Critical Appraisal Paper
The SMD Critical Appraisal Check List for Research Papers (50 marks)
You will be expected to provide a short detailed answer to each question. Yes or No are not sufficient
This may need a literature search to establish the use of any reference used by the authors of this research paper.
It is essential to use the format of this checklist to facilitate marking.
The potential marks for each question are in brackets.
1) Give the full citation of the paper (1) Kunchur, Ranjit, Allan Need, Toby Hughes, and Alastair Goss. "Clinical investigation of C-terminal cross-linking telopeptide test in prevention and management of bisphosphonate-associated osteonecrosis of the jaws." Journal of Oral and Maxillofacial Surgery 67, no. 6 (2009): 1167-1173. …show more content…
2) Title Does the title correctly describes the subject of the paper? (2) Yes, the title of the paper correctly describes the subject. The purpose, patients and methods, results, and discussions of this study clearly outlines that this study is done to determine, in a clinical setting, the effectiveness of the C-terminal cross-linking telopeptide test (CTX) in the prevention and management of osteonecrosis of the jaws (ONJ) in patients taking bisphosphonates. On the other hand, the title of the research paper is "Clinical investigation of C-terminal cross-linking telopeptide test in prevention and management of bisphosphonate-associated osteonecrosis of the jaws."
3) Abstract Does the abstract describe the work succinctly but in adequate detail?
(2) Yes, the abstract succinctly describes the purpose of the clinical investigation posed in the paper, the patients and methods used for the investigation, the results, and the conclusions. Yes, the purpose, patients and methods, results, and conclusions, provided in the abstract, are with adequate details. The purpose briefly mentions what is the subject of the investigation and why it has done; the patients and methods concisely informs who were the patients and what methods were used; the results summarizes the most important results obtained; the conclusions succinctly notes what the results mean and how these outcomes can …show more content…
help.
4) Introduction
a) Is the published background literature unbiased and accurately quoted? (2) Yes, the published background literature is unbiased. It neutrally described the problem, bisphosphonate associated risk of osteonecrosis of the jaws (ONJ), investigated. It summarized relevant research to provide context, key terms, and concepts so that readers could understand the importance of clinical investigation. And, yes, the background literature is accurately quoted.
b) Was this study focused or a blind fishing expedition? (2) Yes, this study was focused, and not a blind fishing expedition. The background literature published succinctly described the investigation: hypothesis (es), relevant research (s), research question (s); general experimental design or method; justification of method -- why it was used.
c)10 Was the project worth doing? (1) Yes, the project was worth doing, as it was done to determine the effectiveness of the CTX test in the prevention and management of bisphosphonates associated ONJ. Many early researches speculated that CTX test could be predictive of the development and management of ONJ, but still there is not enough scientific evidence behind the speculation. So, from that point of view, the importance of this study was worthy.
5) Methods
a) Was the trial well designed and based on the PICO protocol? (1) Yes, the design was well designed and it was based on the PICO protocol. All the key elements of PICO -- patient or population (P), intervention (I), comparison (C) and outcome(s) (O) -- were considered during the trial. The study design described what eligibility requirements for patients were, how this design made the most efficient use of patients, why was the experimental intervention selected, how the control intervention was appropriate, and what the primary endpoint of the trail was.
b) Were the inclusion and exclusion criteria appropriate? (2) Yes, the inclusion and exclusion criteria were appropriate. The patients included in the trial were taking bisphosphonates and had mainly been referred for extractions -- but also for management of ONJ. These patients had been referred to the South Australian Oral and Maxillofacial Surgery Unit during a 14-month period. On the other hand, excluded patients were patents with local tumours in the jaws, because those were with a history of head and neck radiotherapy involving the jaws.
c) Were the outcome measure methods previously validated? (2) Yes, the outcome measure methods were previously validated -- and had been subjected to independent validation by the bone metabolic clinicians at the institution. See reference 13 and 14 for more details.
d) On which of the following 3 research protocols was the experimental design based? (5)
• an Experimental Randomised Controlled Trial, if so were the subjects clearly and ethically randomized?
No, it 's not an Experimental Randomised Controlled Trial, rather the data reflect clinical practice. Patients were referred, assessments made, informed consent given, and outcomes recorded. Was it a single blind, double blind or open design? None
• an Observational Study (i.e cohort, case control, or cross sectional)? Were the clinical data recorded prospectively and accurately? Yes, it 's an Observational Study (case control) and done to determine the effectiveness of CTX text comparing a high risk group, a affected group, and a control group. The data were recorded using a stand-alone personal computer and appropriate statistical tests were performed. The study was performed in accordance with the clinical and laboratory audit procedures of the institutions involved.
• or was this paper simply a descriptive case review? No, it 's not a descriptive review. It 's a single-center
study.
e) Was adequate group power established to avoid a type 2 error? (2) Yes, an adequate group power was established. The 348 patients were divided into the following groups: 222 patients referred for extractions, 15 patients with ONJ, and 113 control patients without extractions or ONJ. These groups were further subdivided into those taking oral and intravenous bisphosphonates. Comorbidities were allocated to 3 groups.
6) Results
a) Are the results credible and supported by valid and intelligible statistics? (3) Yes, the results are credible and supported by valid and intelligible statistics. The results were succinctly summarized with accompanying text -- but without detail of Methods section. The text contained adequate reference to tables that contain all information, including statistical parameters, required to support the stated results as well as inform and convince the reader. Multiple data points that were critical for the reader to evaluate the experiment were shown in tables.
b) Was there a significant difference in outcome of the study; i.e p<0.05? (2) When the CTX value for 222 patients taking oral bisphosphonates were compared with the known clinical risk factors for ONJ, a statistically significant difference (P < .0001) was found between patients taking alendronate who had a lower CTX value than those taking risedronate. Other statistically significant differences were found between bisphosphonate group undergoing extractions and premenopausal women (P < .005) & postmenopausal women (P < .0001).
c) Were confounding factors and drop-outs accounted for? (3) Yes, confounding factors and dropouts were accounted in the clinical investigation. A CTX value of less than 150 pg/mL did not correlate with the clinical risk factors of age, gender, comorbidities, bone disease, or bisphosphonate duration. the only correlation was in the group with ONJ. But, it was between a low CTX value and ongoing bisphosphonate therapy, and when therapy ceased, the value increased. No record of dropouts was found in the trial.
d) Do the figures and the tables clearly contribute to the publication? (3) There is no figure in the Results section. Only tables are shown to reflect the outcomes. The tables present information in an easily evaluable format for the reader. They are sequentially numbered and concisely summarized. It is possible to figure out the meaning of tables without referring to the text.
e) Was the IMRAD scientific format used? (2) Yes, the IMRAD scientific format was used for the clinical investigation. The research paper included introduction, methods, results, and discussion sections and provided information following the format of IMRAD.
7) Discussion Did the discussion clearly state the value of the work? (4) Yes, the discussion clearly stated the value of the clinical investigation. The discussion section critically analysed, compared, and discussed the results found in the investigation. And, It was done in relation to the originally stated problem, hypotheses, and methods. The section stated that although The CTX test is not predictive of the development of ONJ for an individual patient, the CTX value does help the clinician determine whether the patient is in the "at risk zone", which is a value of less than 150 pg/mL to 200 pg/mL, for developing ONJ. In addition, the section also mentioned that the results of this study showed that patients taking bisphosphonates all had a low, but variable, CTX value.
8) References Are they correctly cited and credibly used. Can you tell if they were read? (3) Inappropriate citation was not found in the published background literature. The references used for the literature are from peer-reviewed journals, respected books, and authentic sources. Yes, they were read, because it would be impossible for the authors to cite sources without reading them.
9) Summary and conclusions
a) Has the work contributed to clinical science and practice? (3) The results of the study showed that CTX testing could further help identify "at risk" patients taking bisphosphonates who require extractions. The gender balance of 75% women reflected the common pattern for osteoporosis, which was the main bone disease treated with bisphosphonates. The relative proportion of alendronate and risedronate represents the market share in Australia. Thus, the findings of the study are directly useful to oral and maxillofacial surgeons in clinical practice. The findings of the study also confirmed that patients receiving intravenous bisphosphonates for bone cancer and multiple myeloma had a low CTX value.
b) Are the findings applicable in your practice? (3) Yes, it is applicable. The CTX test is not predictive of the development of ONJ for an individual patient but does identify those in the "risk zone." So, in practice, the CTX test can help identify “at risk” patients taking bisphosphonates who require extractions. On the other hand, the CTX test is a simple automated blood test. It requires a small blood sample obtained in the morning from a fasted patient because of diurnal variation. In Australia, the cost is funded under Medicare Australia, at a cost of approximately $US20 per test.
c) 70 Was the paper clearly written? (2) Yes, the paper was clearly written. The authors followed general rules for scientific writing. The paper was easy to follow and organized logically -- and clearly stated the rational. The authors were not charged with emotion and bias, the language was objective. The writing style followed in the paper was suitable for the intended audience, and it was not style stilted or unnecessarily complicated.
MH/15.02.14
You will be expected to provide a short detailed answer to each question. Yes or No are not sufficient
This may need a literature search to establish the use of any reference used by the authors of this research paper.
It is essential to use the format of this checklist to facilitate marking.
The potential marks for each question are in brackets.
1) Give the full citation of the paper (1) Kunchur, Ranjit, Allan Need, Toby Hughes, and Alastair Goss. "Clinical investigation of C-terminal cross-linking telopeptide test in prevention and management of bisphosphonate-associated osteonecrosis of the jaws." Journal of Oral and Maxillofacial Surgery 67, no. 6 (2009): 1167-1173. …show more content…
2) Title Does the title correctly describes the subject of the paper? (2) Yes, the title of the paper correctly describes the subject. The purpose, patients and methods, results, and discussions of this study clearly outlines that this study is done to determine, in a clinical setting, the effectiveness of the C-terminal cross-linking telopeptide test (CTX) in the prevention and management of osteonecrosis of the jaws (ONJ) in patients taking bisphosphonates. On the other hand, the title of the research paper is "Clinical investigation of C-terminal cross-linking telopeptide test in prevention and management of bisphosphonate-associated osteonecrosis of the jaws."
3) Abstract Does the abstract describe the work succinctly but in adequate detail?
(2) Yes, the abstract succinctly describes the purpose of the clinical investigation posed in the paper, the patients and methods used for the investigation, the results, and the conclusions. Yes, the purpose, patients and methods, results, and conclusions, provided in the abstract, are with adequate details. The purpose briefly mentions what is the subject of the investigation and why it has done; the patients and methods concisely informs who were the patients and what methods were used; the results summarizes the most important results obtained; the conclusions succinctly notes what the results mean and how these outcomes can …show more content…
help.
4) Introduction
a) Is the published background literature unbiased and accurately quoted? (2) Yes, the published background literature is unbiased. It neutrally described the problem, bisphosphonate associated risk of osteonecrosis of the jaws (ONJ), investigated. It summarized relevant research to provide context, key terms, and concepts so that readers could understand the importance of clinical investigation. And, yes, the background literature is accurately quoted.
b) Was this study focused or a blind fishing expedition? (2) Yes, this study was focused, and not a blind fishing expedition. The background literature published succinctly described the investigation: hypothesis (es), relevant research (s), research question (s); general experimental design or method; justification of method -- why it was used.
c)10 Was the project worth doing? (1) Yes, the project was worth doing, as it was done to determine the effectiveness of the CTX test in the prevention and management of bisphosphonates associated ONJ. Many early researches speculated that CTX test could be predictive of the development and management of ONJ, but still there is not enough scientific evidence behind the speculation. So, from that point of view, the importance of this study was worthy.
5) Methods
a) Was the trial well designed and based on the PICO protocol? (1) Yes, the design was well designed and it was based on the PICO protocol. All the key elements of PICO -- patient or population (P), intervention (I), comparison (C) and outcome(s) (O) -- were considered during the trial. The study design described what eligibility requirements for patients were, how this design made the most efficient use of patients, why was the experimental intervention selected, how the control intervention was appropriate, and what the primary endpoint of the trail was.
b) Were the inclusion and exclusion criteria appropriate? (2) Yes, the inclusion and exclusion criteria were appropriate. The patients included in the trial were taking bisphosphonates and had mainly been referred for extractions -- but also for management of ONJ. These patients had been referred to the South Australian Oral and Maxillofacial Surgery Unit during a 14-month period. On the other hand, excluded patients were patents with local tumours in the jaws, because those were with a history of head and neck radiotherapy involving the jaws.
c) Were the outcome measure methods previously validated? (2) Yes, the outcome measure methods were previously validated -- and had been subjected to independent validation by the bone metabolic clinicians at the institution. See reference 13 and 14 for more details.
d) On which of the following 3 research protocols was the experimental design based? (5)
• an Experimental Randomised Controlled Trial, if so were the subjects clearly and ethically randomized?
No, it 's not an Experimental Randomised Controlled Trial, rather the data reflect clinical practice. Patients were referred, assessments made, informed consent given, and outcomes recorded. Was it a single blind, double blind or open design? None
• an Observational Study (i.e cohort, case control, or cross sectional)? Were the clinical data recorded prospectively and accurately? Yes, it 's an Observational Study (case control) and done to determine the effectiveness of CTX text comparing a high risk group, a affected group, and a control group. The data were recorded using a stand-alone personal computer and appropriate statistical tests were performed. The study was performed in accordance with the clinical and laboratory audit procedures of the institutions involved.
• or was this paper simply a descriptive case review? No, it 's not a descriptive review. It 's a single-center
study.
e) Was adequate group power established to avoid a type 2 error? (2) Yes, an adequate group power was established. The 348 patients were divided into the following groups: 222 patients referred for extractions, 15 patients with ONJ, and 113 control patients without extractions or ONJ. These groups were further subdivided into those taking oral and intravenous bisphosphonates. Comorbidities were allocated to 3 groups.
6) Results
a) Are the results credible and supported by valid and intelligible statistics? (3) Yes, the results are credible and supported by valid and intelligible statistics. The results were succinctly summarized with accompanying text -- but without detail of Methods section. The text contained adequate reference to tables that contain all information, including statistical parameters, required to support the stated results as well as inform and convince the reader. Multiple data points that were critical for the reader to evaluate the experiment were shown in tables.
b) Was there a significant difference in outcome of the study; i.e p<0.05? (2) When the CTX value for 222 patients taking oral bisphosphonates were compared with the known clinical risk factors for ONJ, a statistically significant difference (P < .0001) was found between patients taking alendronate who had a lower CTX value than those taking risedronate. Other statistically significant differences were found between bisphosphonate group undergoing extractions and premenopausal women (P < .005) & postmenopausal women (P < .0001).
c) Were confounding factors and drop-outs accounted for? (3) Yes, confounding factors and dropouts were accounted in the clinical investigation. A CTX value of less than 150 pg/mL did not correlate with the clinical risk factors of age, gender, comorbidities, bone disease, or bisphosphonate duration. the only correlation was in the group with ONJ. But, it was between a low CTX value and ongoing bisphosphonate therapy, and when therapy ceased, the value increased. No record of dropouts was found in the trial.
d) Do the figures and the tables clearly contribute to the publication? (3) There is no figure in the Results section. Only tables are shown to reflect the outcomes. The tables present information in an easily evaluable format for the reader. They are sequentially numbered and concisely summarized. It is possible to figure out the meaning of tables without referring to the text.
e) Was the IMRAD scientific format used? (2) Yes, the IMRAD scientific format was used for the clinical investigation. The research paper included introduction, methods, results, and discussion sections and provided information following the format of IMRAD.
7) Discussion Did the discussion clearly state the value of the work? (4) Yes, the discussion clearly stated the value of the clinical investigation. The discussion section critically analysed, compared, and discussed the results found in the investigation. And, It was done in relation to the originally stated problem, hypotheses, and methods. The section stated that although The CTX test is not predictive of the development of ONJ for an individual patient, the CTX value does help the clinician determine whether the patient is in the "at risk zone", which is a value of less than 150 pg/mL to 200 pg/mL, for developing ONJ. In addition, the section also mentioned that the results of this study showed that patients taking bisphosphonates all had a low, but variable, CTX value.
8) References Are they correctly cited and credibly used. Can you tell if they were read? (3) Inappropriate citation was not found in the published background literature. The references used for the literature are from peer-reviewed journals, respected books, and authentic sources. Yes, they were read, because it would be impossible for the authors to cite sources without reading them.
9) Summary and conclusions
a) Has the work contributed to clinical science and practice? (3) The results of the study showed that CTX testing could further help identify "at risk" patients taking bisphosphonates who require extractions. The gender balance of 75% women reflected the common pattern for osteoporosis, which was the main bone disease treated with bisphosphonates. The relative proportion of alendronate and risedronate represents the market share in Australia. Thus, the findings of the study are directly useful to oral and maxillofacial surgeons in clinical practice. The findings of the study also confirmed that patients receiving intravenous bisphosphonates for bone cancer and multiple myeloma had a low CTX value.
b) Are the findings applicable in your practice? (3) Yes, it is applicable. The CTX test is not predictive of the development of ONJ for an individual patient but does identify those in the "risk zone." So, in practice, the CTX test can help identify “at risk” patients taking bisphosphonates who require extractions. On the other hand, the CTX test is a simple automated blood test. It requires a small blood sample obtained in the morning from a fasted patient because of diurnal variation. In Australia, the cost is funded under Medicare Australia, at a cost of approximately $US20 per test.
c) 70 Was the paper clearly written? (2) Yes, the paper was clearly written. The authors followed general rules for scientific writing. The paper was easy to follow and organized logically -- and clearly stated the rational. The authors were not charged with emotion and bias, the language was objective. The writing style followed in the paper was suitable for the intended audience, and it was not style stilted or unnecessarily complicated.
MH/15.02.14