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  • 1.
    Bohman, Tony
    et al.
    Karolinska institutet.
    Alfredsson, Lars
    Jensen, Irene
    Hallqvist, Johan
    Vingård, Eva
    Skillgate, Eva
    Does a healthy lifestyle behaviour influence the prognosis of low back pain among men and women in a general population? A population-based cohort study2014In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 4, no 12, article id e005713Article in journal (Refereed)
    Abstract [en]

    OBJECTIVES: To study the influence of healthy lifestyle behaviour on the prognosis of occasional low back pain among men and women in a general population.

    DESIGN: Cohort study with a 4-year follow-up.

    SETTINGS: General population in Stockholm County, Sweden.

    PARTICIPANTS: The study sample comprised 3938 men and 5056 women aged 18-84 from the Stockholm Public Health Cohort reporting occasional low back pain in the baseline questionnaire 2006.

    MEASURES: Lifestyle factors and potential confounders were assessed at baseline. The lifestyle factors smoking habits, alcohol consumption, leisure physical activity and consumption of fruit and vegetables were dichotomised using recommendations for a health-enhancing lifestyle and combined to form the exposure variable 'healthy lifestyle behaviour'. The exposure was categorised into five levels according to the number of healthy lifestyle factors met. The follow-up questionnaire in 2010 gave information about the outcome, long duration troublesome low back pain. Crude and adjusted binomial regression models were applied to estimate the association between the exposure and the outcome analysing men and women separately.

    RESULTS: The risk of developing long duration troublesome low back pain among women with occasional low back pain decreased with increasing healthy lifestyle behaviour (trend test: p=0.006). 21% (28/131) among women with no healthy lifestyle factor (reference) experienced the outcome compared to 9% (36/420) among women with all four factors. Compared to the reference group, the risk was reduced by 35% (RR 0.65, 95% CI 0.44 to 0.96) for women with one healthy lifestyle factor and 52% (RR 0.48, 95% CI 0.31 to 0.77) for women with all four healthy lifestyle factors. There were no clear associations found among men.

    CONCLUSIONS: Healthy lifestyle behaviour seems to decrease the risk of developing long duration troublesome low back pain among women with occasional low back pain and may be recommended to improve the prognosis.

  • 2.
    Bohman, Tony
    et al.
    Karolinska institutet.
    Bottai, Matteo
    Björklund, Martin
    Predictive models for short-term and long-term improvement in women under physiotherapy for chronic disabling neck pain: a longitudinal cohort study.2019In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 9, no 4, article id e024557Article in journal (Refereed)
    Abstract [en]

    OBJECTIVES: To develop predictive models for short-term and long-term clinically important improvement in women with non-specific chronic disabling neck pain during the clinical course of physiotherapy.

    DESIGN: Longitudinal cohort study based on data from a randomised controlled trial evaluating short-term and long-term effects on sensorimotor function over 11 weeks of physiotherapy.

    PARTICIPANTS AND SETTINGS: Eighty-nine women aged 31-65 years with non-specific chronic disabling neck pain from Gävle, Sweden.

    MEASURES: The outcome, clinically important improvement, was measured with the Patient Global Impression of Change Scale (PGICS) and the Neck Disability Index (NDI), assessed by self-administered questionnaires at 3, 9 and 15 months from the start of the interventions (baseline). Twelve baseline prognostic factors were considered in the analyses. The predictive models were built using random-effects logistic regression. The predictive ability of the models was measured by the area under the receiver operating characteristic curve (AUC). Internal validity was assessed with cross-validation using the bootstrap resampling technique.

    RESULTS: Factors included in the final PGICS model were neck disability and age, and in the NDI model, neck disability, depression and catastrophising. In both models, the odds for short-term and long-term improvement increased with higher baseline neck disability, while the odds decreased with increasing age (PGICS model), and with increasing level of depression (NDI model). In the NDI model, higher baseline levels of catastrophising indicated increased odds for short-term improvement and decreased odds for long-term improvement. Both models showed acceptable predictive validity with an AUC of 0.64 (95% CI 0.55 to 0.73) and 0.67 (95% CI 0.59 to 0.75), respectively.

    CONCLUSION: Age, neck disability and psychological factors seem to be important predictors of improvement, and may inform clinical decisions about physiotherapy in women with chronic neck pain. Before using the developed predictive models in clinical practice, however, they should be validated in other populations and tested in clinical settings.

  • 3.
    Borg, Sixten
    et al.
    Lund University, Department of Clinical Sciences in Malmö, Health Economics Unit, Medicon Village, SE-223 81 Lund, Sweden.
    Eeg-Olofsson, Katarina
    University of Gothenburg, Sahlgrenska Academy, Institute of Medicine, SE-413 46 Gothenburg, Sweden and Sahlgrenska University Hospital, Gothenburg, Sweden.
    Palaszewski, Bo
    Region Västra Götaland, Department of Data Management and Analysis, SE-405 44 Gothenburg, Sweden.
    Svedbo Engström, Maria
    Dalarna University, School of Education, Health and Social Studies, Caring Science/Nursing. University of Gothenburg, Sahlgrenska Academy, Institute of Medicine, SE-413 46 Gothenburg, Sweden.
    Gerdtham, Ulf-G
    Lund University, Department of Clinical Sciences in Malmö, Health Economics Unit, Medicon Village, SE-223 81 Lund, Sweden; The Swedish Institute for Health Economics (IHE), Box 2127, SE-220 02 Lund, Sweden; Department of Economics, School of Economics and Management, Box 7082, SE-220 07 Lund, Sweden.
    Gudbjörnsdottir, Soffia
    University of Gothenburg, Sahlgrenska Academy, Institute of Medicine, SE-413 46 Gothenburg, Sweden and Centre of Registers Västra Götaland, SE-413 45 Gothenburg, Sweden.
    Patient-reported outcome and experience measures for diabetes: development of scale models, differences between patient groups and relationships with cardiovascular and diabetes complication risk factors, in a combined registry and survey study in Sweden2018In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 9, no 1, article id e025033Article in journal (Refereed)
    Abstract [en]

    Purpose The Swedish National Diabetes Register (NDR) has developed a diabetes-specific questionnaire to collect information on individuals' management of their diabetes, collaboration with healthcare providers and the disease’s impact on daily life. Our main objective was to develop measures of well-being, abilities to manage diabetes and judgements of diabetes care, and to detect and quantify differences using the NDR questionnaire.

    Design, setting and participants The questionnaire was analysed with using responses from 3689 participants with type 1 and 2 diabetes, randomly sampled from the NDR population, combined with register data on patient characteristics and cardiovascular and diabetes complication risk factors.

    Methods We used item response theory to develop scales for measuring well-being, abilities to manage diabetes and judgements of diabetes care (scores). Test–retest reliability on the scale level was analysed with intraclass correlation. Associations between scores and risk factor levels were investigated with subgroup analyses and correlations.

    Results We obtained scales with satisfactory measurement properties, covering patient reported outcome measures such as general well-being and being free of worries, and patient reported experience measure, for example, access and continuity in diabetes care. All scales had acceptable test–retest reliability and could detect differences between diabetes types, age, gender and treatment subgroups. In several aspects, for example, freedom of worries, type 1 patients report lower than type 2, and younger patients lower than older. Associations were found between some scores and glycated haemoglobin, but none with systolic blood pressure or low-density lipoprotein cholesterol. Clinicians report positive experience of using scores, visually presented, in the patient dialogue.

    Conclusions The questionnaire measures and detects differences in patient well-being, abilities and judgements of diabetes care, and identifies areas for improvement. To further improve diabetes care, we conclude that patient-reported measures are important supplements to cardiovascular and diabetes complication risk factors, reflecting patient experiences of living with diabetes and diabetes care.

  • 4.
    Byrskog, Ulrika
    et al.
    Dalarna University, School of Education, Health and Social Studies, Caring Science/Nursing.
    Ahrne, Malin
    Small, Rhonda
    Andersson, Ewa
    Essen, Birgitta
    Adan, Aisha
    Ahmed, Fardosa Hassen
    Tesser, Karin
    Åhman-Berndtsson, Anna
    Schytt, Erica
    Rationale, development and feasibility of group antenatal care for immigrant women in Sweden: a study protocol for the Hooyo Project2019In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 9, no 7, article id e030314Article in journal (Refereed)
    Abstract [en]

    INTRODUCTION: Somali-born women comprise a large group of immigrant women of childbearing age in Sweden, with increased risks for perinatal morbidity and mortality and poor experiences of care, despite the goal of providing equitable healthcare for the entire population. Rethinking how care is provided may help to improve outcomes.

    OVERALL AIM: To develop and test the acceptability, feasibility and immediate impacts of group antenatal care for Somali-born immigrant women, in an effort to improve experiences of antenatal care, knowledge about childbearing and the Swedish healthcare system, emotional well-being and ultimately, pregnancy outcomes. This protocol describes the rationale, planning and development of the study.

    METHODS AND ANALYSIS: An intervention development and feasibility study. Phase I includes needs assessment and development of contextual understanding using focus group discussions. In phase II, the intervention and evaluation tools, based on core values for quality care and person-centred care, are developed. Phase III includes the historically controlled evaluation in which relevant outcome measures are compared for women receiving individual care (2016-2018) and women receiving group antenatal care (2018-2019): care satisfaction (Migrant Friendly Maternity Care Questionnaire), emotional well-being (Edinburgh Postnatal Depression Scale), social support, childbirth fear, knowledge of Swedish maternity care, delivery outcomes. Phase IV includes the process evaluation, investigate process, feasibility and mechanisms of impact using field notes, observations, interviews and questionnaires. All phases are conducted in collaboration with a stakeholder reference group.

    ETHICS AND DISSEMINATION: The study is approved by the Regional Ethical Review Board, Stockholm, Sweden. Participants receive information about the study and their right to decline/withdraw without consequences. Consent is given prior to enrolment. Findings will be disseminated at antenatal care units, national/international conferences, through publications in peer-reviewed journals, seminars involving stakeholders, practitioners, community and via the project website. Participating women will receive a summary of results in their language.

  • 5. de Alwis, M. P.
    et al.
    Lo Martire, Riccardo
    Äng, Björn
    Garme, K.
    Development and validation of a web-based questionnaire for surveying the health and working conditions of high-performance marine craft populations2016In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 6, no 6, article id e011681Article in journal (Refereed)
  • 6.
    Eldh, Ann Catrine
    et al.
    Dalarna University, School of Education, Health and Social Studies, Caring Science/Nursing. Uppsala universitet.
    Wallin, Lars
    Dalarna University, School of Education, Health and Social Studies, Caring Science/Nursing. Karolinska institutet.
    Fredriksson, Mio
    Uppsala universitet.
    Vengberg, Sofie
    Uppsala universitet.
    Winblad, Ulrika
    Uppsala universitet.
    Halford, Christina
    Uppsala universitet.
    Dahlström, Tobias
    Uppsala universitet.
    Factors facilitating a national quality registry to aid clinical quality improvement: findings of a national survey2016In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 6, no 11, article id e011562Article in journal (Refereed)
    Abstract [en]

    Objectives: While national quality registries (NQRs) are suggested to provide opportunities for systematic follow-up and learning opportunities, and thus clinical improvements, features in registries and contexts triggering such processes are not fully known. This study focuses on one of the world's largest stroke registries, the Swedish NQR Riksstroke, investigating what aspects of the registry and healthcare organisations facilitate or hinder the use of registry data in clinical quality improvement.

    Methods: Following particular qualitative studies, we performed a quantitative survey in an exploratory sequential design. The survey, including 50 items on context, processes and the registry, was sent to managers, physicians and nurses engaged in Riksstroke in all 72 Swedish stroke units. Altogether, 242 individuals were presented with the survey; 163 responded, representing all but two units. Data were analysed descriptively and through multiple linear regression.

    Results: A majority (88%) considered Riksstroke data to facilitate detection of stroke care improvement needs and acknowledged that their data motivated quality improvements (78%). The use of Riksstroke for quality improvement initiatives was associated (R2=0.76) with ‘Colleagues’ call for local results’ (p=<0.001), ‘Management Request of Registry data’ (p=<0.001), and it was said to be ‘Simple to explain the results to colleagues’ (p=0.02). Using stepwise regression, ‘Colleagues’ call for local results’ was identified as the most influential factor. Yet, while 73% reported that managers request registry data, only 39% reported that their colleagues call for the unit's Riksstroke results.

    Conclusions: While an NQR like Riksstroke demonstrates improvement needs and motivates stakeholders to make progress, local stroke care staff and managers need to engage to keep the momentum going in terms of applying registry data when planning, performing and evaluating quality initiatives.

  • 7.
    Ericson, Jenny
    et al.
    Uppsala University; Centre for Clinical Research Dalarna, Falun; Department of Paediatrics, Falu Hospital.
    Flacking, Renée
    Dalarna University, School of Education, Health and Social Studies, Caring Science/Nursing.
    Hellström-Westas, Lena
    Eriksson, Mats
    Changes in the prevalence of breast feeding in preterm infants discharged from neonatal units: a register study over 10 years2016In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 6, article id e012900Article in journal (Refereed)
    Abstract [en]

    Objective: There are indications that the prevalence of exclusively breastfed preterm infants is decreasing in Sweden. The objective was to investigate trends in exclusive breast feeding at discharge from Swedish neonatal units and associated factors in preterm infants.

    Design, setting and participants: This is a register study with data from the Swedish Neonatal Quality Register. Data from 29 445 preterm infants (gestational age (GA) <37 weeks) who were born during the period 2004–2013 were retrieved. Data included maternal, perinatal and neonatal characteristics. Data were analysed for the whole population as well as for 3 GA groups.

    Results: From 2004 to 2013, the prevalence of exclusive breast feeding decreased, in extremely preterm (GA 22–27 weeks) from 55% to 16%, in very preterm (GA 28–31 weeks) from 41% to 34% and in moderately preterm infants (GA 32–36 weeks) from 64% to 49%. The decline was statistically significant (p<0.001) in all 3 GA groups. This decline remained significant when adjustments were made for factors negatively associated with exclusive breast feeding and which became more prevalent during the study period, that is, small for GA (all groups) and maternal mental illness (very preterm and moderately preterm infants).

    Conclusions: In the past 10 years, Sweden has experienced a lower rate of exclusive breast feeding in preterm infants, especially in extremely preterm infants. The factors analysed in this study explain only a small proportion of this decline. The decline in exclusive breast feeding at discharge from neonatal units raises concern and present challenges to the units to support and promote breast feeding.

  • 8. Göras, Camilla
    et al.
    Olin, Karolina
    Unbeck, Maria
    Pukk-Härenstam, Karin
    Ehrenberg, Anna
    Dalarna University, School of Education, Health and Social Studies, Caring Science/Nursing.
    Tessma, Mesfin Kassaye
    Nilsson, Ulrica
    Ekstedt, Mirjam
    Tasks, multitasking and interruptions among the surgical team in an operating room: a prospective observational study.2019In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 9, no 5, article id e026410Article in journal (Refereed)
    Abstract [en]

    OBJECTIVES: The work context of the operating room (OR) is considered complex and dynamic with high cognitive demands. A multidimensional view of the complete preoperative and intraoperative work process of the surgical team in the OR has been sparsely described. The aim of this study was to describe the type and frequency of tasks, multitasking, interruptions and their causes during surgical procedures from a multidimensional perspective on the surgical team in the OR.

    DESIGN: Prospective observational study using the Work Observation Method By Activity Timing tool.

    SETTING: An OR department at a county hospital in Sweden.

    PARTICIPANTS: OR nurses (ORNs) (n=10), registered nurse anaesthetists (RNAs) (n=8) and surgeons (n=9).

    RESULTS: The type, frequency and time spent on specific tasks, multitasking and interruptions were measured. From a multidimensional view, the surgical team performed 64 tasks per hour. Communication represented almost half (45.7%) of all observed tasks. Concerning task time, direct care dominated the surgeons' and ORNs' intraoperative time, while in RNAs' work, it was intra-indirect care. In total, 48.2% of time was spent in multitasking and was most often observed in ORNs' and surgeons' work during communication. Interruptions occurred 3.0 per hour, and the largest proportion, 26.7%, was related to equipment. Interruptions were most commonly followed by professional communication.

    CONCLUSIONS: The surgical team constantly dealt with multitasking and interruptions, both with potential impact on workflow and patient safety. Interruptions were commonly followed by professional communication, which may reflect the interactions and constant adaptations in a complex adaptive system. Future research should focus on understanding the complexity within the system, on the design of different work processes and on how teams meet the challenges of a complex adaptive system.

    TRIAL REGISTRATION NUMBER: 2016/264.

  • 9. Göras, Camilla
    et al.
    Unbeck, Maria
    Nilsson, Ulrica
    Ehrenberg, Anna
    Dalarna University, School of Education, Health and Social Studies, Caring Science/Nursing. Örebro universitet.
    Interprofessional team assessments of the patient safety climate in Swedish operating rooms: a cross-sectional survey2017In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 7, no 9, article id e015607Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: A positive patient safety climate within teams has been associated with higher safety performance. The aim of this study was to describe and compare attitudes to patient safety among the various professionals in surgical teams in Swedish operating room (OR) departments. A further aim was to study nurse managers in the OR and medical directors' estimations of their staffs' attitudes to patient safety.

    METHODS: A cross-sectional survey with the Safety Attitudes Questionnaire (SAQ) was used to elicit estimations from surgical teams. To evoke estimations from nurse managers and medical directors about staff attitudes to patient safety, a short questionnaire, based on SAQ, was used. Three OR departments at three different hospitals in Sweden participated. All licensed practical nurses (n=124), perioperative nurses (n=233), physicians (n=184) and their respective manager (n=22) were invited to participate.

    RESULTS: Mean percentage positive scores for the six SAQ factors and the three professional groups varied, and most factors (safety climate, teamwork climate, stress recognition, working conditions and perceptions of management), except job satisfaction, were below 60%. Significantly lower mean values were found for perioperative nurses compared with physicians for perceptions of management (56.4 vs 61.4, p=0.013) and working conditions (63.7 vs 69.8, p=0.007). Nurse managers and medical directors' estimations of their staffs' ratings of the safety climate cohered fairly well.

    CONCLUSIONS: This study shows variations and some weak areas for patient safety climate in the studied ORs as reported by front-line staff and acknowledged by nurse managers and medical directors. This finding is a concern because a weak patient safety climate has been associated with poor patient outcomes. To raise awareness, managers need to support patient safety work in the OR.

  • 10. Hjorth, Maria
    et al.
    Sjöberg, Daniel
    Svanberg, Anncarin
    Dalarna University, School of Education, Health and Social Studies, Caring Science/Nursing. Uppsala universitet.
    Kaminsky, Elenor
    Langenskiöld, Sophie
    Rorsman, Fredrik
    Nurse-led clinic for patients with liver cirrhosis-effects on health-related quality of life: study protocol of a pragmatic multicentre randomised controlled trial2018In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 8, no 10, article id e023064Article in journal (Refereed)
    Abstract [en]

    INTRODUCTION: Liver cirrhosis affects health-related quality of life (HRQoL) even in its early stages. Morbidity is especially high when the disease decompensates and self-care actions become essential. Nurse involvement in secondary prevention in other chronic diseases has contributed to better symptom control, less need of inpatient care and improved HRQoL. In order to evaluate the impact of nurse involvement in the follow-up of patients with liver cirrhosis, we decided to compare structured nurse-led clinics, inspired by Dorothea Orem's nursing theory and motivational strategies, with a group of patients receiving standard care. The primary outcome is HRQoL and the secondary outcomes are quality of care, visits to outpatient clinics or hospitals, disease progress and health literacy.

    METHODS AND ANALYSIS: This is a pragmatic, multicentre randomised controlled study conducted at six Swedish hepatology departments. Eligible patients are adults with diagnosed cirrhosis of the liver (n=500). Participants are randomised into either an intervention with nurse-led follow-up group or into a standard of care group. Recruitment started in November 2016 and is expected to proceed until 2020. Primary outcomes are physical and mental HRQoL measured by RAND-36 at enrolment, after 1 and 2 years.

    ETHICS AND DISSEMINATION: The study is ethically approved by the Regional Ethical Review Board in Uppsala. The results shall be disseminated in international conferences and peer-reviewed articles.

    TRIAL REGISTRATION NUMBER: NCT02957253; Pre-results.

  • 11.
    Hogmark, Sara
    et al.
    Falu County Hospital, Obstetrics and Gynaecology, Department of Women's and Children's Health (IMCH), Uppsala University, Uppsala, Sweden.
    Klingberg-Allvin, Marie
    Dalarna University, School of Education, Health and Social Studies, Caring Science/Nursing. Department of Women's and Children's Health, Karolinska Institutet, School of Social and Health Science, Dalarna University, Falun, Sweden.
    Gemzell-Danielsson, Kristina
    Karolinska Institutet, Womens and Childrens Health.
    Ohlsson, Hannes
    Uppsala University, Womens and Childrens Health.
    Essén, Birgitta
    Uppsala University, Womens and Childrens Health.
    Medical students’ knowledge, attitudes, and perceptions on contraceptive use and counselling: a cross-sectional survey in Maharashtra, India2013In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 3, no 12, article id e003739Article in journal (Refereed)
    Abstract [en]

    Objectives. This study aimed to investigate the knowledge, attitudes and perceptionstowards contraceptive use and counselling among medical students in Maharashtra, India.

    Setting. Considerable global maternal mortality and morbidity could be avoided through theuse of effective contraception. In India, contraception services are frequently unavailable or there are obstacles to obtaining modern, reversible contraceptives.

    Participants. A cross-sectional descriptive study using a self-administered questionnaire was conducted among 1996 medical students in their fifth year of study at 27 medical colleges in the state of Maharashtra, India. Descriptive and analytical statistics interpreted the survey instrument and significant results were presented with 95% CI.

    Results. Respondents expressed a desire to provide contraceptive services. A few studentshad experienced training in abortion care. There were misconceptions about moderncontraceptive methods and the impact of sex education. Attitudes towards contraceptionwere mainly positive, premarital counselling was supported and the influence of traditional values and negative provider attitudes on services was recognised. Gender, area of upbringing and type of medical college did not change the results.

    Conclusions. Despite mostly positive attitudes towards modern contraceptives, sex education and family planning counselling, medical students in Maharashtra have misconceptions about modern methods of contraception. Preservice and in-service training in contraceptive counselling should be implemented in order to increase women's access to evidence-based maternal healthcare services.

  • 12. Holst, Anna
    et al.
    Ginter, Annika
    Björkelund, Cecilia
    Hange, Dominique
    Petersson, Eva-Lisa
    Svenningsson, Irene
    Westman, Jeanette
    André, Malin
    Wallin, Lars
    Karolinska institutet; Göteborgs universitet.
    Svensson, Mikael
    Cost-effectiveness of a care manager collaborative care programme for patients with depression in primary care: economic evaluation of a pragmatic randomised controlled study2018In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 8, no 11, article id e024741Article in journal (Refereed)
    Abstract [en]

    OBJECTIVE: To evaluate the cost-effectiveness of a care manager (CM) programme compared with care as usual (CAU) for treatment of depression at primary care centres (PCCs) from a healthcare as well as societal perspective.

    DESIGN: Cost-effectiveness analysis.

    SETTING: 23 PCCs in two Swedish regions.

    PARTICIPANTS: Patients with depression (n=342).

    MAIN OUTCOME MEASURES: A cost-effectiveness analysis was applied on a cluster randomised trial at PCC level where patients with depression had 3 months of contact with a CM (11 intervention PCCs, n=163) or CAU (12 control PCCs, n=179), with follow-up 3 and 6 months. Effectiveness measures were based on the number of depression-free days (DFDs) calculated from the Montgomery-Åsberg Depression Rating Scale-Self and quality-adjusted life years (QALYs). Results were expressed as the incremental cost-effectiveness ratio: ∆Cost/∆QALY and ∆Cost/∆DFD. Sampling uncertainty was assessed based on non-parametric bootstrapping.

    RESULTS: Health benefits were higher in intervention group compared with CAU group: QALYs (0.357 vs 0.333, p<0.001) and DFD reduction of depressive symptom score (79.43 vs 60.14, p<0.001). The mean costs per patient for the 6-month period were €368 (healthcare perspective) and €6217 (societal perspective) for the intervention patients and €246 (healthcare perspective) and €7371 (societal perspective) for the control patients (n.s.). The cost per QALY gained was €6773 (healthcare perspective) and from a societal perspective the CM programme was dominant.

    DISCUSSION: The CM programme was associated with a gain in QALYs as well as in DFD, while also being cost saving compared with CAU from a societal perspective. This result is of high relevance for decision-makers on a national level, but it must be observed that a CM programme for depression implies increased costs at the primary care level.

    TRIAL REGISTRATION NUMBER: NCT02378272; Results.

  • 13. Kaping, K.
    et al.
    Äng, Björn
    Rasmussen-Barr, E.
    The abdominal drawing-in manoeuvre for detecting activity in the deep abdominal muscles: is this clinical tool reliable and valid?2015In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 5, no 12, p. e008711-Article in journal (Refereed)
  • 14. Lo Martire, Riccardo
    et al.
    de Alwis, Manudul Pahansen
    Äng, Björn
    Dalarna University, School of Education, Health and Social Studies, Medical Science. Karolinska institutet.
    Garme, Karl
    Construction of a web-based questionnaire for longitudinal investigation of work exposure, musculoskeletal pain and performance impairments in high-performance marine craft populations2017In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 7, no 7, article id e016006Article in journal (Refereed)
    Abstract [en]

    OBJECTIVE: High-performance marine craft personnel (HPMCP) are regularly exposed to vibration and repeated shock (VRS) levels exceeding maximum limitations stated by international legislation. Whereas such exposure reportedly is detrimental to health and performance, the epidemiological data necessary to link these adverse effects causally to VRS are not available in the scientific literature, and no suitable tools for acquiring such data exist. This study therefore constructed a questionnaire for longitudinal investigations in HPMCP.

    METHODS: A consensus panel defined content domains, identified relevant items and outlined a questionnaire. The relevance and simplicity of the questionnaire's content were then systematically assessed by expert raters in three consecutive stages, each followed by revisions. An item-level content validity index (I-CVI) was computed as the proportion of experts rating an item as relevant and simple, and a scale-level content validity index (S-CVI/Ave) as the average I-CVI across items. The thresholds for acceptable content validity were 0.78 and 0.90, respectively. Finally, a dynamic web version of the questionnaire was constructed and pilot tested over a 1-month period during a marine exercise in a study population sample of eight subjects, while accelerometers simultaneously quantified VRS exposure.

    RESULTS: Content domains were defined as work exposure, musculoskeletal pain and human performance, and items were selected to reflect these constructs. Ratings from nine experts yielded S-CVI/Ave of 0.97 and 1.00 for relevance and simplicity, respectively, and the pilot test suggested that responses were sensitive to change in acceleration and that the questionnaire, following some adjustments, was feasible for its intended purpose.

    CONCLUSIONS: A dynamic web-based questionnaire for longitudinal survey of key variables in HPMCP was constructed. Expert ratings supported that the questionnaire content is relevant, simple and sufficiently comprehensive, and the pilot test suggested that the questionnaire is feasible for longitudinal measurements in the study population.

  • 15. Makenzius, Marlene
    et al.
    Oguttu, Monica
    Klingberg-Allvin, Marie
    Dalarna University, School of Education, Health and Social Studies, Caring Science/Nursing. Karolinska institutet.
    Gemzell-Danielsson, Kristina
    Odero, Theresa M A
    Faxelid, Elisabeth
    Post-abortion care with misoprostol - equally effective, safe and accepted when administered by midwives compared to physicians: a randomised controlled equivalence trial in a low-resource setting in Kenya2017In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 7, no 10, article id e016157Article in journal (Refereed)
    Abstract [en]

    OBJECTIVE: To assess the effectiveness of midwives administering misoprostol to women with incomplete abortion seeking post-abortion care (PAC), compared with physicians.

    DESIGN: A multicentre randomised controlled equivalence trial. The study was not masked.

    SETTINGS: Gynaecological departments in two hospitals in a low-resource setting, Kenya.

    POPULATION: Women (n=1094) with incomplete abortion in the first trimester, seeking PAC between 1 June 2013 to 31 May 2016. Participants were randomly assigned to receive treatment from midwives or physicians. 409 and 401 women in the midwife and physician groups, respectively, were included in the per-protocol analysis.

    INTERVENTIONS: 600 µg misoprostol orally, and contraceptive counselling by a physician or midwife.

    MAIN OUTCOME MEASURES: Complete abortion not needing surgical intervention within 7-10 days. The main outcome was analysed on the per-protocol population with a generalised estimating equation model. The predefined equivalence range was -4% to 4%. Secondary outcomes were analysed descriptively.

    RESULTS: The proportion of complete abortion was 94.8% (768/810): 390 (95.4%) in the midwife group and 378 (94.3%) in the physician group. The proportion of incomplete abortion was 5.2% (42/810), similarly distributed between midwives and physicians. The model-based risk difference for midwives versus physicians was 1.0% (-4.1 to 2.2). Most women felt safe (97%; 779/799), and 93% (748/801) perceived the treatment as expected/easier than expected. After contraceptive counselling the uptake of a contraceptive method after 7-10 days occurred in 76% (613/810). No serious adverse events were recorded.

    CONCLUSIONS: Treatment of incomplete abortion with misoprostol provided by midwives is equally effective, safe and accepted by women as when administered by physicians in a low-resource setting. Systematically provided contraceptive counselling in PAC is effective to mitigate unmet need for contraception.

    TRIAL REGISTRATION NUMBER: NCT01865136; Results.

  • 16. Monnier, A.
    et al.
    Larsson, H.
    Djupsjobacka, M.
    Brodin, L. A.
    Äng, Björn
    Musculoskeletal pain and limitations in work ability in Swedish marines: a cross-sectional survey of prevalence and associated factors2015In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 5, no 10, p. e007943-Article in journal (Refereed)
  • 17. Monnier, Andreas
    et al.
    Larsson, Helena
    Nero, Håkan
    Djupsjöbacka, Mats
    Äng, Björn
    Dalarna University, School of Education, Health and Social Studies, Medical Science. Karolinska institutet; Uppsala universitet.
    A longitudinal observational study of back pain incidence, risk factors and occupational physical activity in Swedish marine trainees2019In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 9, no 5, article id e025150Article in journal (Refereed)
    Abstract [en]

    OBJECTIVES: To evaluate the occurrence of low back pain (LBP) and LBP that limits work ability, to identify their potential early risks and to quantify occupational physical activity in Swedish Armed Forces (SwAF) marines during their basic 4 month marine training course.

    DESIGN: Prospective observational cohort study with weekly follow-ups.

    PARTICIPANTS: Fifty-three SwAF marines entering the training course.

    OUTCOMES: Incident of LBP and its related effect on work-ability and associated early risks. Occupational physical activity, as monitored using accelerometers and self-reports.

    RESULTS: During the training course, 68% of the marines experienced at least one episode of LBP. This yielded a LBP and LBP limiting work ability incidence rate of 13.5 (95% CI 10.4 to 17.8) and 6.3 (95% CI 4.2 to 10.0) episodes per 1000 person-days, respectively. Previous back pain and shorter body height (≤1.80 m) emerged as independent risks for LBP (HR 2.5, 95% CI 1.4 to 4.3; HR 2.0, 95% CI 1.2 to 3.3, respectively), as well as for LBP that limited work ability (HR 3.6, 95% CI 1.4 to 8.9; HR 4.5, 95% CI 2.0 to 10.0, respectively). Furthermore, managing fewer than four pull-ups emerged as a risk for LBP (HR 1.9, 95% CI 1.2 to 3.0), while physical training of fewer than three sessions per week emerged as a risk for LBP that limited work ability (HR 3.0, 95% CI 1.2 to 7.4). More than 80% of the work time measured was spent performing low levels of ambulation, however, combat equipment (≥17.5 kg) was carried for more than half of the work time.

    CONCLUSIONS: Incidents of LBP are common in SwAF marines' early careers. The link between LBP and previous pain as well as low levels of exercise highlights the need for preventive actions early on in a marine's career. The role of body height on LBP needs further investigation, including its relationship with body-worn equipment, before it can effectively contribute to LBP prevention.

  • 18. Nyberg, André
    et al.
    Wadell, Karin
    Lindgren, Helena
    Tistad, Malin
    Dalarna University, School of Education, Health and Social Studies, Medical Science. Umeå universitet, Institutionen för samhällsmedicin och rehabilitering, Fysioterapin.
    Internet-based support for self-management strategies for people with COPD-protocol for a controlled pragmatic pilot trial of effectiveness and a process evaluation in primary healthcare2017In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 7, no 7, article id e016851Article in journal (Refereed)
    Abstract [en]

    INTRODUCTION: The use of adequate self-management strategies for people with chronic obstructive pulmonary disease (COPD) reduces healthcare use, improves health-related quality of life (HRQoL) and recovery after acute exacerbations. However, not many people with COPD receive support that promotes the use of such strategies and therefore new methods to facilitate and promote the use of self-management strategies are highly warranted. This pilot trial aims to evaluate the feasibility of the study design and study procedures considering effectiveness of the novel intervention, the COPD-web. METHODS AND ANALYSIS: The overall design is a pragmatic controlled pilot trial with preassessments and postassessments and a parallel process evaluation. Patients with the diagnosis of COPD will be eligible for the study. The intervention group will be recruited when visiting one of the six participating primary care units in Sweden. The control group will be identified from the unit's computerised registers. The intervention, the COPD-web, is an interactive web page with two sections; one directed at people with COPD and one at healthcare professionals. The sections aim to support patients' self-management skills-and to facilitate the provision of support for self-management strategies, respectively. Effectiveness with regard to patients' symptoms, HRQoL, knowledge of and readiness for COPD-related self-management, health literacy, self-efficacy for physical activity and time spent in physical activity and time being sedentary, and further, healthcare professionals' knowledge of and readiness to support COPD-related self-management strategies will be assessed using questionnaires at 3 and 12 months. The process evaluation will include observations and interviews.

    ETHICS AND DISSEMINATION: Ethical approval has been obtained. Findings will be presented at conferences, submitted for publication in peer-reviewed publications and presented to the involved healthcare professionals, patients and to patient organisations.

    TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT02696187.

  • 19.
    Orrell, Alison
    et al.
    University of Sheffield.
    McKee, Kevin
    Dalarna University, School of Education, Health and Social Studies, Social Work.
    Dahlberg, Lena
    Dalarna University, School of Education, Health and Social Studies, Social Work.
    Gilhooly, Mary
    Brunel University.
    Parker, Stuart
    University of Sheffield.
    Improving continence services for older people from the service-providers’ perspective: a qualitative interview study2013In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 3, no 7Article in journal (Refereed)
    Abstract [en]

    Objective: To examine in depth the views and experiences of continence service leads in England on key service and continence management characteristics in order to identify and to improve our understanding of barriers to a good-quality service and potential facilitators to develop and to improve services for older people with urinary incontinence (UI).

    Design: Qualitative semistructured interviews using a purposive sample recruited across 16 continence services.

    Setting: 3 acute and 13 primary care National Health Service Trusts in England.

    Participants: 16 continence service leads in England actively treating and managing older people with UI.

    Results: In terms of barriers to a good-quality service, participants highlighted a failure on the part of commissioners, managers and other health professionals in recognising the problem of UI and in acknowledging the importance of continence for older people and prevalent negative attitudes towards continence and older people. Patient assessment and continence promotion regardless of age, rather than pad provision, were identified as important steps for a good-quality service for older people with UI. More rapid and appropriate patient referral pathways, investment in service capacity, for example, more trained staff and strengthened interservice collaborations and a higher profile within medical and nurse training were specified as being important facilitators for delivering an equitable and highquality continence service. There is a need, however, to consider the accounts given by our participants as perhaps serving the interests of their professional group within the context of interprofessional work.

    Conclusions: Our data point to important barriers and facilitators of a good-quality service for older people with UI, from the perspective of continence service leads. Further research should address the views of other stakeholders, and explore options for the empirical evaluation of the effectiveness of identified service facilitators.

  • 20.
    Osman, Fatumo
    et al.
    Dalarna University, School of Education, Health and Social Studies, Caring Science/Nursing. Karolinska institutet.
    Salari, Raziye
    Klingberg-Allvin, Marie
    Dalarna University, School of Education, Health and Social Studies, Caring Science/Nursing. Karolinska institutet.
    Schön, Ulla-Karin
    Dalarna University, School of Education, Health and Social Studies, Social Work.
    Flacking, Renée
    Dalarna University, School of Education, Health and Social Studies, Caring Science/Nursing.
    Effects of a culturally tailored parenting support programme in Somali-born parents' mental health and sense of competence in parenting: a randomised controlled trial2017In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 7, no 12, article id e017600Article in journal (Refereed)
    Abstract [en]

    OBJECTIVES: To evaluate the effectiveness of a culturally tailored parenting support programme on Somali-born parents' mental health and sense of competence in parenting.

    DESIGN: Randomised controlled trial.

    SETTING: A city in the middle of Sweden.

    PARTICIPANTS: Somali-born parents (n=120) with children aged 11-16 years and self-perceived stress in their parenting were randomised to an intervention group (n=60) or a waiting-list control group (n=60).

    INTERVENTION: Parents in the intervention group received culturally tailored societal information combined with the Connect parenting programme during 12 weeks for 1-2 hours per week. The intervention consisted of a standardised training programme delivered by nine group leaders of Somali background.

    OUTCOME: The General Health Questionnaire 12 was used to measure parents' mental health and the Parenting Sense of Competence scale to measure parent satisfaction and efficacy in the parent role. Analysis was conducted using intention-to-treat principles.

    RESULTS: The results indicated that parents in the intervention group showed significant improvement in mental health compared with the parents in the control group at a 2-month follow-up: B=3.62, 95% CI 2.01 to 5.18, p<0.001. Further, significant improvement was found for efficacy (B=-6.72, 95% CI -8.15 to -5.28, p<0.001) and satisfaction (B=-4.48, 95% CI -6.27 to -2.69, p<0.001) for parents in the intervention group. Parents' satisfaction mediated the intervention effect on parental mental health (β=-0.88, 95% CI -1.84 to -0.16, p=0.047).

    CONCLUSION: The culturally tailored parenting support programme led to improved mental health of Somali-born parents and their sense of competence in parenting 2 months after the intervention. The study underlines the importance of acknowledging immigrant parents' need for societal information in parent support programmes and the importance of delivering these programmes in a culturally sensitive manner.

    CLINICAL TRIAL REGISTRATION: NCT02114593.

  • 21.
    Palstam, Annie
    et al.
    Sahlgrenska Academy, University of Gothenburg.
    Törnbom, Marie
    Sunnerhagen, Katharina Stibrant
    Experiences of returning to work and maintaining work 7 to 8 years after a stroke: a qualitative interview study in Sweden2018In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 8, no 7, article id e021182Article in journal (Refereed)
    Abstract [en]

    OBJECTIVE: To explore how persons experienced return to work (RTW) and their work situation 7 to 8 years after a stroke.

    DESIGN: An explorative qualitative design with individual interviews. The data analysis was inductive thematic and three researchers collaborated during the analysis process.

    PARTICIPANTS: The study population included five women and eight men who had a stroke during 2009-2010, received care at the Sahlgrenska University Hospital in Gothenburg, Sweden and RTW after stroke and it was a heterogenic sample based on age, occupation, stroke severity and time to RTW.

    RESULTS: The analysis led to four themes; motivated and RTW while struggling with impairments, mixed feelings in the RTW process, still at work though restricted and social support for a sustainable work situation. The themes revealed that participants were motivated to RTW while struggling with impairments. The RTW process evoked mixed feelings of worry and grief over lost functions but also acceptance and gratitude for being able to work. Although maintaining work 7 to 8 years after experiencing a stroke, most were restricted in some way. Fatigue and cognitive impairments meant having to set limits, omit work tasks and rest at work, but also rest during free time and refraining from social activities in order to manage work. Participants avoided work-related stress if they could because of aggravated symptoms and/or fear of a new stroke. Support from supervisors and colleagues was often crucial for a sustainable work situation.

    CONCLUSION: Maintaining work can be a continuous struggle with invisible impairments many years after a stroke. Strategies for managing work are dependent on each individual work situation, where support and understanding at work seem to be crucial for a sustainable work situation.

  • 22. Saarijärvi, Markus
    et al.
    Wallin, Lars
    Dalarna University, School of Education, Health and Social Studies, Caring Science/Nursing. Göteborgs universitet; Karolinska institutet.
    Moons, Philip
    Gyllensten, Hanna
    Bratt, Ewa-Lena
    Transition program for adolescents with congenital heart disease in transition to adulthood: protocol for a mixed-method process evaluation study (the STEPSTONES project)2019In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 9, no 8, article id e028229Article in journal (Refereed)
    Abstract [en]

    INTRODUCTION: Today, the majority of young persons living with chronic conditions in high-income countries survive into adulthood and will need life-long medical follow-up. Therefore, transition programmes have been developed to facilitate transfer to adult care, and to support self-management and independence during adulthood. The Swedish Transition Effects Project Supporting Teenagers with chrONic mEdical conditionS (STEPSTONES) project aims to evaluate the effectiveness of a person-centred transition programme for empowering adolescents with congenital heart disease in transition to adulthood. To understand how the transition programme causes change and how outcomes are created, process evaluation is imperative to assess implementation, context and mechanisms of impact. This protocol aims to describe the process evaluation of the STEPSTONES transition programme.

    METHODS AND DESIGN: Medical Research Council guidance for process evaluation of complex interventions will be the guiding framework for this mixed-method study. The combination of qualitative and quantitative data will capture different aspects of programme delivery. The sample will consist of participants in the STEPSTONES randomised controlled trial (RCT), persons implementing the programme and healthcare professionals. Quantitative data will consist of protocols and routine monitoring documents from the RCT, data collected from patient registries and sociodemographic data to assess the implementation of the intervention. This data will be analysed with quantitative content analysis, along with descriptive and inferential statistics. Qualitative data will consist of participatory observations, logbooks and interviews with persons implementing the programme, participants and healthcare professionals. Analyses will be performed using qualitative content analysis to investigate mechanism of impact, context and delivery. Quantitative and qualitative data will be integrated in the final stage by using a triangulation protocol according to mixed-method guidelines.

    ETHICS AND DISSEMINATION: The study is approved by the Regional Ethical Review Board in Gothenburg, Sweden. Results will be presented in open access, peer-reviewed journals and at international scientific conferences.

  • 23.
    Svedbo Engström, Maria
    et al.
    Dalarna University, School of Education, Health and Social Studies, Caring Science/Nursing. Göteborgs universitet.
    Leksell, Janeth
    Dalarna University, School of Education, Health and Social Studies, Caring Science/Nursing. Uppsala universitet.
    Johansson, Unn-Britt
    Gudbjörnsdottir, Soffia
    What is important for you? A qualitative interview study of living with diabetes and experiences of diabetes care to establish a basis for a tailored Patient-Reported Outcome Measure for the Swedish National Diabetes Register2016In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 6, no 3, article id e010249Article in journal (Refereed)
    Abstract [en]

    OBJECTIVES: There is a growing emphasis on the perspective of individuals living with diabetes and the need for a more person-centred diabetes care. At present, the Swedish National Diabetes Register (NDR) lacks patient-reported outcome measures (PROMs) based on the perspective of the patient. As a basis for a new PROM, the aim of this study was to describe important aspects in life for adult individuals with diabetes.

    DESIGN: Semistructured qualitative interviews analysed using content analysis.

    SETTING: Hospital-based outpatient clinics and primary healthcare clinics in Sweden.

    PARTICIPANTS: 29 adults with type 1 diabetes mellitus (DM) (n=15) and type 2 DM (n=14).

    INCLUSION CRITERIA: Swedish adults (≥18 years) living with type 1 DM or type 2 DM (duration ≥5 years) able to describe their situation in Swedish. Purposive sampling generated heterogeneous characteristics.

    RESULTS: To live a good life with diabetes is demanding for the individual, but experienced barriers can be eased by support from others in the personal sphere, and by professional support from diabetes care. Diabetes care was a crucial resource to nurture the individual's ability and knowledge to manage diabetes, and to facilitate life with diabetes by supplying support, guidance, medical treatment and technical devices tailored to individual needs. The analysis resulted in the overarching theme 'To live a good life with diabetes' constituting the two main categories 'How I feel and how things are going with my diabetes' and 'Support from diabetes care in managing diabetes' including five different categories.

    CONCLUSIONS: Common aspects were identified including the experience of living with diabetes and support from diabetes care. These will be used to establish a basis for a tailored PROM for the NDR.

  • 24.
    Tistad, Malin
    et al.
    Dalarna University, School of Education, Health and Social Studies, Medical Science. Karolinska institutet; Umeå universitet.
    Flink, Maria
    Ytterberg, Charlotte
    Eriksson, Gunilla
    Guidetti, Susanne
    Tham, Kerstin
    von Koch, Lena
    Resource use of healthcare services 1 year after stroke: a secondary analysis of a cluster-randomised controlled trial of a client-centred activities of daily living intervention2018In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 8, no 8, article id e022222Article in journal (Refereed)
    Abstract [en]

    OBJECTIVE: The objective of the study was to compare the total use of healthcare services in the course of the first year after a stroke between participants who, after the acute care, had received occupational therapy as a client-centred activities of daily living (ADL) intervention (CADL) and participants who had received usual ADL intervention (UADL).

    DESIGN: A secondary analysis of a multicentre cluster-randomised controlled trial (RCT).

    SETTING: Primary and secondary care in Sweden.

    PARTICIPANTS: Participants were included if they: (1) had received CADL or UADL in the RCT, either as inpatients in geriatric rehabilitation units or in their own homes, and (2) data could be retrieved about their use of healthcare services provided by the county council from computerised registers.

    INTERVENTIONS: CADL or UADL.

    OUTCOME MEASURES: Inpatient and outpatient healthcare in the course of the first year after stroke.

    RESULTS: Participants from 7 of the 16 units included in the RCT met the criteria. Participants in the CADL group (n=26) who received geriatric inpatient rehabilitation had a shorter length of hospital stay (p=0.03) than participants in the UADL group (n=46), and the CADL group with home rehabilitation (n=13) had fewer outpatient contacts (p=0.01) compared with the UADL group (n=25). Multiple regression analyses showed that in four of the models, a higher age was associated with a lower use of healthcare services. The use of healthcare services was also associated (some of the models) with dependence in ADL, stroke severity and type of rehabilitation received, CADL or UADL.

    CONCLUSIONS: The provision of client-centred occupational therapy after stroke did not appear to increase the use of healthcare services during the first year after stroke.rrrrr TRIAL REGISTRATION NUMBER: NCT01417585.

  • 25. Torstensen, Tom Arild
    et al.
    Grooten, Wilhelmus J A
    Østerås, Håvard
    Heijne, Annette
    Harms-Ringdahl, Karin
    Äng, Björn
    Dalarna University, School of Education, Health and Social Studies, Medical Science.
    How does exercise dose affect patients with long-term osteoarthritis of the knee? A study protocol of a randomised controlled trial in Sweden and Norway: the SWENOR Study2018In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 8, no 5, article id e018471Article in journal (Refereed)
    Abstract [en]

    INTRODUCTION: Osteoarthritis (OA) of the knee is characterised by knee pain, disability and degenerative changes, and places a burden on societies all over the world. Exercise therapy is an often-used modality, but there is little evidence of what type of exercise dose is the most effective, indicating a need for controlled studies of the effect of different dosages. Thus, the aim of the study described in this protocol is to evaluate the effects of high-dose versus low-dose medical exercise therapy (MET) in patients with knee OA.

    METHODS AND ANALYSIS: This is a multicentre prospective randomised two-arm trial with blinded assessment and data analysis. We are planning to include 200 patients aged 45-85 years with symptomatic (pain and decreased functioning) and X-ray verified diagnosis of knee OA. Those eligible for participation will be randomly allocated to either high-dose (n=100) or low-dose (n=100) MET. All patients receive three supervised treatments each week for 12 weeks, giving a total of 36 MET sessions. The high-dose group exercises for 70-90 min compared with 20-30 min for the low-dose group. The high-dose group exercises for a longer time, and receives a greater number of exercises with more repetitions and sets. Background and outcome variables are recorded at inclusion, and outcome measures are collected after every sixth treatment, at the end of treatment, and at 6-month and 12-month follow-ups. Primary outcome is self-rated knee functioning and pain using the Knee Injury and Osteoarthritis Outcome Score (KOOS). The primary end point is at the end of treatment after 3 months, and secondary end points are at 6 months and 12 months after the end of treatment.

    ETHICS AND DISSEMINATION: This project has been approved by the Regional Research Ethics Committees in Stockholm, Sweden, and in Norway. Our results will be submitted to peer-reviewed journals and presented at national and international conferences.

    TRIAL REGISTRATION NUMBER: NCT02024126; Pre-results.

  • 26. Walladbegi, Java
    et al.
    Svanberg, Anncarin
    Uppsala University Hospital.
    Gellerstedt, Martin
    Protocol for a randomised controlled trial to study cryoprevention of chemotherapy-induced oral mucositis after autologous stem cell transplantation2019In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 18, no 8, article id e021993Article in journal (Refereed)
    Abstract [en]

    Introduction A majority of patients who receive myeloablative therapy prior to hematopoetic stem cell transplantation develop oral mucositis (OM). This adverse cytotoxic effect manifests as oral mucosal erythema and ulcerations and frequently necessitates high doses of morphine for pain alleviation. OM may also interfere with food intake and result in parenteral nutrition, weight loss and impaired quality of life. To date, there have been a few studies of evidence-based interventions for prevention of OM. Cooling the oral mucosa using ice chips in conjunction with chemotherapy is known to reduce the severity of OM although clinical application is still limited due to several disadvantages. The primary endpoint of this study is therefore to evaluate the efficacy of an innovative intraoral cooling device (Cooral) compared with ice cooling in reducing the degree of OM, in patients with myeloma or lymphoma.

    Method and analysis A total of 180 patients from four different university hospitals in Sweden will be randomised to ice or Cooral in a proportion of 1:1. The degree of OM will be assessed at eight intraoral locations, in accordance with the Oral Mucositis Assessment Scale and WHO scale. Patients will be registered beginning at admission and will continue until discharge or until day +28. The primary variable is analysed in a multiple linear regression model. The significance level used is 5%.

    Ethics and dissemination The study protocol, questionnaire, diaries and letter of invitation to participants have been reviewed by the local ethical board in Göteborg. The trial results will be published in a peer-reviewed journal and disseminated to participants.

    Trial registration number NCT03203733; Pre-results.

    Protocol version Version 4, 2017-06-05

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