Recent KSR Evidence critical appraisals

  • 1

    Gene expression profiling for guiding adjuvant chemotherapy decisions in women with early breast cancer: an evidence-based and economic analysis

    Health Quality Ontario

    Risk of Bias Assessment: High

    Studies were restricted based on language (only English studies were included) and publication format (abstracts and poster presentations were excluded). Only a single reviewer was involved in study selection, and no information was provided regarding the number of authors involved in the data extraction or quality assessment process, meaning reviewer error and bias may be present. Insufficient study characteristics were provided. Quality assessment was not performed using an appropriate tool.

    Bottom line Current evidence suggests that the Oncotype-DX test may reliably predict the risk of disease recurrence or death from any cause in women with newly diagnosed early stage (stage I–IIIa) invasive breast cancer. However, these conclusions should be interpreted with caution, since several methodological issues mean relevant studies may have been missed, and reviewer error and bias may be present. Further high quality studies are needed to formally validate the prognostic and predictive value of the Oncotype-DX test.

    Ont Health Technol Assess Ser 2010;10(23);1-57

  • 2

    A systematic review investigating interventions that can help reduce consumption of sugar-sweetened beverages in children leading to changes in body fatness

    Avery, A. ; Bostock, L. ; McCullough, F.

    Risk of Bias Assessment: High

    Restrictions were applied based on date and langauge, meaning relevant studies may have been missed. While only studies with ≥6 months duration, and with >100 children were included, this was considered appropriate. Study selection was carried out by a single reviewer. No information was provided on the number of reviewers involved in data extraction or quality assessment, meaning that error and bias cannot be ruled out.

    Bottom line Current evidence suggests that programs focussed on school-based education, school-delivered drinks and home-delivered drinks in particular may reduce the consumption of sugar-sweetened beverages and bodyweight. However, these conclusions should be interpreted with caution, since several methodological weaknesses mean relevant studies may have been missed, and reviewer error and bias may have been present. More rigorous studies are needed to support this evidence and help design more effective interventions to assist in addressing childhood obesity.

    J Hum Nutr Diet 2015;28 Suppl 1();52-64

  • 3

    Antigen‐specific active immunotherapy for ovarian cancer

    Paijens, S. T. ; Leffers, N. ; Daemen, T. ; Helfrich, W. ; Boezen, H. M. ; Cohlen, B. J. ; Melief, C. J. M. ; de Bruyn, M. ; Nijman, H. W.

    Risk of Bias Assessment: High

    The author's used an inappropriate (non-validated) tool to assess the risk of bias in non-randomised controlled trials.

    Bottom line Current evidence suggests that, despite promising immune responses, no clinically effective antigen-specific active immunotherapy is yet available for ovarian cancer. It should be noted that this review used inappropriate criteria to assess risk of bias of non-randomised studies, therefore these results should be interpreted with caution. Further studies with standardised clinical endpoints (to improve comparability) are needed to address the current review question.

    Cochrane Database Syst Rev 2018, 9, CD007287, 10.1002/14651858.CD007287.pub4

  • 4

    The effect of aerobic exercise on the number of migraine days, duration and pain intensity in migraine: a systematic literature review and meta-analysis

    Lemmens, J. ; De Pauw, J. ; Van Soom, T. ; Michiels, S. ; Versijpt, J. ; van Breda, E. ; Castien, R. ; De Hertogh, W.

    Risk of Bias Assessment: High

    Studies were restricted based on date and language, only a limited number of databases were searched, and only search keywords were provided, meaning relevant studies may have been missed. Heterogeneity was found to be high for one outcome; this was not assessed further.

    Bottom line Current evidence suggests that aerobic exercise may reduce the number of migraine days compared to no intervention or maintenance of normal activity; additional limited, low quality evidence also suggests that aerobic exercise may also reduce migraine pain intensity and migraine attack duration. However, these conclusions must be interpreted with caution, since several methodological weaknesses mean that relevant studies may have been missed. More high quality studies with standardised outcome measures and sufficiently intense training programmes are needed to fully address the review question.

    J Headache Pain 2019;20(1);16

  • 5

    Evidence for kinesio taping in management of myofascial pain syndrome: a systematic review and meta-analysis

    Zhang, X.-F. ; Liu, L. ; Wang, B.-B. ; Liu, X. ; Li, P.

    Risk of Bias Assessment: High

    Studies were restricted based on publication format, meaning relevant studies may have been missed. Heterogeneity was assessed and found to be moderate or high for several outcomes; the source of this heterogeneity was not fully explained for all outcomes.

    Bottom line Current evidence suggests that kinesio taping may reduce pain intensity and improve range of motion immediately following taping compared to other treatments (especially other non-invasive treatments) for patients with myofascial pain syndrome; however, the impact of kinesio taping over longer periods of time remains unclear. These conclusions should be interpreted with caution since methodological weaknesses mean relevant studies may have been missed and study heterogeneity was not fully addressed for all outcomes. Further large, high-quality trials are needed to provide additional evidence to support the use of kinesio taping over other interventions in patients with myofascial pain syndrome.

    Clin Rehabil 2019;33(5);865-874

  • 6

    Interventions for intra‐operative pain relief during postpartum mini‐laparotomy tubal ligation

    Werawatakul, Y. ; Sothornwit, J. ; Laopaiboon, M. ; Lumbiganon, P. ; Kietpeerakool, C.

    Risk of Bias Assessment: Low

    All domains were considered at low concern.

    Bottom line Limited evidence suggests that EMLA cream may reduce pain during abdominal entry compared to placebo, and that subsequent intraperitoneal instillation of lidocaine may improve pain control (and reduce rescue pain medication use) compared to placebo or intramuscular morphine during post-partum mini-laparotomy tubal ligation. Evidence also suggests that the adverse event profile may be similar for intraperitoneal lidocaine vs. placebo. No methodological issues were identified in the review. Further large, high-quality trials are required to determine the effects of combination intraperitoneal anaesthesia with other local anaesthesia as a multimodal pain management strategy during post-partum mini-laparotomy tubal ligation.

    Cochrane Database Syst Rev 2019, 2, CD011807, 10.1002/14651858.CD011807.pub2

  • 7

    Comparison of efficacy of shock-wave therapy versus corticosteroids in plantar fasciitis: a meta-analysis of randomized controlled trials

    Xiong, Y. ; Wu, Q. ; Mi, B. ; Zhou, W. ; Liu, Y. ; Liu, J. ; Xue, H. ; Hu, L. ; Panayi, A.C. ; Liu, G.

    Risk of Bias Assessment: High

    Authors acknowledged that studies may have been missed due to the restriction to the English language. They also acknowledged the presence of heterogeneity due to the variance of populations, disease duration and outcome scores in the limitations. A full search strategy was not reported, therefore it was not possible to assess if this was adequate. There was no information provided on whether searches were restricted by date, publication format or language. Pre-defined sensitivity analyses were not reported for all relevant outcomes.

    Bottom line Current evidence suggests that shockwave (SW) therapy may improve pain in adults with plantar fasciitis compared to corticosteroid (CS) therapy. Evidence also suggests CS therapy may improve overall pain and functional scores compared to SW therapy; however, there is a large amount of uncertainty associated with this finding. Finally, evidence suggests no difference in plantar fascia thickness for SW compared to CS therapy. Of note, these conclusions must be interpreted with caution, since several methodological issues mean that relevant studies may have been missed and substantial (unexplained) heterogeneity was present in all pooled analyses. Further large, well-designed randomised controlled trials are needed to provide further evidence to compare the long-term efficacy of SW and CS in adults with plantar fasciitis.

    Arch Orthop Trauma Surg 2019;139(4);529-36

  • 8

    Yoga treatment for chronic non-specific low back pain

    Wieland, L. Susan ; Skoetz, Nicole ; Pilkington, Karen ; Vempati, Ramaprabhu ; D'Adamo, Christopher R. ; Berman, Brian M.

    Risk of Bias Assessment: Low

    All domains were considered at low concern.

    Bottom line Current evidence suggests that yoga may improve back-specific functional status, pain, clinical symptoms and physical and mental quality of life compared to no exercise in adults with chronic non-specific low back pain. Yoga may also reduce pain and improve physical and mental quality of life compared to other exercise. However, yoga may be associated with more adverse events than no exercise (although not in comparison to other exercise). Of note, effect sizes were small to moderate and many did not meet clinical significance. The review had no significant methodological weaknesses. Further, well-designed randomised controlled trials are required to improve confidence in and generate longer-term data for the effects of yoga in the treatment of chronic non-specific low back pain in adults.

    Cochrane Database Syst Rev 2017, 1, CD010671, 10.1002/14651858.CD010671.pub2

  • 9

    SGLT2 inhibitors and risk of stroke in patients with type 2 diabetes: a systematic review and meta-analysis

    Guo, M. ; Ding, J. ; Li, J. ; Wang, J. ; Zhang, T. ; Liu, C. ; Huang, W. ; Long, Y. ; Gao, C. ; Xu, Y.

    Risk of Bias Assessment: Low

    All domains were considered at low concern for risk of bias.

    Bottom line Current evidence suggests that sodium-glucose cotransporter 2 (SGLT2) inhibitors do not increase the risk of stroke compared to placebo in patients with type 2 diabetes mellitus. Of note, black patients may have a lower risk of stroke after treatment with SGLT2 inhibitors compared to white or Asian patients. Robust methodology supports these findings. Future studies are needed to explore these ethnic/racial differences and additional sodium-glucose cotransporter 2 inhibitor classes.

    Diabetes Obes Metab 2018;Epub ahead of print();

  • 10

    Effect of blood donor characteristics on transfusion outcomes: a systematic review and meta-analysis

    Chasse, M. ; McIntyre, L. ; English, S. W. ; Tinmouth, A. ; Knoll, G. ; Wolfe, D. ; Wilson, K. ; Shehata, N. ; Forster, A. ; van Walraven, C. ; Fergusson, D. A.

    Risk of Bias Assessment: Low

    The authors acknowledged that the small number of eligible studies for each donor characteristic and outcome made it impossible to perform meaningful prespecified subgroup or sensitivity analysis. Statistical heterogeneity was reported to be high for some outcomes; no attempts were made to explore the source of this heterogeneity.

    Bottom line Limited evidence suggests that older donors, gender matched donors (male-to-male) and donors who have been tested for infections may improve survival in blood transfusion recipients. The review had no significant methodological weaknesses beyond the lack of exploration of sources of heterogeneity; however, the authors acknowledged that the evidence is insufficient to draw definitive conclusions about any donor characteristics. Further well-designed, adequately powered, high-quality studies that place more emphasis on age, gender and other donor characteristics are needed to more fully address the present review question.

    Transfus Med Rev 2016;30(2);69-80

  • 11

    Interventions to improve the uptake of cervical cancer screening among lower socioeconomic groups: a systematic review

    Rees, Imogen ; Jones, Daniel ; Chen, Hong ; Macleod, Una

    Risk of Bias Assessment: Unclear

    No information was provided regarding the number of authors involved in the risk of bias assessment, meaning reviewer error and bias cannot be ruled out.

    Bottom line Current evidence suggests that HPV self-testing or the use of lay health advisors to educate women about cervical cancer and Pap smear testing may improve the uptake of cervical cancer screening among lower socioeconomic groups. However, it was unclear in the review how many reviewers were involved in quality assessment, meaning reviewer error and bias cannot be ruled out. Further high quality studies are needed to further support these findings.

    Prev Med 2018;111();323-335

  • 12

    Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors

    Arbyn, M. ; Xu, L. ; Simoens, C. ; Martin‐Hirsch, P. P. L.

    Risk of Bias Assessment: Low

    All domains were considered at low concern. A range of comments were made about the review which can be found or are cited in the comments section of the review in the Cochrane Library.

    Bottom line HPV vaccines protect against cervical precancer in adolescent girls and women vaccinated between 15 and 26 years of age. The protection is lower when a part of the population is already infected with HPV. Longer-term follow-up is needed to assess the impact on cervical cancer. There are limited data from trials on the effect of vaccines on deaths, stillbirth and babies born with malformations. However, no increased risk of serious adverse effects, miscarriage or pregnancy termination was found. These findings are likely to be reliable.

    Cochrane Database Syst Rev 2018, 5, CD009069, 10.1002/14651858.CD009069.pub3

  • 13

    Oropharyngeal colostrum in preventing mortality and morbidity in preterm infants

    Nasuf, A. W. A. ; Ojha, S. ; Dorling, J.

    Risk of Bias Assessment: Low

    All domains were considered at low concern suggesting no limitations regarding the review process. The authors highlighted how the review was limited by the low number of the included studies which impeded analysing the risk of publication bias via a funnel plot, however abstracts and proceedings of relevant conferences were included. Further, to minimise the potential bias resulting from incomplete reporting of the results, the primary study authors were contacted.

    Bottom line Current evidence suggests that placing a very small volume of colostrum directly onto the buccal mucosa of preterm infants has no impact on rates of necrotising enterocolitis, late-onset invasive infection or death compared to controls. A robust methodology supports these findings. The authors recommend that further, large well-designed trials are required to evaluate more precisely and reliably the effects of oropharyngeal colostrum on important outcomes for preterm infants.

    Cochrane Database Syst Rev 2018, 9, CD011921, 10.1002/14651858.CD011921.pub2

  • 14

    Routine scale and polish for periodontal health in adults

    Lamont, T. ; Worthington, H. V. ; Clarkson, J. E. ; Beirne, P. V.

    Risk of Bias Assessment: Low

    One or two review authors were involved in data extraction; this was considered inadequate to minimise error and bias. However, all other domains were considered to be at low risk.

    Bottom line Limited evidence suggests that regular scale and polish treatments (at 6-month or 12-month intervals) may reduce the level of calculus on teeth compared to no treatment, and that these reductions may be more substantial with a shorter interval between treatments (6-months instead of 12-months). Participants' self-reported perception of oral cleanliness appears to be higher for regular scale and polish treatment compared to no treatment. There was little to no difference reported in gingivitis/gingival bleeding, plaque, probing depths, oral health-related quality of life or costs from an NHS perspective for regular scale and polish treatment compared to no treatment. However, these conclusions should be interpreted with some caution, as the involvement of only one reviewer in some data extractions means reviewer error and bias cannot be ruled out. Further large, high-quality studies are required to provide additional evidence to support these conclusions, particularly with respect to adverse events.

    Cochrane Database Syst Rev 2018, 12, CD004625, 10.1002/14651858.CD004625.pub5

  • 15

    Carbohydrate quality and human health: a series of systematic reviews and meta-analyses

    Reynolds A, Mann J, Cummings J, Winter N, Mete E, Te Morenga L

    Risk of Bias Assessment: Low

    All domains were considered at low risk of bias suggesting no limitations with the review process.

    Bottom line This well-conducted review found that a higher intake of total dietary fibre or whole grains was associated with a reduction in the risk of mortality and in the incidence of a wide range of non-communicable diseases and their risk factors.

    Lancet 2019;393(10170);434-445

  • 16

    Association between intake of non-sugar sweeteners and health outcomes: systematic review and meta-analyses of randomised and non-randomised controlled trials and observational studies

    Toews, Ingrid ; Lohner, Szimonetta ; Küllenberg de Gaudry, Daniela ; Sommer, Harriet ; Meerpohl, Joerg J.

    Risk of Bias Assessment: Unclear

    The authors acknowledged the presence of significant heterogeneity between the studies and also stated that the findings of our review might be biased by the fact that only one reviewer assessed inclusion of studies in the initial title and abstract screening phase. Hence, relevant references could have inadvertently not been included in this review.

    Bottom line The current evidence is limited, and does not allow to draw firm conclusions regarding the association between intake of non-sugar sweeteners and health outcomes. Results should be interpreted cautiously due to significant heterogeneity between the studies. Also, the findings of this review might be biased by the fact that only one reviewer assessed the inclusion of studies in the initial title and abstract screening phase. Hence, relevant references could have inadvertently not been included in this review. Further, well-designed high-quality studies with detailed descriptions of interventions, comparators and outcomes are needed to support these findings.

    BMJ 2019;364();k4718

  • 17

    A systematic review into the incidence, severity and duration of antidepressant withdrawal effects: are guidelines evidence-based?

    Davies, J. ; Read, J.

    Risk of Bias Assessment: High

    Eligibility criteria were not explicitly defined. Only English language studies published in peer-reviewed journals were considered for inclusion in the review. A limited range of databases was searched for study selection process. Search terms were provided but a full search strategy was not reported. No information was provided on the number of reviewers involved in the study selection process and data extraction process. Relevant study results appear to have been extracted. There was no formal assessment of the methodological quality of the included studies. The method of analysis was not explained clearly in the methodology section.

    Bottom line The current evidence suggests that antidepressant withdrawal reactions are widespread and nearly half of them are severe. Hence, the U.K.'s current National Institute for Health and Care Excellence and the American Psychiatric Association's depression guidelines need to be updated immediately. The review had significant methodological weaknesses, so the findings should be interpreted with caution. Further, well-designed studies focused on the dependency-forming nature of antidepressants are needed.

    Addict Behav 2019;97();111-21

  • 18

    Effects of vitamin D supplementation on musculoskeletal health: a systematic review, meta-analysis, and trial sequential analysis

    Bolland MJ, Grey A, Avenell A

    Risk of Bias Assessment: High

    The search strategies were not very sensitive, relevant studies may have been missed.

    Bottom line Evidence indicates that vitamin D supplementation may not prevent fractures or falls, or have clinically meaningful effects on bone mineral density. In addition, there were no differences between the effects of higher and lower doses of vitamin D. There is little justification to use vitamin D supplements to maintain or improve musculoskeletal health. Restriction to one index term for vitamin D in the searches means some relevant studies may have been missed. There was some evidence of publication bias.

    Lancet Diabetes Endocrinol 2018;6(11);847-858

  • 19

    Can screening instruments accurately determine poor outcome risk in adults with recent onset low back pain? A systematic review and meta-analysis

    Karran, E. L. ; McAuley, J. H. ; Traeger, A. C. ; Hillier, S. L. ; Grabherr, L. ; Russek, L. N. ; Moseley, G. L.

    Risk of Bias Assessment: High

    The use or search terms for prognostic/predictive studies, and the inclusion of an English language limit, may have resulted in relevant studies being missed by the searches. Weaknesses in the analysis methods and risk of bias assessments limit the usefulness of the reported results.

    Bottom line The results of this review suggest that low back pain screening instruments may perform better in predicting poor disability and absenteeism outcomes than in predicting poor pain outcomes. However, the evidence presented is not sufficiently robust to support firm conclusions. The use or search terms for prognostic/predictive studies, and the inclusion of an English language limit, may have resulted in relevant studies being missed by the searches. Weaknesses in the analysis methods and risk of bias assessments limit the usefulness of the reported results.

    BMC Med 2017;15(1);

  • 20

    Comparison of effects of seven treatment methods for distal radius fracture on minimizing complex regional pain syndrome

    Wang, J. H. ; Sun, T.

    Risk of Bias Assessment: High

    A restriction to the Chinese and English language means that some relevant studies may have been missed. The search terms were reported, but full details of the search strategy were not reported. No information was provided regarding the number of authors involved in the study selection process.

    Bottom line The current evidence indicates that bridging external fixation, K-wire fixation, dorsal plating, volar plating, dorsal and volar plating, plaster fixation and non-bridging external fixation can have no marked difference in risk of complex regional pain syndrome in distal radius fracture patients. A restriction to the Chinese and English language means that some relevant studies may have been missed. The search terms were reported, but full details of the search strategy were not reported. No information was provided regarding the number of authors involved in the study selection process.

    Arch Med Sci 2017;13(1);163-73

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