Publications by authors named "Manraj N Kaur"

19 Publications

  • Page 1 of 1

Measuring outcomes for temple hollowing treatment: Content validity of new and existing FACE-Q scales.

J Cosmet Dermatol 2021 Dec 2. Epub 2021 Dec 2.

McMaster University, Hamilton, Ontario, Canada.

Background: The FACE-Q, a validated, modular patient-reported outcome measure with global uptake, currently does not have a scale to measure the appearance of the temples. Objectives of our study were to develop a new FACE-Q scale for appearance of temples and assess content validity of two existing FACE-Q scales in the context of temple hollowing: Satisfaction with Facial Appearance and Psychological Function.

Methods: A heterogeneous sample of adults who were seeking or had received treatments for temple hollowing was recruited from three outpatient clinics in the United States. Semi-structured interviews using an interpretive description approach were completed to elicit concepts and generate an item pool and assess content validity of the two existing FACE-Q scales. The item pool data were used to develop preliminary Temple scale, which was refined based on patient and expert feedback.

Results: Participants (N = 15, 55 ± 9 years) described a range of esthetic concerns related to temple hollowing and its treatment. The data were used to draft the FACE-Q Satisfaction with Temples scale, which was refined through input from patients (N = 12) and clinicians (N = 5), resulting in a 16-item FACE-Q Satisfaction with Temples scale. The scale covers concepts of fullness, harmony, scenarios (eg, mirror, bright lights), age, and shape. Content validity of the two existing FACE-Q scales was substantiated.

Conclusion: The FACE-Q Satisfaction with Temples scale fills an important gap in patient-reported outcome measurement in facial esthetics. The scale will be field-tested to finalize content and develop the scoring algorithm prior to implementation in clinical practice and research.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/jocd.14646DOI Listing
December 2021

Cost-effectiveness of eltrombopag versus intravenous immunoglobulin for the perioperative management of immune thrombocytopenia.

Blood Adv 2021 Nov 15. Epub 2021 Nov 15.

McMaster University, Hamilton, Canada.

Eltrombopag has been shown to be non-inferior to intravenous immunoglobulin (IVIG) for improving perioperative platelet counts in patients with immune thrombocytopenia (ITP) in a randomized trial; thus, cost is an important factor for treatment and policy decisions. We used patient-level data from the trial to conduct a cost-effectiveness analysis comparing perioperative eltrombopag 50mg daily starting dose, with IVIG 1 or 2g/kg (according to local practice) from a Canadian public healthcare payer's perspective over the observation period, from preoperative day 21 to postoperative day 28. Resource utilization data were obtained from the trial data (eltrombopag, n=38; IVIG, n=36) and unit costs were collected from the Ontario Schedule of Benefits, Ontario Drug Formulary, and secondary sources. All costs were adjusted to 2020 Canadian dollars. We calculated the incremental cost per patient for all patients randomized. Uncertainty was addressed using non-parametric bootstrapping. The use of perioperative eltrombopag for patients with ITP resulted in a cost-saving of $413 Canadian dollars per patient. Compared with IVIG, the probability of eltrombopag being cost-effective was 70% even with zero willingness to pay. In a sensitivity analysis based on IVIG dose, we found that with the higher dose of IVIG (2g/kg), eltrombopag saved $2,714 per patient; whereas with the lower dose of IVIG (1g/kg), eltrombopag had a higher mean cost of $562 per patient. In summary, based on data from the randomized trial that demonstrated non-inferiority, the use of eltrombopag for the management of ITP in the perioperative setting was less costly than IVIG.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1182/bloodadvances.2021005627DOI Listing
November 2021

Transforming challenges into opportunities: conducting health preference research during the COVID-19 pandemic and beyond.

Qual Life Res 2021 Oct 18. Epub 2021 Oct 18.

School of Health and Related Research, University of Sheffield, Sheffield, UK.

The disruptions to health research during the COVID-19 pandemic are being recognized globally, and there is a growing need for understanding the pandemic's impact on the health and health preferences of patients, caregivers, and the general public. Ongoing and planned health preference research (HPR) has been affected due to problems associated with recruitment, data collection, and data interpretation. While there are no "one size fits all" solutions, this commentary summarizes the key challenges in HPR within the context of the pandemic and offers pragmatic solutions and directions for future research. We recommend recruitment of a diverse, typically under-represented population in HPR using online, quota-based crowdsourcing platforms, and community partnerships. We foresee emerging evidence on remote, and telephone-based HPR modes of administration, with further studies on the shifts in preferences related to health and healthcare services as a result of the pandemic. We believe that the recalibration of HPR, due to what one would hope is an impermanent change, will permanently change how we conduct HPR in the future.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s11136-021-03012-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8521079PMC
October 2021

Prioritizing Health Equity in Patient-Reported Outcome Measurement to Improve Surgical Care.

Ann Surg 2021 Aug 13. Epub 2021 Aug 13.

Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA Patient-Reported Outcomes, Value & Experience (PROVE) Center, Brigham and Women's Hospital, Boston, MA Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston MA Harvard T.H. Chan School of Public Health, Boston, MA Harvard Medical School, Boston, MA Department of Surgery, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA Department of Surgery, University of Michigan, Ann Arbor, MI Department of Surgery, City of Hope National Medical Center, Duarte, CA Division of Gynecologic Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA Mass General Brigham, Somerville, MA Department of Medicine, Priscilla Chan and Mark Zuckerberg San Francisco General Hospital, University of California San Francisco School of Medicine, San Francisco, CA Division of Plastic and Reconstructive Surgery, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1097/SLA.0000000000005169DOI Listing
August 2021

Development and Psychometric Validation of a Patient-Reported Outcome Measure for Arm Lymphedema: The LYMPH-Q Upper Extremity Module.

Ann Surg Oncol 2021 Sep 5;28(9):5166-5182. Epub 2021 Jul 5.

Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.

Background: A multiphased mixed-methods study was performed to develop and validate a comprehensive patient-reported outcome measure (PROM) for arm lymphedema in women with breast cancer (i.e., the LYMPH-Q Upper Extremity Module).

Methods: Qualitative interviews (January 2017 and June 2018) were performed with 15 women to elicit concepts specific to arm lymphedema after breast cancer treatment. Data were audio-recorded, transcribed, and coded. Scales were refined through cognitive interviews (October and Decemeber 2018) with 16 patients and input from 12 clinical experts. The scales were field-tested (October 2019 and January 2020) with an international sample of 3222 women in the United States and Denmark. Rasch measurement theory (RMT) analysis was used to examine reliability and validity.

Results: The qualitative phase resulted in six independently functioning scales that measure arm symptoms, function, appearance, psychological function, and satisfaction with information and with arm sleeves. In the RMT analysis, all items in each scale had ordered thresholds and nonsignificant chi-square p values. For all the scales, the reliability statistics with and without extremes for the Person Separation Index were 0.80 or higher, Cronbach's alpha was 0.89 or higher, and the Intraclass Correlation Coefficients were 0.92 or higher. Lower (worse) scores on the LYMPH-Q Upper Extremity scales were associated with reporting of more severe arm swelling, an arm problem caused by cancer and/or its treatment, and wearing of an arm sleeve in the past 12 months.

Conclusions: The LYMPH-Q Upper Extremity Module can be used to measure outcomes that matter to women with upper extremity lymphedema. This new PROM was designed using a modern psychometric approach and, as such, can be used in research and in clinical care.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1245/s10434-021-09887-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8349351PMC
September 2021

Development and Psychometric Validation of BREAST-Q Scales Measuring Cancer Worry, Fatigue, and Impact on Work.

Ann Surg Oncol 2021 Nov 24;28(12):7410-7420. Epub 2021 May 24.

Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.

Background: The BREAST-Q is a patient-reported outcome measure for women with breast cancer. The aim of this study was to develop new BREAST-Q scales to measure Cancer Worry, Fatigue and Impact on Work.

Methods: Data were collected between January 2017 and November 2019. Phase 1 (qualitative) included participants from Canada and the USA, pre/post any type of breast cancer treatment (surgery, adjuvant, neoadjuvant). Interviews were audio-recorded, transcribed verbatim and coded line-by-line. New scales were drafted and refined through cognitive interviews and expert input. Phase 2 (field-test study) involved USA members of the Love Research Army (LRA). Rasch measurement theory analysis was used to examine reliability and validity.

Results: In phase 1, 57 women were interviewed. Three concepts were identified as important to the breast cancer experience that are not currently covered in the BREAST-Q and developed into scales, i.e., Cancer Worry, Fatigue and Impact on Work. Feedback from nine women and 23 experts was used to establish content validity. The scales were field-tested in the LRA sample (n = 1680), of whom 1006 completed a test-retest. Reliability was > 0.81 for the person separation index, > 0.89 for Cronbach's alpha and > 0.83 for interclass correlation coefficients. Lower scores on all three scales were significantly associated with being closer in time to diagnosis and having a higher cancer stage at diagnosis (p < 0.001 on ANOVA).

Conclusion: These new scales expand the BREAST-Q measurement system and provide a means to evaluate additional important outcomes for breast cancer patients in clinical care and research.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1245/s10434-021-10090-2DOI Listing
November 2021

Development and Psychometric Validation of the BREAST-Q Sensation Module for Women Undergoing Post-Mastectomy Breast Reconstruction.

Ann Surg Oncol 2021 Nov 14;28(12):7842-7853. Epub 2021 May 14.

Harvard Medical School, Brigham and Women's Hospital, Boston, MA, USA.

Background: Reconstructive techniques for restoring sensation to the breast after mastectomy continue to evolve. The BREAST-Q is a patient-reported outcome measure that can be used to evaluate outcomes of breast cancer treatments; however, it previously lacked scales to measure breast sensation. This paper outlines the development and validation of the BREAST-Q Sensation Module.

Methods: Phase 1 (January 2017 through December 2018) involved qualitative and cognitive interviews with women who had undergone breast reconstruction, as well as expert input, to develop and refine the scales. In phase 2 (March through June 2019), Love Research Army (LRA) members completed the scales, and Rasch Measurement Theory (RMT) analysis was performed to examine the reliability and validity of the scales.

Results: In this study, 36 qualitative and 7 cognitive interviews were conducted, and input from 18 experts was obtained. Three scales were developed to measure breast Symptoms (e.g., throbbing, burning, tingling), Sensation (e.g., feeling with light touch, through clothing, sexually), and Quality of Life impact of sensation loss. In phase 2, 1204 LRA members completed the scales. Data for each scale fit the RMT model. Reliability was high, with Person Separation Index, Cronbach alpha, and intraclass correlation coefficient values of 0.81 or higher (with and without extremes) for all three scales. Mean scores were higher (better) on the Symptoms and Quality of Life impact scales for the participants with unilateral (vs. bilateral) and autologous (vs. alloplastic) reconstruction, and for the participants who were farther out from their reconstruction.

Conclusion: The BREAST-Q Sensation Module can be used alone or in conjunction with other BREAST-Q scales to inform clinical care and to evaluate outcomes of new surgical approaches to restoration of breast sensation.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1245/s10434-021-10094-yDOI Listing
November 2021

Development and Psychometric Validation of the BREAST-Q Animation Deformity Scale for Women Undergoing an Implant-Based Breast Reconstruction After Mastectomy.

Ann Surg Oncol 2021 Sep 26;28(9):5183-5193. Epub 2021 Feb 26.

McMaster University, Hamilton, ON, Canada.

Background: To assess the impact of animation deformity on health-related quality of life, a content-specific, valid, and reliable patient-reported outcome measure is needed. This report describes the development and validation of the BREAST-Q Animation Deformity scale.

Methods: Women with breast cancer who had an implant-based reconstruction provided data. In phase 1 (January 2017 and December 2018), qualitive and cognitive patient interviews and expert input were used to develop and refine scale content. In phase 2 (March to June 2019), a field test study with members of the Love Research Army (LRA) was conducted. Rasch Measurement Theory (RMT) analysis was used to examine psychometric properties.

Results: In phase 1 of the study, qualitative (n = 11) and cognitive (n = 4) interview data and expert input (n = 9) led to the development of a 12-item scale measuring animation deformity. In phase 2, 651 LRA members provided data and 349 participated in a test-retest study. In the RMT analysis, the data fit the Rasch model (X(96) = 104.06; p = 0.27). The scale's reliability was high, with person separation index and Cronbach alpha values with/without extremes of ≥ 0.84 and ≥ 0.92 respectively, and an intraclass correlation coefficient of 0.92 (95% confidence interval, 0.90-0.94). Mean scores on the Animation Deformity scale varied as predicted across subgroups of participants who reported differing amounts of change in breast appearance when their arms were lifted overhead or when they lifted something heavy, and for increasing happiness with the overall outcome of their breast reconstruction.

Conclusion: The 12-item Animation Deformity scale forms a new scale in the BREAST-Q Reconstruction Module that can be used in comparative effectiveness research or to inform clinical care.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1245/s10434-021-09619-2DOI Listing
September 2021

An international mixed methods study to develop a new preference-based measure for women with breast cancer: the BREAST-Q Utility module.

BMC Womens Health 2021 01 6;21(1). Epub 2021 Jan 6.

Brigham and Women's Hospital, 75 Francis S, Boston, MA, 02116, USA.

Background: Generic preference-based measures (PBM), though commonly used, may not be optimal for use in economic evaluations of breast cancer interventions. No breast cancer-specific PBM currently exists, and the generic PBMs fail to capture the unique concerns of women with breast cancer (e.g., body image, appearance, treatment-specific adverse effects). Hence, the objective of this study was to develop a breast cancer-specific PBM, the BREAST-Q Utility module.

Methods: Women diagnosed with breast cancer (stage 0-4, any treatment) were recruited from two tertiary hospitals in Canada and one in the US. The study followed an exploratory sequential mixed methods approach, whereby semi-structured interviews were conducted and at the end of the interview, participants were asked to list their top five health-related quality of life (HRQOL) concerns and to rate the importance of each item on the BREAST-Q. Interviews were audio-recorded, transcribed verbatim, and coded. Constant comparison was used to refine the codes and develop a conceptual framework. Qualitative and quantitative data were triangulated to develop the content of the Utility module  that was refined through 2 rounds of cognitive debriefing interviews with women diagnosed with breast cancer and feedback from experts.

Results: Interviews were conducted with 57 women aged 55 ± 10 years. A conceptual framework was developed from 3948 unique codes specific to breasts, arms, abdomen, and cancer experience. Five top-level domains were HRQOL (i.e., physical, psychological, social, and sexual well-being) and appearance. Data from the interviews, top 5 HRQOL concerns, and BREAST-Q item ratings were used to inform dimensions for inclusion in the Utility module. Feedback from women with breast cancer (N = 9) and a multidisciplinary group of experts (N = 27) was used to refine the module. The field-test version of the HSCS consists of 10 unique dimensions. Each dimension is measured with 1 or 2 candidate items that have 4-5 response levels each.

Conclusion: The field-test version of the BREAST-Q Utility module was derived from extensive patient and expert input. This comprehensive approach ensured that the content of the Utility module is relevant, comprehensive, and includes concerns that matter the most to women with breast cancer.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s12905-020-01125-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7789506PMC
January 2021

The BODY-Q Cellulite Scale: A Development and Validation Study.

Aesthet Surg J 2021 01;41(2):206-217

Division of Plastic and Reconstructive Surgery, Department of Surgery, Brigham and Women's Hospital, Boston, MA, USA.

Background: Cellulite is a localized metabolic disorder of the subcutaneous tissue. To measure the impact of cellulite and its treatment(s) on patients' health-related quality of life, a psychometrically sound patient-reported outcome measure is needed.

Objectives: The authors sought to develop and field test a new BODY-Q cellulite scale to measure the appearance of cellulite.

Methods: Appearance-related codes from the original BODY-Q qualitative interviews were reexamined, and a set of cellulite-specific items was developed and refined through cognitive patient interviews (n = 10) and expert input (n = 17). This scale was field-tested in adults with cellulite through 2 crowdworking platforms. Rasch Measurement Theory analysis was employed to refine the scale and examine its psychometric properties.

Results: The field-test sample included 2129 participants. The 15-item scale was reduced in length to 11 items. Data from the sample fit the Rasch model (X2 [99] = 21.32, P = 0.06). All items had ordered thresholds and mapped out a targeted clinical hierarchy. The reliability statistics for the person separation index was 0.94 and for Cronbach's alpha was 0.97. In terms of validity, worse scores on the cellulite scale were associated with being more bothered by how the cellulite looked overall, having more severe cellulite on the Patient-Reported Photo-numeric Cellulite Severity Scale, and having more self-reported cellulite and more areas of the body with cellulite.

Conclusions: The BODY-Q cellulite scale can be utilized to measure appearance of cellulite and provides a solid basis for future studies evaluating the impact of cellulite and its treatment.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/asj/sjaa100DOI Listing
January 2021

Adding scales to BREAST-Q must follow the same rigor as original scales.

J Plast Reconstr Aesthet Surg 2018 08 22;71(8):1216-1230. Epub 2018 May 22.

Department of Surgery, Brigham and Women's Hospital, 75 Francis St, Boston MA 02116, USA.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.bjps.2018.03.023DOI Listing
August 2018

Robotic Versus Video-Assisted Thoracoscopic Lung Resection During Early Program Development.

Ann Thorac Surg 2018 04 2;105(4):1050-1057. Epub 2018 Mar 2.

Boris Family Center for Robotic Surgery Research Program, St. Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada; Division of Thoracic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada. Electronic address:

Background: The objective of this study is to compare robotic portal (RP) to video-assisted thoracoscopic surgery (VATS) pulmonary resections for early stage non-small cell lung cancer with respect to health care resource utilization during the first year of a robotic surgery program in thoracic oncology.

Methods: Patients who underwent anatomic lung resections using RP (n = 42) or VATS (n = 96) for early stage non-small cell lung cancer between April 2014 and March 2015 at a single institution were identified. Patient-level case costing data for hospital and home care-associated resource variables were recorded. We adopted a health care payer perspective and 30-day posthospital discharge/death time horizon. Parametric or nonparametric tests were used as appropriate and incremental cost difference using 10,000 bootstrap samples using bias-corrected and accelerated method to generate 95% confidence intervals for total cost.

Results: Baseline demographic and clinical characteristics were comparable between the two groups. The median total hospital cost per patient was $15,247 (95% confidence interval: $15,643 to $18,945) in the RP cohort, compared with $12,131 (95% confidence interval: $13,218 to $15,879) in the VATS cohort (n = 96; p < 0.001). Longer operating times in the RP group were the main driver of higher hospital costs. Post-hoc analysis of mean operating room time for first 20 RP procedures versus remaining 22 RP procedures found a mean difference of 71 minutes (p = 0.004), resulting in an intraoperative cost difference of $883.38 (p = 0.036).

Conclusions: A micro-costing analysis demonstrates that RP pulmonary resection for early stage non-small cell lung cancer utilizes more health care resource dollars when compared with VATS during early program development, but offers similar perioperative outcomes.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.athoracsur.2017.11.013DOI Listing
April 2018

A Tale of Two Health-Care Systems: Cost-Utility Analysis of Open Carpal Tunnel Release in Canada and the United States.

Plast Surg (Oakv) 2017 Feb 10;25(1):7-13. Epub 2017 Mar 10.

Division of Plastic Surgery, McMaster University, Hamilton, Ontario, Canada.

Purpose: Canadian health care is often criticized for extended wait times, whereas the United States suffers from increased costs. The purpose of this pilot study was to determine the cost-utility of open carpal tunnel release in Canada versus the United States.

Methods: A prospective cohort study evaluated patients undergoing open carpal tunnel release at an institution in Canada and the United States. All costs from a societal perspective were captured. Utility was measured using validated health-related quality of life (HRQOL) scales-the EuroQol-5D and the Michigan Hand Outcome Questionnaire.

Results: Twenty-one patients at the Canadian site and 8 patients at the US site participated. Mean total costs were US $1581 ± $1965 and $2179 (range: $1421-$2741) at the Canadian and US sites, respectively. Health-related quality of life demonstrated significant improvements following surgery ( < .05). Patient utilities preoperatively and at 6 weeks and 3 months postoperatively were 0.72 ± 0.20, 0.86 ± 0.11, and 0.83 ± 0.16 at the Canadian site and 0.81 ± 0.09, 0.86 ± 0.10, and 0.86 ± 0.12 at the US site. Improvements in HRQOL directly related to surgery were not significantly different between patients in Canada and the United States. American patients, however, attained improved HRQOL sooner due to shorter wait times (27 ± 10 vs 214 ± 119 days; < .001). The incremental cost-utility of the US system was $7758/quality-adjusted life year gained compared to the Canadian system. Sensitivity analyses confirmed that these results were robust.

Conclusion: This pilot study suggests that carpal tunnel surgery is more cost-effective in the United States due to prolonged wait times in Canada.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1177/2292550317693817DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5626189PMC
February 2017

Psychometric Properties of the Hindi Version of the Disabilities of Arm, Shoulder, and Hand: A Pilot Study.

Rehabil Res Pract 2015 31;2015:482378. Epub 2015 Dec 31.

School of Physical Therapy, Marshall University, Huntington, WV, USA; Department of Orthopedics Surgery, Marshall University, Huntington, WV, USA.

Objectives. To culturally adapt and translate the Disabilities of Arm, Shoulder, and Hand questionnaire into Hindi (DASH-H) and assess its reliability, validity, and responsiveness in adult patients with shoulder tendonitis. Study Design. Descriptive methodological research, using longitudinal design. Setting. Outpatient clinic. Participants. 30 adult patients aged 53.3 ± 6.9 y with shoulder tendonitis. Data Analyses. DASH-H, visual analogue scales for pain (VAS-P) and disability (VAS-D), and shoulder active range of motion (AROM) were assessed at baseline, 2-3 days later, and 4-5 weeks after baseline. Intraclass correlation coefficients (ICC) assessed test-retest reliability of these scales and responsiveness was examined by calculating effect sizes (ES) and standardized response means (SRM). Cronbach's alpha (CA) was used to examine internal consistency of DASH-H. Convergent construct validity of DASH-H with VAS scales and shoulder AROM was determined using Pearson's Correlation Coefficients (r). Results. DASH-H demonstrated good test-retest reliability and internal consistency (ICC and CA both > 0.75) and excellent responsiveness (ES = 2.2, SRM = 6.1). DASH-H showed high concordance (r = -0.71, p < 0.01) with AROM-flexion and moderate concordance (r > -0.4, p < 0.05) with VAS scales and AROM-external rotation. Conclusion. Analyses indicate that DASH-H demonstrates good test-retest reliability, validity, and responsiveness in patients with shoulder tendonitis.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1155/2015/482378DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4745923PMC
February 2016

A Systematic Review of Surgical Randomized Controlled Trials: Part 2. Funding Source, Conflict of Interest, and Sample Size in Plastic Surgery.

Plast Reconstr Surg 2016 Feb;137(2):453e-461e

Hamilton and Toronto, Ontario, Canada; and Ann Arbor, Mich. From the Divisions of Plastic and Reconstructive Surgery and Orthopedic Surgery, Department of Surgery, the Surgical Outcomes Research Center, the Health Sciences Library, and the Department of Clinical Epidemiology and Biostatistics, McMaster University; the Division of Plastic and Reconstructive Surgery, Department of Surgery, University of Toronto; and the Section of Plastic Surgery, Department of Surgery, The University of Michigan Health System.

Background: The authors examined industry support, conflict of interest, and sample size in plastic surgery randomized controlled trials that compared surgical interventions. They hypothesized that industry-funded trials demonstrate statistically significant outcomes more often, and randomized controlled trials with small sample sizes report statistically significant results more frequently.

Methods: An electronic search identified randomized controlled trials published between 2000 and 2013. Independent reviewers assessed manuscripts and performed data extraction. Funding source, conflict of interest, primary outcome direction, and sample size were examined. Chi-squared and independent-samples t tests were used in the analysis.

Results: The search identified 173 randomized controlled trials, of which 100 (58 percent) did not acknowledge funding status. A relationship between funding source and trial outcome direction was not observed. Both funding status and conflict of interest reporting improved over time. Only 24 percent (six of 25) of industry-funded randomized controlled trials reported authors to have independent control of data and manuscript contents. The mean number of patients randomized was 73 per trial (median, 43, minimum, 3, maximum, 936). Small trials were not found to be positive more often than large trials (p = 0.87).

Conclusions: Randomized controlled trials with small sample size were common; however, this provides great opportunity for the field to engage in further collaboration and produce larger, more definitive trials. Reporting of trial funding and conflict of interest is historically poor, but it greatly improved over the study period. Underreporting at author and journal levels remains a limitation when assessing the relationship between funding source and trial outcomes. Improved reporting and manuscript control should be goals that both authors and journals can actively achieve.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1097/01.prs.0000475767.61031.d1DOI Listing
February 2016

A Systematic Review of Surgical Randomized Controlled Trials: Part I. Risk of Bias and Outcomes: Common Pitfalls Plastic Surgeons Can Overcome.

Plast Reconstr Surg 2016 Feb;137(2):696-706

Hamilton and Toronto, Ontario, Canada; and Ann Arbor, Mich. From the Divisions of Plastic and Reconstructive Surgery and Orthopedic Surgery, Department of Surgery, the Surgical Outcomes Research Center, the Health Sciences Library, and the Department of Clinical Epidemiology and Biostatistics, McMaster University; the Division of Plastic and Reconstructive Surgery, Department of Surgery, University of Toronto; and the Section of Plastic Surgery, Department of Surgery, The University of Michigan Health System.

Background: The authors investigated the methodological validity of plastic surgery randomized controlled trials that compared surgical interventions.

Methods: An electronic search identified randomized controlled trials published between 2000 and 2013. Reviewers, independently and in duplicate, assessed manuscripts and performed data extraction. Methodological safeguards (randomization, allocation concealment, blinding, and incomplete outcome data) were examined using the Cochrane risk of bias tool. Regression analysis was used to identify trial characteristics associated with risk of bias.

Results: Of 1664 potentially eligible studies, 173 randomized controlled trials were included. Proper randomization and allocation concealment methods were described in 61 of 173 (35 percent) and 21 of 173 (12 percent), respectively. Outcome assessors were blinded in 58 of 173 (34 percent) trials, and patients were blinded in 45 of 173 (26 percent). Follow-up rates were high, with 99 of 173 (57 percent) randomized controlled trials appearing to have complete follow-up. An intention-to-treat analysis was used in 19 of 173 (11 percent) trials. One-third (58 of 173, 34 percent) did not state their primary outcomes. The most common type of primary outcome used was a symptom/quality of life, class III, outcome (73 of 173, 42 percent). Multinomial regression demonstrated trials reporting an a priori sample size as more likely to have a low risk of bias (p = 0.001).

Conclusions: This article highlights methodological safeguards that plastic surgeons should consider when interpreting results of a surgical randomized controlled trial. Allocation concealment, outcome assessor blinding, and patient blinding were identified as areas of concern. Valid and reliable outcome measures are being used in plastic surgery. This analysis provides strong rationale for continued focus on the performance and reporting of clinical trials within our specialty.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1097/01.prs.0000475766.83901.5bDOI Listing
February 2016
-->