Shared decision making in breast cancer treatment guidelines: Development of a quality assessment tool and a systematic review.

BACKGROUND: It is not clear whether clinical practice guidelines (CPGs) and consensus statements (CSs) are adequately promoting shared decision making (SDM).
OBJECTIVE: To evaluate the recommendations about SDM in CPGs and CSs concerning breast cancer (BC) treatment. SEARCH STRATEGY: Following protocol registration (Prospero no.: CRD42018106643), CPGs and CSs on BC treatment were identified, without language restrictions, through systematic search of bibliographic databases (MEDLINE, EMBASE, Web of Science, Scopus, CDSR) and online sources (12 guideline databases and 51 professional society websites) from January 2010 to December 2019. INCLUSION CRITERIA: CPGs and CSs on BC treatment were selected whether published in a journal or in an online document. DATA EXTRACTION AND SYNTHESIS: A 31-item SDM quality assessment tool was developed and used to extract data in duplicate. MAIN
RESULTS: There were 167 relevant CPGs (139) and CSs (28); SDM was reported in only 40% of the studies. SDM was reported more often in recent publications after 2015 (42/101 (41.6 %) vs 46/66 (69.7 %), P = .0003) but less often in medical journal publications (44/101 (43.5 %) vs 17/66 (25.7 %), P = .009). In CPGs and CSs with SDM, only 8/66 (12%) met one-fifth (6 of 31) of the quality items; only 14/66 (8%) provided clear and precise SDM recommendations. DISCUSSION AND
CONCLUSIONS: SDM descriptions and recommendations in CPGs and CSs concerning BC treatment need improvement. SDM was more frequently reported in CPGs and CSs in recent years, but surprisingly it was less often covered in medical journals, a feature that needs attention.

INTRODUCTION

Breast cancer (BC) is the most common cancer in women, with 2.1 million new cases each year (25% of all female cancers), and it also causes the greatest number (about 670000 in 2018, 15%) of cancer‐related deaths among women , . Mortality and morbidity from BC have decreased in recent years thanks to early diagnosis and the combination of new treatments in a growing array of different strategies , . The best BC treatment must be personalized , , and choosing the ideal approach requires a high degree of specialization, scientific‐technical updating, multidisciplinary coordination and patient participation , , , .

This participation in shared decision making (SDM) is considered a keystone in the achievement of sustainable high‐quality cancer care, and it becomes especially important when separate treatment options with overall similar potential can yield very different results depending on patients' preferences , . In developed countries, SDM is a legal obligation , , , and it has been shown to increase the satisfaction of the patient , improve cost‐effectiveness and reduce malpractice lawsuit . It is claimed to be a keystone to guarantee good quality cancer care , and it is highly recommended by medical associations , , .

The implementation of SDM has persistent barriers , , , , , and it is still poor , . Many authors have proposed strategies for promotion and practical application of SDM , , , , , . A three‐step model introducing choice, describing options and exploring preferences has been suggested . Another proposal involves encouraging patients to make their own care goals that clinicians translate into treatment plans , . Option Grids and other decision aids are thought to make the SDM process easier , . Measuring SDM as a quality indicator and reimbursing professionals that actually use SDM have been floated as another idea involving incentivization .

This important subject should be adequately covered in clinical practice guidelines (CPGs) and consensus statements (CSs), especially in those that are published in a medical journal. The aim of this systematic review was to evaluate the characteristics of CPGs and CSs with SDM compared to those without, to develop an SDM quality assessment tool and to collate the specific information and recommendations about SDM concerning BC treatment in women.

METHODS

This systematic review was carried out following protocol registration (Prospero No: CRD42018106643) and using a prospective protocol developed based on recommended methods for literature searches and assessment of guidelines. During the course of the work, no SDM assessment tool was identified in the literature, so we developed such a tool for data extraction in our work. It was reported according to the preferred reporting items for systematic reviews and meta‐analyses (PRISMA) , (see Appendix 1).

Data sources and searches

A systematic search combining MeSH terms "shared decision making", "clinical practice guidelines", "guidelines", "consensus", “breast cancer”, “breast cancer treatment” and including word variants was conducted using MEDLINE covering the period January 2010 to December 2019, without language restrictions. We further searched online databases (EMBASE, Web of Science, Scopus, CDSR, etc.), 12 guideline‐specific databases and 51 websites of relevant professional societies (see Appendix ). For completeness, we searched on the World Wide Web and the bibliographies of known relevant publications to identify additional studies of relevance to the review.

Study selection and data extraction

We included CPGs and CSs about BC management, produced by governmental agencies or national and international professional organizations and societies. We excluded CPGs and CSs about screening and diagnosis, obsolete guidelines replaced by updates from the same organization, and CPG and CSs for education and information purpose only.

Two reviewers (MMC and IMMN) independently considered the potential eligibility of each of the titles and abstracts from the citations and requested full‐text versions. Working independently, reviewers assessed the full text to confirm eligibility. Disagreements were resolved by consensus or arbitration by a third reviewer (MMD). Duplicate articles were identified and removed. Where multiple versions of a CPG or CS were retrieved, the most recent version was reviewed. Data were extracted from selected CPGs and CSs in duplicate, independently. The intraclass correlation coefficient (ICC) was used to assess consistency between reviewers in data extraction, and the reliability level was excellent >0.90 . Authoritative guidance on systematic review methods recommends inter‐reviewer reliability assessment that is designed to compare measurements obtained by two or more reviewers extracting data from the same papers.

Guideline quality assessment and data extraction

We conducted a search to identify a quality assessment tool for SDM. No relevant tools were identified, so we constructed one using consensus to create a checklist from a long list of items identified in the literature searches. The quality of CPGs and CSs for SDM to manage patients with BC was independently evaluated by two different reviewers (MMC and IMMN) using a piloted data extraction form. Disagreements between the two authors (MMC and IMMN) over the risk of bias for particular studies were solved by group discussion involving an arbitrator (MMD) who took the final decision.

Data synthesis

Two authors (MMC and IMMN) synthesized the data extracted to summarize key information within using a piloted data extraction form concerning characteristics of CPGs and CSs with the SDM information and recommendations contained within them. Rate data were compared using chi‐square test to examine whether CPGs and CSs with SDM were different to those without SDM.

RESULTS

Study selection

Of the 4116 potential citations identified, a total of 167 documents (139 CPGs , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , and 28 CSs , , , , , , , , , , , , , , , , , , , , , , , , , , , ) were identified for final evaluation (Figure 1). ICC for reviewer agreement was 0.97.

Figure 1

Flow diagram for study selection of CPGs and CSs

Development of a quality assessment tool

Individual quality items were scattered across a number of tools for guidelines assessment , . A long list of items was compiled and presented to a group of four BC and SDM specialists in a consensus meeting. This process including several revisions and iterations which led to a 31‐item checklist grouped into thirteen domains (see Appendix ). Of these, 68% (n = 21) were identified from the AGREE and 48% (n = 15) from the RIGHT tools. Only 13% (n = 4) of these items did not appear in any of these two tools. However, the expert consensus advised their inclusion after examining other literature in the bibliography of interest about SDM , , , , . The consensus meeting following approval of the 31‐item checklist recommended that each item be examined for compliance. The greater the percentage of items complied with, the greater the quality for SDM in the CPG or CS assessed. The consensus meeting did not recommend the construction of a formal score or a cut point for defining quality.

Study characteristics

The distribution by countries of CPGs and CSs that speak about SDM was irregular (Figure 1). Europe stood out with a total of 25 CPGs and CSs (38%). North America developed 29 (44%) CPGs and CSs (USA: 19 and Canada: 10). South America released six (9%) CPGs and CSs (Colombia, Venezuela, Mexico, Peru and two from Costa Rica). Asia also carried out three (5%) CPGs and CSs (Japan, India and Malaysia). Oceania has developed also three (5%)CPGs and CSs: two from Australia and one from New Zealand. The basic characteristics of the CPGs and CSs including organization, country and year of release are summarized in Table 1. The duration since last update of each CPGs or CSs varied. Some AGO , , , , all the NCCN , , , , and one of the AHS CPGs, and ESMO and the Mexican CS were the most recently updated (highlighted in Table 2). Overall, the last update of the CPGs and CSs with SDM was more recent than that of those without SDM (mean 45 months (range: 3‐115) vs 52 months (range: 3‐116), P < .001). In this comparison, 9% (n = 15/167) did not specify the month of updated but only the year. SDM was reported more often in recent CPGs and CSs published after 2015 (42/101 (42.0%) vs 46/66 (69.7%), P =.0003) but less often in CPGs and CSs published in medical journal (44/101 (43.5%) vs 17/66 (25.7%), P = .009) (Table 3).

Table 1

Description of the CPGs and CSs (n = 167) selected for the systematic review on the quality of reporting concerning SDM in BC treatment

		Abbreviated name	Entity	Country	Year
	Name of the CPG
1	Guidelines on the diagnosis and treatment of breast cancer (2011 edition) 32	Chinese BC CPG 32	CMH	China	2012
2	Chinese guidelines for diagnosis and treatment of breast cancer 2018 33	Chinese BC diagnosis treatment 33	NHCPRC	China	2018
3	The Japanese Breast Cancer Society Clinical Practice Guideline for radiation treatment of breast cancer, 2015 edition 34	Japanese RT BC CPG 34	JBCS	Japan	2015
4	The Japanese Breast Cancer Society Clinical Practice Guideline for systemic treatment of breast cancer, 2015 edition 35	Japanese systemic BC CPG 35	JBCS	Japan	2015
5	2013 clinical practice guidelines (The Japanese Breast Cancer Society): history, policy and mission 36	Japanese treatment BC CPG 36	JBCS	Japan	2014
6	Singapore Cancer Network (SCAN) Guidelines for Adjuvant Trastuzumab Use in Early Stage HER2 Positive Breast Cancer 37	SCAN early BC 37	SCAN	Singapore	2015
7	Singapore Cancer Network (SCAN) Guidelines for Bisphosphonate Use in the Adjuvant Breast Cancer Setting 38	SCAN adjuvant BC treatment 38	SCAN	Singapore	2015
8	Breast cancer in women: diagnosis, treatment and follow‐up 39	KCE BC CPG 39	KCE	Belgium	2015
9	Early breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow‐up 40	ESMO BC 2019 40	ESMO	Europe	2019
10	International guidelines for management of metastatic breast cancer (MBC) from the European School of Oncology (ESO) 41	ESO MBC 41	ESO	Europe	2013
11	The European Society of Breast Cancer Specialists recommendations for the management of young women with breast cancer 42	EUSOMA 2012 42	EUSOMA	Europe	2012
12	AGO Recommendations for the Diagnosis and Treatment of Patients with Early Breast Cancer: Update 2019 43	AGO early BC 43	AGO	Germany	2019
13	Lesions of Uncertain Malignant Potential (B3) (ADH, LIN, FEA, Papilloma, Radial Scar) 44	AGO uncertain lesions 44	AGO	Germany	2019
14	Ductal Carcinoma in Situ (DCIS) 45	AGO DCIS 45	AGO	Germany	2019
15	Breast Cancer Surgery Oncological Aspects 46	AGO oncological 46	AGO	Germany	2019
16	Oncoplastic and Reconstructive Surgery 47	AGO oncoplastic 47	AGO	Germany	2019
17	Adjuvant Endocrine Therapy in Pre‐ and Postmenopausal Patients 48	AGO adjuvant endocrine 48	AGO	Germany	2019
18	Adjuvant Cytotoxic and Targeted Therapy 49	AGO cytotoxic 49	AGO	Germany	2019
19	Neoadjuvant (Primary) Systemic Therapy 50	AGO neoadjuvant 50	AGO	Germany	2019
20	Adjuvant Radiotherapy 51	AGO RT 51	AGO	Germany	2019
21	Therapy Side Effects 52	AGO side effects 52	AGO	Germany	2019
22	Supportive Care 53	AGO supportive care 53	AGO	Germany	2019
23	Breast Cancer: Specific Situations 54	AGO‐specific situations 54	AGO	Germany	2019
24	Breast Cancer Follow‐Up 55	AGO follow‐up 55	AGO	Germany	2019
25	Loco‐Regional Recurrence 56	AGO recurrence 56	AGO	Germany	2019
26	Endocrine and “Targeted” Therapy in Metastatic Breast Cancer 57	AGO endocrine MBC 57	AGO	Germany	2019
27	Chemotherapy With or Without Targeted Drugs* in Metastatic Breast Cancer 58	AGO CT MBC 58	AGO	Germany	2019
28	Osteooncology and Bone Health 59	AGO osteooncology 59	AGO	Germany	2019
29	Specific Sites of Metastases 60	AGO‐specific MBC 60	AGO	Germany	2019
30	CNS Metastases in Breast Cancer 61	AGO CNS MBC 61	AGO	Germany	2019
31	Complementary Therapy Survivorship 62	AGO survivorship 62	AGO	Germany	2019
32	Diagnosis and Treatment of Patients with Primary and Metastatic Breast Cancer 63	AGO primary MBC 63	AGO	Germany	2018
33	AGO Recommendations for the Diagnosis and Treatment of Patients with Advanced and Metastatic Breast Cancer: Update 2018 64	AGO advanced MBC 64	AGO	Germany	2018
34	DEGRO practical guidelines for radiotherapy of breast cancer VI: therapy of locoregional breast cancer recurrences 65	DEGRO BC recurrences 65			2014
35	DEGRO practical guidelines: radiotherapy of breast cancer I. Radiotherapy following breast conserving therapy for invasive breast cancer. 66	DEGRO RT conserving BC 66	DEGRO	Germany	2013
36	DEGRO practical guidelines for radiotherapy of breast cancer IV. Radiotherapy following mastectomy for invasive breast cancer 67	DEGRO RT mastectomy BC 67	DEGRO	Germany	2014
37	DEGRO practical guidelines: radiotherapy of breast cancer III—radiotherapy of the lymphatic pathways 68	DEGRO RT lymphatic 68	DEGRO	Germany	2014
38	Diagnosis, staging and treatment of patients with breast cancer. National Clinical Guideline No. 7 69	NCCP 69	NCCP	Ireland	2015
39	Breast cancer 70	Richtlijnendatabase BC 70	Richtlijnen	Netherlands	2018
40	Dutch breast reconstruction guideline 71	Dutch BCR 71	DPRS	Netherlands	2017
41	Breast Cancer 72	IKNL BC 72	IKNL	Netherlands	2012
42	Cáncer de mama/ Breast Cancer 73	Fisterra BC 73	Fisterra	Spain	2017
43	SEOM clinical guidelines in early‐stage breast cancer 74	SEOM early stage 74	SEOM	Spain	2018
44	SEOM clinical guidelines in advanced and recurrent breast cancer 75	SEOM advanced BC 75	SEOM	Spain	2018
45	SEOM clinical guidelines in metastatic breast cancer 76	SEOM MBC 76	SEOM	Spain	2015
46	SEOM clinical guidelines in Hereditary Breast and ovarian cancer 77	SEOM hereditary BC 77	SEOM	Spain	2015
47	Abemaciclib with fulvestrant for treating hormone receptor‐positive, HER2‐negative advanced breast cancer after endocrine the therapy 78	NICE abemaciclib 78	NICE	UK	2019
48	Ribociclib with fulvestrant for treating hormone receptor‐positive, HER2‐negative advanced breast cancer 79	NICE ribociclib 79	NICE	UK	2019
49	Early and locally advanced breast cancer: diagnosis and management 80	NICE early and advanced BC 80	NICE	UK	2018
50	Breast cancer 81	NICE BC 81	NICE	UK	2011
51	Familial breast cancer: classification, care and managing breast cancer and related risks in people with a family history of breast cancer 82	NICE familial BC 82	NICE	UK	2013
52	Breast reconstruction using lipomodelling after breast cancer treatment 83	NICE lipomodelling 83	NICE	UK	2012
53	Gene expression profiling and expanded immunohistochemistry tests for guiding adjuvant chemotherapy decisions in early breast cancer management: MammaPrint, Oncotype DDX,X, IHC4 and Mammostrat 84	NICE gene expression 84	NICE	UK	2013
54	Pertuzumab for the neoadjuvant treatment of HER2‐positive breast cancer 85	NICE pertuzumab BC 85	NICE	UK	2016
55	Intraoperative tests (RD‐100i OSNA system and Metasin test) for detecting sentinel lymph node metastases in breast cancer 86	NICE sentinel lymph 86	NICE	UK	2013
56	Breast reconstruction following prophylactic or therapeutic mastectomy for breast cancer 87	AHS reconstruction BC 87	AHS	Canada	2017
57	Adjuvant systemic therapy for early stage (lymph node negative and lymph node positive) breast cancer 88	AHS early BC 88	AHS	Canada	2018
58	Optimal use of taxanes in metastatic breast cancer (MBC) 89	AHS MBC 89	AHS	Canada	2013
59	Adjuvant radiation therapy for invasive breast cancer 90	AHS RT invasive 90	AHS	Canada	2015
60	Adjuvant radiation therapy for ductal carcinoma in situ 91	AHS RT DCI 91	AHS	Canada	2015
61	Neo‐adjuvant (pre‐operative) therapy for breast cancer ‐ general considerations 92	AHS neo‐adjuvant 92	AHS	Canada	2014
62	The Role of Trastuzumab in Adjuvant and Neoadjuvant Therapy in Women with HER2/neu‐overexpressing Breast Cancer 93	CCO trastuzumab Her2 + BC 93	CCO	Canada	2011
63	Surgical management of early‐stage invasive breast cancer 94	CCO surgical management BC 94	CCO	Canada	2015
64	Breast irradiation in women with early stage invasive breast cancer following breast conserving surgery 95	CCO RT 95	CCO	Canada	2016
65	The role of the taxanes in the management of metastatic breast cancer 96	CCO taxane MBC 96	CCO	Canada	2011
66	Vinorelbine in stage IV breast cancer 97	CCO vinorelbine 97	CCO	Canada	2012
67	The role of aromatase inhibitors in the treatment of postmenopausal women with metastatic breast cancer 98	CCO aromatase inhibitor MBC 98	CCO	Canada	2012
68	Epirubicin, as a single agent or in combination, for metastatic breast cancer 99	CCO epirubicin MBC 99	CCO	Canada	2011
69	Adjuvant taxane therapy for women with early‐stage, invasive breast cancer 100	CCO taxane adjuvant therapy BC 100	CCO	Canada	2011
70	Adjuvant systemic therapy for node‐negative breast cancer 101	CCO sQT for node‐negative BC 101	CCO	Canada	2011
71	Adjuvant ovarian ablation in the treatment of premenopausal women with early stage invasive breast cancer 102	CCO ovarian ablation early stage 102	CCO	Canada	2010
72	The role of gemcitabine in the management of metastatic breast cancer 103	CCO gemcitabine 103	CCO	Canada	2011
73	The role of trastuzumab (herceptin) in the treatment of women with Her2/neu‐overexpressing metastatic breast cancer 104	CCO trastuzumab MBC 104	CCO	Canada	2010
74	Capecitabine in stage IV breast cancer 105	CCO capecitabine 105	CCO	Canada	2011
75	The role of her2/neu in systemic and radiation therapy for women with breast cancer 106	CCO her2/neu and RT treatment 106	CCO	Canada	2012
76	Locoregional therapy of locally advanced breast cancer (LABC) 107	CCO LABC 107	CCO	Canada	2014
77	The role of taxanes in neoadjuvant chemotherapy for women with non‐metastatic breast cancer 108	CCO taxane neoadjuvant therapy 108	CCO	Canada	2011
78	Optimal systemic therapy for early female breast cancer 109	CCO early BC 109	CCO	Canada	2014
79	Use of adjuvant bisphosphonates and other bone‐modifying agents in breast cancer 110	CCO bone‐modifying agent BC 110	CCO	Canada	2016
80	The Role of Aromatase Inhibitors in Adjuvant Therapy for Postmenopausal Women with Hormone Receptor‐positive Breast Cancer 111	CCO aromatase inhibitors HR +  111	CCO	Canada	2012
81	Margin width in breast conservation Surgery 112	ABS margin width BC 112	ABS	UK	2015
82	Antibiotic prophylaxis in breast surgery 113	ABS AB prophylaxis 113	ABS	UK	2015
83	Management of The malignant axilla In early breast cancer 114	ABS axila BC 114	ABS	UK	2015
84	Breast operation note Documentation 115	ABS BC 115	ABS	UK	2015
85	Update on optimal duration of adjuvant antihormonal therapy 116	ABS antihormonal therapy 116	ABS	UK	2015
86	Oncoplastic breast reconstruction 117	ABS/BAPRAS oncoplastic 117	ABS, BAPRAS	UK	2012
87	Acellular dermal matrix (ADM) assisted breast reconstruction procedures 118	ABS/BAPRAS ADM 118	ABS, BAPRAS	UK	2012
88	Breast Cancer Clinical Quality Performance Indicators 119	SCT quality indicators 119	SCT	UK	2016
89	Treatment of primary breast cancer 120	SIGN 120	SIGN	UK	2013
90	Lipomodelling Guidelines for Breast Surgery 121	JGBSA lipomodelling 121	JGBSA	UK	2012
91	Performance and Practice Guidelines for the Use of Neoadjuvant Systemic Therapy in the Management of Breast Cancer 122	ASBS NaQT BC 122	ASBS	USA	2017
92	Performance and Practice Guidelines for Mastectomy 123	ASBS mastectomy 123	ASBS	USA	2014
93	Performance and Practice Guidelines for Breast‐Conserving Surgery/Partial Mastectomy 124	ASBS breast conserving 124	ASBS	USA	2014
94	Performance and Practice Guidelines for Axillary Lymph Node Dissection in Breast Cancer Patients 125	ASBS ALD 125	ASBS	USA	2014
95	Performance and Practice Guidelines for Sentinel Lymph Node Biopsy in Breast Cancer Patients 126	ASBS SLND 126	ASBS	USA	2014
96	Evidence‐Based Clinical Practice Guideline: Autologous Breast Reconstruction with DIEP or Pedicled TRAM Abdominal Flaps 127	ASPS DIEP and TRAM 127	ASPS	USA	2017
97	Use of Endocrine Therapy for Breast Cancer Risk Reduction: ASCO Clinical Practice Guideline Update 128	ASCO endocrine therapy risk BC 128	ASCO	USA	2019
98	Postmastectomy Radiotherapy: An American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology Focused Guideline Update 129	ASCO postmastectomy RT 129	ASCO	USA	2017
99	Breast Cancer Surveillance Guidelines 130	ASCO surveillance 130	ASCO	USA	2013
100	Selection of Optimal Adjuvant Chemotherapy and Targeted Therapy for Early Breast Cancer: ASCO Clinical Practice Guideline Focused Update 131	ASCO treatment for early BC 131	ASCO	USA	2018
101	Systemic Therapy for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: ASCO Clinical Practice Guideline Update 132	ASCO systemic therapy EGR2 BC 132	ASCO	USA	2018
102	Recommendations on Disease Management for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases: ASCO Clinical Practice Guideline Update 133	ASCO EGRF2 MBC 133	ASCO	USA	2018
103	Integrative Therapies During and After Breast Cancer Treatment: ASCO Endorsement of the SIO Clinical Practice Guideline 134	ASCO BC treatment 134	ASCO	USA	2018
104	Chemotherapy and Targeted Therapy for Women With Human Epidermal Growth Factor Receptor 2–Negative (or unknown) Advanced Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline 135	ASCO EGFR2 advanced BC 135	ASCO	USA	2014
105	Role of Bone‐Modifying Agents in Metastatic Breast Cancer: An American Society of Clinical Oncology–Cancer Care Ontario Focused Guideline Update 136	ASCO bone‐modifying agent MBC 136	ASCO	USA	2017
106	Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Update 137	ASCO EGFR2 recommendations 137	ASCO	USA	2013
107	Breast Cancer Follow‐Up and Management After Primary Treatment: American Society of Clinical Oncology Clinical Practice Guideline Update 138	ASCO follow‐up/management BC 138	ASCO	USA	2013
108	Adjuvant Endocrine Therapy for Women With Hormone Receptor–Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update on Ovarian Suppression 139	ASCO ovarian suppression BC 139	ASCO	USA	2016
109	Role of Patient and Disease Factors in Adjuvant Systemic Therapy Decision Making for Early‐Stage, Operable Breast Cancer: American Society of Clinical Oncology Endorsement of Cancer Care Ontario Guideline Recommendations 140	ASCO factors in early BC 140	ASCO	USA	2016
110	Use of Adjuvant Bisphosphonates and Other Bone‐Modifying Agents in Breast Cancer: A Cancer Care Ontario and American Society of Clinical Oncology Clinical Practice Guideline 141	ASCO use bone‐modifying agents BC 141	ASCO	USA	2017
111	Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early‐Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Focused Update 142	ASCO biomarkers in early BC 142	ASCO	USA	2017
112	Use of Biomarkers to Guide Decisions on Systemic Therapy for Women With Metastatic Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline 143	ASCO biomarkers in MBC 143	ASCO	USA	2019
113	American Society of Clinical Oncology Endorsement of the Cancer Care Ontario Practice Guideline on Adjuvant Ovarian Ablation in the Treatment of Premenopausal Women With Early‐Stage Invasive Breast Cancer 144	ASCO ovarian ablation BC 144	ASCO	USA	2011
114	American Society of Clinical Oncology/College of American Pathologists Guideline Recommendations for Immunohistochemical Testing of Estrogen and Progesterone Receptors in Breast Cancer 145	ASCO hormonal BC 145	ASCO	USA	2010
115	Use of Pharmacologic Interventions for Breast Cancer Risk Reduction: American Society of Clinical Oncology Clinical Practice Guideline 146	ASCO risk reduction BC 146	ASCO	USA	2013
116	Endocrine Therapy for Hormone Receptor–Positive Metastatic Breast Cancer: American Society of Clinical Oncology Guideline 147	ASCO endocrine BC 147	ASCO	USA	2016
117	Invasive Breast Cancer. Basic resources. Version 1.2019 148	NCCN invasive BC basic 148	NCCN	USA	2019
118	Invasive Breast Cancer. Core resources. Version 1.2019 149	NCCN invasive BC core 149	NCCN	USA	2019
119	Invasive Breast Cancer. Enhanced resources. Version 1.2019 150	NCCN invasive BC enhanced 150	NCCN	USA	2019
120	Breast Cancer. NCCN Evidence Blocks. Version 1.2019 151	NCCN evidence block BC 151	NCCN	USA	2019
121	Breast Cancer. Version 3.2019 152	NCCN BC 152	NCCN	USA	2019
122	Management of Breast Cancer (2nd Edition) 153	MHM BC 153	MHM	Malaysia	2010
123	Influencing best practice in breast cancer 154	Australia BC 154	AG	Australia	2016
124	Recommendations for staging and managing the axilla 155	CA axilla 155	CA	Australia	2011
125	Recommendations for use of hypofractionated radiotherapy for early operable breast cancer 156	CA RT 156	CA	Australia	2011
126	Recommendations for use of Bisphosphonates 157	CA bisphosphonates 157	CA	Australia	2011
127	Recommendations for the management of early breast cancer in women with an identified BRCA1 or BRCA2 gene mutation or at high risk of a gene mutation 158	CA management BC 158	CA	Australia	2014
128	Guía de Práctica Clínica AUGE Cáncer de Mama 159	GPC Chile 159	MSC	Chile	2015
129	Guía de práctica clínica (GPC) para la detección temprana, tratamiento integral, seguimiento y rehabilitación del cáncer de mama 160	GPC Colombia 160	INC	Colombia	2017
130	Guía de Práctica Clínica del Tratamiento para el Cáncer de Mama 161	GPC Costa Rica 161	IHCAI	Costa Rica	2011
131	Guía de Práctica Clínica para el Tratamiento del Cáncer de Mama 162	GPC Perú 162	DDSS	Perú	2017
132	Guía para el Cáncer de Mama en Venezuela 163	GPC Venezuela 163	SAV	Venezuela	2015
133	Management of Early Breast Cancer 164	New Zealand BC 164	MHNZ	New Zealand	2014
134	The Screening, Diagnosis, Treatment, and Follow‐Up of Breast Cancer 165	Würzburg BC 165	UHW	Germany	2018
135	Breast cancer brain metastases: a review of the literature and a current multidisciplinary management guideline 166	FESEO brain MBC 166	FESEO	Spain	2013
136	Cirugía de la Mama 167	AEC BC 167	AEC	Spain	2017
137	NCA Breast Cancer Clinical Guidelines 168	NCA BC 168	NCA	UK	2019
138	Breast Cancer: Management and Follow‐Up 169	BCMA management and follow‐up 169	BCMA	Canada	2013
139	Clinical Guidelines for the Management of Breast Cancer 170	WMCA BC 170	WMCA	UK	2016
	Name of the CS
140	Consenso costarricense sobre prevención, diagnóstico y tratamiento del cáncer mamario 171	CS Costa Rica 171	CMCCR	Costa Rica	2016
141	Consenso Mexicano sobre diagnóstico y tratamiento del cáncer mamario 172	GPC México 172	SSM	México	2019
142	National consensus in China on diagnosis and treatment of patients with advanced breast cancer 173	Chinese BC CS 173	CECM	China	2015
143	Practical consensus recommendations for hormone receptor‐positive Her2‐negative advanced or metastatic breast cancer 174	Indian ICON CS 174	ICON	India	2013
144	Indian Solutions for Indian Problems—Association of Breast Surgeons of India (ABSI) Practical Consensus Statement, Recommendations, and Guidelines for the Treatment of Breast Cancer in India 175	Indian ABSI CS 175	ABSI	India	2017
145	Consensus document for management of breast cancer 176	Indian ICMR CS 176	ICMR	India	2016
146	4th ESO–ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 4) 177	ABC4 177	ESMO	Europe	2018
147	St. Gallen/Vienna 2019: A Brief Summary of the Consensus Discussion about Escalation and De‐Escalation of Primary Breast Cancer Treatment 178	St. Gallen 2019 178	St. Gallen	Europe	2019
148	ESTRO consensus guideline on target volume delineation for elective radiation therapy of early stage breast cancer 179	ESTRO RT BC 179	ESTRO	Europe	2014
149	Second international consensus guidelines for breast cancer in young women (BCY2) 180	BCY2 180	ESO	Europe	2016
150	Guidelines for diagnostics and treatment of aromatase inhibitor‐induced bone loss in women with breast cancer A consensus of Lithuanian medical oncologists, radiation oncologists, endocrinologists, and family medicine physicians 181	LOEGP 181	LOEGP	Lithuania	2014
151	Biomarkers in breast cancer: A consensus statement by the Spanish Society of Medical Oncology and the Spanish Society of Pathology 182	SEOM and SEAP 182	SEOM	Spain	2017
152	Provincial consensus recommendations for adjuvant systemic therapy for breast cancer 183	CCM 2017 183	CCM	Canada	2017
153	Postoperative radiotherapy for breast cancer: UK consensus statements 184	RCR postoperative RT 184	RCR	UK	2016
154	Consensus Guideline on Accelerated Partial Breast Irradiation 185	ASBS RT 185	ASBS	USA	2018
155	Consensus Guideline on the Use of Transcutaneous and Percutaneous Ablation for the Treatment of Benign and Malignant Tumors of the Breast 186	ASBS ablation 186	ASBS	USA	2018
156	Consensus Guideline on the Management of the Axilla in Patients With Invasive/In‐Situ Breast Cancer 187	ASBS axilla 187	ASBS	USA	2019
157	Consensus Guideline on Breast Cancer Lumpectomy Margins 188	ASBS margins 188	ASBS	USA	2017
158	Consensus Guideline on Concordance Assessment of Image‐Guided Breast Biopsies and Management of Borderline or High‐Risk Lesions 189	ASBS borderline lesions 188	ASBS	USA	2016
159	Contralateral Prophylactic Mastectomy (CPM) Consensus Statement from the American Society of Breast Surgeons: Data on CPM Outcomes and Risks 190	ASBS CPM 190	ASBS	USA	2016
160	Consensus Guideline on Venous Thromboembolism (VTE) Prophylaxis for Patients Undergoing Breast Operations 191	ASBS VTE prophylaxis BC 191	ASBS	USA	2011
161	The American Brachytherapy Society consensus statement on intraoperative radiation therapy 192	AB intraoperative RT 192	AB	USA	2017
162	The American Brachytherapy Society consensus report for accelerated partial breast irradiation using interstitial multicatheter brachytherapy 193	AB partial RT BC 193	AB	USA	2017
163	Society of Surgical Oncology Breast Disease Working Group Statement on Prophylactic (Risk‐Reducing) Mastectomy 194	SSO prophylactic mastectomy 194	SSO	USA	2016
164	SSO‐ASTRO Consensus Guideline on Margins for Breast‐Conserving Surgery with Whole‐Breast Irradiation in Ductal Carcinoma In Situ 195	SSO margins 195	SSO	USA	2016
165	SSO‐ASTRO Consensus Guideline on Margins for Breast‐Conserving Surgery with Whole Breast Irradiation in Stage I and II Invasive Breast Cancer 196	SSO–ASTRO invasive BC 196	SSO ‐ ASTRO	USA	2014
166	Margins for Breast‐Conserving Surgery With Whole‐Breast Irradiation in Stage I and II Invasive Breast Cancer: American Society of Clinical Oncology Endorsement of the Society of Surgical Oncology/American Society for Radiation Oncology Consensus Guideline 197	ASCO margin BC CSs 197	ASCO	USA	2014
167	International expert panel on inflammatory breast cancer: consensus statement for standardized diagnosis and treatment 198	International expert panel BC 198	IEP	International	2010

Table 2

Characteristics of the CPGs and CSs regarding SDM

Characteristics	CPGs or CSs without SDM (n = 101)	CPGs or CSs with SDM (n = 66)	P value
Published after 2015	42 (42.0 %)	46 (69.7 %)	.0003
CPG	83 (82.1 %)	54 (81.8 %)	.95
European guidelines	45 (44.5 %)	25 (37.0 %)	.21
North American guidelines	43 (42.5 %)	28 (42.4 %)	.98
South American guidelines	2 (1.9 %)	5 (7.5 %)	.1
Asia guidelines	9 (8.9 %)	3 (4.5 %)	.15
Oceania guidelines	3 (2.9 %)	3 (4.5 %)	.3
Published in a journal	44 (43.5 %)	17 (25.7 %)	.009

Table 3

Update frequency of each CPGs/CSs where SDM appears

		Entity	First year of publication	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019
	CPGs
3	Japanese RT BC CPG 34	JBCS	2015						*
9	ESMO BC 2019 40	ESMO	2010	*					*				*
11	EUSOMA 2012 42	EUSOMA	2012			*
12	AGO early BC 43	AGO	2012			*	*	*	*				*
14	AGO DCIS 45	AGO	2002	*		*	*	*	*	*	*	*	*
16	AGO oncoplastic 47	AGO	2012				*	*	*	*	*	*	*
17	AGO adjuvant endocrine 48	AGO	2012			*	*	*	*	*	*	*	*
27	AGO CT MBC 58	AGO	2012			*	*	*	*	*	*	*	*
41	IKNL BC 72	IKNL	2008			*
42	Fisterra BC 73	Fisterra	2011		*						*		*
47	NICE abemaciclib 78	NICE	2019										*
48	NICE ribociclib 79	NICE	2019										*
49	NICE early and advanced BC 80	NICE	2018									*
50	NICE BC 81	NICE	2011		*
51	NICE familial BC 82	NICE	2013				*
52	NICE lipomodelling 83	NICE	2012			*
53	NICE gene expression 84	NICE	2013				*
54	NICE pertuzumab BC 85	NICE	2016							*
56	AHS reconstruction BC 87	AHS	2013				*				*
57	AHS early BC 88	AHS	2014					*	*	*		*
63	CCO surgical management BC 94	CCO	1996		*				*
70	CCO sQT for node‐negative BC 101	CCO	1998	*
71	CCO ovarian ablation early stage 102	CCO	2010	*
73	CCO trastuzumab MBC 104	CCO	1999		*
76	CCO LABC 107	CCO	2014					*
79	CCO bone‐modifying agents BC 110	CCO	2016							*
86	ABS/BAPRAS oncoplastic 117	ABS, BAPRAS	2012			*
88	SCT quality indicators 119	SCT	2016							*
98	ASCO postmastectomy RT 129	ASCO	2001					*			*
100	ASCO treatment for early BC 131	ASCO	2016							*		*
104	ASCO EGFR2 advanced BC 135	ASCO	2014					*
105	ASCO bone‐modifying agent MBC 136	ASCO	2000		*						*
108	ASCO ovarian suppression BC 139	ASCO	2016							*
109	ASCO factors in early BC 140	ASCO	2019
110	ASCO use bone‐modifying agent BC 141	ASCO	2017								*
116	ASCO endocrine BC 147	ASCO	2016							*
117	NCCN invasive BC basic 148	NCCN	2015							*		*	*
118	NCCN invasive BC core 149	NCCN	2015							*		*	*
119	NCCN invasive BC enhanced 150	NCCN	2015							*		*	*
120	NCCN evidence block BC 151	NCCN	2015						*	*		*	*
121	NCCN BC 152	NCCN	2015							*		*	*
122	MHM BC 153	MHM	2002	*
123	Australia BC 154	AG	2016							*
124	CA axilla 155	CA	2011		*
129	GPC Colombia 160	INC	2013				*				*
130	IHCAI GPC Costa Rica 161	IHCAI	2011		*
131	GPC Perú 162	IETSI	2017								*
132	GPC Venezuela 163	SAV	2015						*
133	New Zealand BC 164	MHNZ	2009					*
134	Würzburg BC 165	UHW	2018									*
136	AEC BC 167	AEC	2007								*
137	NCA BC 168	NCA	2019										*
138	BCMA management and follow‐up 169	BCMA	2013				*
139	WMCA BC 170	WMCA BC	2016
	CSs
140	CS Costa Rica 171	CMCCR	2016
141	GPC México 172	SSM	1994		*		*		*		*		*
145	Indian ICMR CS 176	ICMR	2016							*
146	ABC4 177	ESMO	2012			*		*		*		*
147	St. Gallen 2019 178	St. Gallen	2015						*		*		*
152	CCM 2017 183	CCM	2017								*
154	ASBS RT 185	ASBS	2018									*
156	ASBS axilla 187	ASBS	2019										*
158	ASBS borderline lesions 189	ASBS	2016							*
159	ASBS CPM 190	ASBS	2016							*
163	SSO prophylactic mastectomy 194	SSO	2007							*
164	SSO margins 195	SSO	2014					*

DEGRO BC recurrences

CCO trastuzumab Her2 + BC

CCO aromatase inhibitors HR +

SDM in CPGs and CSs concerning BC

The analysis of the compliance of the items valued is presented in Figure 2 and Appendix 4. SDM appeared in any section of 66 CPGs and CSs (12/28 (43%) CSs vs 54/139 (39%) CPGs, P = .69). SDM appeared in glossary or indexes in only two documents, and only in one, its basis was explained. In general, CSs had higher overall quality than CPGs (CSs' mean 2.833 vs CPGs' mean 1.12 items, P < .001) (Appendix ).

Figure 2

The analysis of the compliance of the data extraction items

Overall, 39 (23%) stated the value of SDM as an option in the decision‐making process, 14 (8%) provided clear and precise SDM recommendations, 4 (3%) considered benefits versus harms of using SDM, and 4 (2%) identified evidence supporting the use of SDM. Only 9 (5%) of these CPGs and CSs gave advice for the SDM application in practice. The strength of recommendations on SDM was indicated in three (2%). Support for the implementation of SDM was well‐detailed in two documents (1%). The information gathered about SDM affected recommendations and was detailed in one (<1%). Limitations of the CPG or CS about SDM recommendations were described in just one of them (<1%).

Only 4 (2%) of these guides emphasized their interest in SDM appearing in the executive summary. Only in three (2%) of the CPGs and CSs, the table of content talked about SDM. Primary affected population with BC was well‐defined in 22 (13%) articles, and patients’ subgroups with special consideration were discussed in 7 (4%) documents. Appropriateness and relevance of outcomes were considered in only 2 (1%) CPGs. Only one document detailed the consistency of results across studies. Recommendations about SDM for subgroups were separated in only two articles (1%). Facilitators and barriers to SDM application were described in only two articles too (1%).

Ten items (32%) measured in the data extraction instrument were not included in any CPGs and CSs (n = 10/31). The PICO question related to SDM was not specified, search strategy was not reported, the study design and limitations were not pondered, barriers were not described, the cost of SDM implementation was not specified, adherence to recommendations and the impact were not assessed, description of the cost information and suggestions for further research were not provided and finally, professional, financial or intellectual interest about SDM was not described (Figure 2 and Appendix ). Finally, there were 101 (61%) CPGs or CSs did not talk about SDM.

All three reviewers categorized that the 'Alberta Health Services' , 'Australian Government' , 'Ministry of Health from New Zealand' and Costa Rica 'IHCAI' CPGs and 'CMCCR' CS had the highest overall quality in analysing the decision‐making process in BC treatment (Appendix ). In the United States of America, we highlighted two of the 'American Society of Clinical Oncology (ASCO)' , , , , , , , , guidelines and the last version of NCCN , but with a lower mark if you compare with the ones we named before. In Europe, we found the 'European Society for Medical Oncology (ESMO)' , the 'Asociación Española de Cirujanos (AEC)' and the 'ABS‐BAPRAS' CPGs with a score of 6 as the best paradigm of a guide that talks about SDM.

DISCUSSION

Main findings

We developed a standardized quality assessment tool for assessing the coverage of SDM in recommendation documents. Our review and analysis showed that SDM description, clarification and recommendations CPGs and CSs concerning BC treatment were poor, leaving a large scope for improvement in this area. SDM more frequently reported in CPGs and CSs in recent years but surprising SDM was less often covered in medical journals (Figure 3).

Figure 3

Comparison between the year of publication of the guide according to whether or not SDM appearance

Strengths and weaknesses

The validity of findings depends on the strength and limitations of methods, which should be understood first before assessing their implications . A key strength of this study was a global perspective with a big number of CPGs and CSs included, without language restrictions or data sources limitations. We developed and deployed a prospective protocol with a specific SDM quality assessment tool incorporating the AGREE II instrument , RIGHT statement and other related papers , , , , . Unfortunately, as there were no other similar studies, we could not compare our results with other findings. There have been evaluations of risk of bias in other papers, but our focus was on examining the reporting of guidance about SDM. One perceived limitation of this study could be related to the subjective nature of the data extraction; however, as we used duplicate data extraction with arbitration, we minimized this methodological issue. Quality assessment tool performance may be a further issue, and we addressed this by following a standard methodology for tool development. Not all quality items can have the same relevance and weight, and future research should focus on scoring them creating a threshold for rating quality. Because the items mainly came from two wide‐used indexes , , demonstrably our tool should be considered to have face validity. Therefore, we are confident that our finding of poverty of SDM information in practice recommendations is trustworthy and merits further consideration.

Inter‐examiner reliability should be calculated in systematic reviews as the data extracted should be the same by different reviewers . Intra‐examiner reliability is a pre‐condition for inter‐observer reliability, and so was not calculated or reported . In our paper, the inter‐examiner reliability score was found to be excellent (ICC = 0.97).

Implications

To our knowledge, information and recommendations about SDM in BC CPGs and CSs have not been systematically analysed previously. Neither did we find a tool to evaluate SDM reporting quality. This is surprising because SDM is a legal obligation , , and a key component for high‐quality patient‐centred cancer care , , , , .

Breast cancer is the paradigm of the situation where a two‐way exchange not only of information but also of treatment preferences is needed to find the best option for a particular patient, as different strategies may show a priori similar advantages and disadvantages but possible outcomes are deeply related to the patient’s values and personal situation , .

Formal recommendations should promote SDM application in clinical routine practice, but this has proved difficult and slow , , , , , . It would require changing attitudes, acquiring new skills, developing specific tools and ensuring an environment where communication and sharing perspectives are valued , , , , . Effective implementation strategies could be underpinned by SDM detailed in CPGs and CSs as these documents should be expected to provide this specific content , , . Our work has identified a gap that offers an important contribution in directing further research and debate, including assessment of risk of bias in guidelines. It highlights the need for more objective‐specific tools for SDM assessment, evaluation of their psychometric properties and promotion in CPGs and CSs for diverse malignancies. Future studies should be required in that direction.

CONCLUSIONS

This systematic review found that BC treatment CPGs and CSs insufficiently addressed SDM. Implementation of this practice is important for high‐quality patient‐centred cancer care, but lack of knowledge is a known barrier. SDM descriptions and recommendations in CPGs and CSs concerning BC treatment need improvement. SDM was more frequently reported in CPGs and CSs in recent years, but surprisingly it was less often covered in medical journals, a feature that needs attention. In the future, SDM should be suitably explained and encouraged and specific tools should be applied to assess its dealing and promotion in specific cancer treatment CPGs and CSs. Medical journals should play a strong role in promoting SDM in CPGs and CSs they publish in the future.

CONFLICTS OF INTEREST

The study was conducted in Granada, Spain. There are no conflicts of interest.

AUTHOR CONTRIBUTIONS

Each author certifies that he/she has made a direct and substantial contribution to the conception and design of the study, development of the search strategy, the establishment of the inclusion and exclusion criteria, data extraction, analysis and interpretation. MMC was involved in the design of the study, literature search, data collection and analysis, quality appraisal and writing. IMMN was involved in the literature search and data collection. MMD was involved in the design of this study, analysis of data and writing. LM was involved in writing. KSK was involved in the design of this study, conducted the quality appraisal, in the writing, and provided critical revision of the paper. ABC was involved in the design of this study and provided critical revision of the paper. All authors read and provided the final approval of the version to be published.

Appendix S1

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Appendix S2

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Appendix S3

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Appendix S4

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Appendix S5

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