Hysterectomy for heavy menstrual bleeding: rapid health technology assessment

Source at https://www.fhi.no/publ/2021/hysterektomi-ved-kraftige-menstruasjonsblodninger/Vi har på oppdrag fra Bestillerforum for nye metoder utarbeidet en forenklet metodevurdering om hysterektomi (kirurgisk fjerning av livmor) ved kraftige menstruasjonsblødninger. Dette er en pilot i et prosjekt innen revurdering som ledes av Helse Midt-Norge RHF. Vi har hentet ut resultater for effekt og sikkerhet og vurderinger av tillit til resultatene for effekt fra en rapport av The National Institute of Health and Care Excellence, og utført en kostnadsanalyse. Resultatene må ses i sammenheng med andre faktorer som påvirker valg av behandling, og at vanlig praksis bør være å forsøke mindre invasive alternativer først

Use of Swedish smokeless tobacco during pregnancy: a systematic review of pregnancy and early life health risk

This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.Background and Aims: Smokeless tobacco is a heterogeneous product group with diverse composition and prevalence globally. Tobacco use during pregnancy is concerning due to the risk of adverse pregnancy outcomes and effects on child health. Nicotine may mediate several of these effects. This systematic review measured health outcomes from Swedish smokeless tobacco (snus) use during pregnancy. Method: Literature search was conducted by an information specialist in May 2022. We included human studies of snus use during pregnancy compared with no tobacco use, assessed risk of bias, conducted a meta-analysis and assessed confidence in effectestimates using Grading of Recommendations, Assessment, Development and Evaluations (GRADE). Results: We included 18 cohort studies (42 to 1 006 398 participants). Snus use during pregnancy probably (moderate confidence in risk estimates) increase the risk of neonatal apnea, adjusted odds ratio 95% confidence interval [aOR (95% CI)] 1.96 (1.30 to 2.96). Snus use during pregnancy possibly (low confidence in risk estimates) increase the risk of stillbirths aOR 1.43 (1.02 to 1.99), extremely premature births aOR 1.69 (1.17 to 2.45), moderately premature birth aOR 1.26 (1.15 to 1.38), SGA aOR 1.26 (1.09 to 1.46), reduced birth weight mean difference of 72.47 g (110.58 g to 34.35 g reduction) and oral cleft malformations aOR 1.48 (1.00 to 2.21). It is uncertain (low confidence in risk estimates, CI crossing 1) whether snus use during pregnancy affects risk of preeclampsia aOR 1.11 (0.97 to 1.28), antenatal bleeding aOR 1.15 (0.92 to 1.44) and very premature birth aOR 1.26 (0.95 to 1.66). Risk of early neonatal mortality and altered heart rate variability is uncertain, very low confidence. Snus using mothers had increased prevalence of caesarean sections, low confidence. Conclusions: This systematic review reveals that use of smokeless tobacco (snus) during pregnancy may adversely impact the developing child.publishedVersio

Effekt av tiltak for barn og unge med overvekt eller fedme

Om lag 14 % av barn og ungdom i Norge har overvekt eller fedme. Overvekt og fedme kan påvirke den fysiske og psykososiale helsen, og behandling vil kunne gi helsemessige gevinster. Vi har vurdert effekten av tiltak for barn og unge med overvekt eller fedme. Basert på resultatene kan vi konkludere: Sammensatte livsstilstiltak med kombinasjoner av kostholdsendring, økt fysisk aktivitet og atferdsendringsstrategier kan trolig gi større reduksjon av kroppsmasseindeks (KMI) og kroppsmasseindeks standardavviksskår (KMI z-skår) enn lite eller ingen tiltak. Vi har middels tillit til dokumentasjonen Økt fysisk aktivitet kan trolig gi reduksjon av KMI sammenlignet med lite eller ingen tiltak. Vi har middels tillit til dokumentasjonen. Det er uvisst om dietter med lav glykemisk indeks eller belastning kan redusere KMI z-skår mer enn fettredusert diett og diett med høy glykemisk indeks. Kunnskapsgrunnlaget er for lite til å kunne konkludere om andre dietter og kostholdstiltak. Medikamenter (metformin) i tillegg til livsstilstiltak, kan muligens redusere KMI z-skår mer enn placebo hos ungdom med fedme og nedsatt glukosetoleranse. Vi har lav tillit til dokumentasjonen. Kirurgisk behandling kan trolig gi større reduksjon av KMI og KMI z-skår enn intensive livsstilstiltak hos unge med fedme. Vi har middels tillit til dokumentasjonen

Multicomponent Lifestyle Interventions for Treating Overweight and Obesity in Children and Adolescents: A Systematic Review and Meta-Analyses

Background: Treatment of childhood obesity is important in preventing development of obesity-related diseases later in life. This systematic review evaluates the effect of multicomponent lifestyle interventions for children and adolescents from 2 to 18 years. Methods and Results: We performed systematic searches in nine databases. Thirty-nine studies met the criteria for meta-analyses. We found a significant difference in body mass index (BMI) after 6 months (MD −0.99 (95% CI −1.36 to −0.61)), 12 months (MD −0.67 (95% CI −1.01 to −0.32)), and 24 months (MD −0.96 (95% CI −1.63 to −0.29)) in favour of multicomponent lifestyle interventions compared to standard, minimal, and no treatment. We also found a significant difference in BMI Z scores after 6 months (MD −0.12 (95% CI −0.17 to −0.06)), 12 months (MD −0.16 (95% CI −0.21 to −0.11)), and 24 months (MD −0.16 (95% CI −0.21 to −0.10)) in favour of multicomponent lifestyle interventions. Subgroup analyses suggested an increased effect in specialist health care with a group treatment component included in the intervention. Conclusion: Multicomponent lifestyle interventions have a moderate effect on change in BMI and BMI Z score after 6, 12, and 24 months compared with standard, minimal, and no treatment

Vurdering av fire intensive habiliteringsprogram for barn og unge med hjerneskade: en fullstendig metodevurdering

Background Some children and adolescents with brain damage and their families use intensive rehabilitation programs like Advanced Bio-Mechanical Rehabilitation, the Institutes for the Achievement of Human Potential program, the Family Hope Center program and the Kozijavkin method. However, the programs are controversial among medical professionals and represent major costs to health care services and society. Objective In this health technology assessment, we assessed the clinical efficacy and safety of intensive programs for children and adolescents with brain damage, performed a health economic evaluation related to the programs and two Norwegian regional programs as comparator, and highlighted some ethical challenges. Method Clinical efficacy and safety: We performed systematic literature searches in nine databases for controlled studies on the above-mentioned intensive habilitation programs. We critically assessed studies using the Risk of Bias-tool, descriptively summarized outcome data and graded overall results using Grading of Recommendations Assessment, Development and Evaluation. Health Economic Evaluation: We described costs of the four intensive habilitation programs, and two Norwegian intensive rehabilitation program as comparator. Cost description included an estimate for total costs and mean costs per participant with family. We described costs in a healthcare perspective, with a time horizon of 1 year. Ethical assessment: We used a stepwise method that included identification of stakeholders, identification of moral questions, illuminating questions through literature search, hearings and user involvement, and summarization of process. Results Clinical efficacy and safety: We found three small controlled trials involving 94 participants that assessed the effectiveness of the Institutes for the Achievement of Human Potential program and the Family Hope Center program compared to standard treatment. Over time, none of the studies found difference in gross motor, fine motor and cognitive function between the interventions and control conditions but the evidence had very low quality assessed by the Grading of Recommendations Assessment, Development and Evaluation (GRADE). None of the studies assessed safety outcomes of the programs. We found no controlled studies on efficacy and safety of Advanced Bio-Mechanical Rehabilitation and the Kozijavkin method. Health Economic Evaluation: In 2015, the total costs of the four intensive programs were 31,876,669 Norwegian kroner. The mean cost per participant with family was 426,146 Norwegian kroner. Two Norwegian intensive programs used as comparison had in 2015 an estimated total cost of 9,675,202 million Norwegian kroner and a mean cost per participant with family of 225,005 Norwegian kroner. Ethical assessment: A practice in which patients participating in foreign intensive habilitation programs receive public funding for both participation in and training between program participation may legitimize the use of non-documented treatment and in some cases impair patients' possibility for normal social participation. Discussion Clinical efficacy and safety: Despite thorough searches in nine databases and review of the programs' websites, we found only three studies with control groups on the Institutes for the Achievement of Human Potential program and the Family Hope Center program. Two of the studies were over 35 years old. The included studies used different tools for evaluation of efficacy, and lack of description of the variation in outcomes data (standard deviation or confidence interval) in two of the studies prevented synthesizing of data in meta-analysis. We identified no controlled studies on Advanced Bio-Mechanical Rehabilitation or the Kozijavkin method. Health Economic Evaluation: Absence of guidelines and lack of documentation for effectiveness of the foreign intensive habilitation programs indicated that it was not relevant to perform a full economic evaluation. Ethical assessment: Extensive use of foreign habilitation programs raises several moral questions. Our goal was to shed light on some ethical questions related to this issue, but the topic could have been wider illuminated in a complete ethical analysis. Conclusion None of the studies on the Institutes for the Achievement of Human Potential program and the Family Hope Center program found difference in the effect on gross motor, fine motor and cognitive function over time, compared to standard treatment, but the quality of the documentation was very low. Lack of data prevents us from concluding on safety of the Institutes for the Achievement of Human Potential program and the Family Hope Center program. Lack of controlled studies indicates that we cannot conclude on the efficacy and safety of Advanced Bio-Mechanical Rehabilitation and the Kozijavkin method. The mean cost per patient with brain damage and their family is about twice as high for foreign habilitation compared to two Norwegian intensive habilitation programs. Based on an ethical perspective, the practice of public funding of participation in foreign habilitation programs may contribute to legitimization of non-documented treatment. Participation in some intensive programs can also reduce children and families' opportunities for normal social interaction and self-expression. Despite this, many parents experience that they are well taken care of in the programs

Surgical Treatment of Carpal Tunnel Syndrome: A Health Technology Assessment

Executive summary Background Carpal tunnel syndrome is a clinical syndrome characterized by symptoms and signs of irritation or impairment of the median nerve at the level of the wrist. Typical symptoms are numbness, tingling and pain in the hand, sometimes also in the arm and shoulder. Although surgical treatment with release of the transverse carpal ligament is an established treatment, the relative benefits and risks compared with non-surgical treatments is unclear. Objective The objective of this health technology assessment is to summarize the current knowledge on the efficacy and safety of decompression surgery for carpal tunnel syndrome compared to non-surgical treatments with wrist splinting, combinations of nonsurgical treatments, local corticosteroid injection (steroid injection) and physical therapy (including manual therapy). We planned to analyse outcomes based on pre-treatment severity of carpal tunnel syndrome (mild, moderate, and severe) if reported, to evaluate whether some subpopulations seem to benefit more from surgery than others. Methods We developed a project plan with input from the external experts and patient representatives. We searched for systematic reviews in the Cochrane Database of Systematic Reviews (Wiley), Epistemonikos (Epistemonikos Foundation), INAHTA (International Network of Agencies for Health Technology Assessment), MEDLINE (Ovid) and Embase (Ovid), and for randomized controlled trials (RCTs) in MEDLINE (Ovid), Embase (Ovid), and Cochrane Central (Wiley) up to December 2020. Additionally, we identified randomized controlled trials from the systematic reviews. We included randomized controlled trials comparing surgery with the selected nonsurgical treatments in individuals aged 18 years or older, regardless of other comorbidities or severity of carpal tunnel syndrome. Our primary outcomes were symptom severity including paraesthesia and pain, functional impairment, and health-related quality of life. Secondary outcomes included adverse events. Data from 6 months, 1 year, 2 years and 5 years were retrieved, and primary time point of interest was set at 1 year. Two researchers independently selected trials for inclusion and assessed risk of bias of the included randomized controlled trials according to the Cochrane Handbook for Systematic Reviews of Interventions (ROB1). One researcher extracted data, and one checked the accuracy of the data. We calculated measures of effect as mean difference (MD) or standardized mean difference (SMD) with 95% confidence interval (CI) for continuous outcomes, and risk ratio (RR) with 95% CI for dichotomous outcomes. We merged data into meta-analyses when possible, and we present data as forest plots if appropriate. We assessed certainty of evidence for the primary outcomes at 1 year with Grading of Recommendations Assessment, Development and Evaluation (GRADE). Due to great uncertainty in the estimates of the relative efficacy, we conducted a simplified assessment of economic consequences in the form of a cost analysis where the costs of the relevant non-surgical treatment alternatives in Norway, i.e., steroid injection and splinting, were estimated and compared to the costs of surgery for patients with mild to moderate carpal tunnel syndrome. In addition, we conducted a simple budget impact analysis to show possible cost savings. Results We included 10 randomized controlled trials (13 publications) with 960 patients or wrists with carpal tunnel syndrome. Mean age ranged from 41 to 53 years, and 51 to 100% of the participants were females. Seven trials excluded patients with severe carpal tunnel syndrome. All trials were at high risk of bias for at least two domains; lack of blinding of participants and assessors. Some trials had serious methodological concerns. None of the trials reported outcomes according to pre-treatment severity with mild, moderate, and severe carpal tunnel syndrome. Three trials compared surgery with splinting. At 1 year, low-certainty evidence from one trial (downgraded for bias and imprecision) suggested a superior, but small, effect of surgery on symptom severity, daytime paraesthesia, and function. For symptoms, which was considered as the most important outcome by the patient representatives and the project’s clinical experts, patients reported less severity after surgery than after splinting; the standardized mean difference between groups from the intention to treat (ITT) analyses was -0.47 (95% confidence intervals, CI -0.78 to -0.15). Notably, 38% of the patients allocated to splinting had undergone surgery at 1 year. Three trials compared surgery with non-surgical treatments. At 1 year, low-certainty evidence from one trial (downgraded for bias and imprecision) suggested a superior, but small, effect of surgery on symptom severity and hand function, and little or no difference in effect on pain. Mean difference between groups in symptom severity was - 0.33 points (95% CI -0.65 to -0.01). In this trial 44% of the patients allocated to nonsurgical treatment had undergone surgery at 1 year. “As treated” analyses revealed a larger mean difference between groups; -0.84 (95% CI -0.55 to -1.13) points. Two trials compared surgery with steroid injections and three trials compared surgery with manual therapy. We are uncertain of the efficacy of surgery compared to steroid injection and of surgery compared to manual therapy very low-certainty evidence (downgraded for bias and imprecision). Overall, few serious adverse events were reported, but rare adverse events such as complex regional pain syndrome did occur after surgery. The results of our economic evaluation showed that surgery is the most costly treatment at Norwegian kroner (NOK) 11,200 for treatment of patients with mild to moderate carpal tunnel syndrome. The non-surgical treatment alternatives splinting and local 8 Executive summary steroid injection cost approximately NOK 3,100. We estimated potential cost savings at the national level to be between 14.5 and 27.5 million NOK kroner over five years. Discussion Current evidence is insufficient to draw firm conclusions about the efficacy of surgery compared to non-surgical treatments. Low-certainty evidence demonstrated a superior effect of surgery compared to splinting and combinations of non-surgical treatments in patients with mild to moderate carpal tunnel syndrome, but the effect sizes were small, and the clinical relevance is therefore uncertain. An important finding from the trials was that a substantial proportion of patients allocated to non-surgical treatment had been treated with surgery at 1 year, suggesting that the patients were not satisfied with the conservative means. A planned Norwegian trial and other ongoing trials may further elucidate the relative efficacy of surgery to steroid injections. The trials of manual therapy were conducted at one single centre and other studies are needed to confirm the findings from these trials. We have conducted a simple analysis of the costs associated with the treatments in the short term. Therefore, we have not included subsequent treatment after initial treatment. If more reliable evidence becomes available, the long-term effect of the different treatment alternatives should be evaluated in a model-based analysis. There is moderate geographical variation in the provision of surgery for carpal tunnel syndrome in Norway. The need for surgery should be expected to be the same irrespective of geographic area. According to clinical experts, patients with mild to moderate carpal tunnel syndrome could initially have non-surgical treatments. We therefore performed a simple budget impact analysis to show possible cost-savings. However, there is uncertainty regarding this analysis. We did not have information about the distribution of disease severity in the surgically treated population in Norway and therefore we are uncertain about how many patients who could have been treated conservatively instead. This may have over- or underestimated the feasibility of the non-surgical treatments in the patient population used. Conclusion Overall, low-certainty evidence suggests that decompression surgery is slightly more effective than splinting and combinations of non-surgical treatments at 1 year in patients with mild to moderate carpal tunnel syndrome. There is insufficient evidence regarding the efficacy of surgery compared to steroid injections and manual therapy. Overall, few serious adverse events were reported, but small randomized trials are not suitable to make reliable comparisons of adverse events. Surgery is the most costly treatment alternative for patients with mild to moderate carpal tunnel syndrome. An observed regional variation in the provision of surgery in Norway suggests a potential for cost-saving per health region and at the national level if patients with mild to moderate carpal tunnel syndrome are initially treated with the non-surgical alternatives

Hysterektomi ved kraftige menstruasjonsblødninger: forenklet metodevurdering

Hovedbudskap: Vi har på oppdrag fra Bestillerforum for nye metoder utarbeidet en forenklet metodevurdering om hysterektomi (kirurgisk fjerning av livmor) ved kraftige menstruasjonsblødninger. Dette er en pilot i et prosjekt innen revurdering som ledes av Helse Midt-Norge RHF. Vi har hentet ut resultater for effekt og sikkerhet og vurderinger av tillit til resultatene for effekt fra en rapport av The National Institute of Health and Care Excellence, og utført en kostnadsanalyse. Resultatene må ses i sammenheng med andre faktorer som påvirker valg av behandling, og at vanlig praksis bør være å forsøke mindre invasive alternativer først. Kunnskapsgrunnlaget (lav til svært lav tillit til effektestimatene) viste at for kvinner med muskelknuter i livmor var det liten eller ingen forskjell mellom hysterektomi og embolisering av livmorarterier i helserelatert livskvalitet og pasienttilfredshet Kunnskapsgrunnlaget (tillit til effektestimater ikke vurdert) viste at for kvinner uten identifisert patologi ga hysterektomi samme eller bedre helserelatert livskvalitet og pasienttilfredshet sammenlignet med hormonspiral, og første- og andregenerasjons reseksjon/ablasjon Hysterektomi kan gi mer alvorlige komplikasjoner enn alternativene, men små randomiserte kontrollerte studier er lite egnet for å vurdere komplikasjoner Hysterektomi og embolisering av livmorarterie er de mest kostbare behandlingsmetodene, hovedsakelig på grunn av innleggelse. De koster omtrent 72 000 og 91 000 kroner. Endometriereseksjon/-ablasjon og transcervikal myomreseksjon koster cirka 25 000 og 27 000 kroner. Hormonspiral er svært lite kostbart og den brukes allerede vanligvis som førstevalg. Ved de andre metodene enn hysterektomi er det en risiko for behov for ny behandling ved utilfredsstillende virknin