Research Unit for General Medicine and Primary Health Care, Faculty of Medicine, School of Health Sciences, University of Ioannina, Ioannina, Greece.
Clinic of Social and Family Medicine, School of Medicine, University of Crete, Crete, Greece.
Fam Pract. 2023 Feb 9;40(1):128-137. doi: 10.1093/fampra/cmac067.
To quantify the different types of health outcomes assessed as primary outcomes in randomized controlled trials (RCTs) in the primary care (PC) setting during the last 20 years and identify whether potential gaps exist in specific types of health care and types of intervention.
We systematically searched PubMed, Scopus, and Cochrane Central Register of Controlled Trials, from January 2000 to September 2020 for published RCTs in PC. We recorded characteristics of eligible studies and mapped evidence by health outcome category (patient health outcomes, health services outcomes); and for each outcome category, by types of health care (preventive, acute, chronic, palliative), and by types of intervention (drug, behavioural, on structure, and on process). For RCTs assessing patient health outcomes as primary outcomes, we further mapped using the quality-of-care dimensions, that is, effectiveness, safety, and patient-centredness.
Of the 518 eligible RCTs in PC, 357 (68.9%) evaluated a patient health outcome as the primary outcome, and 161 (31.1%) evaluated only health services outcomes as primary outcomes. Many focused on population with chronic illness (224 trials; 43.2%) and evaluated interventions on processes of health care (239 trials; 46.1%). Research gaps identified include preventive and palliative care, behavioural interventions, and safety and patient-centredness outcomes as primary outcomes.
Our evidence map showed research gaps in certain types of health care and interventions. It also showed research gaps in assessing safety and measures to place patient at the centre of health care delivery as primary outcomes.
量化过去 20 年来在基层医疗（PC）环境中作为主要结局评估的随机对照试验（RCT）的不同类型的健康结局，并确定在特定类型的医疗保健和干预措施中是否存在潜在差距。
我们系统地检索了 PubMed、Scopus 和 Cochrane 对照试验中心注册库，从 2000 年 1 月到 2020 年 9 月，以获取在 PC 中发表的 RCT 。我们记录了合格研究的特征，并按健康结局类别（患者健康结局、卫生服务结局）和每种结局类别（预防、急性、慢性、姑息）进行映射，按干预措施类型（药物、行为、结构、过程）进行映射。对于评估患者健康结局为主要结局的 RCT，我们进一步使用护理质量维度进行映射，即有效性、安全性和以患者为中心。
在 518 项符合条件的 PC RCT 中，357 项（68.9%）评估了患者健康结局作为主要结局，161 项（31.1%）仅评估了卫生服务结局作为主要结局。许多研究都集中在患有慢性病的人群上（224 项试验；43.2%），并评估了卫生保健过程中的干预措施（239 项试验；46.1%）。确定的研究空白包括预防和姑息治疗、行为干预以及安全性和以患者为中心的结局作为主要结局。
我们的证据图谱显示了某些类型的医疗保健和干预措施存在研究空白。它还显示了在评估安全性和将患者置于医疗保健提供中心的措施作为主要结局方面存在研究空白。
