Hossain Mohammad Sohrab, Harvey Lisa A, Liu Hueiming, Islam Md Shofiqul, Rahman Md Akhlasur, Muldoon Stephen, Biering-Sorensen Fin, Cameron Ian D, Chhabra Harvinder S, Lindley Richard I, Jan Stephen
John Walsh Centre for Rehabilitation Research, Kolling Institute, Sydney Medical School/Northern, University of Sydney, Sydney, New South Wales, Australia.
George Institute for Global Health, Sydney, New South Wales, Australia.
BMJ Open. 2018 Jul 16;8(7):e024226. doi: 10.1136/bmjopen-2018-024226.
People with spinal cord injuries in low-income and middle-income countries are highly vulnerable to life-threatening complications in the period immediately after discharge from hospital. We are conducting a randomised controlled trial in Bangladesh to determine whether all-cause mortality at 2 years can be reduced if health professionals regularly ring and visit participants in their homes following discharge. We will conduct a process evaluation alongside the trial to explain the trial results and determine the feasibility of scaling this intervention up in low-income and middle-income countries if it is found to be effective.
Our process evaluation is based on the Realist and Reach, Effectiveness, Adoption, Implementation and Maintenance frameworks. We will use a mixed methods approach that uses both qualitative and quantitative data. For example, we will audit a sample of telephone interactions between intervention participants and the healthcare professionals, and we will conduct semistructured interviews with people reflective of various interest groups. Quantitative data will also be collected to determine the number and length of interactions between the healthcare professionals and participants, the types of issues identified during each interaction and the nature of the support and advice provided by the healthcare professionals. All quantitative and qualitative data will be analysed iteratively before the final analysis of the trial results. These data will then be triangulated with the final results of the primary outcome.
Ethics approval was obtained from the institutional ethics committee at the site in Bangladesh and from the University of Sydney, Australia. The study will be conducted in compliance with all stipulations of its protocol, the conditions of ethics committee approval and the relevant regulatory bodies. The results of the trial will be disseminated through publications in peer-reviewed scientific journals and presentations at scientific conferences.
ACTRN12615000630516.
在低收入和中等收入国家，脊髓损伤患者在出院后的短期内极易出现危及生命的并发症。我们正在孟加拉国进行一项随机对照试验，以确定出院后卫生专业人员定期给参与者打电话并上门家访是否能降低两年内的全因死亡率。我们将在试验过程中进行一项过程评估，以解释试验结果，并确定如果该干预措施被证明有效，在低收入和中等收入国家扩大规模的可行性。
我们的过程评估基于现实主义与可及性、有效性、采用、实施和维持框架。我们将采用混合方法，使用定性和定量数据。例如，我们将审计干预参与者与医疗保健专业人员之间电话互动的样本，并对代表不同利益群体的人员进行半结构化访谈。还将收集定量数据，以确定医疗保健专业人员与参与者之间互动的次数和时长、每次互动中发现的问题类型以及医疗保健专业人员提供的支持和建议的性质。在对试验结果进行最终分析之前，将对所有定量和定性数据进行迭代分析。然后，这些数据将与主要结果的最终结果进行三角验证。
已获得孟加拉国当地机构伦理委员会和澳大利亚悉尼大学的伦理批准。该研究将按照其方案的所有规定、伦理委员会批准的条件以及相关监管机构的要求进行。试验结果将通过在同行评审科学期刊上发表以及在科学会议上展示的方式进行传播。
ACTRN12615000630516。
