Development and Validation of the Study Quality Assessment of Design (SQUAD) Tool for Systematic Reviews

Abstract

Background

Quality assessment of included studies is an integral component of rigorous systematic reviews as this step helps to ensure findings are externally valid. However, systematic reviews often include both randomized controlled trials (RCTs) and observational studies, and existing quality assessment tools are limited in the degree to which they allow for quality comparisons across these different study designs. Many existing quality tools tend to favor RCTs over other study designs, and while RCTs are among the most rigorous studies, observational studies often generate valuable evidence in situations where an RCT is not feasible. In this paper, we describe the development and validation of a novel Study Quality Assessment of Design (SQUAD) tool that can be used to assess the quality of multiple types of study designs within a systematic review.

Methods

The SQUAD tool was developed for a systematic review of studies examining the effects of clinician-patient interpersonal interventions on Quadruple Aim outcomes (i.e., population health, cost, patient and provider experience)¹⁹. First, we conducted a search for existing quality assessment tools using PubMed, Google, and systematic reviews in the literature. For each of the 6 tools that we identified,^{12,29,30,52,59,79} we examined the quality assessment criteria and the types of studies that could be assessed with the tool. Our search suggested that existing tools were unable to adequately handle diverse study designs. We determined that a tool combining the Cochrane tool for grading RCTs⁵² and the risk of bias criteria developed for controlled observational studies developed by the Effective Practice and Organisation of Care (EPOC) reviews²⁹ could be used to compare quality across both RCTs and observational studies. Thus, both formed the foundation for the SQUAD tool, which incorporates elements of Cochrane and EPOC assessments, with simplified language and processes for ease of use. The domains of the SQUAD tool are listed in Table 1.

To test and refine the tool, we performed a multi-phase pilot with 12 studies drawn from the systematic review (8 RCTs and 4 observational studies).^{2,5,9,16,20-23,32,37,53,75} For each phase, 3-4 studies were assessed by two raters (AT and SB). Ratings for the studies were reviewed by a third team member (MH), and discrepancies were resolved by consensus. The tool was revised after each of these meetings before additional studies were reviewed. Most differences between the two raters were due to missing or misplaced information in the text; discrepancies rarely arose due to different interpretations of the descriptions of the domains. We examined inter-rater reliability after each iteration by calculating the model 3 intra-class correlation coefficient for raters.

After refining the SQUAD tool, we tested it in an evaluation of all 77 studies for the systematic review^{1-11,13-18, 20-28,31-51,53-58,60-78,80-84} that included 68 RCTs and 9 observational studies. Four reviewers randomly rated different studies using the Covidence systematic review online interface (Covidence, Vertitas Health Innovation Ltd, Melbourne, 2018), until there were two sets of ratings for each study. We examined inter-rater reliability for the quality assessments by calculating the model 2 intra-class correlation coefficient. Statistical analysis was conducted in R (RStudio Inc., Boston, Version 1.1.383, 2017).

Results

     The SQUAD tool is available in the online Appendix. During the pilot with 12 studies^{2,5,9,16,20-23,32,37,53,75} (8 RCTs and 4 observational studies), the ICC (1,1) improved with each iteration: 0.41, 0.64, 0.69, 0.89. During the assessment of 77 studies in the systematic review (68 RCTs and 9 observational studies), the ICC (2,1) was 0.72. ICCs are presented in Table 2.

Discussion

            The SQUAD tool offers a pragmatic approach to quality assessment for researchers evaluating RCTs and observational studies in systematic reviews. It is unique in that it can handle both types of studies without being biased towards a single study design, while maintaining the rigor necessary to help ensure external validity.  It is also simple and accessible to researchers with varying levels of experience. A limitation of the design process is that it was tested in a single systematic review of RCTs and observational studies of clinician-patient interpersonal interventions. Additional testing is warranted to validate the tool across      more      study designs covering diverse content. However, our goal at this stage is to present a novel tool for use in systematic reviews of studies with a mixture of designs. The authors acknowledge that the tool could use further refinement, and is an avenue for future research.

Conclusions

SQUAD is a practical and reliable tool for assessing the quality of randomized trials and observational studies when synthesizing findings for systematic reviews. This tool will help ensure that results from systematic reviews maintain external validity when      incorporating multiple study designs.

Abbreviations

ICC = intraclass correlation coefficient

RCT= randomized control trial

Declarations

Ethics approval and consent to participate: Not applicable

Consent for publication: Not applicable

Availability of data and material: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Competing interests: The authors declare that they have no competing interests.

Funding: This study was supported by a grant from the Gordon and Betty Moore Foundation (#6382).

Authors’ contributions: AT performed the search for existing tools and helped create the SQUAD domains, conducted quality assessment ratings, analyzed and interpreted data regarding all statistical analyses performed, and drafted the manuscript. MH led the systematic review, oversaw the creation of SQUAD and its domains, and was an editor of the manuscript. SB conducted quality assessment ratings and was an editor of the manuscript. DZ was the primary mentor for the systematic review and SQUAD tool development, and was an editor of the manuscript.

Acknowledgments: The authors would like to acknowledge Derek Boothroyd for his guidance in data analysis, and Gabriella Piccininni and Laura Jacobson for their contributions towards the quality assessments for the systematic review.

Disclaimer: The contents of this article do not represent the views of VA or the United States Government.

References

1. Aboumatar, H. J., Carson, K. A., Beach, M. C., Roter, D. L., & Cooper, L. A. The impact of health literacy on desire for participation in healthcare, medical visit communication, and patient reported outcomes among patients with hypertension. J Gen Intern Med. 2013; doi:10.1007/s11606-013-2466-5.
2. Aiarzaguena, J. M., Grandes, G., Gaminde, I., Salazar, A., Sanchez, A., & Arino, J. A randomized controlled clinical trial of a psychosocial and communication intervention carried out by GPs for patients with medically unexplained symptoms. Psychol Med. 2007; doi:10.1017/s0033291706009536.
3. Ajam, A. A., Nguyen, X. V, Kelly, R. A., Ladapo, J. A., & Lang, E. V. Effects of Interpersonal Skills Training on MRI Operations in a Saturated Market: A Randomized Trial. Journal of the American College of Radiology. 2017; doi:10.1016/j.jacr.2017.03.015.
4. Akturan, S., Kaya Ç, A., Ünalan, P. C., & Akman, M. The effect of the BATHE interview technique on the empowerment of diabetic patients in primary care: A cluster randomised controlled study. Prim Care Diabetes. 2017; doi:10.1016/j.pcd.2016.12.003
5. Alder, J., Christen, R., Zemp, E., & Bitzer, J. Communication skills training in obstetrics and gynaecology: whom should we train? A randomized controlled trial. Arch Gynecol Obstet. 2007; doi:10.1007/s00404-007-0399-0.
6. Altiner, A., Brockmann, S., Sielk, M., Wilm, S., Wegscheider, K., & Abholz, H. H. Reducing antibiotic prescriptions for acute cough by motivating GPs to change their attitudes to communication and empowering patients: A cluster-randomized intervention study. Journal of Antimicrobial Chemotherapy. 2007; doi:10.1093/jac/dkm254
7. Au, D. H., Udris, E. M., Engelberg, R. A., Diehr, P. H., Bryson, C. L., Reinke, L. F., & Curtis, J. R. A randomized trial to improve communication about end-of-life care among patients with COPD. Chest. 2012; doi:10.1378/chest.11-0362.
8. Aubin-Auger, I., Laouenan, C., Le Bel, J., Mercier, A., Baruch, D., et al. Efficacy of communication skills training on colorectal cancer screening by GPs: a cluster randomised controlled trial. Eur J Cancer Care (Engl). 2016; doi:10.1111/ecc.12310.
9. Bakker, I. M., Terluin, B., van Marwijk, H. W. J., van der Windt, D. A. W. M., Rijmen, F., van Mechelen, W., & Stalman, W. A. B. A cluster-randomised trial evaluating an intervention for patients with stress-related mental disorders and sick leave in primary care. PLoS Clinical Trials. 2007; doi:10.1371/journal.pctr.0020026.
10. Bashour, H. N., Kanaan, M., Kharouf, M. H., Abdulsalam, A. A., Tabbaa, M. A., & Cheikha, S. A. The effect of training doctors in communication skills on women’s satisfaction with doctor-woman relationship during labour and delivery: A stepped wedge cluster randomised trial in Damascus. BMJ Open. 2013; doi:10.1136/bmjopen-2013-002674.
11. Bellón, J. A., Rodríguez-Bayón, A., Luna, J. de D., & Torres-González, F. Successful GP intervention with frequent attenders in primary care: Randomised controlled trial. British Journal of General Practice. 2008; doi:10.3399/bjgp08X280182.
12. Berkman ND, Lohr KN, Ansari M, McDonagh M, Balk E, Whitlock E, et al. Grading the Strength of a Body of Evidence When Assessing Health Care Interventions for the Effective Health Care Program of the Agency for Healthcare Research and Quality: An Update. Methods Guide for Comparative Effectiveness Reviews (Prepared by the RTI-UNC Evidence-based Practice Center under Contract No. 2902007-10056-I). AHRQ Publication No. 13(14)-EHC130-EF. Rockville, MD: Agency for Healthcare Research and Quality. November 2013. www.effectivehealthcare.ahrq.gov/reports/final.cfm.
13. Bernhard, J., Butow, P., Aldridge, J., Juraskova, I., Ribi, K., & Brown, R. Communication about standard treatment options and clinical trials: can we teach doctors new skills to improve patient outcomes? Psychooncology. 2012; doi:10.1002/pon.2044.
14. Bieber, C., Muller, K. G., Blumenstiel, K., Hochlehnert, A., Wilke, S., Hartmann, M., & Eich, W. A shared decision-making communication training program for physicians treating fibromyalgia patients: effects of a randomized controlled trial. J Psychosom Res. 2008; doi:10.1016/j.jpsychores.2007.05.009.
15. Bieber, C., Muller, K. G., Blumenstiel, K., Schneider, A., Richter, A., Wilke, S., et al. Long-term effects of a shared decision-making intervention on physician-patient interaction and outcome in fibromyalgia. A qualitative and quantitative 1 year follow-up of a randomized controlled trial. Patient Educ Couns. 2006; doi:10.1016/j.pec.2006.05.003.
16. Bittner, A., Bittner, J., Jonietz, A., Dybowski, C., & Harendza, S. Translating medical documents improves students’ communication skills in simulated physician-patient encounters. BMC Med Educ. 2016; doi:10.1186/s12909-016-0594-4.
17. Blatt, B., LeLacheur, S. F., Galinsky, A. D., Simmens, S. J., & Greenberg, L. Does perspective-taking increase patient satisfaction in medical encounters? Acad Med. 2010; doi:10.1097/ACM.0b013e3181eae5ec.
18. Blodt, S., Mittring, N., Schutzler, L., Fischer, F., Holmberg, C., Horneber, M., et al. A consultation training program for physicians for communication about complementary medicine with breast cancer patients: a prospective, multi-center, cluster-randomized, mixed-method pilot study. BMC Cancer. 2016; doi:10.1186/s12885-016-2884-y.
19. Bodenheimer, T., & Sinsky, C. From triple to quadruple aim: Care of the patient requires care of the provider. The Annals of Family Medicine. 2014; doi:10.1370/afm.1713.
20. Boissy, A., Windover, A. K., Bokar, D., Karafa, M., Neuendorf, K., Frankel, R. M., et al. Communication Skills Training for Physicians Improves Patient Satisfaction. J Gen Intern Med. 2016; doi.org/10.1007/s11606-016-3597-2.
21. Bowles, N., Mackintosh, C., & Torn, A. Nurses’ communication skills: an evaluation of the impact of solution-focused communication training. J Adv Nurs. 2001;36:347–54.
22. Briel, M., Langewitz, W., Tschudi, P., Young, J., Hugenschmidt, C., & Bucher, H. C. (2006). Communication training and antibiotic use in acute respiratory tract infections: A cluster-randomised controlled trial in general practice. Swiss Med Wkly. 2006;136:241–7.
23. Brock, D. M., Mauksch, L. B., Witteborn, S., Hummel, J., Nagasawa, P., & Robins, L. S. Effectiveness of intensive physician training in upfront agenda setting. J Gen Intern Med. 2011; doi:10.1007/s11606-011-1773-y.
24. Brown, J. B., Boles, M., Mullooly, J. P., & Levinson, W. Effect of clinician communication skills training on patient satisfaction. A randomized, controlled trial. Ann Intern Med. 1999;131:822-9.
25. Brown, L. D., de Negri, B., Hernandez, O., Dominguez, L., Sanchack, J. H., & Roter, D. An evaluation of the impact of training Honduran health care providers in interpersonal communication. Int J Qual Health Care. 2000;12:495–501.
26. Byrne, M. K., & Deane, F. P. Enhancing patient adherence: outcomes of medication alliance training on therapeutic alliance, insight, adherence, and psychopathology with mental health patients. Int J Ment Health Nurs. 2011; doi:10.1111/j.1447-0349.2010.00722.x.
27. Cals, J. W. L., Ament, A. J. H. A., Hood, K., Butler, C. C., Hopstaken, R. M., Wassink, G. F., & Dinant, G. J. C-reactive protein point of care testing and physician communication skills training for lower respiratory tract infections in general practice: Economic evaluation of a cluster randomized trial. J Eval Clin Pract. 2011; doi:10.1111/j.1365-2753.2010.01472.x.
28. Cals, J. W., de Bock, L., Beckers, P. J., Francis, N. A., Hopstaken, R. M., Hood, K., et al. Enhanced communication skills and C-reactive protein point-of-care testing for respiratory tract infection: 3.5-year follow-up of a cluster randomized trial. Ann Fam Med. 2013; doi:10.1370/afm.1477.
29. Cochrane Effective Practice and Organisation of Care (EPOC). Suggested risk of bias criteria for EPOC reviews. EPOC Resources for review authors. 2017. Available at: http://epoc.cochrane.org/resources/epoc-resources-review-authors.
30. Cochrane Effective Practice and Organisation of Care Review Group (EPOC): Data Collection Checklist. https://methods.cochrane.org/sites/methods.cochrane.org.bias/files/public/uploads/EPOC%20Data%20Collection%20Checklist.pdf. Accessed 26 October 2017.
31. Cooper, L. A., Ghods Dinoso, B. K., Ford, D. E., Roter, D. L., Primm, A. B., Larson, S. M., et al. Comparative effectiveness of standard versus patient-centered collaborative care interventions for depression among African Americans in primary care settings: The BRIDGE study. Health Serv Res. 2013; doi:10.1111/j.1475-6773.2012.01435.x.
32. Cooper, L. A., Roter, D. L., Carson, K. A., Bone, L. R., Larson, S. M., Miller 3rd, E. R., et al. A randomized trial to improve patient-centered care and hypertension control in underserved primary care patients. J Gen Intern Med. 2011; doi:10.1007/s11606-011-1794-6.
33. Curtis, J. R., Back, A. L., Ford, D. W., Downey, L., Shannon, S. E., Doorenbos, A. Z., et al. Effect of communication skills training for residents and nurse practitioners on quality of communication with patients with serious illness: a randomized trial. JAMA. 2013; doi:10.1001/jama.2013.282081.
34. Daly, B. J., Douglas, S. L., O’Toole, E., Gordon, N. H., Hejal, R., Peerless, J., et al. Effectiveness trial of an intensive communication structure for families of long-stay ICU patients. Chest. 2010; doi:10.1378/chest.10-0292.
35. Delvaux, N., Razavi, D., Marchal, S., Bredart, A., Farvacques, C., & Slachmuylder, J. L. Effects of a 105 hours psychological training program on attitudes, communication skills and occupational stress in oncology: a randomised study. Br J Cancer. 2004; doi:10.1038/sj.bjc.6601459.
36. DeMaria  Jr., S., DeMaria, A. P., Silvay, G., & Flynn, B. C. Use of the BATHE method in the preanesthetic clinic visit. Anesth Analg. 2011; doi:10.1213/ANE.0b013e318229497b.
37. Dunn, R., Callahan, J. L., Swift, J. K., & Ivanovic, M. Effects of pre-session centering for therapists on session presence and effectiveness. Psychother Res. 2013; doi:10.1080/10503307.2012.731713.
38. Edgoose, J. Y., Regner, C. J., & Zakletskaia, L. I. BREATHE OUT: a randomized controlled trial of a structured intervention to improve clinician satisfaction with “difficult” visits. J Am Board Fam Med. 2015; doi:10.3122/jabfm.2015.01.130323.
39. Edwards, A., Elwyn, G., Hood, K., Atwell, C., Robling, M., Houston, H., et al. Patient-based outcome results from a cluster randomized trial of shared decision making skill development and use of risk communication aids in general practice. Fam Pract. 2004; doi:10.1093/fampra/cmh402
40. Epstein, R. M., Duberstein, P. R., Fenton, J. J., Fiscella, K., Hoerger, M., Tancredi, D.J., et al. Effect of a Patient-Centered Communication Intervention on Oncologist-Patient Communication, Quality of Life, and Health Care Utilization in Advanced Cancer: The VOICE Randomized Clinical Trial. JAMA Oncol. 2017; doi.org/10.1001/jamaoncol.2016.4373.
41. Finnema, E., Droes, R. M., Ettema, T., Ooms, M., Ader, H., Ribbe, M., & van Tilburg, W. The effect of integrated emotion-oriented care versus usual care on elderly persons with dementia in the nursing home and on nursing assistants: a randomized clinical trial. Int J Geriatr Psychiatry. 2005; doi:10.1002/gps.1286.
42. Fujimori, M., Shirai, Y., Asai, M., Kubota, K., Katsumata, N., & Uchitomi, Y. Effect of communication skills training program for oncologists based on patient preferences for communication when receiving bad news: a randomized controlled trial. J Clin Oncol. 2014; doi:10.1200/jco.2013.51.2756.
43. Fukui, S., Ogawa, K., & Yamagishi, A. Effectiveness of communication skills training of nurses on the quality of life and satisfaction with healthcare professionals among newly diagnosed cancer patients: a preliminary study. Psychooncology. 2011; doi:10.1002/pon.1840.
44. Fukui, S., Ogawa, K., Ohtsuka, M., & Fukui, N. Effect of communication skills training on nurses’ detection of patients’ distress and related factors after cancer diagnosis: A randomized study. Psychooncology. 2009; doi:10.1002/pon.1429.
45. Grepmair, L., Mitterlehner, F., Loew, T., Bachler, E., Rother, W., & Nickel, M. Promoting mindfulness in psychotherapists in training influences the treatment results of their patients: A randomized, double-blind, controlled study. Psychother Psychosom. 2007; doi:10.1159/000107560.
46. Griffey, R. T., Shin, N., Jones, S., Aginam, N., Gross, M., Kinsella, Y., et al. The impact of teach-back on comprehension of discharge instructions and satisfaction among emergency patients with limited health literacy: A randomized, controlled study. J Commun Healthc. 2015; doi:10.1179/1753807615y.0000000001.
47. Harmsen, H., Bernsen, R., Meeuwesen, L., Thomas, S., Dorrenboom, G., Pinto, D., & Bruijnzeels, M. The effect of educational intervention on intercultural communication: results of a randomised controlled trial. Br J Gen Pract. 2005;55:343–350.
48. Hart, C. N., Drotar, D., Gori, A., & Lewin, L. Enhancing parent-provider communication in ambulatory pediatric practice. Patient Education and Counseling. 2006; doi:10.1016/j.pec.2005.08.007.
49. Haskard, K. B., Williams, S. L., DiMatteo, M. R., Rosenthal, R., White, M. K., & Goldstein, M. G. Physician and patient communication training in primary care: effects on participation and satisfaction. Health Psychol. 2008; doi:10.1037/0278-6133.27.5.513.
50. Heritage, J., Robinson, J. D., Elliott, M. N., Beckett, M., & Wilkes, M. Reducing patients’ unmet concerns in primary care: the difference one word can make. J Gen Intern Med. 2007; doi:10.1007/s11606-007-0279-0.
51. Hietanen, P. S., Aro, A. R., Holli, K. A., Schreck, M., Peura, A., & Joensuu, H. T. A short communication course for physicians improves the quality of patient information in a clinical trial. Acta Oncol. 2007;46:42–8.
52. Higgins JPT, Sterne JAC, Savović J, Page MJ, Hróbjartsson A, Boutron I, Reeves B, Eldridge S. A revised tool for assessing risk of bias in randomized trials In: Chandler J, McKenzie J, Boutron I, Welch V (editors). Cochrane Methods. Cochrane Database of Systematic Reviews 2016. 2016; doi:10.1002/14651858.CD201601.
53. Jaffray, M., Matheson, C., Bond, C. M., Lee, A. J., McLernon, D. J., Johnstone, A., et al. Does training in motivational interviewing for community pharmacists improve outcomes for methadone patients? A cluster randomised controlled trial. International Journal of Pharmacy Practice. 2014; doi:10.1111/ijpp.12049.
54. Johnson, R. L., Sadosty, A. T., Weaver, A. L., & Goyal, D. G. To sit or not to sit? Ann Emerg Med. 2008; doi:10.1016/j.annemergmed.2007.04.024.
55. Jones, D. L., Sued, O., Cecchini, D., Bofill, L., Cook, R., Lucas, M., et al. Improving Adherence to Care Among “Hard to Reach” HIV-Infected Patients in Argentina. AIDS Behav. 2016; doi:10.1007/s10461-015-1133-8.
56. Kim, J. H., Park, Y. N., Park, E. W., Cheong, Y. S., & Choi, E. Y. Effects of BATHE Interview Protocol on Patient Satisfaction. Korean J Fam Med. 2012; doi:10.4082/kjfm.2012.33.6.366.
57. Kinmonth, A. L., Woodcock, A., Griffin, S., Spiegal, N., & Campbell, M. J. Randomised controlled trial of patient centred care of diabetes in general practice: Impact on current wellbeing and future disease risk. British Medical Journal. 1998;317:1202–8.
58. Langewitz, W. A., Eich, P., Kiss, A., & Wössmer, B. Improving communication skills - A randomized controlled behaviorally oriented intervention study for residents in internal medicine. Psychosom Med. 1998;60:268–276.
59. Liberati, A, Altman, DG, Tetzlaff, J, Murlow, C, Gøtzche, PC, Ioannidis, JPA, et al. The PRISMA Statement for Reporting Systematic Reviews and Meta-Analyses of Studies That Evaluate Health Care Interventions: Explanation and Elaboration. Ann Intern Med. 2009; 151: W-65-W-94.
60. Little, P., White, P., Kelly, J., Everitt, H., & Mercer, S. Randomised controlled trial of a brief intervention targeting predominantly non-verbal communication in general practice consultations. Br J Gen Pract. 2015; doi:10.3399/bjgp15X685237.
61. Loh, A., Simon, D., Wills, C. E., Kriston, L., Niebling, W., & Harter, M. The effects of a shared decision-making intervention in primary care of depression: a cluster-randomized controlled trial. Patient Educ Couns. 2007; doi:10.1016/j.pec.2007.03.023.
62. Lonsdale, C., Hall, A. M., Murray, A., Williams, G. C., McDonough, S. M., Ntoumanis, N., et al. Communication Skills Training for Practitioners to Increase Patient Adherence to Home-Based Rehabilitation for Chronic Low Back Pain: Results of a Cluster Randomized Controlled Trial. Arch Phys Med Rehabil. 2017; doi:10.1016/j.apmr.2017.02.025.
63. Luo, Z., Goddeeris, J., Gardiner, J. C., & Smith, R. C. Costs of an intervention for primary care patients with medically unexplained symptoms: a randomized controlled trial. Psychiatr Serv. 2007; doi:10.1176/ps.2007.58.8.1079.
64. Maatouk-Bürmann, B., Ringel, N., Spang, J., Weiss, C., Möltner, A., Riemann, U., et al. Improving patient-centered communication: Results of a randomized controlled trial. Patient Educ Couns. 2016; doi:10.1016/j.pec.2015.08.012.
65. Manze, M. G., Orner, M. B., Glickman, M., Pbert, L., Berlowitz, D., & Kressin, N. R. Brief provider communication skills training fails to impact patient hypertension outcomes. Patient Educ Couns. 2015; doi:10.1016/j.pec.2014.10.014.
66. Mercer, S. W., Fitzpatrick, B., Guthrie, B., Fenwick, E., Grieve, E., Lawson, K., et al. The CARE Plus study - a whole-system intervention to improve quality of life of primary care patients with multimorbidity in areas of high socioeconomic deprivation: exploratory cluster randomised controlled trial and cost-utility analysis. BMC Med. 2016; doi:10.1186/s12916-016-0634-2.
67. Merckaert, I., Delevallez, F., Gibon, A. S., Lienard, A., Libert, Y., Delvaux, N., et al. Transfer of communication skills to the workplace: impact of a 38-hour communication skills training program designed for radiotherapy teams. J Clin Oncol. 2015; doi:10.1200/jco.2014.57.3287.
68. Middleton, J. F., McKinley, R. K., & Gillies, C. L. Effect of patient completed agenda forms and doctors’ education about the agenda on the outcome of consultations: randomised controlled trial. BMJ. 2006; doi:10.1136/bmj.38841.444861.7C.
69. Moral, R. R., Torres, L. A., Ortega, L. P., Larumbe, M. C., Villalobos, A. R., Garcia, J. A., & Rejano, J. M. Effectiveness of motivational interviewing to improve therapeutic adherence in patients over 65 years old with chronic diseases: A cluster randomized clinical trial in primary care. Patient Educ Couns. 2015; doi:10.1016/j.pec.2015.03.008.
70. Muñoz Alamo, M., Ruiz Moral, R., & Pérula de Torres, L. Evaluation of a patient-centered approach in generalized musculoskeletal chronic pain/fibromyalgia patients in primary care. Patient Educ Couns. 2002;48:23–31.
71. Penner, L. A., Gaertner, S., Dovidio, J. F., Hagiwara, N., Porcerelli, J., Markova, T., & Albrecht, T. L. A social psychological approach to improving the outcomes of racially discordant medical interactions. J Gen Intern Med. 2013; doi:10.1007/s11606-013-2339-y.
72. Pill, R., Stott, N. C., Rollnick, S. R., & Rees, M. A randomized controlled trial of an intervention designed to improve the care given in general practice to Type II diabetic patients: patient outcomes and professional ability to change behaviour. Fam Pract. 1998;15:229–35.
73. Rakel, D. P., Hoeft, T. J., Barrett, B. P., Chewning, B. A., Craig, B. M., & Niu, M. Practitioner empathy and the duration of the common cold. Fam Med. 2009;41:494–501.
74. Rakel, D., Barrett, B., Zhang, Z., Hoeft, T., Chewning, B., Marchand, L., & Scheder, J. Perception of empathy in the therapeutic encounter: effects on the common cold. Patient Educ Couns. 2011; doi.org/10.1016/j.pec.2011.01.009.
75. Rask, M. T., Jensen, M. L., Andersen, J., & Zachariae, R. Effects of an intervention aimed at improving nurse-patient communication in an oncology outpatient clinic. Cancer Nurs. 2009; doi:10.1097/01.ncc.0000343365.13871.12.
76. Roter, D., Rosenbaum, J., de Negri, B., Renaud, D., DiPrete-Brown, L., & Hernandez, O. The effects of a continuing medical education programme in interpersonal communication skills on doctor practice and patient satisfaction in Trinidad and Tobago. Med Educ. 1998;32:181–189.
77. Smith, R. C., Lyles, J. S., Mettler, J., Stoffelmayr, B. E., Van Egeren, L. F., Marshall, A. A., et al. The effectiveness of intensive training for residents in interviewing. A randomized, controlled study. Ann Intern Med. 1998;128:118–26.
78. Song, M. K., Ward, S. E., Fine, J. P., Hanson, L. C., Lin, F. C., Hladik, G. A., et al. Advance care planning and end-of-life decision making in dialysis: a randomized controlled trial targeting patients and their surrogates. Am J Kidney Dis. 2015; doi:10.1053/j.ajkd.2015.05.018.
79. Sterne, JAC, Hernán, MA, Reeves, BC, Savović, J, Berkman, ND, Viswanathan, M, et al. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ. 2016; doi:10.1136/bmj.i4919.
80. Stewart, M., Brown, J. B., Hammerton, J., Donner, A., Gavin, A., Holliday, R. L., et al. Improving communication between doctors and breast cancer patients. Ann Fam Med. 2007; doi:10.1370/afm.721.
81. Swanson, A. J., Pantalon, M. V, & Cohen, K. R. Motivational interviewing and treatment adherence among psychiatric and dually diagnosed patients. Journal of Nervous and Mental Disease. 1999; doi:10.1097/00005053-199910000-00007.
82. Thom, D. H., Bloch, D. A., & Segal, E. S. An intervention to increase patients’ trust in their physicians. Stanford Trust Study Physician Group. Acad Med. 1999;74:195–198.
83. Wolf, D. M., Lehman, L., Quinlin, R., Zullo, T., & Hoffman, L. Effect of patient-centered care on patient satisfaction and quality of care. Journal of Nursing Care Quality. 2008; doi:10.1097/01.NCQ.0000336672.02725.a5.
84. Wolf, D., Lehman, L., Quinlin, R., Rosenzweig, M., Friede, S., Zullo, T., & Hoffman, L. (2008). Can nurses impact patient outcomes using a patient-centered care model? J Nurs Adm. 2008; doi:10.1097/NNA.0b013e31818ebf4f.

Tables