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Davidson, Thomas
Publications (10 of 55) Show all publications
Kassymova, G., Davidson, T., Sydsjö, G., Borendal Wodlin, N., Nilsson, L. & Kjölhede, P. (2025). Cost analysis of nurse-lead telephone follow-ups after benign hysterectomy: a randomized, single-blinded, four-arm, controlled multicenter trial. Archives of Gynecology and Obstetrics, 312(2), 515-523
Open this publication in new window or tab >>Cost analysis of nurse-lead telephone follow-ups after benign hysterectomy: a randomized, single-blinded, four-arm, controlled multicenter trial
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2025 (English)In: Archives of Gynecology and Obstetrics, ISSN 0932-0067, E-ISSN 1432-0711, Vol. 312, no 2, p. 515-523Article in journal (Refereed) Published
Abstract [en]

PurposeThe aim of the study was to evaluate the health economics of nurse-led telephone follow-up contacts (TFUs) within six weeks after benign hysterectomy in a societal perspective, using a cost minimization analysis model.MethodsA randomized, single-blinded, controlled, Swedish multicenter study comprising 487 women undergoing benign hysterectomy. The women were allocated 1:1:1:1 to either Group A (no TFUs), Group B (one clinically structured TFU the day after discharge), Group C (as B, but with additional TFUs once weekly for six weeks, in total six TFUs), or Group D (as C, but by applying a coaching technique). Time consumption for planned TFUs, informal care, and the number of unplanned telephone contacts and visits were recorded. Costs were assessed using a cost-per-patient price list for Link & ouml;ping University Hospital.ResultsThe total cost per patient more than doubled in the groups with repeated TFUs (Groups C and D) compared with no TFUs (Group A). Group D demonstrated fewer unplanned telephone contacts and lower informal care costs. Group B, with only one TFU, exhibited the highest time consumption for TFU. The additional costs of six TFUs, with or without coaching, substantially increased the costs. The coaching TFU group (Group D) had the lowest cost for informal care.ConclusionTFUs appeared to be costly and an inefficient way of using healthcare resources after benign hysterectomy. The coaching TFU seemed to reduce unplanned telephone contacts and lower informal care costs. Careful consideration of the costs and the impact on clinical outcomes is important before implementing TFU after surgery.Trial registrationThis study is registered retrospectively in ClinicalTrial.gov: NCT01526668 on January 27, 2012. Date of enrollment of first patient: October 11; 2011.

Place, publisher, year, edition, pages
SPRINGER HEIDELBERG, 2025
Keywords
Hysterectomy; Telephone follow-up; Cost minimization analysis; Healthcare; Patient-centered care
National Category
Gynaecology, Obstetrics and Reproductive Medicine
Identifiers
urn:nbn:se:liu:diva-213565 (URN)10.1007/s00404-025-08035-1 (DOI)001480165500001 ()40314809 (PubMedID)2-s2.0-105003948036 (Scopus ID)
Note

Funding Agencies|Linkoping University; Medical Research Council of Southeast Sweden [FORSS-155141, FORSS-222211, FORSS-308441, FORSS-387761]; Futurum-the Academy of Health and Care, Region Jonkoping Council [FUTURUM-487481, FUTURUM 579171]

Available from: 2025-05-14 Created: 2025-05-14 Last updated: 2025-10-23Bibliographically approved
Blomma, C., Aronsson, K., Bågesund, M., Risberg, M. B., Wärnberg-Gerdin, E. & Davidson, T. (2024). Evaluation of an early childhood caries preventive programme starting during pregnancy-Results after 3 and 6 years. International Journal of Paediatric Dentistry, 34(6), 744-754
Open this publication in new window or tab >>Evaluation of an early childhood caries preventive programme starting during pregnancy-Results after 3 and 6 years
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2024 (English)In: International Journal of Paediatric Dentistry, ISSN 0960-7439, E-ISSN 1365-263X, Vol. 34, no 6, p. 744-754Article in journal (Refereed) Published
Abstract [en]

Background: Early childhood caries (ECC) has been found to be up to five times more common among children living in areas of low socio-economic status (SES) than among children in areas of higher SES. Aim: To evaluate an ECC prevention programme from pregnancy to 3 and 6 years of age. Design: A prospective, controlled, intervention cohort study was initiated in 2013 in a low-SES area in Sweden. The intervention group received an individual interdisciplinary ECC prevention programme starting pre-birth, consisting of supportive oral health-promoting talks using motivational interviewing techniques and individual ECC preventive actions. A control group, consisting of pregnant women living in a comparable area, received ordinary routines. Results: Of the 336 pregnant women, 64 mothers (with 64 children) completed the programme, and 394 children were born in the control group. At the sixth year examination, the proportion of children with no caries was similar between the groups (53% resp. 52%, p = .976), whereas the proportion with decayed, missed, filled primary teeth (dmft = 1-5) was slightly lower (23% resp. 36%, p = .063), and the proportion with severe caries disease (dmft > 5) was higher (p = .013) in the intervention group (25%) than in the control group (12%). Conclusion: No preventive effect regarding caries can be demonstrated at sixth year of age. Maternal behavioural change in dental care was not sufficient to even out inequalities in oral health in children, eventually due to difficulties in reaching the target group and the lack of effects among the families reached.

Place, publisher, year, edition, pages
WILEY, 2024
Keywords
caries; children; inequality; interdisciplinary; promotion
National Category
Dentistry
Identifiers
urn:nbn:se:liu:diva-202278 (URN)10.1111/ipd.13174 (DOI)001181768300001 ()38462758 (PubMedID)2-s2.0-85187479140 (Scopus ID)
Note

Funding Agencies|Public Dental Service Ostergotland; Region Ostergotland

Available from: 2024-04-09 Created: 2024-04-09 Last updated: 2025-10-24Bibliographically approved
Davidson, T., Sjödahl, R., Aldman, A., Lennmarken, C., Kammerlind, A.-S. & Theodorsson, E. (2024). Robot-assisted pelvic and renal surgery compared with laparoscopic or open surgery: Literature review of cost-effectiveness and clinical outcomes. Scandinavian Journal of Surgery, 113(1), 13-20
Open this publication in new window or tab >>Robot-assisted pelvic and renal surgery compared with laparoscopic or open surgery: Literature review of cost-effectiveness and clinical outcomes
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2024 (English)In: Scandinavian Journal of Surgery, ISSN 1457-4969, E-ISSN 1799-7267, Vol. 113, no 1, p. 13-20Article, review/survey (Refereed) Published
Abstract [en]

Background and aim: The purpose of this study was to evaluate clinical experiences and cost-effectiveness by comparing robot-assisted surgery with laparoscopic- or open surgery for pelvic and renal operations. Methods: A narrative review was carried out. Results: When using robotic-assisted surgery, oncological and functional results are similar to after laparoscopic or open surgery. One exception may be a shorter survival in cancer of the cervix uteri. In addition, postoperative complications after robotic-assisted surgery are similar, bleeding and transfusion needs are less, and the hospital stay is shorter but the preparation of the operating theater before and after surgery and the operation times are longer. Finally, robot-assisted surgery has, in several studies, been reported to be not cost-effective primarily due to high investment costs. However, more recent studies provide improved cost-effectiveness estimates due to more effective preparation of the operating theater before surgery, improved surgeon experience, and decreased investment costs. Conclusions: Complications and functional and oncological outcomes after robot-assisted surgery are similar to open surgery and laparoscopic surgery. The cost-effectiveness of robot-assisted surgery is likely to equal or surpass the alternatives.

Place, publisher, year, edition, pages
SAGE PUBLICATIONS LTD, 2024
Keywords
Robot-assisted surgery; pelvic and renal surgery; cost-effectiveness; ergonomics
National Category
Surgery
Identifiers
urn:nbn:se:liu:diva-197512 (URN)10.1177/14574969231186283 (DOI)001044680300001 ()37555486 (PubMedID)2-s2.0-85167412501 (Scopus ID)
Available from: 2023-09-07 Created: 2023-09-07 Last updated: 2025-08-15Bibliographically approved
Hedmo, C., Lindsten, R., Josefsson, E. & Davidson, T. (2023). A cost analysis of orthodontic space closure and implant treatment in patients missing maxillary lateral incisors with a long-term perspective. European Journal of Orthodontics, 45(4), 468-474
Open this publication in new window or tab >>A cost analysis of orthodontic space closure and implant treatment in patients missing maxillary lateral incisors with a long-term perspective
2023 (English)In: European Journal of Orthodontics, ISSN 0141-5387, E-ISSN 1460-2210, Vol. 45, no 4, p. 468-474Article in journal (Refereed) Published
Abstract [en]

Objective Few studies within orthodontics present both economic and clinical findings. Missing maxillary lateral incisors is a frequently occurring anomaly. The treatment alternatives most used are orthodontic space closure and prosthetic replacement of the missing tooth. Our aim is to compare the total societal costs of orthodontic space closure (SC) and implant therapy (IT) in patients missing maxillary lateral incisors. Methods Records of 32 patients treated with SC (n = 18) or IT (n = 14) due to missing maxillary lateral incisors were retrieved from the archives. Direct costs and indirect costs in the short- and long-term were analysed using a cost analysis with a societal perspective up of to 12 years post-treatment. Results Comparing cases treated with SC and IT, the difference in direct short-term costs for treatment is euro735.54, whereas SC is the least costly. There is no difference between SC and IT in short-term parent loss of productivity, long-term loss of productivity, costs for transportation, or direct long-term costs. A difference was found between SC and IT-in favour of SC-when comparing patients loss of productivity (P = 0.007), short-term societal costs (P < 0.001), long-term societal costs (P = 0.037), and total societal costs (P < 0.001). Limitations There is a limited number of patient records. Local factors such as subsidies, urban versus rural areas, taxes, etc. can influence monetary variables, so the transferability to other settings may be limited. Conclusion Patients treated with SC have a lower total societal cost compared to patients treated with IT. There was a difference in productivity loss for patients between SC and IT; however, concerning other indirect parameters and direct long-term costs, there was no difference between the two treatments.

Place, publisher, year, edition, pages
OXFORD UNIV PRESS, 2023
National Category
Dentistry
Identifiers
urn:nbn:se:liu:diva-194179 (URN)10.1093/ejo/cjad008 (DOI)000982914600001 ()37071917 (PubMedID)
Available from: 2023-05-31 Created: 2023-05-31 Last updated: 2024-03-26Bibliographically approved
Ax, A.-K., Husberg, M., Johansson, B., Demmelmaier, I., Berntsen, S., Sjövall, K., . . . Davidson, T. (2023). Cost-effectiveness of different exercise intensities during oncological treatment in the Phys-Can RCT. Acta Oncologica, 62(4), 414-421
Open this publication in new window or tab >>Cost-effectiveness of different exercise intensities during oncological treatment in the Phys-Can RCT
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2023 (English)In: Acta Oncologica, ISSN 0284-186X, E-ISSN 1651-226X, Vol. 62, no 4, p. 414-421Article in journal (Refereed) Published
Abstract [en]

Background

Cost-effectiveness is important in the prioritisation between interventions in health care. Exercise is cost-effective compared to usual care during oncological treatment; however, the significance of exercise intensity to the cost-effectiveness is unclear. In the present study, we aimed to evaluate the long-term cost-effectiveness of the randomised controlled trial Phys-Can, a six-month exercise programme of high (HI) or low-to-moderate intensity (LMI) during (neo)adjuvant oncological treatment.

Methods

A cost-effectiveness analysis was performed, based on 189 participants with breast, colorectal, or prostate cancer (HI: n = 99 and LMI: n = 90) from the Phys-Can RCT in Sweden. Costs were estimated from a societal perspective, and included cost of the exercise intervention, health care utilisation and productivity loss. Health outcomes were assessed as quality-adjusted life-years (QALYs), using EQ-5D-5L at baseline, post intervention and 12 months after the completion of the intervention.

Results

At 12-month follow-up after the intervention, the total cost per participant did not differ significantly between HI (€27,314) and LMI exercise (€29,788). There was no significant difference in health outcome between the intensity groups. On average HI generated 1.190 QALYs and LMI 1.185 QALYs. The mean incremental cost-effectiveness ratio indicated that HI was cost effective compared with LMI, but the uncertainty was large.

Conclusions

We conclude that HI and LMI exercise have similar costs and effects during oncological treatment. Hence, based on cost-effectiveness, we suggest that decision makers and clinicians can consider implementing both HI and LMI exercise programmes and recommend either intensity to the patients with cancer during oncological treatment to facilitate improvement of health.

Place, publisher, year, edition, pages
Taylor & Francis, 2023
Keywords
Cancer, exercise, health, cost-effectiveness
National Category
Cancer and Oncology
Identifiers
urn:nbn:se:liu:diva-193277 (URN)10.1080/0284186X.2023.2200149 (DOI)000971022300001 ()37074759 (PubMedID)
Note

Funding agencies: This work was supported by grants from the Swedish Cancer Society; the Swedish Research Council, and the Region Östergötland, Sweden.

Available from: 2023-04-27 Created: 2023-04-27 Last updated: 2024-05-02Bibliographically approved
Ax, A.-K., Husberg, M., Johansson, B., Demmelmaier, I., Berntsen, S., Sjövall, K., . . . Davidson, T. (2022). Long-term resource utilisation and associated costs of exercise during (neo)adjuvant oncological treatment: the Phys-Can project. Acta Oncologica, 61(7), 888-896
Open this publication in new window or tab >>Long-term resource utilisation and associated costs of exercise during (neo)adjuvant oncological treatment: the Phys-Can project
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2022 (English)In: Acta Oncologica, ISSN 0284-186X, E-ISSN 1651-226X, Vol. 61, no 7, p. 888-896Article in journal (Refereed) Published
Abstract [en]

Background Exercise during oncological treatment is beneficial to patient health and can counteract the side effects of treatment. Knowledge of the societal costs associated with an exercise intervention, however, is limited. The aims of the present study were to evaluate the long-term resource utilisation and societal costs of an exercise intervention conducted during (neo)adjuvant oncological treatment in a randomised control trial (RCT) versus usual care (UC), and to compare high-intensity (HI) versus low-to-moderate intensity (LMI) exercise in the RCT. Methods We used data from the Physical Training and Cancer (Phys-Can) project. In the RCT, 577 participants were randomised to HI or to LMI of combined endurance and resistance training for 6 months, during oncological treatment. The project also included 89 participants with UC in a longitudinal observational study. We measured at baseline and after 18 months. Resource utilisation and costs of the exercise intervention, health care, and productivity loss were compared using analyses of covariance (RCT vs. UC) and t test (HI vs. LMI). Results Complete data were available for 619 participants (RCT HI: n = 269, LMI: n = 265, and UC: n = 85). We found no difference in total societal costs between the exercise intervention groups in the RCT and UC. However, participants in the RCT had lower rates of disability pension days (p < .001), corresponding costs (p = .001), and pharmacy costs (p = .018) than the UC group. Nor did we find differences in resource utilisation or costs between HI and LMI exercise int the RCT. Conclusion Our study showed no difference in total societal costs between the comprehensive exercise intervention and UC or between the exercise intensities. This suggests that exercise, with its well-documented health benefits during oncological treatment, produces neither additional costs nor savings.

Place, publisher, year, edition, pages
Taylor & Francis Ltd, 2022
Keywords
Cancer; exercise; health care costs; sick leave; costs; cost analysis
National Category
Health Care Service and Management, Health Policy and Services and Health Economy
Identifiers
urn:nbn:se:liu:diva-185605 (URN)10.1080/0284186X.2022.2075238 (DOI)000799825800001 ()35607981 (PubMedID)
Note

Funding Agencies|Swedish Cancer Society; Swedish Research Council; Region Ostergotland, Sweden

Available from: 2022-06-09 Created: 2022-06-09 Last updated: 2023-05-04Bibliographically approved
Sjödahl, R., Davidson, T., Aldman, Å., Lennmarken, C., Kammerlind, A.-S., Gustavsson, E. & Theodorsson, E. (2022). Robotassisterad bäcken- och njurkirurgi – en utvärdering. Läkartidningen, 119, Article ID 21172.
Open this publication in new window or tab >>Robotassisterad bäcken- och njurkirurgi – en utvärdering
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2022 (Swedish)In: Läkartidningen, ISSN 0023-7205, E-ISSN 1652-7518, Vol. 119, article id 21172Article, review/survey (Refereed) Published
Abstract [en]

Current studies indicate that robotic-assisted surgery is not inferior to laparoscopic or open surgery regarding oncologic or functional outcomes. An exception may be uterine cervix cancer, where the survival after minimal invasive surgery might not be as good as after open surgery. There is less bleeding and need for blood transfusion after robotic-assisted surgery, and postoperative complications are similar to open or laparoscopic surgery. Robotic-assisted surgery offers ergonomic advantages compared to laparoscopic surgery. The effect of the surgical learning curve is not sufficiently studied. Presently robotic-assisted surgery is not cost-effective due to high costs of investments. The operation is more time consuming than laparoscopic or open surgery with risks of delaying and cancellation of other operations.

Abstract [sv]

Onkologiskt och funktionellt resultat vid robotassisterad kirurgi skiljer sig inte från laparoskopisk eller öppen kirurgi. Ett undantag kan vara sämre överlevnad vid cervixcancer.

Robotassisterad kirurgi är inte kostnadseffektiv i dagsläget på grund av investeringskostnaderna.

Robotassisterad kirurgi erbjuder ergonomiska fördelar och ger ingen ökning av postoperativa komplikationer. Operationstiderna är längre, men möjligen är blödning och transfusionsbehov mindre och vårdtiden kortare.

Inlärningseffekterna är ofullständigt undersökta.

Det finns etiska skäl att vara observant på undanträngningseffekter till följd av ökad användning av robotkirurgi.

Place, publisher, year, edition, pages
Stockholm, Sweden: Sveriges läkarförbund, 2022
National Category
Cancer and Oncology
Identifiers
urn:nbn:se:liu:diva-192046 (URN)35471726 (PubMedID)
Available from: 2023-02-28 Created: 2023-02-28 Last updated: 2023-05-02Bibliographically approved
Wigsten, E., Kvist, T., Jonasson, P., Davidson, T., Jonasson, P. & Kvist, T. (2020). Comparing Quality of Life of Patients Undergoing Root Canal Treatment or Tooth Extraction. Journal of Endodontics, 46(105), 19-28
Open this publication in new window or tab >>Comparing Quality of Life of Patients Undergoing Root Canal Treatment or Tooth Extraction
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2020 (English)In: Journal of Endodontics, ISSN 0099-2399, E-ISSN 1878-3554, Vol. 46, no 105, p. 19-28Article in journal (Refereed) Published
Abstract [en]

Introduction

The knowledge of patient-centered outcomes concerning the consequences of root canal treatment in daily life is limited. The treatment option is often tooth extraction with possible prosthetic replacement. This study aimed to achieve a greater understanding of the patient perspective by evaluating the effect of root canal treatment in terms of quality of life and quality-adjusted life year (QALY) weights in comparison with patients who underwent tooth extraction.

Methods

Patients with either root canal treatment or extraction were recruited from 6 clinics in the general public dental service during a predetermined period of 8 weeks. Three different instruments were used: the Oral Health Impact Profile evaluating the oral health–related quality of life (OHRQOL), the EQ-5D-5L evaluating health-related quality of life (HRQOL) and QALY weights, and a disease-specific questionnaire evaluating satisfaction regarding the root canal treatment. The evaluation was assessed at the initiation of treatment and after 1 month. Patient-based and tooth-specific characteristics were obtained from the dental records.

Results

Eighty-five patients were included. The distribution between sexes was even, with 43 women and 42 men. The mean age was 51.1 years. Forty-eight patients (56.5%) had a tooth extraction, and 37 patients (43.5%) initiated root canal treatment. The response rate for the questionnaire at baseline was 95.3%, and at the 1-month follow-up, it was 74.1%. Two relevant and comparable groups were obtained after exclusion of the extracted third molars (n = 20), resulting in 65 patients for further analyses. At follow-up, the patients who initiated root canal treatment registered a significant improvement in perceived HRQOL according to the QALY weights (P = .02 and P < .01, respectively). Patients initiating root canal treatment reported generally high satisfaction.

Conclusions

A cohort of patients either initiating root canal treatment or tooth extraction as a control group was established. Initiating root canal treatment had a positive impact on perceived HRQOL. The included patients in general dental practice registered overall high satisfaction regarding root canal treatment.

Place, publisher, year, edition, pages
Elsevier, 2020
Keywords
Endodontics; EQ-5D-5L; general dental care; Oral Health Impact Profile; patient-centered outcomes; quality-adjusted life year
National Category
Dentistry
Identifiers
urn:nbn:se:liu:diva-163372 (URN)10.1016/j.joen.2019.10.012 (DOI)000506468700004 ()31843125 (PubMedID)2-s2.0-85076232093 (Scopus ID)
Note

Funding Agencies|Folktandrden Vastra Gotaland; Goteborgs Tandlakare-Sallskap; Institute of Odontology, University of Gothenburg; Centre for Medical Technology Assessment, Department of Medical and Health Sciences, Linkoping University, Sweden

Available from: 2020-02-03 Created: 2020-02-03 Last updated: 2021-04-29Bibliographically approved
Davidson, T. (2020). Kostnader och konsekvenser av blodflödesbaserad riskbedömning för identifiering av individer med risk för trycksår. Linköping: Linköping University Electronic Press
Open this publication in new window or tab >>Kostnader och konsekvenser av blodflödesbaserad riskbedömning för identifiering av individer med risk för trycksår
2020 (Swedish)Report (Other academic)
Abstract [sv]

Syftet med den här rapporten var att studera potentiella konsekvenser avseende förekomst av trycksår och kostnader vid användning av PU sensor som tillägg till redan existerande riskbedömningar inom slutenvård och äldreomsorg.

Den huvudsakliga metoden i rapporten var beräkningar i enlighet med metodiken för en kostnadsanalys. Beräkningar gjordes av vad olika riskbedömningsmetoder för att identifiera individer med risk för trycksår, var för sig eller i kombination, ger för konsekvenser i form av antal trycksår och kostnader. Kostnadsberäkningen använde ett hälso- och sjukvårdsperspektiv inklusive äldreomsorg och inkluderade kostnader för riskbedömning, eventuella förebyggande insatser samt kostnader för eventuella trycksår. Data har baserats utifrån publicerade artiklar, register samt skattningar.

Beräkningarna visade att om PU sensor används som extra bedömning för 1000 patienter inom slutenvården uppkommer en extra kostnad om 120 000 kronor för bedömningen, och att 25 extra riskpatienter identifieras. Om preventiva åtgärder sätts in för alla extra identifierade patienter med risk skulle detta leda till 20 färre patienter med trycksår. Användning av PU sensor för 1000 patienter skulle därmed leda till en besparing om 1 791 500 kronor.

Även inom äldreomsorgen visade beräkningarna att användning av PU sensor leder till en besparing, men inte lika stor som inom slutenvården. För 1000 patienter skulle användning av PU sensor leda till 15,5 identifierade patienter med risk. Genom preventiva åtgärder skulle 12,4 patienter undvika att utveckla trycksår till en besparing om 325 310 kronor.

Känslighetsanalyser visade att kostnaden för användning av PU sensor har liten påverkan på resultatet men att kostnaden för trycksår har stor påverkan. Kostnaden för prevention har liten påverkan medan andelen patienter med risk samt sensitiviteten hos PU sensor att identifiera riskpatienter är av stor betydelse. Sammantaget visar dessa känslighetsanalyser att det huvudsakliga resultatet är robust och att PU sensor förväntas leda till färre uppkomna trycksår och besparingar. Därtill tillkommer den ökade livskvaliteten som en konsekvens av förhindrade trycksår.

Place, publisher, year, edition, pages
Linköping: Linköping University Electronic Press, 2020. p. 22
Series
CMT Report, ISSN 0283-1228, E-ISSN 1653-7556 ; 2020:2
Keywords
PU sensor; kostnad; trycksår; riskbedömning
National Category
Health Care Service and Management, Health Policy and Services and Health Economy
Identifiers
urn:nbn:se:liu:diva-171832 (URN)
Note

Projektet har finansierats av PU sensor AB.

Available from: 2020-12-08 Created: 2020-12-08 Last updated: 2020-12-15Bibliographically approved
Gustavsson, E., Juth, N., Raaschou, P., Bonnard, A., Davidson, T., Lärfars, G. & Sandman, L. (2020). Sjukdomsmodifierande läkemedel mot Alzheimers sjukdom: etiska aspekter av prioriteringar och screening. Linköping: Linköping University Electronic Press
Open this publication in new window or tab >>Sjukdomsmodifierande läkemedel mot Alzheimers sjukdom: etiska aspekter av prioriteringar och screening
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2020 (Swedish)Report (Other academic)
Alternative title[en]
Ethical challenges associated with Alzheimer’s disease with a special focus on healthcare priority setting and screening
Abstract [sv]

I skrivande stund pågår det intensiv forskning för att få fram ett sjukdomsmodifierande läkemedel mot Alzheimers sjukdom (AD). Vid introduktion av sådana läkemedel kommer en rad etiskt svåra frågor kring screening och prioriteringar av vårdens resurser, att aktualiseras. Föreliggande rapport behandlar dessa frågor.

Trots att de nya läkemedlens effekt sannolikt har en påverkan på närstående till personer med AD så är det vår bedömning att den svenska etiska plattformen inte lämnar något utrymme för sådan hänsyn. Det finns också skäl att vara särskilt uppmärksam på utsträckningen i vilken de surrogatmått som används i de kliniska studierna faktiskt är av klinisk relevans.

När det gäller att väga samman patientnytta som tillfaller olika individer är det vår bedömning att plattformen inte tillåter aggregering av patientnytta på ett sådant sätt. Det innebär att det faktum att personer med AD utgör en stor patientgrupp utgör i sig inte ett skäl för högre prioritet då effekten skall bedömas med avseende på hur den tillfaller varje enskild individ. I ett scenario där budgetpåverkan blir så stor att man behöver prioritera inom gruppen så tycks det saknas för prioriteringar relevanta kriterier.

Manifest AD är ett tillstånd med mycket stor svårighetsgrad. Men eftersom de nya läkemedlen siktar in sig på den prekliniska eller fasen i vilken patienter har en lindrig kognitiv störning så bör svårighetsgraden av tillståndet viktas ned med avseende på sannolikheten att faktiskt insjukna i AD. Tillståndets svårighetsgrad blir därmed olika för läkemedel som siktar på den prekliniska fasen, de som siktar på fasen med lindrig kognitiv störning och de som siktar på kliniska stadier av AD. Eftersom personer med AD kan ha sämre förutsättningar än andra patientgrupper att kommunicera sina behov bör de beaktas särskilt. Det innebär dock inte någon högre prioritet utan en markering att personer med AD har samma rätt till hälso- och sjukvård som andra grupper med liknande behov.

Populationsscreening för AD är förknippat med flera problem. Det finns generella problem med screening ur exempelvis autonomisynpunkt. Men det finns också problem som relaterar till att nuvarande metoder för riskstratifiering är så opålitliga vilket i sin tur resulterar i falska negativa (med risk för underbehandling) och falska positiva (med risk för överbehandling). Screening i fasen då patienten har en lindrig kognitiv störning har (förutom de problem som kommer med populationsscreening) problem med ojämlikhet och godtycke. När den kliniska fasen inträder har poängen med screening gått förlorad: ju senare identifikation, desto mindre potentiella behandlingsfördelar jämfört med vanlig diagnostik som den går till idag.

Det är vår sammantagna bedömning att de nya läkemedlen måste generera stora hälsovinster för personer som riskerar att insjukna i AD för att berättigas allmän finansiering och för att rättfärdiga de etiska kostnader som kommer med de nuvarande diagnostiska metoderna.

Abstract [en]

Intensive research is carried out by several pharmaceutical companies in order to develop a disease modifying drug for Alzheimer’s disease (AD). The development of drug candidates which reduce Aß and tau in the brain seems particularly promising. These drugs and the characteristics of AD raise a number of ethical challenges. In this report we analyze these challenges in relation to priority setting and the diagnostic measures associated with these drugs. The former analysis draws primarily on the Swedish ethical platform for health care priority setting, whereas the latter draws on the guidelines for screening developed by the National Board of Health and Welfare.

Although the effect of the new drugs is likely to have an impact on relatives of people with AD, it is our interpretation that the Swedish ethical platform leaves no room for such considerations.

In relation to the effect of the drugs there is also reason to pay special attention to the extent to which the surrogate measures used in the clinical studies are of clinical relevance.

When it comes to aggregating benefits across individuals, it is our interpretation that the platform does not allow aggregation of patient benefits in such a way. This means that the fact that people with AD constitute a large group of patients does not in itself constitute a reason for giving this group a higher priority. The ethical platform rather seems to prescribe that the effect must be assessed with regard to how it accrues to each individual. In a scenario where the budgetary impact becomes so great that decision makers need to prioritize within the group, it seems that there are no relevant criteria for these priorities.

AD is a condition with a very high degree of severity. However, as the new drugs are targeting the preclinical or Mild Cognitive Impairment (MCI) phase, the severity of the condition should be decreased with respect to the likelihood of actually developing AD. The severity of the condition thus becomes different for drugs that aim at the preclinical phase, those that aim at the MCI phase and those that aim at clinical stages of AD.

Solidarity considerations in the platform prescribes that people with AD may be less able than other patient groups to communicate their needs, they should therefore be given special consideration. However, this does not mean a higher priority but to stress that people with AD have the same right to health care as other groups with similar needs.

Population screening for AD is associated with several problems. There are general problems with screening from, for example, an autonomy point of view. But there are also problems related to the fact that current methods of risk stratification are so unreliable, which in turn results in false negatives (with risk of undertreatment) and false positives (with risk of overtreatment).

Screening in the MCI phase has (in addition to the problems that come with population screening) problems with inequality and arbitrariness. When the clinical phase begins, there is no longer any point with screening: the later the identification, the less potential treatment benefits compared to standard diagnostics.

It is our overall assessment that the new drugs must generate large health benefits for people at risk of developing AD in order to be eligible for general funding and to justify the ethical costs that come with current diagnostic methods.

Place, publisher, year, edition, pages
Linköping: Linköping University Electronic Press, 2020. p. 42
Series
National Center for Priority Setting in Health Care, ISSN 1650-8475 ; 2020:1
Keywords
Alzheimers sjukdom; screening; prioritering; etik; patientnytta, Läkemedel
National Category
Medical Ethics
Identifiers
urn:nbn:se:liu:diva-169932 (URN)
Available from: 2020-09-25 Created: 2020-09-25 Last updated: 2021-05-07Bibliographically approved
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