to classical scientific laboratory disputes, but also connecting it to its societal manifestations.

Det personliga är sociologiskt : 14 professorer om svensk sociologi

This special issue of Sociologisk Forskning contains 14 papers by distinguished Swedish sociologists on the development of sociology in Sweden during the last decades and the forming of their own academic habitus in relation to that development. Contributors are: Göran Ahrne, Boel Berner, Margareta Bertilsson, Ulla Björnberg, Thomas Brante, Hedvig Ekerwald, Rosmarie Eliasson-Lappalainen, Johanna Esseveld, Bengt Furåker, Staffan Lindberg, Gunnar Olofsson, Sune Sunesson, Göran Therborn and Karin Widerberg. The volume is edited by Gunnar Andersson, Thomas Brante and Christofer Edling.

User perspectives on the Swedish Maternal Health Care Register

Background: Established in 1999, the Swedish Maternal Health Care Register (MHCR) collects data on pregnancy, birth, and the postpartum period for most pregnant women in Sweden. Antenatal care (ANC) midwives manually enter data into the Web-application that is designed for MHCR. The aim of this study was to investigate midwives? experiences, opinions and use of the MHCR. Method: A national, cross-sectional, questionnaire survey, addressing all Swedish midwives working in ANC, was conducted January to March 2012. The questionnaire included demographic data, preformed statements with six response options ranging from zero to five (0 = totally disagree and 5 = totally agree), and opportunities to add information or further clarification in the form of free text comments. Parametric and non-parametric methods and logistic regression analyses were applied, and content analysis was used for free text comments. Results: The estimated response rate was 53.1%. Most participants were positive towards the Web-application and the included variables in the MHCR. Midwives exclusively engaged in patient-related work tasks perceived the register as burdensome (70.3%) and 44.2% questioned the benefit of the register. The corresponding figures for midwives also engaged in administrative supervision were 37.8% and 18.5%, respectively. Direct electronic transfer of data from the medical records to the MHCR was emphasised as significant future improvement. In addition, the midwives suggested that new variables of interest should be included in the MHCR ? e.g., infertility, outcomes of previous pregnancy and birth, and complications of the index pregnancy. Conclusions: In general, the MHCR was valued positively, although perceived as burdensome. Direct electronic transfer of data from the medical records to the MHCR is a prioritized issue to facilitate the working situation for midwives. Finally, the data suggest that the MHCR is an underused source for operational planning and quality assessment in local ANC centres.

"An on-going individual adjustment" : a qualitative study of midwives' experiences counselling pregnant women on physical activity in Sweden

Background: In Sweden, midwives play prominent supportive role in antenatal care by counselling and promoting healthy lifestyles. This study aimed to explore how Swedish midwives experience the counselling of pregnant women on physical activity, specifically focusing on facilitators and barriers during pregnancy. Also, addressing whether the midwives perceive that their own lifestyle and body shape may influence the content of the counselling they provide. Methods: Eight focus group discussions (FGD) were conducted with 41 midwives working in antenatal care clinics in different parts of Sweden between September 2013 and January 2014. Purposive sampling was applied to ensure a variation in age, work experience, and geographical location. The FGD were digitally recorded, transcribed verbatim, and analyzed using manifest and latent content analysis. Results: The main theme- "An on-going individual adjustment" was built on three categories: "Counselling as a challenge"; "Counselling as walking the thin ice" and "Counselling as an opportunity" reflecting the midwives on-going need to adjust their counselling depending on each woman's specific situation. Furthermore, counselling pregnant women on physical activity was experienced as complex and ambiguous, presenting challenges as well as opportunities. When midwives challenged barriers to physical activity, they risked being rejected by the pregnant women. Despite risking rejection, the midwives tried to promote increased physical activity based on their assessment of individual needs of the pregnant woman. Some participants felt that their own lifestyle and body shape might negatively influence the counselling; however, the majority of participants did not agree with this perspective. Conclusions: Counselling on physical activity during pregnancy may be a challenging task for midwives, characterized by on-going adjustments based on a pregnant woman's individual needs. Midwives strive to find individual solutions to encourage physical activity. However, to improve their counselling, midwives may benefit from further training, also organizational and financial barriers need to be addressed. Such efforts might result in improved opportunities to further support pregnant women's motivation for performance of physical activity.

Internal validity of the Swedish Maternal Health Care Register

Background: The Swedish Maternal Health Care Register (MHCR) is a national quality register that has been collecting pregnancy, delivery, and postpartum data since 1999. A substantial revision of the MHCR resulted in a Web-based version of the register in 2010. Although MHCR provides data for health care services and research, the validity of the MHCR data has not been evaluated. This study investigated degree of coverage and internal validity of specific variables in the MHCR and identified possible systematic errors. Methods: This cross-sectional observational study compared pregnancy and delivery data in medical records with corresponding data in the MHCR. The medical record was considered the gold standard. The medical records from nine Swedish hospitals were selected for data extraction. This study compared data from 878 women registered in both medical records and in the MHCR. To evaluate the quality of the initial data extraction, a second data extraction of 150 medical records was performed. Statistical analyses were performed for degree of coverage, agreement and correlation of data, and sensitivity and specificity. Results: Degree of coverage of specified variables in the MHCR varied from 90.0% to 100%. Identical information in both medical records and the MHCR ranged from 71.4% to 99.7%. For more than half of the investigated variables, 95% or more of the information was identical. Sensitivity and specificity were analysed for binary variables. Probable systematic errors were identified for two variables. Conclusions: When comparing data from medical records and data registered in the MHCR, most variables in the MHCR demonstrated good to very good degree of coverage, agreement, and internal validity. Hence, data from the MHCR may be regarded as reliable for research as well as for evaluating, planning, and decision-making with respect to Swedish maternal health care services.

No consensus on gestational diabetes mellitus screening regimes in Sweden : pregnancy outcomes in relation to different screening regimes 2011 to 2012, a cross-sectional study

Background: Although associated adverse pregnancy outcomes, no international or Swedish consensus exists that identifies a cut-off value or what screening method to use for definition of gestational diabetes mellitus. This study investigates the following: i) guidelines for screening of GDM; ii) background and risk factors for GDM and selection to OGTT; and iii) pregnancy outcomes in relation to GDM, screening regimes and levels of OGTT 2 hour glucose values. Methods: This cross-sectional and population-based study uses data from the Swedish Maternal Health Care Register (MHCR) (2011 and 2012) combined with guidelines for GDM screening (2011-2012) from each Maternal Health Care Area (MHCA) in Sweden. The sample consisted of 184, 183 women: 88, 140 in 2011 and 96,043 in 2012. Chi-square and two independent samples t-tests were used. Univariate and multivariate logistic regression analyses were performed. Results: Four screening regimes of oral glucose tolerance test (OGTT) (75 g of glucose) were used: A) universal screening with a 2-hour cut-off value of 10.0 mmol/L; B) selective screening with a 2-hour cut-off value of 8.9 mmol/L; C) selective screening with a 2-hour cut-off value of 10.0 mmol/L; and D) selective screening with a 2-hour cut-off value of 12.2 mmol/L. The highest prevalence of GDM (2.9%) was found with a 2-hour cut-off value of 8.9 mmol/L when selective screening was applied. Unemployment and low educational level were associated with an increased risk of GDM. The OR was 4.14 (CI 95%: 3.81-4.50) for GDM in obese women compared to women with BMI <30 kg/m(2). Women with non-Nordic origin presented a more than doubled risk for GDM compared to women with Nordic origin (OR = 2.24; CI 95%: 2.06-2.43). Increasing OGTT values were associated with increasing risks of adverse pregnancy outcomes. Conclusions: There was no consensus regarding screening regimes for GDM from 2011 through 2012 when four different regimes were applied in Sweden. Increasing levels of OGTT 2-hour glucose values were strongly associated with adverse pregnancy outcomes. Based on these findings, we suggest that Sweden adopts the recent recommendations of the International Association of Diabetes and Pregnancy Study Group (IADPSG) concerning the performance of OGTT and the diagnostic criteria for GDM.

Pregnancy-related low back pain and pelvic girdle pain approximately 14 months after pregnancy : pain status, self-rated health and family situation

Background: Pelvic girdle pain (PGP) in pregnancy is distinct from pregnancy-related low back pain (PLBP). However, women with combined PLBP and PGP report more serious consequences in terms of health and function. PGP has been estimated to affect about half of pregnant women, where 25% experience serious pain and 8% experience severe disability. To date there are relatively few studies regarding persistent PLBP/PGP postpartum of more than 3 months, thus the main objective was to identify the prevalence of persistent PLBP and PGP as well as the differences over time in regard to pain status, self-rated health (SRH) and family situation at 12 months postpartum. Methods: The study is a 12 month follow-up of a cohort of pregnant women developing PLBP and PGP during pregnancy, and who experienced persistent pain at 6 month follow-up after pregnancy. Women reporting PLBP/PGP (n = 639) during pregnancy were followed up with a second questionnaire at approximately six month after delivery. Women reporting recurrent or persistent LBP/PGP at the second questionnaire (n = 200) were sent a third questionnaire at 12 month postpartum. Results: A total of 176 women responded to the questionnaire. Thirty-four women (19.3%) reported remission of LBP/PGP, whereas 65.3% (n = 115) and 15.3% (n = 27), reported recurrent LBP/PGP or continuous LBP/PGP, respectively. The time between base line and the 12 months follow-up was in actuality 14 months. Women with previous LBP before pregnancy had an increased odds ratio (OR) of reporting 'recurrent pain' (OR = 2.47) or 'continuous pain' (OR = 3.35) postpartum compared to women who reported 'no pain' at the follow-up. Women with 'continuous pain' reported statistically significant higher level of pain at all measure points (0, 6 and 12 months postpartum). Non-responders were found to report a statistically significant less positive scoring regarding relationship satisfaction compared to responders. Conclusions: The results from this study demonstrate that persistent PLBP/PGP is a major individual and public health issue among women 14 months postpartum, negatively affecting their self-reported health. However, the perceived relationship satisfaction seems to be stable between the groups.

Struggling with daily life and enduring pain : a qualitative study of women's experiences with pelvic girdle pain during pregnancy

Background. Few studies have investigated the experiences of living with pelvic girdle pain (PGP) and its impact on pregnant women’s lives. To address this gap in knowledge, this study investigates the experiences of women living with PGP during pregnancy. Methods. A purposive sample, of nine pregnant women with diagnosed PGP, were interviewed about their experiences. Interviews were recorded, transcribed to text and analysed using a Grounded Theory approach. Results. The core category that evolved from the analysis of experiences of living with PGP in pregnancy was “struggling with daily life and enduring pain”. Three properties addressing the actions caused by PGP were identified: i) grasping the incomprehensible; ii) balancing support and dependence and iii) managing the losses. These experiences expressed by the informants constitute a basis for the consequences of PGP: iv) enduring pain; v) being a burden; vi) calculating the risks and the experiences of the informants as vii) abdicating as a mother. Finally, the informants’ experiences of the consequences regarding the current pregnancy and any potential future pregnancies is presented in viii) paying the price and reconsidering the future. A conceptual model of the actions and consequences experienced by the pregnant informants living with PGP is presented. Conclusions. PGP during pregnancy greatly affects the informant’s experiences of her pregnancy, her roles in relationships, and her social context. For informants with young children, PGP negatively affects the role of being a mother, a situation that further strains the experience. As the constant pain disturbs most aspects of the lives of the informants, improvements in the treatment of PGP is of importance as to increase the quality of life. This pregnancy-related condition is prevalent and must be considered a major public health concern during pregnancy.

'Ultrasound is an invaluable third eye, but it can't see everything' : a qualitative study with obstetricians in Australia

Background: Obstetric ultrasound has come to play a significant role in obstetrics since its introduction in clinical care. Today, most pregnant women in the developed world are exposed to obstetric ultrasound examinations, and there is no doubt that the advantages of obstetric ultrasound technique have led to improvements in pregnancy outcomes. However, at the same time, the increasing use has also raised many ethical challenges. This study aimed to explore obstetricians' experiences of the significance of obstetric ultrasound for clinical management of complicated pregnancy and their perceptions of expectant parents' experiences. Methods: A qualitative study was undertaken in November 2012 as part of the CROss-Country Ultrasound Study (CROCUS). Semi-structured individual interviews were held with 14 obstetricians working at two large hospitals in Victoria, Australia. Transcribed data underwent qualitative content analysis. Results: An overall theme emerged during the analyses, 'Obstetric ultrasound - a third eye', reflecting the significance and meaning of ultrasound in pregnancy, and the importance of the additional information that ultrasound offers clinicians managing the surveillance of a pregnant woman and her fetus. This theme was built on four categories: I:'Everyday-tool' for pregnancy surveillance, II: Significance for managing complicated pregnancy, III: Differing perspectives on obstetric ultrasound, and IV: Counselling as a balancing act. In summary, the obstetricians viewed obstetric ultrasound as an invaluable tool in their everyday practice. More importantly however, the findings emphasise some of the clinical dilemmas that occur due to its use: the obstetricians' and expectant parents' differing perspectives and expectations of obstetric ultrasound examinations, the challenges of uncertain ultrasound findings, and how this information was conveyed and balanced by obstetricians in counselling expectant parents. Conclusions: This study highlights a range of previously rarely acknowledged clinical dilemmas that obstetricians face in relation to the use of obstetric ultrasound. Despite being a tool of considerable significance in the surveillance of pregnancy, there are limitations and uncertainties that arise with its use that make counselling expectant parents challenging. Research is needed which further investigates the effects and experiences of the continuing worldwide rapid technical advances in surveillance of pregnancies.

Unlicensed personnel administering medications to older persons living at home : a challenge for social and care services

BACKGROUND: Administration of medication to care recipients is delegated to home-care assistants working in the municipal social care, alongside responsibility for providing personal assistance for older people. Home-care assistants have practical administration skills, but lack formal medical knowledge. AIM: The aim of this study was to explore how home-care assistants perceive administration of medication to older people living at home, as delegated to them in the context of social care. METHODS: Four focus groups consisting of 19 home-care assistants were conducted. Data were analysed using qualitative content analysis. RESULTS: According to home-care assistants, health and social care depends on delegation arrangements to function effectively, but in the first place it relieves a burden for district nurses. Even when the delegation had expired, administration of medication continued, placing the statutes of regulation in a subordinate position. There was low awareness among home-care assistants about the content of the statutes of delegation. Accepting delegation to administer medications has become an implicit prerequisite for social care work in the municipality. CONCLUSIONS: Accepting the delegation to administer medication was inevitable and routine. In practice, the regulating statute is made subordinate and consequently patient safety can be threatened. The organisation of health and social care relies on the delegation arrangement to meet the needs of a growing number of older home-care recipients. IMPLICATIONS FOR PRACTICE: This is a crucial task which management within both the healthcare professions and municipal social care needs to address, to bridge the gap between statutes and practice, to create arenas for mutual collaboration in the care recipients' best interest and to ensure patient safety.

Older people's experience of utilisation and administration of medicines in a health- and social care context

BACKGROUND: People living at home who lack ability to manage their medicine are entitled to assistance to improve adherence provided by a home care assistant employed by social care. AIM: The aim was to describe how older people with chronic diseases, living at home, experience the use and assistance of administration of medicines in the context of social care. DESIGN: A qualitative descriptive study. METHODS: Ten participants (age 65+) living at home were interviewed in the participants' own homes. Latent content analysis was used. FINDINGS: The assistance eases daily life with regard to practical matters and increases adherence to a medicine regimen. There were mixed feelings about being dependent on assistance; it interferes with self-sufficiency at a time of health transition. Participants were balancing empowerment and a dubious perception of the home care assistants' knowledge of medicine and safety. Physicians' and district nurses' professional knowledge was a safety guarantee for the medicine process. CONCLUSIONS: Assistance eases daily life and medicine regimen adherence. Dependence on assistance may affect self-sufficiency. Perceived safety varied relating to home care assistants' knowledge of medicine. RELEVANCE TO CLINICAL PRACTICE: A well-functioning medicine assistance is crucial to enable older people to remain at home. A person-centred approach to health- and social care delivery is efficient and improve outcome for the recipient of care.

Funktionelle Bedeutung von P-Glykoprotein für Wirkungen und Nebenwirkungen von Antipsychotika

Therapeutisches Drug Monitoring (TDM) ist eine Maßnahme, bei der durch Messung der Medikamentenspiegel im Blut die Dosis ermittelt wird, bei der mit höchster Wahrscheinlichkeit mit Therapieansprechen gerechnet werden kann. Dabei wird angenommen, dass die Konzentrationen im Blut mit denen im Wirkkompartiment korrelieren. Für Antipsychotika wurde gezeigt, dass die Konzentrationen im Blut direkt mit denen im Gehirn korrelieren, die Verteilung zwischen den beiden Kompartimenten ist jedoch für die verschiedenen Antipsychotika sehr unterschiedlich. Die Distribution von Arzneistoffen zwischen Blut und Gehirn wird durch Effluxtransporter in der Blut-Hirn-Schranke kontrolliert. Welche Rolle dabei P-Glykoprotein (P-gp) für die Verteilung von atypischen Antipsychotika spielt und wie die Pharmakokinetik und –dynamik durch diesen Transporter beeinflusst werden, sollte in dieser Arbeit untersucht werden. Für die Messung des neu eingeführten Antipsychotikums Aripiprazol, sowie für seinen aktiven Metaboliten Dehydroaripiprazol, wurde eine hochleistungsflüssigchromatographische (HPLC) Methode mit Säulenschaltung und spektrophotometrischer Detektion etabliert. Die Methode wurde für die Messung von Serumproben schizophrener Patienten eingesetzt, um einen therapeutischen Bereich für Aripiprazol zu ermitteln. Aus der Analyse von 523 Patientenproben wurde herausgefunden, dass Aripiprazol-Serumkonzentrationen von 150 bis 300 ng/ml mit gutem klinischen Ansprechen und einem geringen Risiko für Nebenwirkungen einhergingen. Weiterhin wurde festgestellt, dass die Serumspiegel bei gleichzeitiger Gabe von Inhibitoren und Induktoren der Cytochrom P450 (CYP) Isoenzyme CYP2D6 und CYP3A4 erhöht bzw. gesenkt wurden. Am Modell der P-gp Knockout Maus im Vergleich zu FVB Wildtyp Mäusen wurden Konzentrationsverläufe von Antipsychotika nach i.p. Gabe von Amisulprid, Aripiprazol, Dehydroaripiprazol, Clozapin, Desmethylclozapin, Haloperidol, Olanzapin, Quetiapin, Risperidon und 9-Hydroxyrisperidon sowie der Kontrollsubstanz Domperidon im Gehirn und Blut über 24 Stunden mittels HPLC-Methoden gemessen. Welchen Einfluss eine verminderte Expression von P-gp auf die Pharmakodynamik hat, wurde in zwei Verhaltenstests untersucht. Mit Hilfe des Rotarods wurden motorische Effekte der Arzneistoffe erfasst und mittels Radial Arm Water Maze kognitive Fähigkeiten. Risperidon und sein aktiver Metabolit 9-Hydroxyrisperidon waren die stärksten Substrate von P-gp. 10-fach höhere Konzentrationen im Gehirn der P-gp Knockout Mäuse führten zu 10-fach stärkeren Beeinträchtigungen in den pharmakodynamischen Untersuchungen im Vergleich zu Wildtyp Tieren. Amisulprid, Aripiprazol, Dehydroaripiprazol, Desmethylclozapin und Quetiapin konnten ebenfalls als Substrate von P-gp identifiziert werden. Olanzapin, Haloperidol und Clozapin wurden durch P-gp wenig bzw. nicht in ihrer Pharmakokinetik und –dynamik beeinflusst. Da P-gp von Nagern und Menschen nach derzeitiger Kenntnis in ihren Substrateigenschaften weitgehend übereinstimmen, muss bei einer Behandlung von schizophrenen Patienten mit Antipsychotika, die als Substrate von P-gp identifiziert wurden, davon ausgegangen werden, dass eine Veränderung der Expression oder Aktivität von P-gp, genetisch verursacht oder durch Medikamente bedingt, für das Therapieansprechen oder das Auftreten von Nebenwirkungen bedeutsam sind.

Pulse-pressure variation and hemodynamic response in patients with elevated pulmonary artery pressure: a clinical study

Pulse-pressure variation (PPV) due to increased right ventricular afterload and dysfunction may misleadingly suggest volume responsiveness. We aimed to assess prediction of volume responsiveness with PPV in patients with increased pulmonary artery pressure.

Hospital for joint diseases participates in international spine registry Spine Tango after successful pilot study

Spine Tango is currently the only international spine registry in existence. It was developed under the auspices of Eurospine, the Spine Society of Europe, and is hosted at the University of Bern, Switzerland. The HJD Spine Center successfully tested Spine Tango during a 3-month pilot study and has since expanded documentation activities to more surgeons. Workflow integration and dedicated research staff are key factors for such an endeavor. Participation enables benchmarking against national and international peers and outcome research and quality assurance of surgical and non-surgical treatments.