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

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